chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen, sore lymph nodes under arms; swollen, sore lymph nodes under arms; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 41-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date: Unknown), via an unspecified route of administration in arm left on 05Feb2021 19:15 as single dose for COVID-19 immunisation in Health Clinic. Medical history included GERD from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. Patient received unspecified concomitant medication. The patient did not receive any other vaccine in four weeks. The patient had not been tested for COVID-19 since having the vaccine. The patient experienced swollen, sore lymph nodes under arms on 08Feb2021 18:00. The patient did not receive any treatment for events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness
Clinical narrative: something like flu; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number not provided), via an unspecified route of administration on an unspecified date(at the age of 79-years-old) as a single dose for COVID-19 immunization. The patient had received ibuprofen, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for an unspecified indication. The patient medical history and concomitant medications were not reported. She has received both doses of the Pfizer COVID-19 vaccine and experienced an AE that was something like flu. She took ibuprofen for that. Upon watching a program yesterday, she learned that aspirin would reduce the effectiveness of the vaccine. She would like to know more information on that. She had her second shot two weeks the day after tomorrow. Stated that she had a side effect of light flu. Stated that she was watching television and a call in said that if one takes Tylenol that it would not have effectiveness of vaccine. Stated that she took Ibuprofen and wanted to know would that cause a side effect of the vaccine or not. Is Pfizer COVID vaccine.The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: On 06Feb2021, Caller reported to have experienced "severe neck pain" Caller clarified: muscle pain/neck pain that got really, really awful; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 84-year-old female patient received bnt162b2 (BNT162B2, Pfizer-Biontech COVID-19 mRNA Vaccine, Batch/Lot Number: EL9262) via an unspecified route of administration on 22Jan2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing. Concomitant medications included warfarin (WARFARIN) taken for atrial fibrillation, start and stop date were not reported. Patient didnot receive other vaccinations within 4 weeks prior to vaccination. On 06Feb2021, caller reported to have experienced "severe neck pain" clarified muscle pain/neck pain that got really, really awful. Therapeutic measures were taken as a result of on 06feb2021, caller reported to have experienced "severe neck pain" caller clarified: muscle pain/neck pain that got really, really awful Tylenol eight hour-controlled release. Patient stated that the product complaint was Severe neck pain that was ongoing. After she takes Tylenol and moves around it is bearable patient didn't received any physical therapy for the event. Pain was always pretty stabby sample of the product complaint was not returned no information was reported packaging of the seal was intact expiry date and strength of the product was not reported. The outcome of the event neck pain was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: feeling a little dizzy; couldn't breath; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 72, Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The first dose of the Pfizer-BioNtech Covid-19 vaccine on Saturday at 5 o'clock, 20 minutes later she started feeling a little dizzy and that she couldn't breathe further she describes these symptoms as slight, and they didn't escalate. She is scared about what may happen after the second dose of the vaccine, which is scheduled on 27Feb2021. Reporter also said that some people after the first dose of the vaccine only had a sore arm. She also takes blood pressure pills in the morning. Patient questions if she would like to know if this is related to the side effects that she experienced. Also, if she can receive the Moderna vaccine for the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Rash
Clinical narrative: face rash; Increased heart rate; trouble breathing; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 18:15(at the age of 21 years old) as single for COVID-19 immunisation at workplace clinic. Medical history included covid-19 from an unknown date and unknown if ongoing prior to vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 18:30 the patient experienced Increased heart rate, trouble breathing, dizziness, and face rash. Treatment were received for events with allergy medicine. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Pruritus
Clinical narrative: developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; itching in the scalp and the right eye; This is a spontaneous report from a contactable consumer (patient).   An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3302 and Expiration date: unknown), via an unknown route of administration, administered in left arm close to shoulder on 01Feb2021 around 02:30 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy unspecified from an unknown date. There were no concomitant medications. The patient previously took clonidine 0.1 mg, hydralazine 10 mg, cipro (ciprofloxacin) and sulfa for blood pressure abnormal and had itching. Patient also took spironolactone tablets for blood pressure abnormal and had a little rash of bumps under the skin on her right arm. On 01Feb2021, she received covid vaccine probably about 02:30. When she got home, about 2.5 hours later at 05:00, she started itching somewhat, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. There was nothing she could see in those places. She went ahead and called the pharmacist. The pharmacist told her to take Benadryl, so she took one 25 mg liquigel. It took the itch away. She went to bed and decided it had subsided. She decided to go ahead and take one more through for the night. When she woke up in the morning, she didn't have a problem. She was wondering if she should be concerned for the second shot. She didn't have a prescribing doctor. She got the invite to get it. It was gone through the night. Therapeutic measures were taken as a result of developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. Outcome of events was recovered on 02Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Palpitations, Paraesthesia oral, Swelling face
Clinical narrative: my lips started to tingle and numbness; my lips started to tingle and numbness; my face started to swell; it felt like her heart was racing; This is a spontaneous report from a contactable Consumer. This 69-year-old female Consumer reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 10:00 (Batch/Lot Number: EL9262) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included thyroid cancer, thyroidectomy, COVID-19 Virus in 2020, joint injury, knee surgery from an unknown date and unknown if ongoing she was using the prescription anti-inflammatory for her knee that she had surgery on. There were no concomitant medications. The patient previously took aleve. Reported she has no allergies she is aware of but had an immediate lip tingling after receiving her first COVID-19 Vaccine dose. She said the left side of her face started to swell 5-10 minutes after getting the COVID-19 Vaccine. She said it felt like her heart was racing, too. She said she did not have any tongue swelling. She said her facial swelling went away in about 2 to 2-1/2 hours, and then it was like nothing had ever happened. Reported she may have taken a Tylenol but doesn't know for sure that she did. No further details provided. She was on a prescription anti-inflammatory medication for about a month and stopped taking the prescription 2 weeks prior to getting her first COVID-19 Vaccine shot. She said the prescription anti-inflammatory was for a problem she has with her knee. She said she may have taken some Aleve in between stopping the prescription anti-inflammatory and getting her first COVID-19 Vaccine dose. She said she knows she did not take any Aleve the day she received her COVID-19 Vaccine. She said the prescription anti-inflammatory is a common medication that is prescribed, and she was using the prescription anti-inflammatory for her knee that she had surgery on. Reported she had thyroid cancer, saying she has no thyroid. She said she had the thyroid cancer many years ago and has been on a cocktail of thyroid medicines since then. No further details provided. Reported she is still healing from having the COVID-19 Virus in 2020. She said she is getting episodes with "COVID toes", clarifying her skin is blackened around her toes at times. The outcome of the events was recovered on 28Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site abscess, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Raised red bump/abscess at injection site; Raised red bump/abscess at injection site; Raised red bump/abscess at injection site; Hot; itchy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), dose 1 via an unspecified route of administrtion, administered in arm left on 02Feb2021 at 16:15 (at the age 68-years-old) as dose 1, single for COVID-19 immunisation. Medical history included heart disease, high blood pressure and hypothyroid. The patient had no known allergies. Concomitant medications included amlodipine; duloxetine; levothyroxine and metoprolol. Facility type where the vaccine was administered was a hospital. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 09Feb2021 at 14:30, the patient experienced raised red bump/abscess at injection site, hot and itchy. The raised red bump/abscess at injection site was approximately two inches in diameter. The patient did not receive treatment for the events. The outcome of all the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy all over and had a couple of hives; Itchy all over and had a couple of hives; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient wife) via medical information team. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not re-ported. On an unknown date in 2021, the patient experienced itchy all over and had a couple of hives. It was reported that the patient was itchy all over and had a couple of hives after the receipt of the Pfizer-BioNTech COVID-19 vaccine, a week and a half ago. The patient reaction was brief, and he took a couple of Benadryl for it. The reporter further explained the vaccination provider did not consider the patient reaction as severe and they stated they will monitor him for one hour post second injection, due to his reaction to the first dose. The reporter asked if his reaction would be considered a severe reaction to the vaccine and if it was part of the reported side effects for the vaccine. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Tongue erythema
Clinical narrative: Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283 and Expiration Date not reported) dose 1 via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of flu shot  (no details provided) in September. The patient has no known allergies. The patient received the first dose of the COVID-19 vaccine a week ago and had a reaction of itching and the tip of her tongue got a little red and a bit swollen. She says she was scheduled to take the next dose of the vaccine on the 25th of this month and had some concerns. She said that the reason she called was she wanted to make sure it was ok for her to take second dose. She said she already talked to her doctor who told her to call Pfizer. The patient told that, the itching was probably for 12 hours. The patient said that, the tongue redness and being a bit swollen did not last long, she came home and had lunch and drank a lot of water. She said that the itching stayed until almost the next day and her tongue was better. She said she was concerned and went to her doctor. The patient received treatment with Benadryl one time at night, UPC: Unknown and product did not have a barcode on it and it was small tablet size and Diphenhydramine HCI 25mg said it as antihistamine on the label, with EXP Dec2021 and LOT SEF004 and took one by mouth one time. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Dyspnoea, Mass, Pruritus
Clinical narrative: Itching on back, arms, thighs and hands; occasional shortness breath.; Bumps on thighs and arms; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EM9809), dose 1 intramuscular, administered in Arm Left on 09Feb2021 15:00 (at the age of 68 years) as dose 1, single for COVID-19 immunisation at health Department. Medical history included high blood pressure, high cholesterol and hormone replacement. Concomitant medication(s) included amlodipine besylate (AMLODIPINE BESYLATE) taken for hypertension (taking it for a few years), simvastatin (SIMVASTATIN) taken for blood cholesterol increased (taking for years), estradiol (ESTRADIOL) taken for hormone replacement therapy (taking for a long time but not as long as her others. On 11Feb2021, consumer experienced itching, bumps and sometimes shortness of breath. Consumer would like to know what consumer can do about it and was there something can take so it won't come back or will it come back. Prescriber not provided. Itching and bumps came late at night around midnight and it went away all during the day and then it came back again at night, but today, it came back this morning. It did not do that yesterday. Shortness of breath came back this morning but consumer does not have it now. The patient underwent lab tests and procedures on an unspecified date which included blood cholesterol and blood pressure measurement: high. The outcome of event occasional shortness breath was recovering and for all rest events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pruritus, SARS-CoV-2 test negative
Clinical narrative: bad allergic reactions; itchy on my hand, fingers and feet; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left on 14Feb2021 09:45 as DOSE 1, SINGLE for COVID-19 immunization. Patient is allergic to Solumedrol, Methylprednisolone and Penicillin. Patient took shots of methyprednisolone and Solumedrol shot, 2 weeks before the Pfizer vaccine shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient had a bad allergic reaction off the methyprednisolone and Solumedrol shot. Possibly patient still had it still in the system. Patient had had itchy on the hand, fingers and feet from the Pfizer vaccine shot on 14Feb2021. Adverse event resulted in emergency room/department or urgent care and received treatment with Benadryl for the adverse event. Event recovered on an unspecified date. Since the vaccination, patient underwent sars-cov-2 test/nasal swab: negative on unspecified date.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pruritus
Clinical narrative: Itchiness all over body/ inside of mouth was itchy too; Itchiness all over body/ inside of mouth was itchy too; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 at 11:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history includes Augmentin allergy. Concomitant medications were not reported. There was no other vaccine within four weeks of vaccination. The patient did not had Covid prior vaccination and not tested for Covid post vaccination. On 15Feb2021 at 17:30, the patient experienced itchiness all over body and inside of mouth was itchy too. The event subsided with Benadryl. The patient recovered from event in 2021.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Disorientation
Clinical narrative: blood pressure at 273; disoriented; weak; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable Consumer reported for a female patient. A female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Medical history included patient was diabetic. Concomitant medication was not reported. On an unspecified date, patient experienced blood pressure at 273, disoriented and weak. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure 10 days after receiving second dose on 11Feb2021.  He felt off, and his neck felt weird, and he checked his blood pressure.  His was usually 110/70 and now it was around 165/100.; This is a spontaneous report from a contactable consumer (patient himself). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry dates were not provided), via unspecified route of administration, in the left arm, on 01Feb2021 (at the age of 75-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included pain was stared from unknown dates and unknown if ongoing. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication included meloxicam (strength: 15mg) 15mg once a day by mouth for pain, works really good, taking about 3 years or so. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry dates were not provided), via unspecified route of administration, on an unknown date (it was 21 days before his second dose) as a single dose for COVID-19 immunization. Patient received second Pfizer dose on 01Feb2021. Patient developed high blood pressure 10 days after receiving second dose on 11Feb2021. He felt off, and his neck felt weird, and he checked his blood pressure. It was usually 110/70 and now it was around 165/100. Patient stated that about 10 days after taking the second shot, he got high blood pressure, states he cannot say if it was related to the vaccine, but has never had high blood pressure in his life, wants to know if other people have experienced this. Patient did go to the doctor and was put on medication, it has not helped much, medication is the generic for Norvasc, amlodipine 5mg, one time a day by mouth. Patient received amlodipine treatment for high blood pressure and amlodipine not helped much. Patient required a physician Office visit for event. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paresthesias in his hands and feet; This is a spontaneous report from a contactable pharmacist. This report was received via a sales representative. A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced paraesthesia in his hands and feet. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: she had Mild pain at injection site; she discovered she has a swollen lymph node near her collar bone; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9269), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism. Concomitant medication included: levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. The patient received the first shot on Tuesday 09Feb2021. She had mild pain at injection site. She was doing great. But today Friday 12Feb2021, she discovered she had a swollen lymph node near her collar bone. The outcome of the events was unknown.  No follow-up attempts are possible. No further Information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain left hip; This is a spontaneous report from a contactable consumer (patient). An 80-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 15Feb2021 at 01:00 PM as single dose for covid-19 immunisation at doctor's office/urgent care. The patient had penicillin allergy and other relevant medical history was reported as none. Concomitant medications included budesonide, omeprazole, hydrocodone bitartrate, paracetamol (NORCO), lovastatin and metoclopramide (METROPRASIL) all received within two weeks of vaccination. The patient did not have covid prior to vaccination and was not tested for covid-19 post vaccination. Patient did not receive any other vaccine in four weeks. On 15Feb2021, at 05:00 PM, the patient experienced muscle pain left hip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain left hip included chiropractor adjustment. The outcome of the event muscle pain left hip was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Paraesthesia oral
Clinical narrative: her lips turned a blueish tint and were tingling; her lips turned a blueish tint and were tingling; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Pharmacist. A female patient (age:70, unit: not reported) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced her lips turned a blueish tint and were tingling. It was reported that a female patient around the age of 70 had her lips turned a blueish tint and were tingling, after the receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine. The reporter explained that the patient consulted with a doctor who prescribed Benadryl and her symptoms went away and further added that she was told not to receive the second dose of the vaccine. The reporter wanted to confirm if the lips turning blue was sufficient to warrant the contraindication to the second dose. The reported also asked if the patient should get the second dose of the vaccine if that was what happened. The patient received treatment for the events with Benadryl. The reporter assessed events as non serious. The outcome of the events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy shoulder for ten minutes very minor/little itchy at the wound site; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A female patient (age of 92) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Feb2021 at 15:00 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, the caller did not wish to be transferred to HCF but was okay with a call back if more information was needed. It was reported that, a week ago today, the patient went and received the Pfizer vaccine, everything went well, nice experience. Stated that, no after effects. The only thing was she should have been given a card and it would tell her when her next appointment was. Stated that, her granddaughter took her cause she was on oxygen. Just a couple of days later, she had an itchy shoulder for ten minutes very minor, on 14Feb2021, Sunday morning, following vaccine on Friday afternoon at 3 pm of first dose of the Pfizer vaccine. It was a little itchy at the wound site, that's all and she didn't do anything about that. Stated that, she didn't think anything of that, it was on her right side. Treatment was not received for the event. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Dizziness, Fatigue
Clinical narrative: mild nausea; Fatigue; diffuse myalgia; Arthralgia; T 37.5; Palpitations; Tingling in feet and hands; mild lightheadedness; headache; This is a spontaneous report received from a contactable other healthcare professional (patient). A 43-year-old female patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot Number: EL3249), intramuscular, administered in arm left on 09Feb2021 12:15 as dose 1, single for covid-19 immunisation. Medical history included ongoing headache, GI discomfort from NSAIDs, possibly gluten. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, did not experienced covid prior and post vaccination. On 09Feb2021 12:45 (after 30 min after injection), the patient experienced tingling in feet and hands, mild lightheadedness, headache, on 09Feb2021 20:15 (after 8 hrs after injection), the patient experienced palpitations, on 10Feb2021 00:15 (12 hrs after injection), the patient experienced mild nausea, fatigue, diffuse myalgia, arthralgia, temp 37.5. On 10Feb2021, the patient underwent lab tests which included body temperature: 37.5. Therapeutic measures were taken as a result of temperature 37.5 (body temperature abnormal). The clinical outcome of the tingling in feet and hands, mild lightheadedness, palpitations, mild nausea, fatigue, diffuse myalgia, arthralgia was unknown and of the headache, temp 37.5 was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Palpitations, Paraesthesia
Clinical narrative: mild nausea; Fatigue; diffuse myalgia; Arthralgia; T 37.5; Palpitations; Tingling in feet and hands; mild lightheadedness; headache; This is a spontaneous report received from a contactable other healthcare professional (patient). A 43-year-old female patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot Number: EL3249), intramuscular, administered in arm left on 09Feb2021 12:15 as dose 1, single for covid-19 immunisation. Medical history included ongoing headache, GI discomfort from NSAIDs, possibly gluten. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, did not experienced covid prior and post vaccination. On 09Feb2021 12:45 (after 30 min after injection), the patient experienced tingling in feet and hands, mild lightheadedness, headache, on 09Feb2021 20:15 (after 8 hrs after injection), the patient experienced palpitations, on 10Feb2021 00:15 (12 hrs after injection), the patient experienced mild nausea, fatigue, diffuse myalgia, arthralgia, temp 37.5. On 10Feb2021, the patient underwent lab tests which included body temperature: 37.5. Therapeutic measures were taken as a result of temperature 37.5 (body temperature abnormal). The clinical outcome of the tingling in feet and hands, mild lightheadedness, palpitations, mild nausea, fatigue, diffuse myalgia, arthralgia was unknown and of the headache, temp 37.5 was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Diarrhoea
Clinical narrative: got restless; pain in muscles bones joints; muscles bones joints; muscles bones joints; fever 99.8; skin sensitive; chills; nausea; raging headache; massive thirst; loose stool; significant site pain; This is a spontaneous report from a contactable Nurse (patient) reported that: A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 12:00 PM, (Batch/Lot Number: EL9261) as dose 2 single for covid-19 immunization. The past medical history includes hiv-undetectsble and healthy. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for an unspecified indication, pravastatin taken for an unspecified indication, celecoxib (CELEBREX) taken for an unspecified indication, fluticasone propionate taken for an unspecified indication and azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Feb2021 12hr after the vaccination the patient experienced got restless, pain in muscles bones joints, fever 99.8, skin sensitive, chills, nausea-no emesis, raging headache, massive thirst, loose stool-not diarrhea, and significant site pain-no swelling or redness. The lab test include: body temperature: Result:99.8 on 10Feb2021.The patient is treated with Tylenol, tramadol and massive hydration. The event outcome was recovered on unspecified date 2021.   No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Restlessness
Clinical narrative: got restless; pain in muscles bones joints; muscles bones joints; muscles bones joints; fever 99.8; skin sensitive; chills; nausea; raging headache; massive thirst; loose stool; significant site pain; This is a spontaneous report from a contactable Nurse (patient) reported that: A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 12:00 PM, (Batch/Lot Number: EL9261) as dose 2 single for covid-19 immunization. The past medical history includes hiv-undetectsble and healthy. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for an unspecified indication, pravastatin taken for an unspecified indication, celecoxib (CELEBREX) taken for an unspecified indication, fluticasone propionate taken for an unspecified indication and azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Feb2021 12hr after the vaccination the patient experienced got restless, pain in muscles bones joints, fever 99.8, skin sensitive, chills, nausea-no emesis, raging headache, massive thirst, loose stool-not diarrhea, and significant site pain-no swelling or redness. The lab test include: body temperature: Result:99.8 on 10Feb2021.The patient is treated with Tylenol, tramadol and massive hydration. The event outcome was recovered on unspecified date 2021.   No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin sensitisation, Thirst, Vaccination site pain
Clinical narrative: got restless; pain in muscles bones joints; muscles bones joints; muscles bones joints; fever 99.8; skin sensitive; chills; nausea; raging headache; massive thirst; loose stool; significant site pain; This is a spontaneous report from a contactable Nurse (patient) reported that: A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 12:00 PM, (Batch/Lot Number: EL9261) as dose 2 single for covid-19 immunization. The past medical history includes hiv-undetectsble and healthy. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for an unspecified indication, pravastatin taken for an unspecified indication, celecoxib (CELEBREX) taken for an unspecified indication, fluticasone propionate taken for an unspecified indication and azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Feb2021 12hr after the vaccination the patient experienced got restless, pain in muscles bones joints, fever 99.8, skin sensitive, chills, nausea-no emesis, raging headache, massive thirst, loose stool-not diarrhea, and significant site pain-no swelling or redness. The lab test include: body temperature: Result:99.8 on 10Feb2021.The patient is treated with Tylenol, tramadol and massive hydration. The event outcome was recovered on unspecified date 2021.   No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; As days went by it is worsening; Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; Tingling in pinky and ring finger; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9261), via an unspecified route of administration on 20Jan2021 at 16:00 (at the age of 58-year-old), as dose 1, single in left arm for COVID-19 immunisation at nursing home. The patient's medical history included chicken pox at age 32; and flu vaccine, but it was beyond 4 weeks. Patient did not receive any vaccine within 4 weeks prior vaccinations. Concomitant medications were not reported. On 20Jan2021, right after COVID Vaccine, the patient experienced weird tingling in pinky and ring finger. Patient thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Patient felt like she had pins and needles around her body. Patient doesn't want to get the second shot on scheduled day. Patient was concerned because the pins and needle feeling were not going away. Figured reaction was initially arm pain. It progressively spread around her body. Patient thought it was going to get better, but it didn't. It had been three weeks in. Patient was confident and praying it will go away. Pins and needles feeling occurred every day but stopped and appeared depending on how patient moves. Patient thought it was a nerve problem. Patient never had this. Patient tried to take a lot of vitamins and took care of herself. The clinical outcome of all events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: slight rise of temperature after the first dose; This is a spontaneous report from a contactable consumer or other non healthcare professional..A 85-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced slight rise of temperature after the first dose on 2021. The patient underwent lab tests and procedures which included slight rise of body temperature. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Urticaria
Clinical narrative: Itching; Redness; Rashes further spreading over both her legs and also both her arms; hives all over; felt warm to touch her lower back only; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 01Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took pneumonia shot and had adverse reactions on it. Patient received her COVID vaccine the first dose of on the 01Feb2021 and after receiving the vaccine about five hours, on unspecified date of feb2021, she noticed itching, redness and that felt warm to touch on her lower back only and day later she noticed it was spreading to her legs and her arms. Patient prescribed with topical steroid cream (Unspecified Medication) and that was not helping. She also tried using hydroxyzine which she tried for one night and she did not notice any improvement, then she noticed her rash further spreading over both her legs and also both her arms and lots of itching/very severe itching. She visited to the physician on 08Feb2021, and the physician observe that, she had hives all over her body and put her on prednisone for five days 40 mg daily for 5 days and also told her to start Claritin 10 mg daily and take Benadryl as needed, after that she thinks she was feeling better she felt about 40 to 50 percent better, the hives has gotten better but she seems to still had periodic itching which was quite severe, and for that she was using steroid cream and which does seem to help. The clinical outcome of the event hives has recovering, the event itching it was not recovered and for other it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Hypertensive crisis
Clinical narrative: blood pressure went up; blood pressure went up/Blood Pressure 180/100, her baseline is 130/80; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265),via an unspecified route of administration, administered in Arm Left on 28Jan2021 13:00 (at the age of 85-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing basedow's disease (Graves' disease: she had this for 30 years) and it was ongoing; blood pressure increased and it was ongoing; fibromyalgia (she has not had an episode in the last 10 years but had several earlier in her life, this one thing that concerns her about the second dose as she doesn't want to have any more episodes). The patient's concomitant medications were not reported. The patient previously took tetanus toxoid (she had a reaction to tetanus toxoid, it was a long time ago and given at the doctor's office, she has no manufacturer, NDC, lot, or expiry for that product). Patient did not have any adverse events prior vaccination, as reported. No family medical history. Patient did not receive other vaccine in four weeks of vaccination. On Jan2021, the patient experienced blood pressure went up. The patient had high blood pressure for years but has been under control until noticing the big jump. Doctor put her on another medication, more Hydrochlorothiazide, which is the water medication. It was clarified that the dose was increased for the Hydrochlorothiazide and that is continuing now, not a new medication that was added. She has no NDC, Lot, or Expiry for that product. The patient visited physician office for adverse event. The events was serious (medically significant). The patient underwent lab tests and procedures which included blood pressure measurement: high bp 180/100 (noted by the caller 180/100) on Jan2021 and normal bp 130/80 on Feb2021 (baseline is 130/80, as reported). Therapeutic measures were taken as a result of blood pressure went up. The Outcome of events was recovered on Feb2021.  Additional Context: Caller, reporting on the Pfizer COVID vaccine, and who explains she had the first vaccine and a day or so later her blood pressure went up until the doctor gave more medicine. Caller has questions about the vaccine. Caller was an X-ray tech. It was stated the first shot was given on 28Jan2021. She noticed on either 29Jan2021 or 30Jan2021. Caller explains that about a week after the event is when the issue resolved. It was noted by the caller 180/100, her baseline is 130/80. No other testing lab or treatment other than the increase in her dose of Hydrochlorothiazide. She is going for the second vaccine in a few days and has concerns regarding her fibromyalgia. Caller asks if we are keeping tract to the reaction after the second dose, what to expect.   Follow-up attempts completed. No further information expected.