chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Urticaria
Clinical narrative: itching and hives on her neck; Chills; Ache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 07Feb2021 as single dose and received first dose of (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3246) dose via unspecified route of administration on 17th January2021 as a single dose for covid-19 immunisation. Medical history included pain in extremity from an unknown date and unknown if ongoing, rash from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient reported that she had second dose of COVID-19 vaccination on 07Feb2021 (not clarified). After the second shot, she had minor reaction. Chills and aches which was resolved after 24 hours. 3-4 days later she began itching and hives on her neck and that was continuing. She was taking half a tablet benadryl every 4 hours round the clock because it wakes her up in the middle night when it wears off. The minute it starts wearing off hive and severe itchiness returns. The patient reported that benadryl makes sleepy. So, she was looking for an alternative and an end to this, that she cannot take it around the clock. She did not take benadryl prior to receiving the second dose. So, she wants to know, when this will go away. The patient was not recovered from itching and hives and recovered from chills and ache on an unspecified date in FEB-2021.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pruritus, Weight
Clinical narrative: Allergic reaction; my leg was like just itching; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 10Feb2021 (at the age of 74-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 patient experienced leg was like just itching and allergic reaction on an unspecified date. It was reported that her height is about 5 Feet and 6 inches. She think and weight should be about 300 Pounds not positive about the weight." The only thing it says here is Pfizer and that number that she gave you and there is a date which was 02/10 and that is the only thing seeing except my name and birth date." Well, she took Zyrtec. Anyway so she did take Zyrtec this morning but that itching, she had taken that yesterday. That itching was something that was not usual." She queried Can you tell me is this something that would normally happen, a rash of any kind. I guess that is what I am concerned with." When Informed about the role of Pfizer Drug Safety again, she stated, "So, you do not have advice whether I should I be concerned about this or somewhere I should go to check this out." Patient did not underwent any lab test. She just need someone to tell her that if this is something to check out or is it something that normally happens. That is what it is. The itching is uncomfortable. she was unwilling to complete the report. Hence, limited information was available over the call. The outcome of the event was unknown.  Follow-up (21May2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocardial infarction, Pain
Clinical narrative: I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; The pain was so bad I thought I was having a heart attack. It was primarily on the left side of my chest and felt like a stabbing pain. I went to the dr that following week.; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 32-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: el1283), via an unspecified route of administration, administered in Arm Right on 02Feb2021 13:30 (at the time of vaccination 32-years-old), as a single dose for COVID-19 immunization. The patient's medical history included thyroid. The patient's concomitant medications were not reported. The patient had no known allergies from food sensitivities. Patient had no other vaccine in fourweeks and no other medications in twoweeks. Patient did not have covid prior vaccination and no covid tested post vaccination. On 02Feb2021, the patient experienced the pain was so bad i thought i was having a heart attack, it was primarily on the left side of my chest and felt like a stabbing pain, i went to the dr that following week (myocardial infarction) (medically significant); and i had severe chest pain from tuesday evening- friday and still have minor residual pain when i take a deep breath. The patient visited to Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pernicious anaemia
Clinical narrative: pernicious anemia; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), (Lot number and expiry date was not reported) dose 1 via an unspecified route of administration on 28Jan2021 as a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pernicious anaemia. The patient's 2nd dose will be on 18Feb, she should be on B12 injections, but she missed it this month due to the vaccine, she had pernicious anaemia. She would like to know if she can take it with the covid vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: needle pain sensation all over my body; joint pain; mild fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age:48; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, she has been administered both doses of Pfizer covid vaccine. She is experiencing covid like symptoms. She had a negative PCR test and waiting on results from another PCR test. After her first dose, the day after, she had needle pain sensation all over my body and joint pain and mild fatigue. That lasted only a day, she had gone out and got the PCR test, and that test was negative. Outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Lacrimation increased, Pruritus, Pyrexia
Clinical narrative: body itchy; Fever; watery eyes; has been working with a person that found out that he is positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 08Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had a vaccine yesterday and after that the patient experienced body itchy, fever and watery eyes on unspecified date. The patient Wanted to know if this is normal if the vaccine does this. The patient takes care of an elderly person and before he got the vaccine that the person had a Covid test which he got back and they told him that it was positive on an unspecified date. The patient reported he is a provides care to this elderly person that is 86 years old and Wanted to know if he can still work with him. The events outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: generalized itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection; Lot Number: EN6200) via an unspecified route of administration in arm left on Wednesday, 17Feb2021 10:00 (at the age of 69-year-old), as dose 1, single for COVID-19 immunization. Medical history included kidney transplant from 2011 to 2011, takes a lot of medicines (routine immunosuppressant medications), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities including diabetes and obesity. The patient's relevant family medical history was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient's concomitant medication included unspecified routine immunosuppressant medications. On 17Feb2021, Wednesday after receiving the vaccination, the patient experienced generalized itching (starting in the afternoon), with no rash but got itching everywhere. she had no problems breathing and no swelling. She confirmed that she had a history of a kidney transplant and was taking routine immunosuppressant medications. Patient asked if generalized itching was a common side effect from the vaccine and asked if she should get her second dose. At transplant centre, nephrologist said it was okay to get the shot. At about 10: 00 AM, in the afternoon her skin has been itching everywhere. She has no problems breathing, no swelling. No lab and relevant test. The clinical outcome of the event was not resolved. The reporter assessed case non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Lip swelling
Clinical narrative: Blood pressure went to 180/82/ another hour BP was 164/75/ remained up at 154/75 at bed time/ did drop to 135/70 the next morning; 1 hour after the vaccination lower left lip swelled for 15 minutes and slowly went down.; This is a spontaneous report received from a contactable consumer (patient). A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm left on 12Feb2021 14:30 (at the age of 81-year-old) as dose 1, single for covid-19 immunisation. Medical history included stroke-heart stents. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication and levothyroxine sodium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took hydrochlorothiazide and experienced allergies. The patient did not have other vaccine in four weeks. The patient had amlodipine besilate and levothyroxine sodium medications in two weeks. The patient did not have covid prior vaccination and no covid tested post vaccination. On 12Feb2021 15:30, one hour after the vaccination lower left lip swelled for 15 minutes and slowly went down and blood pressure (BP) went to 180/82. After another hour BP was 164/75. Blood pressure remained up at 154/75 at bed time and did drop to 135/70 the next morning. The patient did not received treatment for events. The clinical outcome of the events was recovered on an unspecified date in Feb2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Muscle twitching
Clinical narrative: Body twitching while trying to sleep. Almost like the brain was "jerking" the body awake; Body twitching while trying to sleep. Almost like the brain was "jerking" the body awake; slight spasm would take place; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, administered in arm Left on 10Feb2021 at 11:00 AM (at the age of 42 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient experienced body twitching while trying to sleep. Almost like the brain was "jerking" the body awake, and a slight spasm would take place. No treatment taken for the events. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: a slight vibration feeling in my legs.; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnent female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 09:15 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient do not have allergies to medications, food, or other products. Previously patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:15 (Batch/Lot Number: EL9263) for covid-19 immunization. The patient experienced a slight vibration feeling in her legs on 16Feb2021 10:00. After getting home from vaccine, she noticed a slight vibration feeling in her legs. She had noticed this feeling since having the vaccine through her body. It was almost 1 week since having the vaccine. She noticed it when standing still, laying down, etc. it felt like they were standing on a floor that was vibrating slightly. It does not caused pain but was worrisome and not sure why it was happening. It very annoying feeling to have all the time. It comes and goes. The sensation was not painful but was worrisome. She actually filed out the thing while she was waiting, but she thought she would talk to someone. She wanted to know if they give feedback. The symptom she thinks she had had ever since she got the second shot was a mild vibration in her body. Obviously, she doesn't hear that as a normal symptom of the COVID vaccine. Caller clarified that she was looking for information about mild vibration in her body after the second dose of the COVID vaccine. Caller confirmed that there had not been a new event since she reported her experience. She enquired that is this something that has  been reported before. The patient referred to HCP for treatment if symptom persists. No treatment was received for the event.The outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: I had shingles the day after I got the vaccine; The initial case was missing the following minimum criteria: Invalid for Other-Info not qualifying for AE reporting-Medical Information. Upon receipt of follow-up information on 14Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Thyroid, glaucoma, pain back. Concomitant medication(s) included pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; timolol maleate (TIMOPTIC) taken for glaucoma, start and stop date were not reported. The patient had no prior vaccinations. The patient got first Pfizer COVID shot on Wednesday (24Feb2021) night and she think she had shingles, she probably had them Wednesday night, she probably had then when she got the shot. She did laboratory test this week (Feb2021) and the results were normal. She was wondering how that effects it and if she had to go on to the anti-viral drug for shingles. The patient stated the next vaccination dose due date, maybe it's 19Mar2021. How that would affect her getting second COVID shot. When probed for start date, consumer stated, "she think it actually started before then but she just know she was just having some pain in her back but she didn't look at her back and she think there were probably some blisters that's there until recently when her, she told her husband that her back was sore, he looked and saw the blisters. But she think they were there before she got the shot." She think they were shingles. When probed for treatment for the problem, consumer stated, "For shingles, not yet. She was going to see a doctor." First covid vaccine. Now had shingles. Inquiring if there was any relations and if she could take the second dose. Upon follow up on 14Jun2021, the patient reported that she had no side effect from the COVID vaccine. She had shingles the day after she got the vaccine on 25Feb2021. Took antiviral 3days after the COVID shot. Outcome of the event was recovered on 25May2021.  Follow-up (14Jun2021): New information received from a contactable consumer (patient) included: Case considered valid with event shingles, onset date, end date, outcome, treatment received added for event shingles.  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Electrocardiogram, Heart rate
Clinical narrative: elevated BP (180/105) and pulse (100); elevated BP (180/105) and pulse (100); My pulse was also irregular; I experienced pressure in my chest especially over my sternum; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunization at Hospital. Medical history included hypothyroidism, migraine and had allergies with niacin, codeine, Brazil nuts, onions. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine and no other medications in four weeks. She did not have covid prior vaccination. Patient did not test covid post vaccination. On 25Feb2021 21:30 (Thursday), after having the shot on Wednesday patient experienced pressure in her chest especially over her sternum, elevated BP (180/105) and pulse (100). Her pulse was normally about 48- 53 and BP 120/64 to 128/70. Her pulse was also irregular. She went to the emergency room (ER) where her electrocardiogram (EKG) was normal, and her pulse was about 74 and BP 170/100. She asked that it be checked again after waiting for an extended period without being seen. At that time, it 148/72. When she arrived home, we checked it again and it was 128/68 later coming down to 119/64. She never had an episode like that before. Patient did not received treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: elevated BP (180/105) and pulse (100); elevated BP (180/105) and pulse (100); My pulse was also irregular; I experienced pressure in my chest especially over my sternum; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunization at Hospital. Medical history included hypothyroidism, migraine and had allergies with niacin, codeine, Brazil nuts, onions. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine and no other medications in four weeks. She did not have covid prior vaccination. Patient did not test covid post vaccination. On 25Feb2021 21:30 (Thursday), after having the shot on Wednesday patient experienced pressure in her chest especially over her sternum, elevated BP (180/105) and pulse (100). Her pulse was normally about 48- 53 and BP 120/64 to 128/70. Her pulse was also irregular. She went to the emergency room (ER) where her electrocardiogram (EKG) was normal, and her pulse was about 74 and BP 170/100. She asked that it be checked again after waiting for an extended period without being seen. At that time, it 148/72. When she arrived home, we checked it again and it was 128/68 later coming down to 119/64. She never had an episode like that before. Patient did not received treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Circumstance or information capable of leading to medication error, Hypertension
Clinical narrative: he doesn't want to get the second injection if he was going to have that problem.; he took his blood pressure and it read 197/100/ he checked his blood pressure today and it was 195/92; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot number was not reported expiry date was Not Provided) via an unspecified route of administration on 08Mar2021 as a single dose covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient took his blood pressure and it read 197/100/ he checked his blood pressure today and it was 195/92 (hypertension) (medically significant) on 09Mar2021, blood pressure measurement: high, 195/97  on 09Mar2021, blood pressure measurement: 135/70 on an unknown date in Mar2021 His blood pressure last week was 135/70. He took BP medicine. His blood pressure last week was 135/70 and he is concerned as to whether that could be associated with the vaccine. He wants to know because that is high, 195/97 and he doesn't want to get the second injection if he was going to have that problem. He clarified he was calling about the Pfizer COVID 19 vaccine. He has trouble hearing. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye swelling, Fatigue, Lip swelling, Malaise
Clinical narrative: recurrence of eyes and lips swelling; lips swelling; massive diarrhea; malaise; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:15 (at the age of 69-year-old), single dose, for Covid-19 immunisation. The patient's medical history included rheumatoid arthritis (RA), four back surgeries and allergic sinusitis. Patient did not receive any other vaccination on the same date, and she did not receive any other vaccine in four weeks of Pfizer vaccine. Patient was not diagnosed with covid-19 prior to Pfizer vaccination, and she was not tested positive since vaccination. Concomitant medications included prednisone, indometacin sodium trihydrate (INDOMETHACIN AGILA), tolterodine l-tartrate (DETROL), metoprolol succinate (TOPROL) and famotidine (FAMOTIDINE). The patient previously took ibuprofen, morphine and sulfonamides and experienced allergy; and patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: E l3247), via an unspecified route of administration, administered in Arm Left on, 22Jan2021 at 11:30 AM, for Covid-19 immunization and experienced swelling of face (lips, eyes, cheeks), severe itching of both hands, difficulty swallowing, massive diarrhea, extreme tiredness, and swelling of eyes and lips. On an unspecified date in Feb2021 (one week after the second dose), the patient experienced recurrence of eyes and lips swelling (on 24Feb2021 or 25Feb2021) and on an unspecified date in 2021, she continued to have massive diarrhea, malaise and fatigue until after administration of methylprednisolone 03Mar2021. Still taking Allegra twice a day (BID). The patient received treatment with prednisone, Benadryl, Allegra, and prednisone injection, as a result of adverse events. The outcome of events was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Dry mouth, Feeling abnormal
Clinical narrative: High BP/BP 195/95; Blurry vision; Dizzy; Weak; Spacy; Headache; Mouth began getting dry; Very sore arm with lump and redness; Very sore arm with lump and redness; Very sore arm with lump and redness; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 (Batch/Lot Number: EP6198) as UNKNOWN, SINGLE for covid-19 immunization. The patient past Medical history included High BP, obesity, bronchitis, occasional asthma and covid-19(If covid prior vaccination Yes). The allergy includes Thimerosol and Bacitracin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar2021 at 13:00 15 min after vaccination, the patient experienced BP 195/95 probably from high BP, Blurry vision, Dizzy, weak, spacy and after 20- 15 minutes later mouth began getting dry, Very sore arm with lump and redness & a little soreness still present. The patient did not receive any other treatment. The event outcome was Not recovered for Very sore arm with lump and redness and for rest of the events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: High BP/BP 195/95; Blurry vision; Dizzy; Weak; Spacy; Headache; Mouth began getting dry; Very sore arm with lump and redness; Very sore arm with lump and redness; Very sore arm with lump and redness; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 (Batch/Lot Number: EP6198) as UNKNOWN, SINGLE for covid-19 immunization. The patient past Medical history included High BP, obesity, bronchitis, occasional asthma and covid-19(If covid prior vaccination Yes). The allergy includes Thimerosol and Bacitracin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar2021 at 13:00 15 min after vaccination, the patient experienced BP 195/95 probably from high BP, Blurry vision, Dizzy, weak, spacy and after 20- 15 minutes later mouth began getting dry, Very sore arm with lump and redness & a little soreness still present. The patient did not receive any other treatment. The event outcome was Not recovered for Very sore arm with lump and redness and for rest of the events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: High BP/BP 195/95; Blurry vision; Dizzy; Weak; Spacy; Headache; Mouth began getting dry; Very sore arm with lump and redness; Very sore arm with lump and redness; Very sore arm with lump and redness; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 (Batch/Lot Number: EP6198) as UNKNOWN, SINGLE for covid-19 immunization. The patient past Medical history included High BP, obesity, bronchitis, occasional asthma and covid-19(If covid prior vaccination Yes). The allergy includes Thimerosol and Bacitracin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar2021 at 13:00 15 min after vaccination, the patient experienced BP 195/95 probably from high BP, Blurry vision, Dizzy, weak, spacy and after 20- 15 minutes later mouth began getting dry, Very sore arm with lump and redness & a little soreness still present. The patient did not receive any other treatment. The event outcome was Not recovered for Very sore arm with lump and redness and for rest of the events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Illness, Malaise
Clinical narrative: arm pain; pressure went up; headache; cold; felt sick; sore throat; fever; not feeling well; This is a spontaneous report from a contactable consumer or other non-healthcare professional and from a Pfizer sponsored program. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Mar2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history included pneumonectomy, she had one lung because one lung was removed when she was born, so her heart is over and turned, she also had Type 2 Diabetes but is not on medicine and blood pressure, her blood pressure went up even while taking her blood pressure medication. The patient's concomitant medications were not reported. It was reported that, enquired, the caller had her first dose on last Tuesday (09Mar2021). She had some side effects like pain in the arm, headache, high blood pressure and not feeling well. She heard from other people that the second dose of the vaccine will have worse side effects than the first. Stated that, whether they will be worse she doesn't know if she wants the vaccine. Stated that, she spoke with her doctor and they left it up to her but all of her doctors recommended her to get it. She wanted some advice because she was scared and nervous to take the second dose of her vaccine due on 29Mar2021. She stated her side effects after the first dose were all normal ones. Her symptoms after the first dose included arm pain but it didn't bother her and went away quickly. The next day it was sore but then it was gone. Her blood pressure went up even while taking her blood pressure medication (she has been on hydrochlorothiazide every morning for months). Her blood pressure was 150s/90s. She had a headache for a couple days and stated that, this could have been from the elevated blood pressure. She developed a cold and felt sick. The cold was with her nose and she had a sore throat. She had a fever but was unsure how high because she was taking Tylenol for the headache. She was not sure whether the cold was coincidental or not but it all got better in a couple days. She asked whether people had reported elevated blood pressure. Enquired, the caller asked if after getting the first dose people are nervous about getting the second dose due on 29Mar2021 and just get one dose. Therapeutic measures were taken as a result of pressure went up (blood pressure increased) and headache (headache). On an unspecified date, the patient underwent lab tests and procedures which included her blood pressure went up even while taking her blood pressure medication (blood pressure measurement), resulted as 150s/90s, her blood pressure was 150s/90s. The outcome of the events for pain in arm, cold was recovered while for the other events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: arm pain; pressure went up; headache; cold; felt sick; sore throat; fever; not feeling well; This is a spontaneous report from a contactable consumer or other non-healthcare professional and from a Pfizer sponsored program. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Mar2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history included pneumonectomy, she had one lung because one lung was removed when she was born, so her heart is over and turned, she also had Type 2 Diabetes but is not on medicine and blood pressure, her blood pressure went up even while taking her blood pressure medication. The patient's concomitant medications were not reported. It was reported that, enquired, the caller had her first dose on last Tuesday (09Mar2021). She had some side effects like pain in the arm, headache, high blood pressure and not feeling well. She heard from other people that the second dose of the vaccine will have worse side effects than the first. Stated that, whether they will be worse she doesn't know if she wants the vaccine. Stated that, she spoke with her doctor and they left it up to her but all of her doctors recommended her to get it. She wanted some advice because she was scared and nervous to take the second dose of her vaccine due on 29Mar2021. She stated her side effects after the first dose were all normal ones. Her symptoms after the first dose included arm pain but it didn't bother her and went away quickly. The next day it was sore but then it was gone. Her blood pressure went up even while taking her blood pressure medication (she has been on hydrochlorothiazide every morning for months). Her blood pressure was 150s/90s. She had a headache for a couple days and stated that, this could have been from the elevated blood pressure. She developed a cold and felt sick. The cold was with her nose and she had a sore throat. She had a fever but was unsure how high because she was taking Tylenol for the headache. She was not sure whether the cold was coincidental or not but it all got better in a couple days. She asked whether people had reported elevated blood pressure. Enquired, the caller asked if after getting the first dose people are nervous about getting the second dose due on 29Mar2021 and just get one dose. Therapeutic measures were taken as a result of pressure went up (blood pressure increased) and headache (headache). On an unspecified date, the patient underwent lab tests and procedures which included her blood pressure went up even while taking her blood pressure medication (blood pressure measurement), resulted as 150s/90s, her blood pressure was 150s/90s. The outcome of the events for pain in arm, cold was recovered while for the other events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: Fever; Cough; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 22-year-old (non-pregnant) female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EN6207) via unspecified route of administration in the left arm on 20Mar2021 16:30 (at the age of 22-year-old) at dose 2, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 22-year-old) at a dose 1, single for COVID-19 immunisation. Prior to vaccination, patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient experienced fever, cough and fatigue. The patient did not receive treatment for the reported events. The clinical outcome of fever, cough and fatigue was not resolved.   No follow-up attempts are needed. No further information is expected.  Amendment (30Jun2021): This follow-up report is being submitted to amend previously reported information: The age and unit for 'Historical Vaccine' update as 22 years. Narrative 'Since the vaccination, the patient had not tested positive for COVID-19' was updated as 'Since the vaccination, the patient had not been tested for COVID-19'.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash macular, Rash papular, Rash pruritic
Clinical narrative: rash appeared over most of body and very itchy.; white blotches in red area which looked like sunburn; few raised areas (like hives); warm to touch; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8727), via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported and no known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6202), via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced itchy rash over most of the body after 10 hours after second dose, blotchy/some white blotches in red area which looked like sunburn, heat rash/warm to touch and raised rash/a few raised areas like hives. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with anti-histamine for the events like itchy rash, blotchy, heat rash and raised rash. The clinical outcome of itchy rash, blotchy, heat rash and raised rash was recovering.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information included patient Country added, Age/units entered in historical vaccine and administration time was 16:30 added in Notes, Physician Office Visit checked for events, Event description updated as warm to touch to match with source. "The patient did not receive any other vaccines within four weeks prior to the COVID vaccine" removed from narrative since not reported on source.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Tremor
Clinical narrative: the patient began to experience shakiness; Feeling faint; Diaphoresis; This is a spontaneous report from a non-contactable health care professional. A 42-year-old female patient received first dose of her BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. During 15 minutes of her waiting period on 22Mar2021, the patient experienced shakiness, feeling faint and diaphoresis and denied of events like rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures for diaphoresis, shakiness and feeling faint included water and rest. Follow up response to treatment with excellent, the patient discharged with stable condition and planned to follow up with primary care physician. The clinical outcome of the event diaphoresis, shakiness and felt faint was resolving at the time of this report.   No follow-up attempts needed. No further information expected  Amendment: This follow-up report is being submitted to amend previously reported information: Country US added for patient in patient tab. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: The patient began to experience numbness; Tingling in the left arm; Aching in left hand; This is a spontaneous report from a non-contactable health care professional. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 22Mar2021 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. During his 15-minutes waiting period after the injection, the patient experienced numbness and tingling in the left arm and aching in left hand on 22Mar2021. He denied rash, hives, difficulty breathing, wheezing and light headedness. The patient had no daily prescription medications for numbness and tingling of left arm/hand. The patient did not receive any treatment for events. Follow up response to treatment was good (as reported). The patient was discharged to home as stable. The outcome of the events numbness and tingling in the left arm and aching in left hand were resolved in Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Historical vaccine details (39 years added as age/units) and leading sentence updated to a non-contactable health care professional.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema
Clinical narrative: Red inflamed area on face. both cheeks; Red inflamed area on face. both cheeks; This is a spontaneous report received from a non-contactable consumer (Patient). A 58-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: EP7534 and expiration date was not reported) via an unspecified route of administration on an unknown date as unknown single dose for COVID-19 immunisation. The patient was allergic to sulphur drugs and erythromycin. Concomitant therapies were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On unspecified date the patient experienced red inflamed area on face on both cheeks. No therapeutic measures were reported for the events red inflamed area on face. The clinical outcome of red face and skin inflammation was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's Initial captured in First name. 2. Dose Number leave blank. 3.  For relevant med history#1, the verbatim was updated as Known_allergies: Sulphur drugs; For relevant med history#2, the verbatim was updated as Known_allergies: sulphur drugs, erythromycin; 4. Narrative updated from "This is a spontaneous report received from a contactable consumer" to "This is a spontaneous report received from a non-contactable consumer".