chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on abdomen; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO-140), via an unspecified route of administration on left arm at 10:15 on 03Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced rash on abdomen on 05Jan2021 at 08:00. The patient did not receive any treatment for event. The outcome of event was not recovered. The patient was not diagnosed COVID prior vaccination; The patient had not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling hot, Palmar erythema, Paraesthesia, Petechiae
Clinical narrative: itchy almost everywhere; palms very pink and can see tiny vessels (petechia); palms very pink and can see tiny vessels (petechia); feels like a lot of blood to extremities - warm and tingly; feels like a lot of blood to extremities - warm and tingly; huge rashes on bilateral abdomen and neck.; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced huge rashes on bilateral abdomen and neck on 08Jan2021 and itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly on 10Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient received the first dose of vaccine on 05Jan2021 and three days later, on 08Jan2021, noticed huge rashes on bilateral abdomen and neck. The rash was noticed after shower and went away after about an hour and a half (as reported). The patient woke up on 10Jan2021, itchy almost everywhere. The palms were very pink and can see tiny vessels (petechia). It was reported to have felt like when you go for a run and feel like you get a lot of blood to your extremities - warm and tingly (as reported). The patient was seen at an urgent care and did a blood test, on an unspecified date, with results still pending (unknown results). The clinical outcome of huge rashes on bilateral abdomen and neck was recovered in Jan2021 and of itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy almost everywhere; palms very pink and can see tiny vessels (petechia); palms very pink and can see tiny vessels (petechia); feels like a lot of blood to extremities - warm and tingly; feels like a lot of blood to extremities - warm and tingly; huge rashes on bilateral abdomen and neck.; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced huge rashes on bilateral abdomen and neck on 08Jan2021 and itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly on 10Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient received the first dose of vaccine on 05Jan2021 and three days later, on 08Jan2021, noticed huge rashes on bilateral abdomen and neck. The rash was noticed after shower and went away after about an hour and a half (as reported). The patient woke up on 10Jan2021, itchy almost everywhere. The palms were very pink and can see tiny vessels (petechia). It was reported to have felt like when you go for a run and feel like you get a lot of blood to your extremities - warm and tingly (as reported). The patient was seen at an urgent care and did a blood test, on an unspecified date, with results still pending (unknown results). The clinical outcome of huge rashes on bilateral abdomen and neck was recovered in Jan2021 and of itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever of 101; chills; This is a spontaneous report from a contactable consumer and nurse.  A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 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 previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization.  The patient experienced a fever of 101 and chills on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date.  The clinical outcome of fever of 101 and chills was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Lethargy
Clinical narrative: Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Decreased appetite, Fatigue
Clinical narrative: Fever; chills; sweating; nausea; elevated BP; pale face; fatigue; loss of appetite; This is a spontaneous report from a contactable Other HCP. A 32-year-old male patient reported that he received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1283), at single dose on 09Jan2021 at 03:30 PM for COVID-19 immunization. The patient had received first dose of BNT162B2 (lot number: EJ1685)  on 19Dec2020. O n 12Dec2020 the patient was Covid tested via Nasal Swab COVID-19 PCR and the result was negative. On 10Jan2021 at 12:30 PM the patient experienced fever, chills, sweating, nausea, elevated BP, pale face, fatigue, loss of appetite. No treatment was received. The patient did not have Covid prior vaccination.  At the time of reporting the patient had not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pallor, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; chills; sweating; nausea; elevated BP; pale face; fatigue; loss of appetite; This is a spontaneous report from a contactable Other HCP. A 32-year-old male patient reported that he received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1283), at single dose on 09Jan2021 at 03:30 PM for COVID-19 immunization. The patient had received first dose of BNT162B2 (lot number: EJ1685)  on 19Dec2020. O n 12Dec2020 the patient was Covid tested via Nasal Swab COVID-19 PCR and the result was negative. On 10Jan2021 at 12:30 PM the patient experienced fever, chills, sweating, nausea, elevated BP, pale face, fatigue, loss of appetite. No treatment was received. The patient did not have Covid prior vaccination.  At the time of reporting the patient had not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician. A 48-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular 09Jan2021 10:00 am in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. Facility type vaccine was in hospital. Other medications in two weeks was none. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient had fever up to 100.4, chills, body aches on 10Jan2021 09:00 AM.  No treatment was received for the events. Outcome of events were recovering.   Information on the batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Off label use
Clinical narrative: chills; muscle aches; fatigue; a fever of 103 F; currently breastfeeding mother received the vaccine; currently breastfeeding mother received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is the maternal case.   A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the right arm, on 08Jan2021 at 05:45 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension, non-ongoing COVID-19 from Apr2020 to an unspecified date (1.5 weeks with symptoms at 28 weeks pregnant; recovered), and breastfeeding from an unspecified date and ongoing. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included labetalol (MANUFACTURER UNKNOWN) and an unspecified postnatal vitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, muscle aches, fatigue, and a fever of 103 F on 08Jan2021 at 19:00. The events were reported as non-serious. The currently breastfeeding mother received the vaccine on 08Jan2021 at 05:45. The clinical course was reported as follows: Approximately 12 hours (as reported) after the vaccine, the patient developed chills, muscle aches, fatigue, and a fever and body temperature of 103 F on 08Jan2021 at 19:00. The patient was treated with an unspecified antipyretic and the fever and body temperature spiked to 103 F again during the night. The next day (24-48 hours post vaccine), the patient had a fever and body temperature of 100-101.7 F on 09Jan2021, intermittently while treating with ibuprofen (MANUFACTURER UNKNOWN). The chills were not as bad as before, but body aches and fatigue were still present. On 10Jan2021, over 48 hours post-vaccine, the patient felt mostly fatigued with body temperature of 99 F. At 13:00 on 10Jan2021, the fever came back at body temperature of 101.6 F, which was treated with ibuprofen. Therapeutic measures were taken as a result of chills, muscle aches, fatigue, and a fever of 103 F as aforementioned. The clinical outcome of chills, muscle aches, fatigue, and a fever of 103 F was recovering and of currently breastfeeding mother received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022120 same reporter, different patient/event (baby case)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia
Clinical narrative: chills; muscle aches; fatigue; a fever of 103 F; currently breastfeeding mother received the vaccine; currently breastfeeding mother received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is the maternal case.   A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the right arm, on 08Jan2021 at 05:45 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension, non-ongoing COVID-19 from Apr2020 to an unspecified date (1.5 weeks with symptoms at 28 weeks pregnant; recovered), and breastfeeding from an unspecified date and ongoing. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included labetalol (MANUFACTURER UNKNOWN) and an unspecified postnatal vitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, muscle aches, fatigue, and a fever of 103 F on 08Jan2021 at 19:00. The events were reported as non-serious. The currently breastfeeding mother received the vaccine on 08Jan2021 at 05:45. The clinical course was reported as follows: Approximately 12 hours (as reported) after the vaccine, the patient developed chills, muscle aches, fatigue, and a fever and body temperature of 103 F on 08Jan2021 at 19:00. The patient was treated with an unspecified antipyretic and the fever and body temperature spiked to 103 F again during the night. The next day (24-48 hours post vaccine), the patient had a fever and body temperature of 100-101.7 F on 09Jan2021, intermittently while treating with ibuprofen (MANUFACTURER UNKNOWN). The chills were not as bad as before, but body aches and fatigue were still present. On 10Jan2021, over 48 hours post-vaccine, the patient felt mostly fatigued with body temperature of 99 F. At 13:00 on 10Jan2021, the fever came back at body temperature of 101.6 F, which was treated with ibuprofen. Therapeutic measures were taken as a result of chills, muscle aches, fatigue, and a fever of 103 F as aforementioned. The clinical outcome of chills, muscle aches, fatigue, and a fever of 103 F was recovering and of currently breastfeeding mother received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022120 same reporter, different patient/event (baby case)
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache; Fever; Chills; Muscle ache; Feeling nauseous; This is a spontaneous report from a non-contactable consumer (parent of the patient).   A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 06:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, chills, muscle ache, on an unspecified date. These symptoms were gone on unspecified date. On unspecified date the patient has been feeling nauseous all day, with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; This is a spontaneous report from a contactable Physician (patient).  A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 28Dec2020 12:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced r axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination on 29Dec2020 with outcome of recovering. The patient was not treated due to the events. The patient underwent nasal swab covid test on 04Jan2021 and was negative. The patient did not experienced covid prior to vaccination.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Malaise, Nausea
Clinical narrative: just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "having some high blood pressure", she "feels like throwing up" and "she doesn't feel well". The patient outcome of the events was unknown.  The information on the batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Rash
Clinical narrative: Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable other health professional.   This report involves a 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 09Jan2021 10:45 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dose for covid-19 immunisation. On 10Jan2021, the patient experienced rash, temp of 101, body aches with outcome of recovering.  The vaccine was administered at Hospital Facility. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.  Information on the Lot/Batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Right sided cervical lymphadenopathy; 1st dose administration date: 22Dec2020; 2nd dose administration date: 09Jan2021; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 29-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, on 22Dec2020 at 06:45 (lot number: EK5730) at 29 years of age and the second dose on 09Jan2021 at 11:00 (Lot number: EL3248), at 29 years of age, both via an unspecified route of administration in right arm, at single dose for COVID-19 immunization. The patient was vaccinated at facility hospital and was not pregnant when she received the vaccine. Medical history included hypothyroidism and rhinitis allergic, both from an unknown date. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), fluticasone propionate (FLONASE), levothyroxine sodium (SYNTHROID) and cetirizine hydrochloride (ZYRTEC). On 10Jan2021 the patient experienced right sided cervical lymphadenopathy, in deep anterior chain, under right sternocleidomastoid (SCM) muscle, tender to palpation, assessed as non-serious. No treatment was administered to the patient for the reported event. The patient was tested for Covid twice: once in Jul2020 via blood test (SARS COV-2 Antibody) and once in Nov2020 via nasal swab (test name: Sofia Rapid COVID antigen test) and both tests had negative result. At the time of the report the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral mucosal erythema, Swollen tongue, Tongue erythema
Clinical narrative: swollen lips and tongue, redness on tongue and inside of lips.; swollen lips and tongue, redness on tongue and inside of lips.; swollen lips and tongue, redness on tongue and inside of lips.; swollen lips and tongue, redness on tongue and inside of lips.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN), hyperlipidaemia (HLD) and arthritis from. The patient's concomitant medications included adalimumab (HUMIRA).  The patient received her first dose of Pfizer Biontech Covid 19 vaccine on05Jan2021. She began feeling symptoms on 06Jan2021. She reported the following: swollen lips and tongue, redness on tongue and inside of lips. On 07Jan2021, the symptoms persisted, and the patient took Benadryl and Claritin. Her symptoms were still present at the time of report. She would like to know if she should get the second dose. And if there was any literature available for patients who take Humira and receive the vaccine.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site pain
Clinical narrative: My left arm is sore, where the injection site was, near my armpit, the flank below my breast - that area is considerably more swollen than the other; My left arm is sore, where the injection site was, near my armpit, the flank below my breast - that area is considerably more swollen than the other; My left arm is sore, where the injection site was, near my armpit, the flank below my breast - that area is considerably more swollen than the other; This is a spontaneous report from a contactable other health professional. A male patient of an unspecified age (Age: 43; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 20Dec2020 at a single dose on left arm, and the second dose via an unspecified route of administration on 08Jan2021 10:30 at a single dose on left arm, both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported: "got second dose 08Jan2021 at 10:30 am, first dose on 20Dec2020. My left arm is sore, where the injection site was, near my armpit, the flank below my breast - that area is considerably more swollen than the other." The outcome of the events was unknown. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Echocardiogram normal, Hypertensive emergency, Pain
Clinical narrative: Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, SARS-CoV-2 test negative
Clinical narrative: Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Inappropriate schedule of product administration, Lymph node pain
Clinical narrative: High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in Injection site; Lymph nodes swelling and pain; Lymph nodes swilling and pain; received the first dose on 18Dec2020 and the second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3746), via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the left arm on 18Dec2020 at 07:30 at a single dose as COVID-19 immunization. The patient had no other vaccine in four weeks, no COVID prior vaccination, and did not test post-vaccination. The patient had a rash, high fever every 3 hours, vomiting, very bad headache, joint pain, fatigue, pain in injection side, lymph nodes swelling and pain on 08Jan2021 at 12:00. No treatment was administered for the events. The events were resolving.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Rash, Vaccination site pain, Vomiting
Clinical narrative: High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in Injection site; Lymph nodes swelling and pain; Lymph nodes swilling and pain; received the first dose on 18Dec2020 and the second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3746), via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the left arm on 18Dec2020 at 07:30 at a single dose as COVID-19 immunization. The patient had no other vaccine in four weeks, no COVID prior vaccination, and did not test post-vaccination. The patient had a rash, high fever every 3 hours, vomiting, very bad headache, joint pain, fatigue, pain in injection side, lymph nodes swelling and pain on 08Jan2021 at 12:00. No treatment was administered for the events. The events were resolving.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: exposed to covid; antibody test which also came back negative; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he was exposed to COVID, experienced no symptoms but had a rapid test that came back negative and the provider also did an antibody test which also came back negative. The patient asked if it was normal to have a negative IgG antibody test after being vaccinated with his first dose two weeks prior to reporting. Outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: having significant diarrhea intermittently; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 experienced having significant diarrhea intermittently on an unspecified date and wanted to know if diarrhea is a common side effect of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches; fever; This is a spontaneous report from a contactable physician. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot numbers EL0140 and EK9231), first dose via an unspecified route of administration on the left arm on 19Dec2020 at 08:00 and then via an unspecified route of administration on the on second dose via an unspecified route of administration on the right arm at 08:30 at a single dose, all for Covid-19 vaccination. Patient medical history was not reported. The patient has known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID).  Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested. On 19Jan2021, The patient experienced muscle aches and fever. There was no treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Product use issue, Smear test
Clinical narrative: currently lactating; currently lactating; Two swollen lymph nodes above left clavicle; This is a spontaneous report from a contactable other health professional.  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, from 21Dec2020 08:45 at a SINGLE DOSE for covid-19 immunization. Medical history included currently lactating and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included fish oil, calcium and lecithin. The patient experienced two swollen lymph nodes above left clavicle on 26Dec2020. The patient underwent lab tests and procedures on 08Jan2021 which included nasal swab test with negative result. The outcome of event "two swollen lymph nodes above left clavicle" was not recovered whereas the outcome of other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027508 baby case
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: fever; Chills; Fatigue; had flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, fatigue and had flu like symptoms. Clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: fatigue; flu like symptoms; This is a spontaneous report from a contactable nurse via Pfizer sales representative.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue and flu like symptoms on an unspecified date with outcome of unknown. The patient  had to call in sick for days.  That information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very little ache in the arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable other healthcare professional (HCP).  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medications were not reported. The patient experienced very little ache in the arm when he took the first dose. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Limb discomfort, Lymphadenopathy
Clinical narrative: fever with temperature of 100.5; feel like I have the flu; freezing cold chills; nausea; not feeling well; swollen lymph nodes; poking under my arms. little bit to be irritated; more pain and discomfort under my arm/soreness on the arm; discomfort under my arm; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccination with first dose of BNT162B2 on unspecified date and experienced "soreness at reaction site, it was red and swollen. The patient got all but 1-2 regular small effects, fever with temperature of 100.5. The patient stated, "I feel like I have the flu, hit by a bus, freezing cold chills, nausea, not feeling well, swollen lymph nodes, poking under my arms, little bit to be irritated and on a scale of 1-10, it's a 4". The patient have more pain and discomfort under arm, soreness on the arm itself. On Saturday morning, the patient had all the other side effects. The patient has been taking 600-800mg of Tylenol for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Skin irritation
Clinical narrative: fever with temperature of 100.5; feel like I have the flu; freezing cold chills; nausea; not feeling well; swollen lymph nodes; poking under my arms. little bit to be irritated; more pain and discomfort under my arm/soreness on the arm; discomfort under my arm; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccination with first dose of BNT162B2 on unspecified date and experienced "soreness at reaction site, it was red and swollen. The patient got all but 1-2 regular small effects, fever with temperature of 100.5. The patient stated, "I feel like I have the flu, hit by a bus, freezing cold chills, nausea, not feeling well, swollen lymph nodes, poking under my arms, little bit to be irritated and on a scale of 1-10, it's a 4". The patient have more pain and discomfort under arm, soreness on the arm itself. On Saturday morning, the patient had all the other side effects. The patient has been taking 600-800mg of Tylenol for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Neck pain, Vaccination site pain
Clinical narrative: sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: having symptoms, tested covid+(positive); having symptoms, tested covid+(positive); This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient started having symptoms on 23Dec2020 and she was tested for COVID 19 on 27Dec2020 and resulted positive. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015240 Same patient/reporter, 2nd dose of drug, different AE
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Fatigue, Headache
Clinical narrative: My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.