chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dry throat, Influenza like illness, Nausea, Oropharyngeal pain
Clinical narrative: Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on the left arm, first dose on 18Dec2020 (lot number: EH9899) and second dose on 08Jan2021 08:15 (lot number: EL3246), both at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks prior to vaccination. The vaccine was given at a hospital. The patient reported sore/dry throat and nausea started Sunday (03Jan2021), weakness and flu-like symptoms on Monday (04Jan2021), then runny nose and tachycardia on Tuesday (05Jan2021). No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tachycardia
Clinical narrative: Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on the left arm, first dose on 18Dec2020 (lot number: EH9899) and second dose on 08Jan2021 08:15 (lot number: EL3246), both at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks prior to vaccination. The vaccine was given at a hospital. The patient reported sore/dry throat and nausea started Sunday (03Jan2021), weakness and flu-like symptoms on Monday (04Jan2021), then runny nose and tachycardia on Tuesday (05Jan2021). No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia, Lymphadenopathy
Clinical narrative: numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular lymphadenopathy; This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 08Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient had no known allergies. It was unknown if patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 for covid-19 immunization on 18Dec2020 (lot number unknown), via intramuscular route in the left arm. The vaccination was administered in the hospital. On 08Jan2021, the patient experienced numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment as gabapentin for the reported events. The patient was not tested for covid post vaccination. The events numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy were not recovered.   Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine the day before and is having chills and fever on unknown date, and she would like to know what they can take for that since they had none of this information from the place where she got the vaccine at, no information on what to take for a reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement; had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement; This is a spontaneous report from a contactable other health professional (patient).  A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0149), via an unspecified route of administration in arm left on 22Dec2020 09:45 at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination.  Medical history included known allergies: Sulpha, PCN.  Concomitant medication included famotidine (PEPCID).  The patient had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement on 23Dec2020.  The patient did not received treatment. Duration 10 days. Resolved without intervention. The outcome of events was recovered  on 02Jan2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever to 38.3; This is a spontaneous report from a contactable physician. A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm single dose for COVID-19 immunization on 09Jan2021, 06:30 PM, at 69-year-old. Medical history included: hypertension. No known allergies. The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: amlodipine, benazepril. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 19Dec2020, 06:30 PM, at 69-year-old. On 10Jan2021, 07:00 PM, the patient had fever to 38.3 which lasted about two hours. Treatment received as: acetaminophen 500 mg. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolved on 10Jan2021, 09:00 PM.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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. With the first one, the patient didn't feel any side effects other than a sore arm. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: He tested positive for Covid- 3 days without symptoms; He tested positive for Covid- 3 days without symptoms; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, by a contactable consumer (patient).  This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 22Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jan2021, the patient tested positive for Covid, 3 days without symptoms with outcome of unknown. He asked if it's okay to get the second dose. The patient underwent lab tests and procedures which included Sars CoV-2 test: positive on 06Jan2021.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect via a contactable female nurse reported for herself.  The female patient of an unspecified age received first dose BNT162B2(Covid-19) , 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.  The patient tested positive after she got the 1st vaccine, and got sick, both in Jan2021. Outcome of events was unknown.  Information about Lot/Batch has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: fatigue; headache; muscle  ache; injection  pain site; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: El1283; expiration date: unknown), via an unspecified route of administration right arm on 12Jan2021 17:15 at SINGLE DOSE for covid-19 immunization. Medical history included diabetic, high blood pressure, high cholesterol, ADHD (attention deficit hyperactivity disorder), anxiety, depression and IBS (irritable bowel syndrome). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lovastatin (LOVASTAT), bupropion hydrochloride (BUPROPION HCL XL) and networking 750mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer Covid 19 vaccine in a hospital. The patient experienced fatigue, headache and muscle ache and injection pain site on 13Jan2021 06:00 PM (18:00). The patient did not received treatment for the adverse events. The events were reported as non-serious. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever; chills; tachycardia; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), intramuscular, on 09Jan2021 10:30 AM, at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gastrooesophageal reflux disease (GERD). She had no allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685, expiry date: not reported), intramuscular, on 19Dec2020 12:00 PM, at a single dose on right arm for COVID-19 immunization. On 09Jan2021 11:00 AM, the patient experienced headache, nausea, congestion, muscle aches, extreme joint pain, fatigue, dizziness, neck pain, fever, chills and tachycardia. The adverse events resulted to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19; she had undergone Nasal Swab, test name: COVID-19 nasopharyngeal swab, on 11Jan2021 with result of negative. The patient received metoprolol as corrective treatment for the reported adverse events. Outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Neck pain, Pyrexia
Clinical narrative: Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever; chills; tachycardia; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), intramuscular, on 09Jan2021 10:30 AM, at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gastrooesophageal reflux disease (GERD). She had no allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685, expiry date: not reported), intramuscular, on 19Dec2020 12:00 PM, at a single dose on right arm for COVID-19 immunization. On 09Jan2021 11:00 AM, the patient experienced headache, nausea, congestion, muscle aches, extreme joint pain, fatigue, dizziness, neck pain, fever, chills and tachycardia. The adverse events resulted to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19; she had undergone Nasal Swab, test name: COVID-19 nasopharyngeal swab, on 11Jan2021 with result of negative. The patient received metoprolol as corrective treatment for the reported adverse events. Outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever; chills; tachycardia; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), intramuscular, on 09Jan2021 10:30 AM, at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gastrooesophageal reflux disease (GERD). She had no allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685, expiry date: not reported), intramuscular, on 19Dec2020 12:00 PM, at a single dose on right arm for COVID-19 immunization. On 09Jan2021 11:00 AM, the patient experienced headache, nausea, congestion, muscle aches, extreme joint pain, fatigue, dizziness, neck pain, fever, chills and tachycardia. The adverse events resulted to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19; she had undergone Nasal Swab, test name: COVID-19 nasopharyngeal swab, on 11Jan2021 with result of negative. The patient received metoprolol as corrective treatment for the reported adverse events. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: having a quite few side effects/not feeling well; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer(patient).  The female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. She previously received first dose BNT162B2 for COVID-19 immunization. The patient got the 2nd dose of vaccine last week 06Jan2021 but she's still having a quite few side effects/not feeling well in Jan2021. Outcome of event was not recovered.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable physician (patient). An unknown age and gender patient received 1st and 2nd dose of BNT162B2 (COVID 19 vaccine) at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced flu like symptoms after 2nd dose of the Covid 19 vaccine. Subsided the following day. Was able to go for a run. Symptoms were more severe after 2nd dose than first. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Foul taste. Everything tastes like it was slathered in old butter. Nothing tastes right; This is a spontaneous report from a contactable nurse reporting for herself. A 58-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), via an unspecified route of administration, on 06Jan2021 04:30 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient was not pregnant at the time of vaccination. Medical history included asthma and hypothyroidism. The patient had no known allergies. Concomitant medications included unspecified medications. It was reported that the patient received other medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: not reported), via an unspecified route of administration, on 16Dec2020 11:00 AM at a single dose on the right arm for COVID-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 04:30 AM, the patient experienced "Foul taste, everything tastes like it was slathered in old butter, nothing tastes right." The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any treatment for the reported adverse event. Outcome of the event was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: headache; chills; fever; muscle soreness; injection site soreness; This is a spontaneous report from a non-contactable consumer (wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 14Jan2021 19:00, the patient had headache, chills, fever, muscle soreness and injection site soreness. Outcome was unknown. Information on batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable health professional (reported for herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 (07:30 AM) at single dose for Covid-19 immunization. The patient's medical history included psoriatic arthritis, seizure disorder, and allergy to latex. Concomitant medication included esomeprazole sodium (NEXIUM). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea on 15Jan2021 (06:00 AM). There was no treatment received for the adverse event. The outcome of event was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: experience funny taste in her mouth (somewhat metallic like); This is a spontaneous report received from a non-contactable other healthcare professional. A 62-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included ongoing disability and gait disturbance (difficulty ambulating long distances due to being disabled). The patient's concomitant medications were not reported. During the patient's 15-minute waiting period after the vaccination, the patient began to experience funny taste in her mouth (somewhat metallic like). Treatment included antihistamines (unspecified). The response to treatment was good. The patient was doing well upon discharge/leaving. She was escorted out via wheelchair only due difficulty ambulating long distances due to being disabled but is otherwise at baseline. The outcome of the event was recovering (reported as "reports some improvement in change in taste prior to discharge/leaving"). The reporter assessed this case as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at site of injection; This is a spontaneous report from a contactable healthcare professional. A 48-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular (left arm) from 14Jan2021 15:00 to 14Jan2021 15:00 at a single dose for covid-19 immunization. Medical history included High Blood Pressure. Concomitant medication included losartan. The patient experienced sore arm at site of injection on 14Jan2021 21:00. No treatment was received for the event. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: after vaccination with fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 1st of 6th reports. A patient of unspecified age and gender received 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 fever, headache and body aches on an unspecified date. Event took place after use of product. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034234 Same reporter/drug/event/different patient;US-PFIZER INC-2021034230 Same reporter/drug/event/different patient;US-PFIZER INC-2021034231 Same reporter/drug/event/different patient;US-PFIZER INC-2021034232 Same reporter/drug/event/different patient;US-PFIZER INC-2021034233 Same reporter/drug/event/different patient
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: after vaccination with fever; headache; body aches; This is a spontaneous report from contactable nurse. This nurse reported similar events for 6 patients. This is 2nd of 6 reports. A patient of an unknown age and gender received 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. The patient experienced fever, headache and body aches on an unspecified date. Event took place after use of product. It was reported that "6 staff call in the day after vaccination with fever, headache and body aches". The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: after vaccination with fever; headache; body aches; This is a spontaneous report from contactable nurse. This nurse reported similar events for 6 patients. This is 3rd of 6 reports. A patient of an unknown age and gender received 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 fever, headache and body aches on an unspecified date. Event took place after use of product. It was reported that "6 staff call in the day after vaccination with fever, headache and body aches".  The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: after vaccination with fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 4th of 6th reports. A patient of unspecified age and gender received 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 fever, headache and body aches on an unspecified date. Event took place after use of product. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; body aches; This is a spontaneous report from a contactable Nurse via sales representative. This Nurse reported similar events for 6 patients. This is 5th of 6 reports.  A patient of unspecified age and gender received 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 was not reported.  The patient's concomitant medications were not reported.  The patient experienced fever, headache, body aches on an unspecified date. The outcome of events was unknown.    information on the LOT/Batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 6th of six reports. A patient of unspecified age and gender received 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 fever, headache, body aches on an unspecified date. The outcome of events was unknown.    information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Urticaria
Clinical narrative: Experiencing numbness in lips; Hives after first dose; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history included severe allergy to grass (carries an EpiPen). Concomitant medications were not reported. The patient experienced numbness in lips and hives after first dose on unspecified date. Patient was not sure if she should get the second dose which is scheduled for 21Jan. Event took place after use of product. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Nausea
Clinical narrative: Nausea; Intestinal cramping; This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. In Jan2021, the patient was experiencing nausea/intestinal cramping. Outcome was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experienced mild soreness in arm after each injection; This is a spontaneous report from a contactable physician. This physician (patient) with unknown age and gender reported that he received the first and second dose (21 days apart) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at arm (deltoid) on an unknown dates at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Patient experienced mild soreness in arm after each injection on an unknown date. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: INR last month was 2.5 and it now went up to 3.9.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (husband) of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced INR (international normalized ratio) last month was 2.5 and it now went up to 3.9 in Jan2021. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. Her husband got the 1st Covid vaccine yesterday and his INR last month was 2.5 and it now went up to 3.9. She stated he was on blood thinner's. She wanted to know if that was because of the Covid vaccine. Provided PMI number and cold transferred to PSCC for AE, since caller's husband INR test results went up after getting the 1st Covid vaccine. The patient underwent lab tests and procedures which included INR: 2.5 in Dec2020, INR: 3.9 in Jan2021. The outcome of event was unknown. Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feel very good; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), 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. Patient described that the vaccine made him "not feel very good" on an unspecified date. He did not sound overly concerned. No treatment received for the event. The outcome of the event was recovered. The event was considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal inflammation
Clinical narrative: Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and throat; Inflammation of the tongue and throat; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine for hypothyroidism. The patient previously took Demerol and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 08:30 AM, the patient experienced numbness and tingling of the lips, inflammation of the tongue and throat. No treatment was given to patient for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.  Information on the lot/batch number has been requested.?
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: Site pain; Low grade fever; Body aches; Fatigue; Loss of appetite; Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the 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 experienced site pain, low grade fever, body aches, fatigue, loss of appetite, and joint pain following 2nd dose of covid vaccine on an unspecified date. Outcome of events were unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Site pain; Low grade fever; Body aches; Fatigue; Loss of appetite; Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the 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 experienced site pain, low grade fever, body aches, fatigue, loss of appetite, and joint pain following 2nd dose of covid vaccine on an unspecified date. Outcome of events were unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over; This is a spontaneous report from a contactable nurse (reported for herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246; expiry date: not known), via an unspecified route of administration in the left arm on 11Jan2021 11:00 at single dose for COVID-19 immunization, administered in hospital. There was no medical history. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced itching all over on 15Jan2021 08:00. The reported event is considered non-serious. Therapeutic measures were taken as a result of itching all over with diphenhydramine. The outcome of the event was unknown.
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: if BNT162B2 was messing with Adderall or if that could be a symptom or side effects; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), via an unspecified route of administration from an unspecified date at unknown dose for attention deficit hyperactivity disorder (ADHD). Medical history included attention deficit hyperactivity disorder. The patient's concomitant medications were not reported. On 10Jan2021, patient felt like amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate was not working at all, like didn't take it and patient took amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate and it was like patient didn't know if BNT162B2 was messing with amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate or if that could be a symptom or side effects. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area.; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 15Jan2021 08:15 at SINGLE DOSE for COVID-19 vaccination. Medical history included osteoporosis and gastroesophageal reflux disease (GERD). The patient was not pregnant. The patient was allergic to Codeine and derivatives. Concomitant medication in two weeks included denosumab (PROLIA), piroxicam (PAXIL), omeprazole, clarithromycin (CLARITIN).  The patient previously took codeine and experienced drug hypersensitivity. On 15Jan2021 08:30, within 15 min after vaccination the patient became light headed, then tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area. Light headed went away within another 15 min and numbness within another 45, but the latter came back in the left cheek and forehead in approximately four hours. No treatment received for the events. No Covid prior vaccination, no Covid tested post vaccination. The outcome of the event light headed was recovered on 15Jan2021, of other events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Nausea, Pain, Pain in extremity
Clinical narrative: Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported.   Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; Headache; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is report 1st of 3.   A female patient of unspecified age (reported as age: 44; unit: unknown) received 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's medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and headache for about 24 hours. Events took place after receiving BNT162B2. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034919 Same drug and events, Different patient;US-PFIZER INC-2021034920 Same drug, Different patient and events
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable Physician. This reporter reported 3 cases. This is 3rd of the 3 cases. A patient of unspecified age and gender received 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 diarrhea on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034918 same reporter, drug and different pateint;US-PFIZER INC-2021034919 same reporter, drug and different pateint
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: just stiffness/stiffness in the area; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the second of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with Pfizer vaccine yesterday (12Jan2021). The patient had stiffness in the area (just stiffness) where he was injected. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025131 same reporter/drug, similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported same event for 2 patients. This is the second of 2 reports.  A patient of an unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Event was assessed as non-serious by reporter.  Information on lot number/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028267 Same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; difficult sleep; GI Symptoms; fever; body aches; This is a spontaneous report from a contactable Physician. A patient of unspecified age and gender received COVID-19 vaccine (UNSPECIFIED TRADE NAME), 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 experienced sore arm, difficult sleep, GI symptoms, fever and body aches on an unspecified date with outcome of unknown. Events took place after use of product.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: swollen lymph nodes under left arm; fatigue; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient reported swollen lymph nodes under left arm 24 hours post 2nd injection in left arm as well as fatigue after use of product. Symptoms resolved. The outcome of events was resolved.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.