Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the first of two reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration into Left arm on an unspecified date. The patient's concomitant medications were not reported. The patient experienced big red bumpy spot at injection site, pain, trouble lifting arm, all on an unspecified date with outcome of recovered. Follow-up (15AUG2016). This is a follow-up spontaneous report from a contactable Nurse. This nurse reported for the same patient that: Suspect products: TRUMENBA. Adverse events: Skin reaction which was red hot. What happened: Skin reaction which was red hot. Suspect products: TRUMENBA. Is this a Pfizer product: Yes. In your medical opinion, is there a reasonable possibility this event is related to this suspect product? Skin reaction when was red hot: Yes (Related). Additional context: This is the 1st case among two cross linked cases. The nurse mentioned that their sales rep had reported the event and she was reporting it again. The nurse mentioned that two of their employees received the first vaccine and had quite a skin reaction and it lasted for several days. She added it was red hot. The nurse mentioned that the patients had come for their second shot, so she wanted to know was that a bad enough reaction not to give it. The nurse further stated that the sales repo did report it but when she came the other day she said she did not what to do about it. The nurse stated that she was not going to stay on for that long for probing, because this event was already reported to Pfizer by their sales rep (name). She did not have the reference number of the previous call. The nurse stated that all the information was taken from the two girls by their sales rep, including their names when it was reported earlier and they had spent quite a bit of time in finding out what happened but nobody knew whether to give them the second shot or forget it. Causality: The nurse said that in her medical opinion the skin reaction was definitely because of TRUMENBA. The nurse was informed that regarding this concern her call could be transferred to Pfizer Medical Information to which she agreed. This LRN # is cross linked to LRN #. Is there a medical information request: Yes. Please describe the medication information request: The nurse mentioned that their sales rep reported the event and she was reporting it again. The nurse mentioned that two of their employees  received the first vaccine and had quality a skin reaction and it lasted for several days. She added it was red hot. The nurse mentioned that the patients had come for their second shot, so she wanted to know was that a bad enough reaction not to give it. The nurse further started that the sales rep did report it but when she came the other day she said she did not what to do about it. The nurse stated that she was not going to stay on for that long for probing, because this event was already reported to Pfizer by their sales rep (name). She did not have the reference number of the previous call. The nurse stated that all the information was taken from the two girls by their sales rep, including their names when it was reported earlier and they had spent quite a bit of time in finding out what happened but nobody knew whether to give them the second shot or forget it. The nurse just wanted to know whether she could give them the 2nd shot of vaccine or should they stop giving it because they had a reaction.