chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: she had a rapid test performed which indicated a positive test result; she had a rapid test performed which indicated a positive test result; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient indicated she received the first dose of the vaccine on the 18th and due to a family member testing positive, she had a SARS-CoV-2 rapid test performed in Dec2020 which indicated a positive test result. Her employment was questioning as to whether this is due to her receipt of vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; This is a spontaneous report from a contactable physician via a Pfizer sponsored program Pfizer First Connect. A 29-year-old female patient received their first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know how long they have to wait for the second dose of the COVID vaccine as her resident (patient) tested positive for COVID on 27Dec2020, 10 days after the first dose of COVID vaccine given to her on the 17Dec2020. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Dec2020. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE and SARS-CoV-2 test positive, based on temporal relationship.  There is very limited information provided in this report.   This case will be reassessed upon receipt of follow-up information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Suffocation feeling
Clinical narrative: he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; was given the first COVID-19 dose. After some time, the employee got symptomatic and was tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient who is employed in a hospital tested negative for COVID-19 then was given the first COVID-19 dose. After some time, the patient got symptomatic and was tested positive for COVID-19. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. The case will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Condition aggravated, Dizziness, Fatigue, Flushing
Clinical narrative: Angioedema of lips, throat, eyes, hands.  Flushing of hands; Angioedema of lips, throat, eyes, hands.  Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Joint stiffness, Limb discomfort, X-ray
Clinical narrative: Angioedema of lips, throat, eyes, hands.  Flushing of hands; Angioedema of lips, throat, eyes, hands.  Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysgeusia, Heart rate, Palpitations
Clinical narrative: tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash macular, SARS-CoV-2 test, Tachycardia
Clinical narrative: tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Painful, swollen lymph nodes in L chest; Painful, swollen lymph nodes in L chest; arm pit, muscle aches; arm pit, muscle aches; This is a spontaneous report from a contactable nurse (patient) reporting for herself.  A 37-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration at left arm on 24Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension, depression and anxiety. No known allergies to medications, food, or other products. Concomitant medication included alprazolam (XANAX), diclofenac (VOLTAREN), bupropion hydrochloride (WELLBUTRIN XL), amlodipine besilate (NORVASC), and diphenhydramine hydrochloride (BENADRYL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 25Dec2020 05:00, the patient experienced painful, swollen lymph nodes in left (L) chest, and arm pit, muscle aches. No treatment was taken for the above events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pharyngeal swelling
Clinical narrative: Throat swelling; Dizziness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A male patient of unspecified age received the first dose of bnt162b2 (lot number: EL1284), intramuscularly on the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and dizziness on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased
Clinical narrative: chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 26Dec2020. Outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number could not be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, a dispatch operator for a hospital, reported that she received the COVID vaccine a week ago on 22Dec2020. She stated that her period stopped two days prior to receiving the COVID vaccine. On 22Dec2020, after receiving the vaccine, she started bleeding heavily and is still currently bleeding. The patient wanted to know what she should do to stop the bleeding. The clinical outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: feeling rundown; feeling sick; headache; Flu like symptoms; Chills; intermittent fever/ low grade fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration, in left arm on 20Dec2020 at single dose for COVID-19 immunization. His work was offering the vaccine to them, and he was a first responder, so he went to the hospital where they were administering it. Medical history was none. There were no concomitant medications. The patient received no other vaccines or new medications with the COVID-19 vaccine. The patient experienced headache, flu like symptoms and chills on 20Dec2020 and intermittent fever in Dec2020. The patient was a first responder who received the COVID-19 vaccine on 20Dec2020. He experienced headache, flu like symptoms and intermittent fever. The patient stated that he started feeling "a little bit better" for a couple of days but now he has a fever again. His work had him take a COVID-19 test on 24Dec2020 due to his symptoms and he was negative. He was asking what he should do since he is experiencing continued symptoms. The patient said he has some questions about the COVID vaccine, since he received the first dose on 20Dec2020. He said that the day he had it he had a bad headache, chills, and flu like symptoms, then the next day the same thing, then later that night a fever, then the next day a fever. He said on Christmas Eve he got a COVID test to rule it out, and the test was negative. He said he was feeling better, then on 27Dec2020 he started feeling sick with a fever, then on 28Dec2020 a low grade fever and feeling rundown. The patient said he had a nasal swab COVID-19 test done, the one with 3-5 days for results. He said that the test itself was done on 24Dec2020. He said that the temperature for his low grade fever was 100.3 degrees Fahrenheit. His question was about the side effects, since he knew that these are listed that they can be side effects. He said it just kind of worries him since he felt better and now he feels sick again and popped a fever. He said that he called his doctor, and they said they are not gonna do a second COVID test, and told him to rest. He said he doesn't think this is normal though. Treatment of the events included Ibuprofen. The patient clarified to Advil. He said he took the recommended dose of two pills, 200 mg each. Advil: UPC: Unknown, Lot: DL9107 EXP: Jan2023. He said he took the Advil maybe once a day, the first two days. The lab test included temperature: 100.3 degrees Fahrenheit in Dec2020 and COVID-19 nasal swab test: negative on 24Dec2020. The outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: feeling rundown; feeling sick; headache; Flu like symptoms; Chills; intermittent fever/ low grade fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration, in left arm on 20Dec2020 at single dose for COVID-19 immunization. His work was offering the vaccine to them, and he was a first responder, so he went to the hospital where they were administering it. Medical history was none. There were no concomitant medications. The patient received no other vaccines or new medications with the COVID-19 vaccine. The patient experienced headache, flu like symptoms and chills on 20Dec2020 and intermittent fever in Dec2020. The patient was a first responder who received the COVID-19 vaccine on 20Dec2020. He experienced headache, flu like symptoms and intermittent fever. The patient stated that he started feeling "a little bit better" for a couple of days but now he has a fever again. His work had him take a COVID-19 test on 24Dec2020 due to his symptoms and he was negative. He was asking what he should do since he is experiencing continued symptoms. The patient said he has some questions about the COVID vaccine, since he received the first dose on 20Dec2020. He said that the day he had it he had a bad headache, chills, and flu like symptoms, then the next day the same thing, then later that night a fever, then the next day a fever. He said on Christmas Eve he got a COVID test to rule it out, and the test was negative. He said he was feeling better, then on 27Dec2020 he started feeling sick with a fever, then on 28Dec2020 a low grade fever and feeling rundown. The patient said he had a nasal swab COVID-19 test done, the one with 3-5 days for results. He said that the test itself was done on 24Dec2020. He said that the temperature for his low grade fever was 100.3 degrees Fahrenheit. His question was about the side effects, since he knew that these are listed that they can be side effects. He said it just kind of worries him since he felt better and now he feels sick again and popped a fever. He said that he called his doctor, and they said they are not gonna do a second COVID test, and told him to rest. He said he doesn't think this is normal though. Treatment of the events included Ibuprofen. The patient clarified to Advil. He said he took the recommended dose of two pills, 200 mg each. Advil: UPC: Unknown, Lot: DL9107 EXP: Jan2023. He said he took the Advil maybe once a day, the first two days. The lab test included temperature: 100.3 degrees Fahrenheit in Dec2020 and COVID-19 nasal swab test: negative on 24Dec2020. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Throat irritation, Tongue disorder, Vital signs measurement
Clinical narrative: throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site pain, Weight, Weight decreased
Clinical narrative: Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash on his arm/has grown and was now a little bit itchy; This is a spontaneous report from a contactable Physician (patient). A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at right arm on 20Dec2020 around 09:30 at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were none. The patient received Covid 19 vaccine 8 days ago (20Dec2020 around 09:30) and 5 days ago (Dec2020) he noticed a rash on his arm. The patient informed that he was not even sure if this was about the COVID-19 vaccine or if he has just associated it with it, but the rash has grown and was now a little bit itchy (Dec2020). The patient clarified that his first dose of the COVID-19 vaccine was on 20Dec2020 and he had onset of rash about 23Dec2020 or 24Dec2020, he was not exactly sure. The outcome of the event rash on his arm/has grown and was now a little bit itchy was not recovered. The reporter causality was unknown, with the information he has obtained and the conversation he just had with the inbound transfer agent it seemed a very low, slight likelihood that there was a causality relationship.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: the injection site become red and sore; the injection site become red and sore; This is a spontaneous report from a contactable Other HCP (patient). A  female patient of an unspecified age received the first dose of BNT162B2 (batch/lot number and expiration date not provided), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 18Dec2020 and did not initially have any side effects but yesterday(8 days after vaccination) the injection site become red and sore on an unknown date.  The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Freezing phenomenon, Malaise, Pyrexia, Somnolence
Clinical narrative: generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Lymphadenopathy, Swelling
Clinical narrative: L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular area; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: eh9899), intramuscularly on 22Dec2020 12:30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included ongoing hypertension, allergic to shellfish. Concomitant medication within 2 weeks of vaccination included losartan, hydrochlorothiazide, vitamin C [ASCORBIC ACID], colecalciferol (VITAMIN D), zinc, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced L armpit swollen/ L armpit lymph nodes swollen, sensation of heaviness left arm and painful scapular area from 23Dec2020 15:30. No treatment received for the adverse events. The outcome of events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other-healthcare professional (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive on 24Dec2020, and symptoms experiencing include having no taste, smell and slight body ache in Dec2020. The patient asked if she could get the second dose. The outcome of the events was unknown.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID-19, with symptoms of having no taste, smell and slight body ache, and vaccination with BNT162B2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea exertional, Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Feeling abnormal, Hot flush
Clinical narrative: aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.