Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eye swelling, Heart rate increased, Pain in extremity, Peripheral swelling
Clinical narrative: couldn't open her eyes; itching/her wrists and the inside of her elbows were itchy and the same thing; facial swelling; hives; swollen/swollen neck; beet red" face/face was completely beet red; rapid heart rate/her heart was beating quite fast; vomiting/she threw up; and her neck looked like the hunchback of (place name); sore arm; sore back; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jul2021 (at the age of 56 years old) (Batch/Lot Number: EW0181) as single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient inquired about additional information regarding the ingredients of the Pfizer Covid-19 vaccine. She received her first dose of the Pfizer Covid-19 vaccine on 08Jul2021 and reported that the Friday (09Jul2021) following receipt of the vaccine, she experienced a sore arm and sore back. She reports the Saturday (10Jul2021) following receipt of the vaccine, she experienced swollen, beet red face, hives, rapid heart rate, vomiting, and a swollen neck that her husband described as "the hunch back. She reported that taking 2 Benadryl (gel caps 25 mg per capsule, taking 2 every 4 hours) (LOT: 1807907 and Expiry date: Oct2022) and felt better, but upon waking up Sunday (11Jul2021) she felt the same as she did the day before with swelling, hives, itching. She reported that going to the urgent care and was taking Prednisone and continued taking Benadryl and felt good with no issues up until yesterday (18Jul2021) morning when she experienced facial swelling and couldn't open her eyes. She states she heard from one of the urgent care nurses that people who have reactions to shellfish sometimes experience certain symptoms after receiving the Pfizer Covid-19 vaccine. She stated that she realized that it was a rumor, but she has an allergy to shellfish, and she stays away from iodine. The patient asked if there is shellfish or iodine in the vaccine. Reporter confirms her arm being sore and back being sore ended 11Jul2021. Reporter asked since if she should not take the second, since she had a reaction to the first shot and asked for to suggest what to do if she haven't been fully vaccinated. On Saturday, 10Jul2021 she she woke up about 08:00 in the morning and she went into the bathroom and her face was completely beet red, her heart was beating quite fast, she had hives all over her body, she threw up, and her face was completely swollen, and her neck looked like the hunchback. Reporter stated that she took two Benadryl, she went to sleep for a couple of hours, she took two more Benadryl, and she was fine the rest of the day. On 11Jul2021, in the morning, her wrists and the inside of her elbows were itchy and the same thing, she was completely swollen up on her face and had hives, they were just as bad as the day before. Reporter states she took two Benadryl and waited some, she took two more Benadryl, and she went to urgent care. Reporter stated that they saw it was a reaction, they gave her 60 mg of Prednisone and then prescribed her 40 mg Pepcid and 40 mg of Prednisone for 5 days and to continue with the Benadryl every 6 hours. Reporter stated that she did that and everything was back to normal. Reporter stated that the last dose of everything was on this Friday. Reporter stated that on Sunday 18Jul2021, she woke up and her face was completely swollen up again, she couldn't even open her eyes. Reporter states she had no hives, no heart palpitations. Reporter stated that she took two Benadryl and took it easy for a little while then took two more Benadryl and it went down to about a third and then she ran out of Benadryl. Reporter states when she went to the urgent care, the nurse told her that Zyrtec or Claritin might even work better than Benadryl, so she took some Zyrtec and then got really tired. Reporter stated she woke up this morning and her face was still swollen, just as swollen as yesterday, but it is half as better as yesterday, she's still swollen on the top of her lids and the bottom of her lids, but no hives, no other swelling anymore and she hasn't taken Benadryl. Reporter states that she took Zyrtec about 21:00 last night. Reporter states she was against getting the shot because of everything people don't know about it but she's a cashier at a grocery store and they still want people to wear masks. Reporter states something in the back of her head said something was going to go wrong and it did. Reporter stated that her experience on Saturday, 10Jul2021, all symptoms actually all went away by Saturday at 17:00 in the afternoon after taking Benadryl, all her symptoms were gone. Reporter stated her neck wasn't puffed up like it was Saturday either, just had hives, swelling and her heart beating fast too. Reporter states no throwing up, no hunch back, that was just Saturday. Reporter confirmed her face being beet red, neck looking like the hunchback, and her throwing up she recovered completely from on 10Jul2021. Reporter stated all symptoms reported on Sunday, 11Jul2021, subsided on Sunday, 11Jul2021, after she got the 60 mg of Prednisone and Reporter confirms she recovered completely from everything except the swelling face. On Monday, 12Jul2021, she did call out of work because her face was still a little bit swollen. Reporter states she didn't go to work on Monday, but by late Monday, everything was fine when she was taking the Prednisone and Pepcid. Reporter states she was fine Tuesday, Wednesday, Thursday, Friday, and Saturday. Reporter stated that she woke up yesterday, 18Jul2021, and her face was completely swollen again, it's the only symptom she still has. Reporter stated it was ongoing and it was improved. Additional vaccines were not administered on Same Date of the Pfizer Suspect. The adverse events did not require a visit to Emergency Room but went to urgent care. Reporter states it was a Sunday and her primary doctor was closed. No prior Vaccinations were received within 4 weeks of vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events beet red face/face was completely beet red, vomiting/she threw up, her neck looked like the hunchback was recovered on 10Jul2021, Hives, sore arm, sore back, swollen/swollen neck, rapid heart rate/her heart was beating quite fast, itching/her wrists and the inside of her elbows were itchy and the same thing recovered on 11Jul2021, facial swelling was recovering, and unknown for couldn't open her eyes.  Description of complaint: Reporter reporting adverse event regarding the Pfizer Covid 19 Vaccine. Reporter reports taking two Benadryl then waiting a little bit and taking two more Benadryl before she visited an urgent care. Benadryl: gel caps 25 mg per capsule, taking 2 pills every 4 hours. Reporter states it's called Benadryl allergy. LOT: 1807907 NDC: 50580-228-24 Expiry Date: Oct2022.