Signs and symptoms of vaccine reactions

If you or your child experiences any of the symptoms listed below in the hours, days or weeks following vaccination, it should be reported to VAERS***. Some vaccine reaction symptoms include: 

• Pronounced swelling, redness, heat or hardness at the site of the injection;
• Body rash or hives;
• Shock/collapse;
• High pitched screaming or persistent crying for hours;
• Extreme sleepiness or long periods of unresponsiveness;
• High fever (over 103 F)
• Twitching or jerking of the body, arm, leg or head;
• Crossing of eyes;
• Weakness or paralysis of any part of the body;
• Loss of eye contact or awareness or social withdrawal;
• Loss of ability to roll over, sit up or stand up;
• Vision or hearing loss;
• Restlessness, hyperactivity or inability to concentrate;
• Sleep disturbances that change wake/sleep pattern;
• Head banging or onset of repetitive movements (flapping, rubbing, rocking, spinning);
• Joint pain;
• Muscle weakness;
• Disabling fatigue;
• Loss of memory;
• Onset of chronic ear or respiratory infections;
• Violent or persistent diarrhea or chronic constipation;
• Breathing problems (asthma);
• Excessive bleeding (thrombocytopenia) or anemia.

Source: http://www.nvic.org/Ask-Eight-Questions.aspx


Source: http://www.nvic.org/downloads/49-doses-posterb.aspx
Notes:
***VAERS is a short form for Vaccine Adverse Events Reporting System which is established in USA. In Malaysia, currently all matters regarding medicines and vaccines are controlled by Biro Pengawalan Farmaseutikal Kebangsaan (BPFK).

We do not have a system like VAERS (yet), but parents can submit an Adverse Effects Following Immunisation (AEFI) report to BPFK, by downloading this form down here,print it out and send it to BPFK if you suspect your child is having AEFI. AEFI may range from mild temporary effects to severe lifelong effects.

Online form
https://www.bpfk.gov.my/quest2/madrac%20-%20reporting%20online.htm

Download form
http://portal.bpfk.gov.my/aeimages/File/Borang_AEFI_ringan_pindaan_3_2_210213.pdf

Adverse Reactions to HPV Vaccine in Malaysia in 2011

According to Malaysian Adverse Drug Reactions (MADRAC) Newletter, a total of 3183 AEFI reports were received in year 2011, the highest record since  year 2000. This figure is a 32.6% increase from year 2010 and projected to INCREASE. Out of this total, 3,031 reports (95%) were Human Papillomavirus (HPV) vaccine and 152 reports (5%) involved other than HPV vaccine.Wow, that's a lot of cases and most likely there are a lot more cases that aren't reported since people are unaware of vaccine reactions and how to report it.

Where did this sudden spike of reports come from? The HPV vaccine that was launched in year 2010 for Malaysian girls around 13 years old (Form 1). "In year 2011, 3,026 reports were received for Cervarix and 5 (five) for Gardasil. The large number of reports received for Cervarix commensurate with its use as the sole HPV vaccine supplied under the National HPV Vaccination Program."

Sadly, nothing will be done to halt the increase in cases since the report assures us the vaccine adverse effects are relatively mild, the benefits outweighs the risks and the vaccine has no quality issues. Looks like the National HPV Vaccination Program needs to take a cue from Japan, at least Japan suspended its recommendation for the HPV vaccine!

Garis Panduan Farmakovigilans - Keselamatan Vaksin di Malaysia A guide on how to report adverse vaccine effects. The following vaccine information should be collected whenever a vaccine is administered: i) Product registration number ii) Batch number iii) Dose number iv) Date administered

Download from http://www.moh.gov.my/images/gallery/Garispanduan/Garispanduan_Farmakovigilans.pdf

Reference:

1. MADRAC ADR 2012 - April http://portal.bpfk.gov.my/view_file.cfm?fileid=1268