chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports.  An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination.  Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight.  There were no concomitant medications.  The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this.  The patient stated that on 30Dec2020 10:30, "he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened.  When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here". The outcome of the events were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of lightheadedness and pre-syncope due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK 5730, expiry date unknown) via unspecified route of administration at left arm on 30Dec2020 08:30 at single dose for Covid-19 immunization in a hospital facility. The patient was not diagnosed with Covid-19 prior vaccination. Medical history was none. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 08:45, the patient experienced allergic reaction which resulted to patient visiting doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient received treatment of epinephrine, decadron and Benadryl due to the event. The patient was not Covid tested post vaccination. The outcome of the event allergic reaction was recovering at this time of the report. The reporter considered the event non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Allergic reaction cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered.  No treatment received for the events.   Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician.  A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID).  . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Malaise, Nausea
Clinical narrative: feels pretty sick; Nauseous; going to the bathroom a lot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received BNT162b2, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history included tooth extraction and bone graft, and was not feeling real well after that. The patient's concomitant medications were not reported. Patient received COVID vaccine on 28Dec2020. Patient stated she feels pretty sick since getting the COVID-19 Vaccine, saying she is mainly nauseous and going to the bathroom a lot; all from 30Dec2020. The patient said she went to the dentist, and got an antibiotic. She was prescribed Amoxicillin 500mg, three times a day, by her dentist. She said she took her first dose of Amoxicillin 500mg this morning (31Dec2020). She said after she took the first Amoxicillin 500mg dose, she thought she better check to see if it is OK to take an antibiotic after receiving the COVID-19 Vaccine. She did not necessarily think the nausea and going to the bathroom a lot had to do with receiving the COVID-19 Vaccine. She wanted to know if she takes an antibiotic after receiving the COVID-19 Vaccine, will the antibiotic cause a problem with the COVID-19 Vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product events most likely due to patient underlying contributory factors
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain, Product administered at inappropriate site, Sensation of foreign body
Clinical narrative: had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Eyelid function disorder, Facial paralysis, Facial paresis, Hypoaesthesia
Clinical narrative: had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female  patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020.  Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it.  The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: now have a positive cov-19 test results; now have a positive cov-19 test results; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient took first round of cov-19 shot and due to take 2nd one Saturday but now have a positive cov-19 test result.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism.  The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful, swollen lymph node in  left axilla, same side as injection site; Painful, swollen lymph node in  left axilla, same side as injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ek5730), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol, cyclobenzaprine hydrochloride (FLEXERIL), ibuprofen (ADVIL), paracetamol (TYLENOL), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced painful, swollen lymph node in left axilla, same side as injection site. No treatment was given for these events. The clinical outcome of painful, swollen lymph node in left axilla, same side as injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node palpable, Lymphadenopathy
Clinical narrative: swollen lymph node in her left axilla/lymphadenopathy; pain in her left axilla; able to palpate a swollen lymph node in her left axilla; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), intramuscularly in the left arm on 17Dec2020 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine and fexofenadine hydrochloride (ALLEGRA), both for unknown indications from unknown dates and unknown if ongoing. The patient previously took and had an allergy to amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 13:00, the patient developed pain in her left axilla (6 days after vaccination). The patient was able to palpate a swollen lymph node in her left axilla. It continued to become more painful requiring ibuprofen and hot compresses. By 31Dec2020, her symptoms had largely resolved. She saw her physician who also felt the lymphadenopathy and had no other explanation than possible vaccine side effect. The clinical outcome of pain in her left axilla, swollen lymph node in her left axilla/lymphadenopathy, able to palpate a swollen lymph node in her left axilla was recovered on 31Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted covid 19 virus after receiving first dose of vaccine; Contracted covid 19 virus after receiving first dose of vaccine; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Eh9899), intramuscular in left arm on 17Dec2020 18:00 at a single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. The patient had no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). On 27Dec2020 20:00, the patient contracted covid 19 virus after receiving first dose of vaccine. The outcome of the event was recovering. The patient did not received any treatment. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. The patient had nasal swab on 31Dec2020 and had a positive result.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 31Dec2020 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included Type2 DM (diabetes mellitus), hypertension, obesity, gout and Covid-19. Concomitant medications included unspecified medication(s). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was previously diagnosed with COVID-19. On 01Jan2021 at 14:00, the patient experienced fever 37.8, chills and injection site pain. Treatment was provided for the events fever, chills and injection site pain included acetaminophen (TYLENOL 650mg). The outcome of the events fever, chills and injection site pain was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive following the first dose of vaccine; tested positive following the first dose of vaccine; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she has a patient who tested positive following the first dose of vaccine and inquiring as to second dose recommendations. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: There is scant information at this point. Case will be reevaluated based on additional information during the follow-up
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self.  A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa.  the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event.  The palpitations were resolving. The patient wasn't COVID tested post-vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Impulsive behaviour, Insomnia, Psychomotor hyperactivity, Restlessness
Clinical narrative: Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: joint pains; muscle aches; malaise; chills; fatigue; very mild headache; This is a spontaneous report from a contactable physician reporting on himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL0140/expiration date: not provided), via an unspecified route of administration, on 30Dec2020 at 05:00 PM (at the age of 68 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included hypertension, gout, dyslipidemia, and dysthymia. The patient did not have any known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within two weeks were taken but were not provided. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the COVID vaccine. On 31Dec2020, at 08:30 PM, the patient experienced joint pains, muscle aches, malaise, chills, fatigue, and very mild headache. The patient did not receive and treatment for these events. The outcome of the events joint pains, muscle aches, malaise, chills, fatigue, and very mild headache was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: joint pains; muscle aches; malaise; chills; fatigue; very mild headache; This is a spontaneous report from a contactable physician reporting on himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL0140/expiration date: not provided), via an unspecified route of administration, on 30Dec2020 at 05:00 PM (at the age of 68 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included hypertension, gout, dyslipidemia, and dysthymia. The patient did not have any known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within two weeks were taken but were not provided. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the COVID vaccine. On 31Dec2020, at 08:30 PM, the patient experienced joint pains, muscle aches, malaise, chills, fatigue, and very mild headache. The patient did not receive and treatment for these events. The outcome of the events joint pains, muscle aches, malaise, chills, fatigue, and very mild headache was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Pain, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: sore arm; aches and pains for a couple of days; a little headache; I received results yesterday and I am positive; I received results yesterday and I am positive; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first covid vaccine dose on 19Dec2020, and due to get his second dose on 09Jan2021. The problem is he tested for the covid virus on Wednesday 26Dec2020 (was negative). He was tested again on the 30Dec2020, because his wife and son had tested positive on the 26Dec2020, he received the results yesterday and he is positive.  He asked if he should proceed with the 2nd dose, another test on the 30th and tested positive. He reports that, other than initial side effects from the vaccine administration, sore arm, aches and pains for a couple of days, never had fever, a little headache for a day or two, he feels fine. The outcome of the events "a little headache" was recovered on an unspecified date while outcome of the other events was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Lethargy
Clinical narrative: Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient).  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination.  Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient).  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination.  Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat
Clinical narrative: Dry mouth and throat; Dry mouth and throat; This is a spontaneous report from a non-contactable consumer, the patient.  An adult female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Gl5730), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunization.  Medical history and concomitant medication was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020 the patient experienced dry mouth and throat. The events were reported as non-serious. The patient did not receive any treatment for the dry mouth and throat. The clinical outcome of dry mouth and throat was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling, Tenderness, Vaccination site erythema, Vaccination site mass
Clinical narrative: swelling; tenderness; a red lump at the injection site; a red lump at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient was Covid 19 positive in Aug2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling, tenderness, and a red lump at the injection site. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient.  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Paraesthesia, Pruritus
Clinical narrative: Fever; Chills; Itchy neck outside; Itchy throat; Stiff shoulder; Pin and needles; joint pain in shoulder and arms; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1284, expiration date: unknown), intramuscularly on the right arm on 31Dec2020 at 15:30 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Dec2020 at 19:00, the patient experienced fever, chills, itchy neck outside, itchy throat, stiff shoulder, pin and needles, and joint pain in shoulder and arms. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Fever; Chills; Itchy neck outside; Itchy throat; Stiff shoulder; Pin and needles; joint pain in shoulder and arms; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1284, expiration date: unknown), intramuscularly on the right arm on 31Dec2020 at 15:30 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Dec2020 at 19:00, the patient experienced fever, chills, itchy neck outside, itchy throat, stiff shoulder, pin and needles, and joint pain in shoulder and arms. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 03Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On 03Jan2021 (reported as early today), the patient reported she feels fine, but has a little bit of a headache. She did not know if her headache was due to the vaccine or other reasons. The patient wanted to know if she could take ibuprofen. The clinical outcome of the headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Migraine, Nasal congestion
Clinical narrative: could not taste or smell; could not taste or smell; nasal congestion; Achyall over; Vomited; Migraine; lungs started burning; persistent dry cough; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced achy all over, vomited, migraine, lungs started burning, and persistent dry cough on 21Dec2020 and could not taste or smell and nasal congestion on 22Dec2020 at 15:00. The clinical course was reported as: The patient felt a little achy, then vomited. She had a migraine for 2 hours, lungs started burning, and had a persistent dry cough. The patient was achy all over. At about 3:00 PM the next day, the patient could not taste or smell and had nasal congestion. The patient stated that this could be typical for positive COVID-19 infection. The patient was later getting better and feeling better. The clinical outcome of achy all over, vomited, lungs started burning, persistent dry cough, could not taste or smell, and nasal congestion was recovering and of migraine was recovered in Dec2020.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.