chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nausea, Night sweats, Pain
Clinical narrative: left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, SARS-CoV-2 test, Skin reaction
Clinical narrative: left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: extreme sore arm - mild fever 99 degrees- fatigue- severe headache
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 02Jan2021 at 15:15 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were unknown. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Jan2021 at 19:00, the patient experienced tiredness, headache and muscle pain. No treatment was provided for the events tiredness, headache and muscle pain. The outcome of the events tiredness, headache and muscle pain was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; This is a spontaneous report from a contactable nurse.  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left deltoid on 18Dec2020 at single dose for COVID prevention.  The patient had no medical history.  There were no concomitant medications.  The patient got his first dose of the COVID Vaccine on 18Dec2020, and he states that he did fine and had no problems. But on 28Dec2020, when he was going to work, he noticed that he had like a head cold and cold like symptoms. He was swabbed and tested for COVID PCR on that day, and he tested positive for COVID. After his positive COVID test, he was tested for monoclonal antibodies, and at first, he was told that test came back positive, but then about 12 hours later, he was told that the staff had misread it, and he was actually negative for monoclonal antibodies, so the caller was given monoclonal antibody therapy and he did fine with that, and he is recovered now. He is scheduled to go back to work this Thursday, and he is supposed to receive the second dose of the vaccine, on Friday. He checked the schedule for getting the second dose, and he was not on the list, so he called the infection control nurse, and she told the caller that because he received the monoclonal antibody therapy, he now has to wait 90 days to receive the second dose of the vaccine. Caller states that he looked for that information, and he did not see that anywhere, so he is wondering if that is correct, because it almost seems to him that if he waits 90 days, he would have to start the series again. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Generalized hives
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Flank pain
Clinical narrative: Pain in left side/lower back that has persisted from 12/18/2020 til 2nd dose on 01/08/2021
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Migraine
Clinical narrative: soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose,  for COVID-19 vaccination.  Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021.    .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose,  for COVID-19 vaccination.  Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021.    .
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: High blood pressure; My pulse is like a 120; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 01Jan2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced "high blood pressure" and "my pulse is like a 120", both on unspecified dates. It was reported that the consumer stated "I got the shot today and I have been having really bad high blood pressure since I have got the immunization. How long do you think that side effect will last, or should I be going to the ER (emergency room)? My pulse is like a 120." The consumer stated that they "just got the COVID shot at their job today". The consumer was informed about the Information department, to which the consumer inquired "will that be a just a Pfizer rep or will that be an actual doctor?" The consumer was informed that there would be a live agent and that department had the information regarding the side effects of the vaccine. The consumer then asked, "for the side effects I have, I need to go to the ER then?". The consumer was suggested to visit the nearest ER if needed or can call an alternate number that was provided as the department was closed. Limited information was available over the call. The clinical outcome of the events "high blood pressure" and "my pulse is like a 120" were both unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site swelling, Pain, Vomiting
Clinical narrative: Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Menorrhagia, Menstruation irregular, Oropharyngeal pain
Clinical narrative: Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Chills; Sore throat; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history included ongoing chronic migraines.  Concomitant medications included ascorbic acid (VIT C), and ergocalciferol (VIT D). On 21Dec2020, the patient received the vaccine. After 48 hours (23Dec2020), she had chills, and a sore throat but no fever. It was mentioned that the chills and sore throat just lasted for one day. On 03Jan2021, the patient mentioned that her period came one week earlier than planned. It's was more painful and heavier. She mentioned that she always had a difficult period, but this this one seems more intensified (10 times) and was very painful. It was mentioned that the patient was getting the second one next week. The patient recovered from chills and sore throat on 24Dec2020 while not recovered for the remaining events
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Lethargy, Pyrexia
Clinical narrative: low grade fever/low grade fever of 103; chills; dry cough; lethargy; This is a spontaneous report from a contactable nurse. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 with expiry date Mar2021), via an unspecified route of administration in left deltoid on 30Dec2020 14:30 at a single dose for COVID-19 immunization. The administration was one in a local pharmacy. There were no relevant medical history and concomitant medications. On Saturday night, 02Jan2021, the patient started getting a low grade fever of 103, had chills, lethargy and an intermittent dry cough. The outcome of the events was not recovered. The events were considered medically significant events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: after 11 days, I still have a large (1/2 dollar size, red mark at the injection site that is warm to the touch and at times itchy. I had no other symptoms or reactions to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Musculoskeletal stiffness, Pruritus, Urticaria, Vaccination site erythema
Clinical narrative: Experienced swelling at the injection site; experienced redness at the injection site; experienced tenderness, and pain at the injection site; Her arm was very tense; Felt itchy; itchy at the site; A large red hive appeared; discomfort; This is a spontaneous report from a contactable consumer (patient's husband).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose (dose 1, arm) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient is a physician who received the shot at work. Reporter stated patient had a localized reaction to the COVID-19 Vaccine. On the first day after receiving the vaccine, she experienced swelling, redness, tenderness, and pain at the injection site for 24 to 48 hours, and her arm was very tense. After 3 days, the discomfort disappeared but her arm was still tight. 8 days after the injection patient felt itchy and itchy at the site and a large red hive appeared, the injection site was again tender and swollen, the next day the hive was gone but patient's arm was still tight and swollen at the site of the injection. 13 days after the vaccination she returned to normal. Reporter wanted to know if the only contraindication to not receiving the second dose of the vaccine is if someone experienced anaphylaxis after the first dose.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Experienced swelling at the injection site; experienced redness at the injection site; experienced tenderness, and pain at the injection site; Her arm was very tense; Felt itchy; itchy at the site; A large red hive appeared; discomfort; This is a spontaneous report from a contactable consumer (patient's husband).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose (dose 1, arm) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient is a physician who received the shot at work. Reporter stated patient had a localized reaction to the COVID-19 Vaccine. On the first day after receiving the vaccine, she experienced swelling, redness, tenderness, and pain at the injection site for 24 to 48 hours, and her arm was very tense. After 3 days, the discomfort disappeared but her arm was still tight. 8 days after the injection patient felt itchy and itchy at the site and a large red hive appeared, the injection site was again tender and swollen, the next day the hive was gone but patient's arm was still tight and swollen at the site of the injection. 13 days after the vaccination she returned to normal. Reporter wanted to know if the only contraindication to not receiving the second dose of the vaccine is if someone experienced anaphylaxis after the first dose.  Information on the Batch/Lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Restlessness, Sedation
Clinical narrative: Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: patient has a hx of anaphylaxis to pears. Within 5 minutes of  vaccine developed tingling and numbness to lips and tongue.  patient escorted to the emergency department for further evaluation and treatment.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersensitivity, Hypoaesthesia oral, Myalgia
Clinical narrative: tongue started tingling and then went completely numb, in which lasted several hours; tongue started tingling and then went completely numb, in which lasted several hours; headache; muscle pain; chills; mild allergic reaction; This is a spontaneous report from a contactable healthcare professional reporting on herself. A 45 (Unit: Unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Dec2020 as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 18Dec2020, 45 minutes later after receiving the vaccine, the patient experienced her tongue started tingling and then went completely numb, in which lasted several hours. Then she experienced a headache, muscle pain, and chills. The patient inquired if she should receive the second dose of the Covid vaccine after experiencing side effects or a mild allergic reaction. The outcome of the events tongue started tingling and then went completely numb, headache, muscle pain, chills and allergic reaction was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tongue started tingling and then went completely numb, in which lasted several hours; tongue started tingling and then went completely numb, in which lasted several hours; headache; muscle pain; chills; mild allergic reaction; This is a spontaneous report from a contactable healthcare professional reporting on herself. A 45 (Unit: Unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Dec2020 as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 18Dec2020, 45 minutes later after receiving the vaccine, the patient experienced her tongue started tingling and then went completely numb, in which lasted several hours. Then she experienced a headache, muscle pain, and chills. The patient inquired if she should receive the second dose of the Covid vaccine after experiencing side effects or a mild allergic reaction. The outcome of the events tongue started tingling and then went completely numb, headache, muscle pain, chills and allergic reaction was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Gastrooesophageal reflux disease, Myalgia
Clinical narrative: moderate myalgias, fatigue, back pain, extremity pain and weakness
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: moderate myalgias, fatigue, back pain, extremity pain and weakness
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed full body rash; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. On 28Dec2020, the patient had developed full body rash. The rash was further described as mild. The patient had no change in any personal care products, and felt like the rash was due to the vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Respiratory tract irritation, Throat irritation
Clinical narrative: Patient complained of feeling like she "swallowed a feather or a cat hair" - her lungs were tickling.  She said she felt fine, but wanted to be sure to report the "strange feeling".  Patient said she feels well, but wanted to contribute to research.  Patient advised to call 911 or go to the nearest emergency room for any further issues.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: On the morning of Wednesday, January 6th, I woke up with a red splotch on the arm that I received the vaccination on. The splotch was located about 5 inches away from the injection site. It was raised and itchy.  I didn't take anything in hopes that it would dissipate on it's own. On the morning of Thursday, January 7th, I woke up with a splotchy circle directly around the injection site. It was also raised and itchy. I went to work that day and one of the RN's looked at it, they stated that it could be an allergic reaction to the shot and suggested I take Benadryl to see if it would dissipate. I took some last night (Thursday, January 7th) and woke up this morning to find the splotches a little faded. They aren't as raised however they are still itchy. I will continue to take Benadryl for the next few days to see if it completely dissipates.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient started to receive first dose of BNT162B2 (Batch/lot number: EH9899) intramuscular into left deltoid on 15Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension and the patient was on blood pressure (BP) medications. The patient received no other vaccines on the same day as the COVID Vaccine. The patient received first dose on 15Dec2020 and was exposed to someone with COVID on 24Dec2020 and tested positive for COVID 28Dec2020. The patient stated that he was wondering what the recommendations are for receiving the second dose of the product, if someone contracted COVID-19 after receiving the first dose. He tested Positive for COVID-19 on 28Dec2020 and he does not know if it is ongoing or not, as he does not re-test for COVID-19 until Wednesday (30Dec2020), but he currently has no symptoms. The patient stated that he did have symptoms on 26, 27 and 28Dec2020. The lab tests and included COVID-19 PCR test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be completely excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypersomnia, Night sweats, Pyrexia
Clinical narrative: Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Patient was given second Pfizer vaccine at 8:19. About 11 minutes after receiving the vaccine patient complained of chest pain. 911 was called, nasal 02 was administered. BP 150/90, P103. Patient was taken by ambulance to the ED. She stated her chest pain was an 8 out of 10.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: chills; fever; headache; lots of body aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the left arm on 03Jan2021 at 08:00 AM (at the age of 20 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Jan2021, the patient experienced chills, fever, headache, and lots of body aches. The report was reported as non-serious. It was unknown if the patient was treated for chills, fever, headache, and lots of body aches. The clinical outcome of chills, fever, headache, and lots of body aches was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash, Urticaria
Clinical narrative: chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not  treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no drooping to face hives injection site pain
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Side Effects included: headache, body aches (back pain), low-grade fever, chills, soreness in arm after injection and throughout the next 24-48 hours, overall fatigue/tired.   Most went away after the 24 hour mark. After the 24 hour mark -- soreness in arm continued and same with the headache.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Side Effects included: headache, body aches (back pain), low-grade fever, chills, soreness in arm after injection and throughout the next 24-48 hours, overall fatigue/tired.   Most went away after the 24 hour mark. After the 24 hour mark -- soreness in arm continued and same with the headache.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Headache, Nausea
Clinical narrative: temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient).  A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown.  Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient).  A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown.  Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship.  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, Bone pain, Gait disturbance, Myalgia, Pain
Clinical narrative: just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician.  A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in  Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Just shy of twenty-four hours after receiving the vaccine,  the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms.  The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.