Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oropharyngeal pain, Rash
Clinical narrative: diarrhea 2 times today; sore throat; About 1 hour after receiving her COVID-19 vaccine shot, she had a reaction; she felt like her head was swimming; Rashes/ rash on her stomach; headache; stomach ache; sweating all night/ sweaty on her stomach area; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178) dose 1, via an unspecified route of administration in arm left on 06Jul2021 at 14:00 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The family medical history included both parents have allergies. The patient's medical history included mild asthma, stated that she had asthma all her life. The patient's concomitant medications included diphenhydramine hydrochloride (BENADRYL, Lot number: P122740, Expiration date: on an unspecified date in Nov2023), 25 mg (every 6 hours, as needed), taken for mild asthma and montelukast sodium (SINGULAIR MINI), 10 mg, as needed, taken for an unspecified indication. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. The caller had the 1st dose of the Pfizer COVID 19 vaccine last on 06Jul2021 and experienced some reactions - rashes, headache, stomach ache, sweating all night, diarrhea 2 times today on 08Jul2021. Stated that, she does not want to get the 2nd dose due to the symptoms she has been experiencing. The patient was taking Benadryl, asked for the efficacy of the single dose. Response included was referred to healthcare professional. It was reported that, she was called about the COVID-19 Vaccine. Stated that, she had mild asthma and thought she had an allergic reaction to the COVID-19 Vaccine. She clarified that, she got her first COVID-19 Vaccine shot on 06Jul2021 and about 1 hour after she took the vaccine shot, she had a reaction. Stated that, the reaction got worse, but now she felt a little better. Stated that, she felt sweaty on her stomach area. She lifted up her shirt and she had a rash on her stomach. She started to get a headache and sore throat. Stated that, she thought she was having a reaction (to the vaccine) and she thought she would have something happened after she got the COVID-19 Vaccine. Stated that, she never had the COVID-19 Vaccine before and just tried the COVID-19 Vaccine for the first time. Stated that, she thought her allergic reaction would get worse if she didn't take Benadryl. Stated that, she was sweating last night and had a headache and she took Tylenol for the headache. Stated that, she had diarrhea 2 times this morning on 08Jul2021 and the Benadryl was helping her. Stated that, she took Benadryl and allergy medicine, clarified as generic Diphenhydramine 25mg capsule and prescription Singulair prescribed from the doctor at urgent care. Stated that, Equate Brand Allergy Relief Diphenhydramine 25mg capsule (she took 2 capsules after symptoms started on 06Jul2021), NDC number: 49035-901-12, Lot number: P122740, Expiry date: on an unspecified date in Nov2023. The patient stated that, the Equate Brand Allergy Relief Diphenhydramine 25mg capsule product NDC number was really, really, small type and she had to turn a light on to read the NDC number because of the really small print. Singulair 10mg (dispensed in prescription bottle and did not have the NDC, Lot and Expiry date). Stated that, she took the Singulair 10mg, as needed. She took one Singulair 10mg on 06Jul2021. Stated that, her allergic reaction got worse and then better after she took the Equate Brand Allergy Relief Diphenhydramine 25mg capsule. Stated that, she took Benadryl (Diphenhydramine 25mg) every day for her mild asthma, clarifying she took one Benadryl (Diphenhydramine 25mg) every 6 hours, as needed for her mild asthma. She clarified she had been taking Benadryl (Diphenhydramine 25mg) every day since her allergic reaction started on 06Jul2021. Stated that, she got the Generic Tylenol and did not have the NDC, Lot and Expiry date. Stated that, Generic Tylenol helped her headache and she felt like her head was swimming. She felt like she had an allergic reaction (to the COVID-19 Vaccine). Stated that, the allergic reaction was not severe and the allergic reaction was not what she normally gets. Stated that, she was not going to get the second COVID-19 Vaccine and asked whether she was somewhat protected from only having one COVID-19 Vaccine dose. The description of product complaint included Equate Brand Allergy Relief Diphenhydramine. The patient stated that, the Equate Brand Allergy Relief Diphenhydramine 25mg capsule product NDC number was really, really, small type and she had to turn a light on to read the NDC number because of the really small print. Treatment was received for the events about 1 hour after receiving her COVID-19 vaccine shot, she had a reaction, rashes/ rash on her stomach and headache. The investigation assessment was not reported. The outcome of the events for about 1 hour after receiving her COVID-19 vaccine shot, she had a reaction and stomach ache was unknown while for the other events was recovering.