chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: feeling very tired; feeling pretty sick and generally did not feel well; nausea; headache; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information team. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Exactly five days later after the patient received the first dose (on an unspecified date), she started feeling very tired which lasted for two days, and for a week she started feeling pretty sick and generally did not feel well, and for five days experienced nausea and headache. She asked if these side effects were potentially associated with the vaccine. Her doctor said to go ahead with the second dose of the vaccine. She wanted to know if the second dose would make her sicker. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Pain in extremity
Clinical narrative: sore arm; Extreme tiredness; Quick pain in neck 5 min after injection (carotid artery?); This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 08Feb2021 13:00 (at the age of 68-years-old), as dose 1, single for COVID-19 immunisation. Medical history was not reported. Patient has no concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced quick pain in neck 5 min after injection (carotid artery?) on 08Feb2021 13:05, extreme tiredness on 08Feb2021 14:00, 1 hr after injection, and sore arm on 09Feb2021 01:00, 12 hrs after injection. Patient also reported that she weighs less than 100 lbs and wondered If she should have received a smaller dose. Also, she doesn't take any meds and her body is not use to foreign materials. No treatment was received as a result of the events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Fatigue, Feeling jittery, Headache
Clinical narrative: started to get real jittery; was dead tired and went to bed at 6 pm and didn't get up the next day; dizzy; headaches; eyes hurt; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 06Feb2021 (at age of 73-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 06Feb2021, the patient started to get real jittery within 15 minutes. 6 hours later, the patient was dead tired and went to bed at 6 pm and didn't get up the next day. On an unspecified date in Feb2021, the patient was dizzy, had headaches and eyes hurt, but the patient also saw the eye doctor 2 days before. The patient was still having problems with dizziness, headaches and eye pain 4 days later. The patient did not think it was related to the bnt162b2 vaccine. The patient's eye doctor told the patient to try eye drops. The nurse that gave the patient shot said there's usually no side effects for the first dose and the second dose was usually the one with side effects. The outcome of the events started to get real jittery, was dead tired and went to bed at 6 pm and didn't get up the next day was unknown. The outcome of the events dizziness, headaches, and eye pain was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: dizzy; nauseous; fever of 98.7; throw up; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (wife) that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Feb2021, the patient experienced dizzy, nauseous, fever of 98.7 and throw up. The consumer said his wife received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on Monday afternoon. However, he said that this morning, his wife woke up and could not get out of bed, was very dizzy, nauseous, shows a little fever of 98.7 F and has attempted to throw up. He said he called to seek guidance on what to do about these side effects. The patient underwent lab tests and procedures which included body temperature: 98.7 Fahrenheit on Feb2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, X-ray
Clinical narrative: facial swelling/her cheek seemed a little swollen and it extended from her lip down to her chin; her cheek seemed a little swollen and it extended from her lip down to her chin; This is a spontaneous report from a contactable pharmacist. A 95-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL1283) dose 1, via intramuscular, in the right arm on 21Jan2021 at 11:00 (at the age of 95-year-old) as dose 1, single for covid-19 immunisation. Vaccination facility type hospital walk in clinic and no vaccine administered at military facility. The medical history included mastectomy from an unknown date and unknown if ongoing, on left breast, it was done 33 years ago, ongoing high cholesterol and ongoing high blood pressure. Prior vaccinations slight discomfort after the flu vaccine in her right arm. The concomitant medications included hydrochlorothiazide, lisinopril (Lisinopril/HCTZ (HYDROCHLOROTHIAZIDE, LISINOPRIL)) via oral taken for high blood pressure daily (20/25mg one tablet daily by mouth), felodipine taken for high blood pressure via oral at 10 mg, 1x/day, and atorvastatin taken for blood cholesterol via oral at 10 mg, 1x/day all from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. On 10Feb2021, the patient experienced facial swelling/her cheek seemed a little swollen and it extended from her lip down to her chin. Caller stated that she used to be a pharmacist and she was calling about the Covid-19 Vaccine. She would be due to get the second vaccine tomorrow 11Feb2021, but when she woke up this morning her cheek seemed a little swollen and it extended from her lip down to her chin, the right side of her cheek was swollen. She took a Benadryl as a treatment and she believed it had gone down slightly. She asked, if it was safe to take the second vaccine, and the caller requested information following her experience with some facial swelling after receiving the first covid vaccine almost 3 weeks ago. Caller refused fulfilment stating she know this was not from the vaccine, she just wanted to know if she should get it if she had this condition currently. She said that she had this swelling happen one time before and her dentist could not find anything on X-ray and it was gone after about a day on an unknown date. She stated that she had no reaction to the vaccine. Adverse events did not require a visit to emergency room and no physician office. Relatedness of drug to reactions/events: reaction assessed: her cheek was a little swollen, source of assessment: primary source reporter, method of assessment: global introspection, drug result: unrelated. Reporter seriousness for her cheek was a little swollen was not serious. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: her arm hurt; felt lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 (at the age of 84-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her arm hurt, felt lightheaded. 84-year-old consumer would like to report that after receiving the Pfizer Vaccine (Pfizer-BioNTech COVID-19 vaccine) she only had very little side effects: The first day her arm hurt in the evening for just 1 or 2 hours. She felt lightheaded only for 2 days in the morning. Her first dose was administered on 04Feb2021. Reporter was grateful for having experienced only minimal Adverse Reactions to the Pfizer-BioNTech COVID-19 vaccine. Outcome of the events was unknown.  Information on about lot/batch number has been requested.  Follow-up (31Mar2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: she should not have had ibuprofen before receiving the last two vaccines; sore arm; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140), via intramuscular route of administration in right deltoid on 11Jan2021 at 09:30 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation at assisted living facility for people with developmental disabilities, operated by help foundation where she was employed. Medical history included ongoing type 2 diabetes mellitus (diagnosed many years ago, about 7 years ago). There were no concomitant medications. Investigation assessment was not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. She was a head nurse for the "PRIVACY". Back on 11Jan2021, she had the first dose of the COVID vaccine. She was scheduled to return for the second dose on 01Feb2021 which she did. On 27Jan2021 she was admitted to "PRIVACY" and she had major surgery and was discharged a day and half later. She was put on pain medication. She did not realize at the time, that she should not have had ibuprofen before receiving the last two vaccines. She was fine with the first dose. She took 600mg of ibuprofen as an order from her surgeon. She has had zero side effects; she was wondering if by taking ibuprofen did, she destroy or reduce the efficacy of the vaccine. Her primary does not know about all this and she has not seen her primary since the surgery. Full contact details not available. She clarified she had two surgeries on 27Jan2021, she had back-to-back surgeries. She had a hysterectomy and had a sling placed for her bladder, states her bladder was hanging out of her body. She not sure what the second surgery was called. She was admitted at the "PRIVACY", states it was not insignificant when querying seriousness. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Swollen Lymph Nodes at clavicle and under arm; Headache; Chills; Fatigue; Body Aches; Vomiting; This is a spontaneous report from a contactable other hcp. A 44-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 10:00 AM (at the age of 44-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included allergies to sulfa drugs from an unknown date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) via unknown route of administration on 15Jan2021 at 1.00 PM administered on right arm, dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not affected with covid. Post vaccination the patient was not tested for covid. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). It was reported that on 05Feb2021 at 22:00, the patient experienced swollen lymph nodes at clavicle and under arm, headache, chills, fatigue, body aches and vomiting. The did not receive any treatment for events. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Swollen Lymph Nodes at clavicle and under arm; Headache; Chills; Fatigue; Body Aches; Vomiting; This is a spontaneous report from a contactable other hcp. A 44-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 10:00 AM (at the age of 44-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included allergies to sulfa drugs from an unknown date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) via unknown route of administration on 15Jan2021 at 1.00 PM administered on right arm, dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not affected with covid. Post vaccination the patient was not tested for covid. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). It was reported that on 05Feb2021 at 22:00, the patient experienced swollen lymph nodes at clavicle and under arm, headache, chills, fatigue, body aches and vomiting. The did not receive any treatment for events. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Long term Headache; Slight chest pain; Tiredness; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as dose 1, single for covid-19 immunisation. Medical history included Type 2 Diabetes, High Cholesterol from an unknown date and unknown if ongoing. Concomitant medications included empagliflozin (JARDIANCE) and rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. Not known allergies. On 27Jan2021 08:00 AM patient experienced long-term Headache, Slight Chest pain, tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not received treatment. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cold-stimulus headache, Norepinephrine increased, Panic attack, Tremor
Clinical narrative: extreme adrenaline rush; shakiness; Panic; brain fog; This is a spontaneous report from a contactable other hcp (patient). A 56-year-old nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number en9581, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 06Feb2021 11:00 (at the age 56-year-old) as DOSE 1, SINGLE for covid-19 immunization at health care facility. Medical history included type 2 diabetes mellitus, autoimmune thyroiditis and Epstein Barr virus positive mucocutaneous ulcer from an unknown date. The patient was taking other medication with the vaccine in two weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. On 06Feb2021 11:15, 15mins post vaccination the patient had an adrenaline rush, shakiness, panic, brain fog. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as recovered with lasting effects at the time of report.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Hypoaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: shoulder pain in which he can't move it for more than a few degrees; sore arm; He has tingling and numbness in his hand and finger tips; bruise really high on his shoulder; He has tingling and numbness in his hand and finger tips; arm which have been progressively getting worse; extreme shoulder pain; tingling fingertips, hand and arms; This is a spontaneous report from a contactable Consumer. This 26-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FM9809) via intramuscular route of administration on 08Feb2021 at 16:30 on left arm (at 26-year-old), as dose 1, single for COVID-19 immunization. It was mentioned that patient had no other products and underwent no investigation assessment. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks), events following prior vaccinations, medical History (including any illness at time of vaccination), family medical history relevant to events and relevant tests were reported as none. On 08Feb2021, an hour after vaccination he said that he had typical sore arm the night of the vaccination, within a couple of hours the pain started progressing and by the next morning on 09feb2021 he was not able move his shoulder and if he tried it was excruciating pain. On an unknown date in Feb2021 the patient had extreme shoulder pain, tingling fingertips, hand and arms, patient's arm which have been progressively getting worse, he had tingling and numbness in his hand and fingertips and bruise really high on his shoulder. He said that he no major redness or swelling, but he had a bruise really high on his shoulder. He said that he was concerned because he did not expect it to hurt like this and they say that the second dose was worse than the first. Caller asked if there was something that we were seeing with other people and was there any guidance on what to do next. Caller does not have a primary care physician to provide. He asked if this is a common experience and what should he do to address this. The patient did not require emergency Room and physician office visit. The patient had not recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site bruising
Clinical narrative: shoulder pain in which he can't move it for more than a few degrees; sore arm; He has tingling and numbness in his hand and finger tips; bruise really high on his shoulder; He has tingling and numbness in his hand and finger tips; arm which have been progressively getting worse; extreme shoulder pain; tingling fingertips, hand and arms; This is a spontaneous report from a contactable Consumer. This 26-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FM9809) via intramuscular route of administration on 08Feb2021 at 16:30 on left arm (at 26-year-old), as dose 1, single for COVID-19 immunization. It was mentioned that patient had no other products and underwent no investigation assessment. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks), events following prior vaccinations, medical History (including any illness at time of vaccination), family medical history relevant to events and relevant tests were reported as none. On 08Feb2021, an hour after vaccination he said that he had typical sore arm the night of the vaccination, within a couple of hours the pain started progressing and by the next morning on 09feb2021 he was not able move his shoulder and if he tried it was excruciating pain. On an unknown date in Feb2021 the patient had extreme shoulder pain, tingling fingertips, hand and arms, patient's arm which have been progressively getting worse, he had tingling and numbness in his hand and fingertips and bruise really high on his shoulder. He said that he no major redness or swelling, but he had a bruise really high on his shoulder. He said that he was concerned because he did not expect it to hurt like this and they say that the second dose was worse than the first. Caller asked if there was something that we were seeing with other people and was there any guidance on what to do next. Caller does not have a primary care physician to provide. He asked if this is a common experience and what should he do to address this. The patient did not require emergency Room and physician office visit. The patient had not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Rhinorrhoea, Sleep disorder
Clinical narrative: headache; nausea; had to sleep for 2 days; runny nose; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced headache and it got worse and worse, lasted about 5 days and then tapered off although I'm still getting them". On an unspecified date, the patient experienced headache, nausea, had to sleep for 2 days, runny nose. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Vaccination site pain
Clinical narrative: injection site pani; muscle pain; chills; joint pain; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: El9265), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (age at the time of vaccination was 67-year-old) as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, spinal stenosis from an unknown date and unknown if ongoing, hypersensitivity pneumonitis from an unknown date and unknown if ongoing, drug hypersensitivity (Penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient experienced injection site pain, muscle pain, chills, joint pain on 06Feb2021. It lasted for about 26 hours. No treatment was received for the events. Outcome of the events injection site pain, muscle pain, chills, joint pain was reported as recovered on an unspecified date at this time of the report.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Patient had a different taste in my mouth; This is a spontaneous report from a contactable consumer (reported for himself). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EM9810/Batch number was not reported), via an unspecified route of administration, administered in arm left on 08Feb2021 at 09:15 (at the age of 70-years-old) as dose number unknown, single for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included cutaneous t-cell lymphoma and food allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Feb2021 at 10:15, the reporter stated that after 1 hour of vaccination, patient had a different taste in his mouth that lasted 36 hours. No treatment was given for the events. The outcome of the event was resolved on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Vaccination site pain
Clinical narrative: eye swelling; a little sore in the injection site; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (3 days after the administration of the first dose of the Pfizer's COVID-19 vaccine), the patient experienced eye swelling, a little sore in the injection site but not much. The patient reported that, he was not sure if the swelling was caused by the vaccine or jalapeno peppers, he handled with his hands and then rubbed his eyes. He reported that he developed a little sore in the injection site but not much. The reporter wanted to know if he should be administered with the second dose of the Pfizer's COVID-19 vaccine considering the reaction he had in the eye and if eye swelling was a side effect reported for the administration of the Pfizer's COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 50-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 50-years), administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced very sore arm. It was further stated that the vaccine recipient was my landlord she told me today at 9.17 AM via text message that she received the Pfizer vaccine yesterday and that she had a very sore arm and other then the sore arm no other side effect. The treatment was not received for the event. The clinical outcome of the event very sore arm was reported as not recovered.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Pharyngeal erythema, Swollen tongue
Clinical narrative: Red dots in back of throat; slightly swollen tongue and uvula; slightly swollen tongue and uvula; This is a spontaneous report from a contactable other HCP (patient).   A 19-year-old non pregnant female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration administered in Right arm as Dose 1, Single on 10Feb2021 (age at the time of vaccination was 19-year-old), (at 11:00) for Covid-19 immunisation. The patient medical history included asthma. Concomitant medication included Prozac and Ibuprofen in two weeks. The patient did not receive other vaccine in 4 weeks. The patient did not receive covid vaccination priorly and not tested for covid post vaccination. The patient experienced Red dots in back of throat, not painful, slightly swollen tongue and uvula on 10Feb2021 (at 14:30). The patient received Benadryl as a treatment. Outcome of all the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing (some days are worse than others). The patient's concomitant medications were not reported. It was reported by the patient that after receiving the first dose of vaccine on an unspecified date in 2021 she experienced joint pain. She mentioned that she has some joint pain after the injection, not that bad. She was scheduled to get her second dose tomorrow (on an unspecified date). She already spoke to someone earlier if it was ok to take Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia
Clinical narrative: feeling sweaty; could not sleep; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age (Age:79, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on 08Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She got the first dose of the Pfizer covid 19 vaccine two days ago on 08Feb2021 and reported feeling sweaty and could not sleep. She wanted to know if she is contagious because she wants to attend a birthday party on Friday 12Feb2021. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, White blood cell count
Clinical narrative: metallic taste/After the 1st shot she had a metal taste in her mouth; This is a spontaneous report from Pfizer-sponsored program COVAX US Support two contactable consumers one of (patient) via Medical information team. A 65-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL1283), via intramuscular, administered in Arm Right on 08Jan2021 14:00 (age at the vaccination 64-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing fibromyalgia, reflex sympathetic dystrophy, Irregular heartbeat, ongoing hemangioma (In her brain), thyroid problems, low white blood cell counts (patient Was on Tegretol and her white count was down to 1 and she was sent to the hospital), ongoing Pinched nerves in her neck and back, migraines/weather migraines (that cause numbness in nose and foot as well as gastro-intestinal symptoms patient took AMITREX which usually takes for her migraines however it was less effective, and she felt the symptoms until 10PM that night. She has a history of migraines and they cause numbness in her face sometimes. She took migraine meds, and it did not help), numbness in nose and foot (weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms), gastro-intestinal symptoms, burst blood vessel in her eye, burst blood vessel in her eye, diastolic heart failure (She has diastolic heart failure she was diagnosed with about 5 years ago), abdominal pains and numbness in her face. The patient concomitant medications were not reported. The patient historical vaccine include flu shot on an unspecified date in Jul2020. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste/after the 1st shot, she had a metal taste in her mouth on 08Jan2021. The patient underwent lab tests and procedures which included white blood cell count low on, white blood cell count was down to 1 on unspecified date. The outcome of the event was recovered on 08Jan2021.  Follow-up (19MAY2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: dramatic arm pain; stiffness; Headache; chills; fatigue; jaw tension; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 08:30 hours as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rizatriptan taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 09Feb2021 at 11:45 hours, patient had dramatic arm pain, stiffness, headache, chills, fatigue and jaw tension. Patient received no treatment for all the events. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: dramatic arm pain; stiffness; Headache; chills; fatigue; jaw tension; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 08:30 hours as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rizatriptan taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 09Feb2021 at 11:45 hours, patient had dramatic arm pain, stiffness, headache, chills, fatigue and jaw tension. Patient received no treatment for all the events. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pain in extremity, Sinus congestion
Clinical narrative: Sinus congestion; pains/Body aches; Sore left arm; Low energy; This is a spontaneous report from a contactable other Health Care Professional. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:00 AM (at the age of 71 years old) as single dose for covid-19 immunisation. Medical history included breast cancer, sinusitis, tachycardia, covid-19 from an unknown date and unknown if ongoing. The patient had known allergies to sulfur. Concomitant medication in two weeks included blood pressure, vitamins. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 06Feb2021, patient experienced body aches, pains, sore left arm, low energy, sinus congestion. The patient did not received treatment due to the events. The outcome of events was recovered with lasting effects on Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: Severe migraine; Body aches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in left arm on 09Feb2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. Medical history included tested positive for COVID on 30Dec2020. concomitant medication was not reported.There were no other products. On 10Feb2021 at about 11-12 patient had developed body aches and a severe migraine. The body aches were off and on, sometimes he felt them and sometimes he did not, but they were persisting. The migraine was constant (at the time of report). Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Swelling face
Clinical narrative: swelling has moved to left side side of her tongue and to her left cheek.; sore throat; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 08Feb2021 (age at the time of vaccination was not provided) as dose number unknown, single for Covid-19 immunization. The patient's medical history included Covid-19 and heart attack. Caller mentioned she had COVID and a heart attack around thanksgiving that was why she decided to get the vaccine. It was verified that this occurred prior to getting the Covid-19 vaccine. The patient's concomitant medications were not provided. The patient calling about the Covid-19 Vaccine and stated that she had the vaccine on Monday 08Feb2021. She had a sore throat yesterday on 09Feb2021, and the lymph nodes on the left side of her neck were swollen yesterday on 09Feb2021. Stated that it felt like her tongue was bothering her too on that side, and now the swelling is moving up to her cheek today on that left side; kind of looks like the mumps on 10Feb2021. She asks if she should get medical attention. She mentioned that she was hospitalized the week of thanksgiving with Covid and a heart attack. It was verified that this occurred prior to getting the Covid-19 vaccine. She declined to provide email address. Caller wanted to know if these symptoms have been associated with the vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Hypersensitivity, Lip swelling, Vaccination site pain
Clinical narrative: lost his voice/could barely whisper; upper lip blew up, gradually increased in size after losing his voice; allergic reaction; pain at the injection site; This a spontaneous report from a contactable consumer (patient) via medical information team and from a Health Authority. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 05Feb2021 as dose 1, single for covid-19 immunisation. Medical history included bad hearing (he has bad hearing, so he needs people to speak loud and clear for him). The patient's concomitant medications were not reported. Approximately 2 hours after the 1st vaccine dose on 05Feb2021, the patient experienced lost his voice/could barely whisper and also reported his upper lip blew up, gradually increased in size after losing his voice. The patient took Benadryl every 4 hours for 24 hours. After "2 days my voice starting becoming normal and then within 72 hours my voice was completely normal and my lip was back to normal. The patient experienced pain at the injection site in Feb2021 and took Advil for that. Patient stated that someone suggested that he take two Benadryl, every four hours because he was probably having an allergic reaction. The outcome of the events lost his voice/could barely whisper and lip swelling was recovered on 07Feb2021 and outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor soreness near the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL3247 and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 30Jan2021 at 13:00 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation. Medical history included sarcoidosis and depression. The patient's concomitant medications were not reported. The patient previously took biaxin and experienced allergy. On 30Jan2021 at 14:00, the patient experienced minor soreness near the injection site. No treatment was received for the event. 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. Outcome of event was recovered on an unspecified date.   Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. This female consumer reported receiving her first injection of covid-19 vaccine, manufacturer unknown. She looked at her vaccination card but did not see a manufacturer name but noticed it did have EL8982 on it. The patient experienced vertigo which started about 2-3 days ago on an unspecified date and was continuing. She was scheduled to receive her second dose of the covid-19 vaccine on Friday. She asked was it still OK for her to get the second shot? The patient said, she does not think her vertigo is due to the covid-19 vaccine. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity
Clinical narrative: third dose of the vaccine; Off-label use; arm pain; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age (Age:91; Unit: Unknown) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated they had a clinic today and gave someone a third dose of the vaccine. He asked if there was any information on this, including any issues that should be looking for. Response received does state the following In a Phase I/II study of COVID-19 mRNA vaccines in adults, different strength doses of COVID-19 mRNA Vaccine BNT162b2 were given. This means that some people in the trials have already received higher doses of a similar vaccine (BNT162b1) than the currently recommended dose. The trial showed that although a stronger dose (100 micrograms) was not harmful, the recipients experienced more local reactions with very painful arms being reported. Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events. If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. They should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: nigh time developed fever 101F; sore arm at injection site; next day feel tired; This is a spontaneous report from a contactable consumer or other non HCP (Patient, self-reporting). A 58-year-old male patient received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 09:30 AM (age at vaccination 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccine in four weeks. On 09Feb2021 at 19:00 after vaccination patient experienced by night time developed fever 101F, sore arm at injection site, next day feel tired and fever subsided after taking 400 mg Tylenol. The did not visited the emergency room or physician office visit. The patient did not receive treatment for the adverse events except fever. No COVID prior to vaccination and not tested COVID post vaccination. The patient underwent lab test and procedure which include body temperature: 101F. The outcome of the patients event was recovering at the of report.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.