chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain and aches a lot; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 19Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, the patient experienced shoulder pain and aches a lot. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with lasting effects (sequel) from the event on an unspecified date.   Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Dry mouth, Head discomfort
Clinical narrative: it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date.  The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade.  The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date.  The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade.  The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Investigation, Pruritus, Rash
Clinical narrative: Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Muscle spasms, Muscle tightness, Muscular weakness
Clinical narrative: Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable  health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies.  Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). 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 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Speech disorder
Clinical narrative: Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable  health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies.  Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). 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 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak,  achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: HCP put her on low  taper dose steroid -mederol to minimize swelling; This is a follow up spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose on 21Dec2020, and she will be receiving 2nd dose of vaccine this coming Monday (11Jan2021). She had oral surgery yesterday on 05Jan2021, the surgery was already planned prior to first dose of vaccine. HCP (health professional) put her on low taper dose steroid, mederol to minimize swelling. The patient asked if there was any reason to continue to take her steroid medication and if is it ok to continue to take. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure during pregnancy, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020/tested positive for COVID-19; This is spontaneous report from a contactable Other Health Professional (patient) via a Pfizer Sponsored Program. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right deltoid on 23Dec2020 14:30 at single dose for COVID-19 vaccination while pregnant.  Medical history was none. Concomitant medication included ongoing ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide (PRENATAL MULTIVITAMIN + DHA, Prenatal Multi + DHA), one soft gel, every morning as prenatal medication. The reporter was asking for recommendations for her in taking the second dose as she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020. She received the first dose of the vaccine last 23Dec2020. She is asking if she should wait 90 days before taking the 2nd dose. Agent has a physical therapist on the phone. She had her first dose of the COVID vaccine on 23Dec2020. She started to show symptoms of COVID on 31Dec2020. She tested positive on 01Jan2020. Caller wants to know does she need to wait 90 days for the second dose. Caller wanted to add she is pregnant as well. She declined to include a healthcare professional for the report. The caller states she started to feel symptoms towards the end of the day on 31Dec2020. She clarifies she felt like she was having a cold coming on. She had some congestion. When probed for outcome, caller stated it had improved quite a bit. She had been improved but today, its kind of like she had a cold again, but that had improved. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior Vaccinations (within 4 weeks): None within 4 weeks. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Relevant Tests: None. Investigation Assessment: Yes. Is a sample of the product available to be returned, if requested (Y/N): Vaccine was administered in hospital. No AE required a visit to emergency room and physician office.  The reporter stated her symptoms have been pretty mild. The patient underwent lab tests and procedures which included COVID Fast-acting (rapid) test: positive on 01Jan2021. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: She did a rapid antigen test and was positive; She did a rapid antigen test and was positive; her arm hurt after vaccination; she lost taste; This is a spontaneous report from a contactable Consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Friend shared that the patient's arm hurt after vaccination and the following day she lost taste. She did a rapid antigen test and was positive. Adverse event start date was 04Jan2021. No treatment was received for the adverse event. AE resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test name: antigen (positive). Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Nasopharyngitis
Clinical narrative: being exposed to someone who is positive for covid; head cold; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "calls to ask if she is able to get the second dose of the vaccine after being exposed to someone who is positive for covid. Caller reports that she received the first dose of the vaccine on 18Dec and is scheduled to get her second dose on 08Jan.  Since her first dose her son and husband have been found positive for covid and she was tested today, no result back yet. She requests information about vaccination following exposure reporting that when she asked her work place they said they didn't have any information about it. Caller also reports that she is experiencing a "head cold" this week but states "it's not from the vaccine".  The outcome of the events were unknown.   Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Headache, Influenza like illness
Clinical narrative: Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; This is a spontaneous report from a contactable health care professional nurse, the patient. A female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020 as a single dose for COVID-19 vaccination. The patient had no known medical history. The patients concomitant medications were not reported. On an unspecified date the patient experienced  I got Covid from a family member.  She reported being symptomatic on 1Jan2021 started with a sore throat, felt like a flu or bad cold. She reported sore throat, headache, body aches and sinus issue. She now has congestion and cough. She had no issue when she got the vaccine.  The patient will be getting the second dose 11Jan2021 and she would like to know  if she is eligible to receive the second dose Pfizer Covid-19 Vaccine. The clinical outcome of the event was unknown   . Information on the Lot number has been requested.; Sender's Comments: The reported "got COVID from a family member" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Respiratory tract congestion, Sinus disorder
Clinical narrative: Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; This is a spontaneous report from a contactable health care professional nurse, the patient. A female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020 as a single dose for COVID-19 vaccination. The patient had no known medical history. The patients concomitant medications were not reported. On an unspecified date the patient experienced  I got Covid from a family member.  She reported being symptomatic on 1Jan2021 started with a sore throat, felt like a flu or bad cold. She reported sore throat, headache, body aches and sinus issue. She now has congestion and cough. She had no issue when she got the vaccine.  The patient will be getting the second dose 11Jan2021 and she would like to know  if she is eligible to receive the second dose Pfizer Covid-19 Vaccine. The clinical outcome of the event was unknown   . Information on the Lot number has been requested.; Sender's Comments: The reported "got COVID from a family member" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pain, Pain in extremity
Clinical narrative: is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving.  Information on the Lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Lip disorder
Clinical narrative: hard lumps at filler sites above upper lip and under left eye - filler injected  7 months prior to vaccine; hard lumps at filler sites above upper lip and under left eye - filler injected  7 months prior to vaccine; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # ekj5730), intramuscular at single dose in the right arm on 28Dec2020 13:00 for COVID-19 immunisation. Medical history included migraine, allergies to Codeine, Hydrocodone. Concomitant medications were not reported. On 29Dec2020 11:00, the patient experienced hard lumps at filler sites above upper lip and under left eye - filler injected  7 months prior to vaccine. The outcome of the events was not recovered. No treatment was performed. The patient was not pregnant at the time of vaccination. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gout, Pain in extremity
Clinical narrative: pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 17Dec2020 15:30 at single dose for Covid-19 immunization. Patient's medical history included gout and shellfish allergy. Concomitant medications included magnesium glycinate (MAGNESIUM GLYCINATE), colecalciferol (VITAMIN D), and finasteride. 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 reported he got his vaccine on 17Dec2020, a week later on 03Jan2021 (04:30 PM) he started having some pain in both big toes and then 3 days ago, he had severe pain in the left big toe with what appears to be acute gouty attack. The patient reported he has a history of gout previously but had controlled it for a long time. There were no other changes that happened. The patient was treated with ibuprofen and colchicine. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: mild runny nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female nurse, who is also the patient, reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild runny nose. The patient reported also that her son was just diagnosed with COVID and she just took a test on an unspecified date but was negative. She was still experiencing a mild runny nose. At the time of the report, the patient had not recovered from the mild runny nose whereas the outcome of the exposure to COVID-19 was unknown.  The Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Pyrexia, Sneezing
Clinical narrative: sneezing; coughing; congestion; fever; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm (triceps muscle) on 30Dec2020 10:30 at single dose for covid-19 immunization. Medical history included seasonal allergy from 1995 and ongoing, seasonal asthma from 1995 and ongoing. The patient had no concomitant medications. The patient experienced fever on 31Dec2020, congestion on 02Jan2021, sneezing and coughing on an unspecified date. Time the vaccination was given around 10:30 a.m, but she known she was okay to leave by 10:45 a.m. No additional administered vaccines. The adverse event was not required a visit to emergency room or physician office. Prior Vaccinations (within 4 weeks) was none. Relevant tests were none. Certified nursing assistant works in hospital where she cares for Covid patients. She received the vaccine on 30Dec2020 and by the next day, she had fever and congestion. The fever has gone away but she was still congested and was sneezing and coughing at home. The caller stated she was a CNA calling on behalf of herself in regard to the Pfizer COVID vaccination. She stated she received the vaccine on 30Dec2020. She had like a fever and everything over the weekend- starting Thursday night, Friday and then part of Saturday. She also had this congestion ever since she got the shot. The caller confirmed she received her first COVID vaccine on 30Dec2020. Late Thursday night, 31Dec2020, she woke up and had a fever. She had her husband check her temperature. She confirmed she recovered completely from the fever. She hadn't a fever since Saturday (02Jan2021), probably around 8pm. She didn't have a fever at all on Sunday. The congestion really didn't start until Saturday morning, 02Jan2021. She stated the congestion was still persisting at this point. Caller stated, " it honestly feels like a sinus infection" The caller was able to provide the Lot number off of her patient card. Caller made the comment the card also had the date she had to go back for her second vaccine. The patient underwent lab tests and procedures which included body temperature: recovered completely from the fever. The outcome of events for fever was resolved on 02Jan2021, for congestion was not resolved, for other events was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable physician (patient). A male patient of an unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 16Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The physician inquired "is it recommended to receive the 2nd dose despite having antibodies and recovered from COVID?"  The doctor had the 1st dose on 16Dec2020 then tested positive for COVID 17Dec2020. He will receive the 2nd dose tomorrow 06Jan2021 and he was recovering.  The patient underwent lab tests and procedures which included COVID test: result positive on 17Dec2020.   Outcome of the event doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020 was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID  after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable physician (patient). A male patient of an unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 16Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The physician inquired "is it recommended to receive the 2nd dose despite having antibodies and recovered from COVID?"  The doctor had the 1st dose on 16Dec2020 then tested positive for COVID 17Dec2020. He will receive the 2nd dose tomorrow 06Jan2021 and he was recovering.  The patient underwent lab tests and procedures which included COVID test: result positive on 17Dec2020.   Outcome of the event doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020 was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID  after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 1 week later I was exposed and i came down w/Covid; 1 week later I was exposed and i came down w/Covid; This is a spontaneous report from a contactable physician via Pfizer-sponsored program Pfizer First Connect, reporting for himself. A male patient of an unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the vaccine and a week later (unspecified in Dec2020) he was exposed and he came down with COVID. He had had symptoms for about 14 days. The patient recovered from the event after a few days and he was asking if there would be contraindications to receiving a second dose and if he still needed to take the second dose despite of recovering from COVID. The second dose ws due on 06Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (came down with COVID) with BNT162b2 can not be fully excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: 1 week later I was exposed and i came down w/Covid; 1 week later I was exposed and i came down w/Covid; This is a spontaneous report from a contactable physician via Pfizer-sponsored program Pfizer First Connect, reporting for himself. A male patient of an unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the vaccine and a week later (unspecified in Dec2020) he was exposed and he came down with COVID. He had had symptoms for about 14 days. The patient recovered from the event after a few days and he was asking if there would be contraindications to receiving a second dose and if he still needed to take the second dose despite of recovering from COVID. The second dose ws due on 06Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (came down with COVID) with BNT162b2 can not be fully excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache
Clinical narrative: I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours.  Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the "mild - moderate". The outcome of events was not resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the "mild - moderate". The outcome of events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, General symptom, Muscle strain, SARS-CoV-2 test positive
Clinical narrative: he received his first dose of the vaccine on 22Dec2020 and tested positive for Covid yesterday (04Jan2021).; he received his first dose of the vaccine on 22Dec2020 and tested positive for Covid yesterday (04Jan2021).; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  He received his first dose of the vaccine on 22Dec2020 and tested positive for COVID yesterday (04Jan2021). He stated his "symptoms were general at first, then weakness after 10 days, chilly and muscle strain".  The other HCP reported "do I need to take the second dose on 11Jan2021?" The patient underwent lab tests and procedures which included COVID test: result positive on 04Jan2021.   Outcome of the event he received his first dose of the vaccine on 22Dec2020 and tested positive for COVID yesterday (04Jan2021) was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported positive test for Covid after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2.  There is no test done to confirm whether patient got COVID-19 or not.  And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2.  There is no test done to confirm whether patient got COVID-19 or not.  And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.