chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6202; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Feb2021 15:00 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient received the historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: el9269; Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 17:00 (at the age of 51-year-old) as 1st dose, single dose for COVID-19 immunization. The patient had no other medical history. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN 81) at a dose of 81 mg, atorvastatin (ATORVASTATIN), multi vitamin. There was no other vaccine on same date or in four weeks of product. The patient did not had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. On 25Feb2021 12:00, the patient experienced constant headache, body pain and aches, extreme fatigue, pain in entire upper arm. Reportedly, constant headache, started 25Feb2021 12pm still present (26feb2021), had body pain & aches, extreme fatigue, pain in entire upper arm until 26Feb2021 06:00, headache still present 26Feb2021 at 20:00. No treatment was given for adverse event. The clinical outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Dyspnoea, Pain in extremity
Clinical narrative: Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; This is a spontaneous report from a contactable consumer (patient). This 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:30 (Lot Number: EN6200) as single dose (at 82 years old) for COVID-19 immunisation.  Medical history included complex regional pain syndrome, scoliosis, primary biliary cholangitis, hypersensitivity. On 26Feb2021 00:30, the patient experienced shortness of breath, pain in left shoulder/arm/breast with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Terribly achy and sore; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Feb2021 13:45 (Batch/Lot number was not reported) as single dose at the age of 46-year-old for covid-19 immunisation, administered at hospital.  Medical history was none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced terribly achy and sore, extreme tiredness on 20Feb2021 12:00 with outcome of recovered in Feb2021.  No treatment received for the adverse events. The events were considered non serious. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed, Information on the lot/batch number has been requested and cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling swelling and redness of a 2 -3 inch circle area adjacent to the injection site; Arm swelling swelling and redness of a 2 -3 inch circle area adjacent to the injection site; Burning; Itching; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm, on 24Feb2021 at 09:45 AM (Batch/Lot Number: 9267), at the age of 73 years old, as second single dose, for COVID-19 immunisation. Medical history included coronary artery disease. The patient was not pregnant at the time of vaccination. The patient received unspecified concomitant drugs within 2 weeks of vaccination. The patient had received the 1st single dose of BNT162b2 on 03Feb2021 at 09:45 AM (lot number: 8982), always in the left arm. The patient had not received any other vaccines within 4 weeks prior to BNT162b2 vaccination. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination, has the patient have not been tested for COVID-19. On 26Feb2021 at 08:00 AM, the patient experienced arm swelling and redness of a 2 -3 inch circle area adjacent to the injection site, with burning and itching. No treatment was needed for the events which were described as non-serious by the reporter (patient). The patient was recovering from the events.   Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Vaccination site joint movement impairment, Vaccination site swelling
Clinical narrative: the arm was killing him and I could not lift it; allergic reaction; soreness in his arm; looks like a giant walnut where she put the shot/arm is still swollen with "a giant walnut on my arm".; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 66-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had a major allergic reaction. He received his first shot on 25Feb2021 and reported that after getting the shot in his upper arm "the arm was killing him and I could not lift it".  The patient went to the hospital for the soreness in his arm and what "looks like a giant walnut where she put the shot". Patient reported that he planned to go back to the hospital in 30 minutes to have his arm looked at again and to get another shot because his arm was still swollen with "a giant walnut on his arm".  The patient stated also that he could not move his left arm. He believed that the nurse stuck the needle into his muscle. He stated, received the vaccine in his upper arm and at the time of reporting that was so sore he cannot lift it and he just said that there was no logic because the nurse hit his muscle, that's what he said to the afterhours services. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: low grade fever / fever around 100; fatigue; intermittent  headache; feel foggy, my head feels a little foggy, strange feeling in my head just a little out of it; Arm pain near injection; some upset stomach; diarrhea; This is a spontaneous report from a contactable female consumer (patient).  A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 22Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose at the age of 39-year-old for COVID-19 immunisation, 24 days apart from dose 1.  Medical history included hypothyroidism subsequent to radioactive thyroid ablation for hyperthyroidism. No known allergies. No COVID prior vaccination. Concomitant medication(s) included levothyroxine sodium (manufacturer unknown) at 125 mcg taken for an unspecified indication, start and stop date were not reported taken for many years. Vaccine history included bnt162b2 (BNT162B2), dose 1 in arm right on 29Jan2021 14:00 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation and experienced arm pain on 29Jan2021 resolved within a day or two. Patient was not pregnant at the time of vaccination. On 22Feb2021 20:00 (also reported as about 24hours after 2nd shot) the patient experienced low grade fever / fever around 100 F, fatigue, intermittent headache, feel foggy/spacey feeling in my head, her head felt a little foggy, strange feeling in her head just a little out of it, arm pain near injection, some upset stomach, diarrhea. She was having continued side effects several days after her vaccine. No treatment received (she was not miserable or anything). COVID was not tested post vaccination. The outcome of arm pain recovered resolved within a day or two in Feb2021, of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: low grade fever / fever around 100; fatigue; intermittent  headache; feel foggy, my head feels a little foggy, strange feeling in my head just a little out of it; Arm pain near injection; some upset stomach; diarrhea; This is a spontaneous report from a contactable female consumer (patient).  A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 22Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose at the age of 39-year-old for COVID-19 immunisation, 24 days apart from dose 1.  Medical history included hypothyroidism subsequent to radioactive thyroid ablation for hyperthyroidism. No known allergies. No COVID prior vaccination. Concomitant medication(s) included levothyroxine sodium (manufacturer unknown) at 125 mcg taken for an unspecified indication, start and stop date were not reported taken for many years. Vaccine history included bnt162b2 (BNT162B2), dose 1 in arm right on 29Jan2021 14:00 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation and experienced arm pain on 29Jan2021 resolved within a day or two. Patient was not pregnant at the time of vaccination. On 22Feb2021 20:00 (also reported as about 24hours after 2nd shot) the patient experienced low grade fever / fever around 100 F, fatigue, intermittent headache, feel foggy/spacey feeling in my head, her head felt a little foggy, strange feeling in her head just a little out of it, arm pain near injection, some upset stomach, diarrhea. She was having continued side effects several days after her vaccine. No treatment received (she was not miserable or anything). COVID was not tested post vaccination. The outcome of arm pain recovered resolved within a day or two in Feb2021, of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Migraine
Clinical narrative: low grade fever / fever around 100; fatigue; intermittent  headache; feel foggy, my head feels a little foggy, strange feeling in my head just a little out of it; Arm pain near injection; some upset stomach; diarrhea; This is a spontaneous report from a contactable female consumer (patient).  A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 22Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose at the age of 39-year-old for COVID-19 immunisation, 24 days apart from dose 1.  Medical history included hypothyroidism subsequent to radioactive thyroid ablation for hyperthyroidism. No known allergies. No COVID prior vaccination. Concomitant medication(s) included levothyroxine sodium (manufacturer unknown) at 125 mcg taken for an unspecified indication, start and stop date were not reported taken for many years. Vaccine history included bnt162b2 (BNT162B2), dose 1 in arm right on 29Jan2021 14:00 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation and experienced arm pain on 29Jan2021 resolved within a day or two. Patient was not pregnant at the time of vaccination. On 22Feb2021 20:00 (also reported as about 24hours after 2nd shot) the patient experienced low grade fever / fever around 100 F, fatigue, intermittent headache, feel foggy/spacey feeling in my head, her head felt a little foggy, strange feeling in her head just a little out of it, arm pain near injection, some upset stomach, diarrhea. She was having continued side effects several days after her vaccine. No treatment received (she was not miserable or anything). COVID was not tested post vaccination. The outcome of arm pain recovered resolved within a day or two in Feb2021, of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 18Jan2021 14:00, at 78 years of age, (Batch/Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included chronotropic incompetence from an unknown date and unknown if ongoing, cardiac pacemaker insertion because of chronotropic incompetence on an unknown date. Concomitant medication included Vitamins and zolpidem tartrate (AMBIEN) taken for an unspecified indication since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19. On 21Jan2021 13:00 the patient experienced first shot sweating, chills and tiredness. No treatment was received. The events outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for COVID after getting the 1st dose PFIZER-BIONTECH COVID-19 VACCINE - Patient received the the 1st dose 21Feb2021 then tested positive for COVID 27Feb2021; This is a spontaneous report from a contactable consumer reporting for his wife (patient). A female patient of an unspecified age (age: 55; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included immunocompromised from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient tested positive for covid after getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE; the patient received the 1st dose on 21feb2021 then tested positive for covid on 27feb2021.The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 27Feb2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Pain, SARS-CoV-2 test
Clinical narrative: Having a hard time breathing; achy; head ache; sweats; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 27Feb2021 13:00 (at the age of 53-years-old) as second dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included estradiol, sertraline and levothyroxine; all taken for an unspecified indication, start and stop dates were not reported. The patient previously took erythromycin and experienced drug allergy. The patient was previously vaccinated with the first dose of BNT162B2 for COVID-19 immunisation. The patient was not pregnant. The patient had no COVID prior to vaccination. The patient has been tested for COVID post vaccination. No other vaccine was given to the patient in four weeks. On 28Feb2021 02:00, the patient experienced having a hard time breathing, achy, head ache and sweats. The events were reported as non-serious. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab (nasopharyngeal) (SARS-CoV-2 test): negative on 22Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Sleeplessness/Insomnia; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 28Feb2021 15:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included probiotics (manufacturer unknown); unspecified daily multi-vitamin (manufacturer unknown); and curcuma longa (TURMERIC) all taken for an unspecified indication and all start and stop dates were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sleeplessness/insomnia, so far two nights in a row, on 01Mar2021 00:00. The patient did not receive any treatment as a result of the events reported. Patient did not consult physician nor urgent care for the events reported. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oral blood blister
Clinical narrative: Blood boil in the mouth on left cheek in the mouth which burst; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6202, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 28Feb2021 12:15 (at the age of 79-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included penicillin allergy, sulpha allergy and heart disease from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 07Feb2021 18:00 (at the age of 79-years-old) for COVID-19 immunisation. The patient experienced blood boil in the mouth on left cheek in the mouth which burst on 01Mar2021 15:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are possible. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: really sick; sore throat; tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.1 week after vaccination, on an unknown date in Feb2021, the patient tested positive for COVID (sars-cov-2 test positive) and had to be in isolation for 10 days, the patient had been out of isolation for a couple of days now, maybe since Thursday or Friday. The patient had been out of school. However, on 01Mar2021 the patient woke up "really sick" with sore throat on the day of her second dose appointment. The patient was supposed to get her second dose on the day of report. The patient was supposed to get the vaccine within the next hour, but she read she shouldn't get the vaccine if she is not feeling well. The caller wants to know should she delay it (second dose) for a week or what. The patient was calling to move the vaccine appointment one week instead of having it on the day of report. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sleep-related event, Somnambulism
Clinical narrative: Sleepwalked outside of his home and urinated in his front yard; Sleepwalked outside of his home and urinated in his front yard; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 01Mar2021 at 10:30 AM (at the age of 33 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included diabetes type 1. The patient's concomitant medications included insulin, Monascus purpureus (RED YEAST RICE), arginine (L ARGININE), apple cider vinegar, and fish oil. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The day of the vaccination, the patient was taking insulin, red yeast rice, l-arginine, apple cider vinegar, and fish oil. The night after the patient got the vaccine, he sleepwalked outside of his home and urinated in his front yard on 02Mar2021 at 06:00 AM. The patient had never slept walked before. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the events. The patient had not been tested for COVID-19 post vaccination. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Pain in extremity, Suspected COVID-19
Clinical narrative: arm was a little sore/pain down her arm almost to her elbow; balance was kind of off; thought that she has Covid too; tired; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration on 26Feb2021 16:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history included back surgery, knee surgery and she have UTI's all the time. The patient's concomitant medications were not reported. The patient stated she felt like she may have had a slight reaction, if she had anything it was very mild. She had pain down her arm almost to her elbow on an unspecified date but not enough to got to the hospital or anything like that. She added that her balance was kind of off on an unspecified date but stated she was okay. She mentioned that she was extremely tired and had been laying down since 4 o'clock this morning (02Mar2021). The patient was doing well. However, her arm was a little sore on an unspecified date. Furthermore, she contacted her nephew  and he thought that she has Covid too because the virus was in the vaccine. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye oedema, Eye swelling, Ocular discomfort, Ocular hyperaemia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269) via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. 2-3 days after vaccine (also reported as a day or 2) the patient started itching on her hip around to her back, described as patch of red upper hip area and her stomach and back were constantly itching. On a day or a few days after the vaccine she also had redness and edema in eyes (really red and swollen), she had a hard time opening her eyes and this occurred 2-3 times. There were no bumps it was just a reddish patch. Her upper hip area was the reddened area and the itching moved into her stomach and back. Second dose was scheduled for 04Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269) via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. 2-3 days after vaccine (also reported as a day or 2) the patient started itching on her hip around to her back, described as patch of red upper hip area and her stomach and back were constantly itching. On a day or a few days after the vaccine she also had redness and edema in eyes (really red and swollen), she had a hard time opening her eyes and this occurred 2-3 times. There were no bumps it was just a reddish patch. Her upper hip area was the reddened area and the itching moved into her stomach and back. Second dose was scheduled for 04Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Dry skin, Hot flush, Laboratory test, Pain in extremity
Clinical narrative: sore arm, Soreness; red rash; bright red area at the injection site; At the injection site itchy; painful; Rash on wrist and ankle; Atopic dermatitis; It looks like it's stuffy and really hot; vaccination site warmth to touch; dry skin; At the injection site itchy; painful; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 12Feb2021 (at the age of 67-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included anxiety, kidney stone disease, high blood pressure, cholesterol, dermatitis. Concomitant medications included hydrochlorothiazide, lisinopril and alprazolam (XANAX), all taken for an unspecified indication, start and stop date were not reported. Concomitant medications included also other unspecified drugs. On 28Feb2021 (reported also as 8 days after the 12th, so probably around 28th) the patient experienced sore arm, soreness, red rash, bright red area at the injection site, at the injection site itchy; painful, rash on wrist and ankle, atopic dermatitis, it looks like it's stuffy and really hot (hot flush), vaccination site warmth to touch and dry skin. The patient reported that she had the first Pfizer covid 19 vaccine on 12Feb2021 and her next dose on 05Mar2021. Patient reported a sore arm ,a bright red area at the injection site and itching. Patient clarified that it was not a rash at the injection site. Patient reported a rash on her wrist and ankles that her doctor said was dry skin because she did not have a dry skin problem. Patient stated the redness was still there but not as bright and did not itch as much. She broke into a pretty significant red rash; redness at the injection site. At the injection site itchy; painful. The patient stated that she had reaction or whatever it was at the vaccine site; it was warm to the touch; extensive itching. It looks like it's stuffy and really hot. She developed a very itchy rash on wrist and ankle. The patient stated that she has been signed to get the vaccine again but she still had a little bit of redness there. The patient stated that at time of reporting it's better it's just red, a little red, it's not as itchy, it's improving, it's subcutaneous you know, it is not what it was before and it's not as hot as it was before. The events were treated with Antihistamine. Patient reported that it was also simultaneous and unrelated also at the same time developed a very itchy rash on wrist and ankle her doctor said that was different, she had dermatitis issue probably from dry skin so he gave her anti-histamine for that, taken for a couple of days. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: sore arm, Soreness; red rash; bright red area at the injection site; At the injection site itchy; painful; Rash on wrist and ankle; Atopic dermatitis; It looks like it's stuffy and really hot; vaccination site warmth to touch; dry skin; At the injection site itchy; painful; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 12Feb2021 (at the age of 67-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included anxiety, kidney stone disease, high blood pressure, cholesterol, dermatitis. Concomitant medications included hydrochlorothiazide, lisinopril and alprazolam (XANAX), all taken for an unspecified indication, start and stop date were not reported. Concomitant medications included also other unspecified drugs. On 28Feb2021 (reported also as 8 days after the 12th, so probably around 28th) the patient experienced sore arm, soreness, red rash, bright red area at the injection site, at the injection site itchy; painful, rash on wrist and ankle, atopic dermatitis, it looks like it's stuffy and really hot (hot flush), vaccination site warmth to touch and dry skin. The patient reported that she had the first Pfizer covid 19 vaccine on 12Feb2021 and her next dose on 05Mar2021. Patient reported a sore arm ,a bright red area at the injection site and itching. Patient clarified that it was not a rash at the injection site. Patient reported a rash on her wrist and ankles that her doctor said was dry skin because she did not have a dry skin problem. Patient stated the redness was still there but not as bright and did not itch as much. She broke into a pretty significant red rash; redness at the injection site. At the injection site itchy; painful. The patient stated that she had reaction or whatever it was at the vaccine site; it was warm to the touch; extensive itching. It looks like it's stuffy and really hot. She developed a very itchy rash on wrist and ankle. The patient stated that she has been signed to get the vaccine again but she still had a little bit of redness there. The patient stated that at time of reporting it's better it's just red, a little red, it's not as itchy, it's improving, it's subcutaneous you know, it is not what it was before and it's not as hot as it was before. The events were treated with Antihistamine. Patient reported that it was also simultaneous and unrelated also at the same time developed a very itchy rash on wrist and ankle her doctor said that was different, she had dermatitis issue probably from dry skin so he gave her anti-histamine for that, taken for a couple of days. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: sore arm, Soreness; red rash; bright red area at the injection site; At the injection site itchy; painful; Rash on wrist and ankle; Atopic dermatitis; It looks like it's stuffy and really hot; vaccination site warmth to touch; dry skin; At the injection site itchy; painful; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 12Feb2021 (at the age of 67-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included anxiety, kidney stone disease, high blood pressure, cholesterol, dermatitis. Concomitant medications included hydrochlorothiazide, lisinopril and alprazolam (XANAX), all taken for an unspecified indication, start and stop date were not reported. Concomitant medications included also other unspecified drugs. On 28Feb2021 (reported also as 8 days after the 12th, so probably around 28th) the patient experienced sore arm, soreness, red rash, bright red area at the injection site, at the injection site itchy; painful, rash on wrist and ankle, atopic dermatitis, it looks like it's stuffy and really hot (hot flush), vaccination site warmth to touch and dry skin. The patient reported that she had the first Pfizer covid 19 vaccine on 12Feb2021 and her next dose on 05Mar2021. Patient reported a sore arm ,a bright red area at the injection site and itching. Patient clarified that it was not a rash at the injection site. Patient reported a rash on her wrist and ankles that her doctor said was dry skin because she did not have a dry skin problem. Patient stated the redness was still there but not as bright and did not itch as much. She broke into a pretty significant red rash; redness at the injection site. At the injection site itchy; painful. The patient stated that she had reaction or whatever it was at the vaccine site; it was warm to the touch; extensive itching. It looks like it's stuffy and really hot. She developed a very itchy rash on wrist and ankle. The patient stated that she has been signed to get the vaccine again but she still had a little bit of redness there. The patient stated that at time of reporting it's better it's just red, a little red, it's not as itchy, it's improving, it's subcutaneous you know, it is not what it was before and it's not as hot as it was before. The events were treated with Antihistamine. Patient reported that it was also simultaneous and unrelated also at the same time developed a very itchy rash on wrist and ankle her doctor said that was different, she had dermatitis issue probably from dry skin so he gave her anti-histamine for that, taken for a couple of days. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Dysstasia, Limb discomfort, Myalgia
Clinical narrative: my legs were weak /leg gave out; Thighs mostly/upper leg- muscles were achy" /muscle hurting and aching; cant get back up again /could not stand; her leg would not cooperate; This is a spontaneous report from a contactable consumer (patient).   An 83-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 17:30 (Batch/Lot number was not reported) as single dose for Covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced my legs were weak /leg gave out (limb discomfort) (non-serious) on 27Feb2021 with outcome of unknown , thighs mostly/upper leg- muscles were achy' /muscle hurting and aching (myalgia) (non-serious) on 27Feb2021 with outcome of unknown, can't get back up again /could not stand (dysstasia) (non-serious) on 27Feb2021 with outcome of unknown, her leg would not cooperate (coordination abnormal) (non-serious) on 27Feb2021 with outcome of unknown.    No follow-up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 23Feb2021 12:45 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Dec2020. The patient did not have concomitant medications. On 01Mar2021, the patient developed runny nose, congestion, a little bit of weakness and tired. He said he felt like he did when he had the COVID-19 virus in Dec2020. He said when he had the COVID-19 Virus in Dec2020, he had the virus for a few days, and the virus was not bad. He clarified he had the COVID-19 Virus for like 10 days total. He clarified he had a runny nose, congestion, a little bit of weakness, and was tired. He said today (on 02Mar2021) his symptoms were not as strong as yesterday, clarifying his symptoms were down by maybe 20% from yesterday. He took some liquid dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) for his symptoms. The events did not require emergency room visit/physician office visit. The patient was recovering from the events.  No follow-up attempts are possible; information about Lot/Batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: tiredness; muscle pains; chills; nausea; diarrhea; headache; felt funny; This is the spontaneous report from a contactable consumer.  A 89-year-old female consumer reported that received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 22Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. She didn't have any effects on Monday, Tuesday, or Wednesday. On Thursday afternoon she felt funny. On Friday she got so sick. She has been sick ever since. She has tiredness, headache, muscle pain, chills, joint pain, diarrhea, and nausea. No fever. She is nauseated but nothing comes up. Seems like she can only keep a piece of bread down.  She is scheduled to get the second one on 15Mar20201 and she is afraid to do it. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tiredness; muscle pains; chills; nausea; diarrhea; headache; felt funny; This is the spontaneous report from a contactable consumer.  A 89-year-old female consumer reported that received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 22Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. She didn't have any effects on Monday, Tuesday, or Wednesday. On Thursday afternoon she felt funny. On Friday she got so sick. She has been sick ever since. She has tiredness, headache, muscle pain, chills, joint pain, diarrhea, and nausea. No fever. She is nauseated but nothing comes up. Seems like she can only keep a piece of bread down.  She is scheduled to get the second one on 15Mar20201 and she is afraid to do it. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200; Expiration date was not reported) on the left arm on 24Feb2021 (10:15) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 25Feb2021 (12:00), the patient had diarrhea. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Dull headache occurred 3 hours post vaccination.; Pre-existing symptoms of tinnitus (ear ringing) decreased; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 at 15:00 (Batch/Lot number: Not reported) (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021 at 18:00 (occurred 3 hours post vaccination), the patient experience dull headache and pre-existing symptoms of tinnitus (ear ringing) decreased. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache
Clinical narrative: Headache; Chest tightness; Cough; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 11:30 (Batch/Lot Number: EL8982) (at the age of 79-year-old) as 1st dose, single for covid-19 immunization. Medical history included latex allergy and A-Fib. Concomitant medication(s) included apixaban (ELIQUIS) and metoprolol (MANUFACTURER UNKNOWN) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jan2021 08:00, the patient experienced headache, chest tightness, cough and difficulty breathing within 24-36 hours. No treatment was given for the events. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site urticaria
Clinical narrative: Splitting headache; Nauseous; Nauseous was reported as worsened; experience some side effects at the injection site (on her left shoulder area) which was huge hive that were red, hard and hurts; Huge hive that is red, hard, and hurts was reported as worsened.; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), dose 1 via an unspecified route of administration, administered in Arm Left (Left shoulder) on 17Feb2021 08:00 as single dose for covid-19 immunisation. The patient medical history was not reported. On concomitant Medication patient initially stated she was in immune suppressant medications. However, when probed for concomitant details stated there were no medications to provide. On 26Feb2021 9:00 AM, she started to experience some side effects at the injection site (on her left shoulder area) which was huge hive that were red, hard and hurts. She also had a splitting headache, and she was nauseous. Found it strange that it started over a week after the vaccine. She was also on immune suppressant drugs and did not know if she should repot this information. She added, she does not feel the COVID Vaccine was administered correctly. She is not sure what happened. The CMA pinched her skin high and then put the shot in. Patient stated that she gives herself weekly shots in her muscle, in the arm, and she is not supposed to pinch the skin. It is supposed to go in the muscle. She was not sure if that had anything to do with it. If due to her immune system. No History of any previous immunizations with the Pfizer vaccine considered as suspect. No additional Vaccines administered on same date of the Pfizer suspect. Patient did not visit emergency Room or physicians Office. Prior Vaccinations within 4 weeks and AEs following prior vaccinations were none. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; nausea; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included known allergies to sulfur. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On an unspecified date, the patient experienced fever, nausea and sore arm. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine
Clinical narrative: I had a series of migraines after dose 1 of the vaccine and even more this week after dose 2.; She had a series of migraines; This is a spontaneous report from a contactable Consumer (patient).  A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm on 20Feb2021 (Batch/Lot Number: EN6200) as single dose at the age of 69-year-old for COVID-19 immunisation, administered at school or student health clinic.  Medical history included COVID-19 from Jul2020 to an unknown date. No known allergies. There were no concomitant medications. No other vaccine in four weeks. Vaccine history included: bnt162b2 (BNT162B2), dose 1 administered in left arm on 30Jan202110:15 AM (Batch/Lot Number: EL9261) as single dose at the age of 69-year-old for COVID-19 immunisation.  Since having COVID in July patient had have had more migraines than normal. She was used to get 4 or 5 a year. She has probably had 10 to 12 since July. She had a series of migraines on 04Feb2021 08:00 AM after dose 1 of the vaccine and even more this week after dose 2 in in Feb2021. No treatment received. COVID was not tested post vaccination. The outcome of event was not recovered.    No follow-up attempts are possible. No further information is expected.