Sex: F
Vaccine: PNC13
Symptoms: Cardiac murmur, Dysphonia, Extra dose administered, Fatigue, Headache
Clinical narrative: horrible fatigue and pain; horrible fatigue and pain/very achy; fever; a horrible headache; rash; She gets really hoarse; has developed a heart murmur; She got two shots of Prevnar 13 and they were 6 months apart; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An adult female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Marisol, reaction: "had bad reactions", notes: Caller mentioned that they used to put Marisol and their products and had bad reactions for that.; Thermerisol, reaction: "she is allergic thermerisol". Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), for Immunization, reaction: "Redness near injection site". The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "horrible fatigue and pain"; PAIN (non-serious), outcome "recovered", described as "horrible fatigue and pain/very achy"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "a horrible headache"; RASH (non-serious), outcome "recovered"; DYSPHONIA (non-serious), outcome "recovered", described as "She gets really hoarse"; CARDIAC MURMUR (non-serious), outcome "recovered", described as "has developed a heart murmur"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "She got two shots of Prevnar 13 and they were 6 months apart".  Additional information: Caller would like to speak with someone to tell her about Prevnar 13 preservatives ingredients that's in the second shot. Caller is trying to rule out. There is something in vaccinations to get that caused her and had terrible reactions. Caller mentioned that they used to put Marisol and their products and had bad reactions for that. But she thinks that they took it all out and so she is trying to need to get a shingles vaccine. Caller added that she had her pneumococcus shot and got Prevnar and two Promenade came in two shots. The first shot did not bother her, but the second shot did. So, she is trying to speak with a nurse so she can start comparing what is causing the problem. The patient had Prevnar 13, 4 years ago, and she received two doses (6 months apart). She called right after the second shot because she had reactions from it. She called a couple of times, but then she forgot about it because everything went away. Now she was looking forward to getting a shingles vaccine. There must be something in the medication, may be a preservative she was allergic to like thimerosal. The first shot didn't bother me, she just had redness near the injection site. After the second shot, she had horrible fatigue and pain, fever, a horrible headache, and also a rash. She was very achy. Also stated her husband got it also and had similar symptoms. Her husband also got this vaccine (2 doses), but he stayed that way. The symptoms didn't go away. Neither of them can take a Z pack, even though we previously had no problems with it. Her daughter went once to the pharmacy in order to get a vaccine for her child, and they got her a vaccine without preservatives. The patient was asking could it be that Prevnar 13 has a preservative. She is 72 years old now and she was supposed to get Prevnar 13 at 65 years old and so she states it may have been more than 4 years ago when she got Prevnar 13. She gets really hoarse and the reason she called was to see what preservatives was in Prevnar 13 since she was thinking it may have been a preservative. She is up for the shingles vaccine and wanted to compare and she knows she is allergic thimerosal, this was captured as provided. States thimerosal used to be put in eye products like contact solution. She got two shots of Prevnar 13, and they were 6 months apart and so did her husband. The USMI agent told her she was only supposed to get one shot so she wants to make sure she got two and not one shot, she will check. Reports since she has developed a heart murmur and she is very hoarse and does not know it has anything at all to do with Prevnar 13. She did not understand the USMI agent when the agent said it was not listed, and mentioned something that it was not put in the formulation for Prevnar 13. She declined transfer back to USMI.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.