Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Laceration, Loss of consciousness, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old patient received the 2nd dose of PREVNAR 13 via an unspecified route of administration at single dose at arm right on an unknown date about 2 years previously as booster shot and on 22Mar2017 at 1300: for immunisation. Medical history included sinus disorder, arthralgia, rhinorrhoea, cough, seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 10 mg, as needed (4 or 5 days in a row) ongoing seasonally for pollen, dextromethorphan hydrobromide, guaifenesin (ROBITUSSIN DM) 2 DF, cap doses from Apr2017 to Apr2017 (He took two doses, either that Wednesday when he received the PREVNAR 13 or that following Thursday) for cough.  The patient previously received the flu shot in early Sep2016 for immunisation and felt a little queasy for a few days after. No additional vaccines were administered on same date of PREVNAR 13. Whend he received his 1st PREVNAR 13 vaccine in early September about 2 years previously as booster shot he had some nausea and flu-like symptoms for a few days. After the 2nd dose received on 22Mar2017, the patient experienced sensation of convulsing or seizure on 23Mar2017 18:15 with outcome of recovered, passed out on 23Mar2017 with outcome of recovered, a lot of blood on 23Mar2017 19:15 with outcome of recovered, gash on forehead on 23Mar2017 19:15 with outcome of recovered with sequelae, cut nose on 23Mar2017 19:15 with outcome of recovering, felt incapacitated on 23Mar2017 with outcome of recovered, nausea on an unspecified date with outcome of recovered, violently ill on 23Mar2017 18:15 with outcome of recovered, flu-like symptoms on an unspecified date with outcome of recovered, arm was spotted, red and achy on an unspecified date with outcome of recovered, arm was spotted, arm swollen at injection site on an unspecified date with outcome of recovered, the cut above his eyebrow is now a huge scar on an unspecified date with outcome of unknown, his cough was so persistent his ribs would hurt from coughing on an unspecified date with outcome of unknown, his cough was so persistent his ribs would hurt from coughing on an unspecified date with outcome of unknown.  Therapeutic measures were taken as a result of gash on forehead (laceration), cut nose (nasal injury). Course of events: The caller patient received his PREVNAR 13 booster shot on 22Mar2017. That following Thursday he never got out of bed. He felt incapacitated. He finally got up at around 6:25 that evening to go get Tylenol. He also had progressive nausea the whole day. When he was going to the kitchen for Tylenol he made haste to get to the bathroom because he felt violently ill. He did not know if he needed to defecate or throw up. When he was sitting on the toilet he had a sensation like he was convulsing or having a seizure. It caused him to pop up and that is the last thing he remembers. He woke up an hour later laying on the floor in a 2 1/2 foot wide puddle of his own blood. He had hit his head and nose and had a huge gash across his forehead above his eyebrow. He cleaned up the cuts with hydrogen peroxide and benzadine solution and applied a butterfly bandage. It took about 2 or 3 days before they stopped bleeding. The nose cut is healing and the cut above his eyebrow is now a huge scar. By that following Saturday morning the nausea had subsided, but then he came down with flu-like symptoms and had that for about 2 weeks. He had had a runny nose and cough for a 2 days prior to receiving the Prevnar 13, so it is possible that he was already developing the flu before getting that shot. Last Tuesday or Wednesday he finally felt like he had regained his strength from the flu-like symptoms he suffered from. He had kept coughing from 2 days prior to the PREVNAR 13 until recently. His cough was so persistent his ribs would hurt from coughing. His whole arm was spotted, red and achy for about 1 week after receiving the PREVNAR 13. He received it in is right upper arm and the red rash was in several places from the top of his arm to his elbow. Also, at the site of injection there was a swollen protruding area the size of a 50 cent piece. He notified his primary care provider about what happened, but they never called him back. He also called the pharmacy where he received the PREVNAR 13 and they told him to report it to Pfizer. He did also see his ENT doctor for a regular appointment and he told him that he had probably hit his artery in his forehead, but that his wounds were healing nicely. He did not have the lot number, NDC number, expiration date or dose of the PREVNAR 13 that was administered, but states that his pharmacy will have that information. He denied any relevant investigations. His ENT confirmed that he had not broken his nose.