chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Hypoaesthesia, Influenza like illness
Clinical narrative: lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021.  Events result in doctor or other healthcare professional office/clinic visit.  All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Smear test, Vaccination site pain
Clinical narrative: lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021.  Events result in doctor or other healthcare professional office/clinic visit.  All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021.  Events result in doctor or other healthcare professional office/clinic visit.  All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: he tested positive for COVID; he tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the right deltoid on 28Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included diabetic (he is a diabetic, but he is not on medication for it) from Nov2018 and ongoing, hepatitis (not ongoing) (He had hepatitis virus for 15 to 20 years. It resolved 5 or 6 years ago. It corrected on it's own), supplement, hypertension and carcinoma of the lung. Everyone in his family has hypertension. His sister had carcinoma of the lung. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not have additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks. There were no adverse events following prior vaccinations. Concomitant medication included doxazosin mesilate (CARDURA), bisoprolol fumarate, hydrochlorothiazide (ZIAC), nystatin (STATIN) taken for lipids, colecalciferol (VITAMIN D) taken for supplement, fish oil, acetylsalicylic acid (BABY ASPIRIN), vitamin C [ascorbic acid]. The patient also received multivitamin. He has been on all concomitant medications for at least three to four years. The patient was scheduled for the next dose on 18Jan2021. On 05Jan2021 he tested positive for COVID. The event was reported as serious as medically significant. The patient was given the antibody infusion and steroid injection. It was outpatient. He was not admitted. Treatment was received for the events. The outcome of the events was unknown.  Information on lot number/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However individuals may not be protected until at least 7 days after their second dose of the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain, Vaccination site swelling
Clinical narrative: Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: About 1 hour later, her left side of her face, her lips and tongue were numb. She says "it did get better but it is still numb"; About 1 hour later, her left side of her face, her lips and tongue were numb. She says "it did get better but it is still numb"; About 1 hour later, her left side of her face, her lips and tongue were numb". She says "it did get better but it is still numb"; left leg is really hurting; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 03Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that after receiving vaccine, "about 1 hour later, her left side of her face, her lips and tongue were numb". She says "it did get better but it is still numb".  She added that her "left leg is really hurting". It hurts when she touches it. The outcome of her left side of her face, her lips and tongue were numb was recovering and outcome of left leg is really hurting was unknown. The patient would like to know if she should receive the 2nd dose?   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: following the receipt of the first dose of the COVID-19 vaccine; testing positive to COVID; This is a spontaneous report from a non-contactable other Healthcare Professional reported for herself. A female patient of an unspecified age (Age: 47, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient explained testing positive to COVID on the 29Dec2020, following the receipt of the first dose of the COVID-19 vaccine on the 20Dec2020. She stated that minor symptoms remain, and asked if she could receive the second dose of the vaccine due on the 10Jan2021. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Sender's Comments: The reported testing positive to 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nasal congestion, Nasopharyngitis, Occupational exposure to SARS-CoV-2
Clinical narrative: Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Paranasal sinus discomfort, SARS-CoV-2 test positive
Clinical narrative: Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; This is a spontaneous report from a contactable Physician (patient's wife).   A 55-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) on 18Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced developed Covid on 24Dec2020 (reported as the following Thursday). The patient underwent lab tests and procedures which included Sars-Cov-2 test: developed Covid. He was fairly symptomatic for 7 days but he was doing well now. The outcome of events was recovering. The reporter quereide whether he should receive the 2nd dose, which is due on 08Jan2021 or should it be deferred.  Information on Lot/Batch number requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination.  Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site swelling
Clinical narrative: allergic reaction to the vaccine; golf sized swelling at the injection site; This is a spontaneous report from a contactable nurse for self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on arm on an unspecified date at single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. She just got her first Pfizer COVID vaccine 11 days ago. She immediately got a golf ball sized swelling at the injection site. She had no other reaction. No systemic reaction. Her arm has lasted until now, but it is definitely better. She is not warred about that any more. She specified that the swelling remained the same size for five days and improved. She then explained that she saw her doctor as she thought that it was infected, but the doctor said that it was an allergic reaction to the vaccine. She then asked if she should receive the second dose of the vaccine, and if her reaction is considered severe. Outcome of event was recovering.   No follow up attempts are possible. Information about Batch/Lot number can not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: developed covid like symptoms a few days later/ tested positive on the 26th; developed covid like symptoms a few days later/tested positive on the 26th; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 18Dec2020 and developed covid like symptoms a few days later in Dec2020 and believed the patient was likely exposed. The patient was tested positive on 26Dec2020. The outcome of the events was unknown.   Information about Lot/Batch number has been requested.; Sender's Comments: The reported covid like symptoms a few days with  tested positive  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Malaise
Clinical narrative: body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly around the low hip area but also "all over"; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: "horrible" muscle aches particularly around the low hip area but also "all over", feeling dizzy, elevated BP 155/100 in Jan2021, "pounding head", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment " it's ridiculous, it's my entire body". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly around the low hip area but also "all over"; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: "horrible" muscle aches particularly around the low hip area but also "all over", feeling dizzy, elevated BP 155/100 in Jan2021, "pounding head", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment " it's ridiculous, it's my entire body". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Lymphadenopathy, Mass, Neck pain
Clinical narrative: she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation.  Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation.  Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Sporadic itching in multiple parts of the body/ Itchiness sporadic multiple places of my body; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at 16:45 on Arm left at single dose for COVID-19 immunization. The patient medical history included Cholesterol y Triglycerides high. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included Multivitamin, ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), Zinc, ibuprofen sodium (IBUPROFEN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sporadic itching in multiple parts of the body (also reported as itchiness sporadic multiple places of her body) on 05Jan2021 at 17:30. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: she felt nauseated; sick stomach; headache; body aches; really sore arm for a couple of days; This is a spontaneous report from a contactable other health professional (patient) received via Medical Information Team.  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient medical history included arthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced really sore arm for a couple of days on Dec2020, the patient felt nauseated, a sick stomach, she has a headache and body aches along with the sick stomach, all on Jan2021. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was tested positive for the COVID-19 virus on an unspecified date after being administered with the vaccine. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment. ,Linked Report(s) : US-PFIZER INC-2021005630 same reporter and drug, different patient and event
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: was tested and diagnosed positive for the SARS-CoV-2 infection; was tested and diagnosed positive for the SARS-CoV-2 infection; developed symptoms after being exposed at work on 27Dec2020; This is a spontaneous report from a contactable nurse. A male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got exposed as a first line nurse working in the emergency room. The nurse reports that her husband developed symptoms after being exposed at work on 27Dec2020 five days after being administered with the first dose of BNT162B2 and he was tested and diagnosed positive for the SARS-CoV-2 infection on 27Dec2020. The outcome of the events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "tested and diagnosed positive for the SARS-CoV-2 infection" is related to BNT162B2.  Event occurred only 5 days after receiving first vaccine and patient was exposed to virus at work.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Influenza like illness, Nausea
Clinical narrative: Body aches; joint pain; nausea; severe chills; fever of 101.4 F; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; feels like she has the flu; This is a spontaneous report from a contactable nurse reporting for herself. A female patient (Age: 53; Units: Unknown) 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 04Jan2021 as a single dose for COVID-19 vaccination. Relevant medical history included she had COVID 19 virus on 13Nov2020. Concomitant medication was not reported. On an unspecified date in Jan2021, the patient reported that she was experiencing the same symptoms she felt when she had COVID 19 virus on 13Nov2020. She was currently experiencing the following symptoms: body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch. The patient reports that she feels like she has the flu. The outcome of the events body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch and feels like she has the flu was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Body aches; joint pain; nausea; severe chills; fever of 101.4 F; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; feels like she has the flu; This is a spontaneous report from a contactable nurse reporting for herself. A female patient (Age: 53; Units: Unknown) 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 04Jan2021 as a single dose for COVID-19 vaccination. Relevant medical history included she had COVID 19 virus on 13Nov2020. Concomitant medication was not reported. On an unspecified date in Jan2021, the patient reported that she was experiencing the same symptoms she felt when she had COVID 19 virus on 13Nov2020. She was currently experiencing the following symptoms: body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch. The patient reports that she feels like she has the flu. The outcome of the events body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch and feels like she has the flu was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: positive COVID test result; positive COVID test result; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old 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 16Dec2020 (at the age of 49 years old) as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 21Dec2020, the patient experienced a strange cough. The patient reported that she received the first dose of COVID vaccine on 16Dec2020 and that she was then exposed to her husband who tested positive on 17Dec2020. Due to a strange cough, she was tested on 21Dec2020, which resulted in a positive COVID test result. The outcome of the events strange cough and positive COVID test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Strength 0.3 ml, lot number: EJ1685, Expiry Date: Mar2021), via intramuscular in left deltoid on 18Dec2020 at 0.3 mL, first single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. Caller is a registered nurse that received the COVID vaccine on 18Dec2020 and her next dose is supposed to be on 08Jan2021. She was exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge. Her work placed her in quarantine till 12Jan2021. She was not having any symptoms. She was asking if she can get her second dose on 08Jan2021. She had a swab test that was negative for COVID on 29Dec2020. Outcome of the event was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Oral disorder, Speech disorder
Clinical narrative: The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt a little tired this morning; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she felt a little tired this morning (on 05Jan2021). It was unknown if treatment was received. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, and unknown if patient had been tested for COVID-19 since the vaccination. Outcome of event was unknown.