chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fall, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: passed out, faint; Bad dry cough; fell and his head hit the concrete; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out, faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G26-B21A and G17-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Past medical history included, smoking for 30+ years and vaping for past two years.  The patient's past medical history included Ex-smoker. Concurrent medical conditions included Vapor cigarette smoker. Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out, faint) (seriousness criterion medically significant), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete). On 12-May-2021, LOSS OF CONSCIOUSNESS (passed out, faint), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information included, an inhaler to help with the "lungs and stuff", cough syrup for a night was provided.  Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-139015 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: woke up in the middle of the night with fever; nausea; foot started to hurt, bottom of it and pain in the top back of left thigh; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (foot started to hurt, bottom of it and pain in the top back of left thigh) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced PAIN IN EXTREMITY (foot started to hurt, bottom of it and pain in the top back of left thigh) (seriousness criterion medically significant). On 18-May-2021, the patient experienced PYREXIA (woke up in the middle of the night with fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (foot started to hurt, bottom of it and pain in the top back of left thigh), PYREXIA (woke up in the middle of the night with fever) and NAUSEA (nausea) outcome was unknown.            Concomitant medication included birth control pills, not otherwise specified. Treatment included ibuprofen.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Loss of consciousness, Pain, Pain in extremity, Product dose omission issue
Clinical narrative: patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now; passed out; chest burning; leg pain; severe pain on one side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now). On 02-Jan-2021, LOSS OF CONSCIOUSNESS (passed out), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Leukaemia, Wound
Clinical narrative: diagnosed with leukemia; open wounds on her legs; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (diagnosed with leukemia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome and Atrial fibrillation. Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced WOUND (open wounds on her legs). On 14-Mar-2021, the patient experienced LEUKAEMIA (diagnosed with leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 11-Mar-2021 due to LEUKAEMIA. At the time of the report, LEUKAEMIA (diagnosed with leukemia) and WOUND (open wounds on her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: bone marrow was tested. On 14-Mar-2021, Biopsy bone marrow: leukemia.         Treatment information not reported.   Concomitant medications also included heart med, but full list not reported.  On an unknown date, after the 1st dose, patient had blood work done. After the 2nd dose, patient was then admitted to the hospital on 11-MAR-2021 due to the weird blood test results.  Company comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Pain, Pancreatitis, Vaccination complication
Clinical narrative: bouts of pancreatitis; Pain; not eating much; feels like crap; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PANCREATITIS (bouts of pancreatitis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (bouts of pancreatitis) (seriousness criteria hospitalization and medically significant), PAIN (Pain), HYPOPHAGIA (not eating much) and VACCINATION COMPLICATION (feels like crap). At the time of the report, PANCREATITIS (bouts of pancreatitis), PAIN (Pain), HYPOPHAGIA (not eating much) and VACCINATION COMPLICATION (feels like crap) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use and treatment information not provided.  A parent reported on behalf of the patient. The patient has bouts of pancreatitis. Ever since he got his first shot, he's been suffering. Caller stated he was released from the hospital last Friday or the Friday before that. He still had pain and was not eating much. He was told to eat a soft diet. Caller stated ever since then he has felt like crap. Patient demographics and vaccine information was not provided. Caller stated the pancreatitis was not caused by the vaccine.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-036788, MOD-2021-036788 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Food refusal, General physical health deterioration, Loss of consciousness
Clinical narrative: passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Retching, Weight decreased
Clinical narrative: passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy with facial drooping; This spontaneous case was reported by a health care professional and describes the occurrence of BELL'S PALSY (Bell's Palsy with facial drooping) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy with facial drooping) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy with facial drooping) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient was treated in the Emergency Department with antiviral therapy.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots under skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots under skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots under skin) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots under skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: low grade fever; cold; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Patient got his 1st COVID vaccine and he knew it was supposed to be 3 weeks later, but the doctors scheduled him 5 weeks out so he wanted to know if that was okay, or if he would have to reschedule it. The patient had a low-grade fever and a cold, but he was able to get the second dose of the vaccine. The outcome of the events was unknown.  Follow-up (27Feb2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (26Feb2021): New information reported from a contactable consumer includes that the patient had a low-grade fever and a cold. The previous item was considered invalid as there was no adverse event. Upon receipt of current item, this case now contains all required information to be considered valid.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Malaise
Clinical narrative: Shortness of breath; Joint pain; Feeling unwell; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient) and in response to Non HCP letter sent. A 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 10Feb2021 at 01:45 on Arm left (at the age of 84-year-old) as 2ND DOSE, SINGLE DOSE (1 shot) for COVID-19 immunisation in Hospital. Vaccine wasn't administered at a Facility. No other products were taken together. There are predisposing factors. The patients medical history was not reported. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 20Jan2021 (at the age of 84-year-old) as 1ST DOSE, SINGLE DOSE for for COVID-19 immunisation. Patient had her 1st shot of the vaccine yesterday (20Jan2021). On the 03Feb2021, she is scheduled to have surgery on her head patient is aware that they will put a shot in it. On 11Feb2021 at 08:00, the patient experienced shortness of breath, Joint pain and feeling unwell. No admission to hospital was involved. No treatment received was received. Patient was feeling fine now. No visit to emergency room and Physician Office. No culture was performed. Outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Hypoaesthesia, Paraesthesia oral, Skin hypertrophy, Swelling face
Clinical narrative: feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: having difficulty breathing; chest is heavy; This is a spontaneous report from a contactable consumer (patient). An 82 year old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 29Jan2021 as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29Jan2021 approximately one and half hours of vaccination had difficulty breathing, and states chest is heavy. She had concerns and asks what she should do. The outcome of the events is unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Arm was sore; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in Arm Left on 20Jan2021 11:50 (at the age of 59-years-old) (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing Heart attack 6-7 years ago, anxiety, anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol 6.25 mg twice daily taken for myocardial infarction, clopidogrel 75mg once daily taken for anticoagulant therapy, rosuvastatin 20mg once daily taken for hypercholesterolaemia, escitalopram 10mg once daily taken for anxiety start and stop date were not reported. There was no AE(s) following prior vaccinations that sometimes when she gets the flu shot, she gets the feeling of the flu after, but it's minor. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient experienced stinging and burning sensation that was not attributed to the needle and arm was sore on 20Jan2021. The patient received her 1st dose about 2 weeks ago and had no issues, but as she had spoken with other people that have gotten it, it left her thinking.  She asked when you get a shot and sometimes you feel the pinch, and sometimes it burns. Further stated that everyone she talked to said it was nothing for them; they didn't have that burning. But for her it burned during the injection and for 10 minutes after. Also states that her arm was sore the next day, which she expected. And everyone else said they had the arm soreness to, but no one had said that it burned during the injection. She just wanted to make sure that she was getting the right thing and was getting the protection. Caller clarified and stated that the burning lasted about 20 minutes after the injection. When asked what time she got her injection, caller stated that her memory was so bad, but she thought it was around 11:50am. The AE did not require a visit to emergency room or physician office. List other relevant diagnostic and confirmatory test results for event(s) was none. Outcome of the event (Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle) was recovered on 20Jan2021 while event (Arm was sore) was recovered on 22Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nodule
Clinical narrative: has some little nodules floating around that she can feel; she experienced swollen lymph nodes in her neck. She said they are still swollen, moving a little.; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 25Jan2021 in left arm as single dose for COVID-19 immunization. Previously the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 06Jan2021 at 02:10pm on left arm as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27-Jan-2021 the patient reported that she experienced swollen lymph nodes in her neck. She said they were still swollen, moving a little. Caller wanted to know how long it takes for them to go away. The caller explained that the swelling had improved and was not as bad and not as tender to the touch as it was previously. However, on an unknown date in 2021 she felt nodules all up in there. Her lymph nodes were originally swollen on both sides her neck and now it seems to be swollen on one side, she doesn't really know. Caller made the comment that she wished they would make the Vaccine Record Card fit in a regular wallet. The caller mentions the writing is so tiny and that she needed to get in better light. Callers believed the beginning letter of the Lot number was an E or it could be an F. She thinks it was an E. It was mentioned that the patient did not receive any other products, had no history and no investigation was done, she did not require emergency Room and physician Office visit, no prior vaccinations (within 4 weeks) was done, and no relevant test were done. The outcome of has some little nodules floating around that she can feel was unknown and Swollen lymph nodes was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Shoulder pain; Chills; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shoulder pain, chills and muscle pain. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Nausea
Clinical narrative: dizziness; weakness; not being able to walk. He had to crawl to the door to let her in. He has been this way all day.; feeling nauseous; This is a spontaneous report from a contactable consumer reported for a male patient on behalf of her uncle. A 61-years-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on unspecified date as unknown dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient experienced dizziness, weakness to the point of not been able to walk (He had to crawl to the door to let her in. He was this way all day. He felt 'really winded' after attempting to remove the snow a day after they got snow), he had nothing to eat all day and feeling nauseous. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the place were I got the shot hurt; This is a spontaneous report received from a contactable consumer (patient) from Pfizer-sponsored program Pfizer First Connect. A female patient of age 70 (units not provided) received the 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 27Jan2021 at 16:00 at a single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in Jan2021, the place were she got the shot hurt. Patient received Tylenol for the site pain. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: Sore arm; Minor swelling at injection site; Headache; Low-grade fever the next day (99 degrees); This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jan2021 at 14:30 (at the age of 41 years) as 1st dose, single dose for COVID-19 immunisation. Medical history included being treated for Grave's Disease, hyperthyroidism, food allergies to tree nuts and pitted fruit. Concomitant medications included methimazole 2.5 mg daily taken for an unspecified indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 29Jan2021 at 00:00, the patient experienced sore arm, minor swelling at injection site, headache, and low-grade fever 99 degrees. Patient received no treatment for the events. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering.  Information about lot and batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: facial swelling; This is a spontaneous report from a contactable other health professional. A 34-years-old non pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685), via an unspecified route of administration, administered in arm left on 08Jan2021 at 15:30 as 1st single dose, for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included iodine allergy, drug hypersensitivity, food allergy, covid-19 and concomitant medication included prednisone (Other medications in two weeks). On 08Jan2021 (after the first dose) the patient experienced facial swelling within a couple hours of the vaccine that lasted for several days. On an unspecified date in 2021, the outcome of the events recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Exposure during pregnancy, Pain in extremity
Clinical narrative: sore arm; Received first COVID vaccine 28Jan2021. She is pregnant and is due in Apr2021; This is a spontaneous report from contactable nurse (patient) via Pfizer Representative.   This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no =EL3248), via an unknown route, on 28Jan2021 02:45 PM at a single dose for COVID-19 immunisation. Vaccine location was Right arm. No relevant medical history was not reported. Concomitant medications include Prenatal (1 tablet per day by mouth) from Jun2020 for because she's pregnant, probiotic (2 capsules a day by mouth) on Jan2021 for GBS clarified as Group B Strep, magnesium (400mg 1 tablet daily by mouth) on Jul2020 for low magnesium and Unisom tablet. The patient is pregnant and due in 12Apr2021. She was wondering there are any studies occurring in pregnant women. The outcome of the events was unknown. On 06Feb2021, it was reported that, Patient was not had covid prior vaccination and not covid tested post vaccination. The Last menstrual date was 06July2020 and gestational period was 29. As of 24Feb2021, it was reported that, patient completed the vaccine and the patient is pregnant (Precautionary AE) Patient was 33 weeks pregnant and got her second Covid vaccine dose yesterday on 23Feb2021, she didn't had an adverse event but she was pregnant. Relevant test results, she had a CT scan done in late Jul2020 because she was having palpitations. Patient had sore arm with first Covid vaccine. Patient was 33 weeks pregnant, estimated Date of Conception was 20Jul2020. Other and father did not smoke, drink alcohol or use illicit drugs during this pregnancy, patient had 3 previous pregnancies and 2 children, the outcome of previous pregnancies, questionable miscarriage, she would say yes but more like a chemical pregnancy in Jun2020.   Follow-up (06Feb2021): New information was received from a contactable nurse (patient) includes: Added suspect details (lot no. EL3248), patent details (The Last menstrual date was 06July2020 and gestational period was 29.), full due date of pregnancy (12Apr2021) and clinical information.   Information about Batch/Lot number has been requested.  Follow-up (24Feb2021): New information was received from a Pfizer-sponsored program and from contactable includes: new event, Concomitant details and clinical information added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: throat and tongue swelling; throat and tongue swelling; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration, administered in left arm on 08Jan2021 at 11:00 (at the age of 51-years age) as single dose for COVID-19 immunization in a hospital. Medical history included hypothyroidism, osteoporosis, and allergies to penicillin, sulfa, nitrofurantoin, levaquin (from an unknown date and unknown if ongoing). Patient received atorvastatin (ATORVASTATIN), levothyroxine sodium (SYNTHROID) and fluticasone (FLUTICASONE) within 2 weeks of vaccination for unspecified indications. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Jan2021 at 11:00, the patient experienced throat and tongue swelling. Events resulted in Emergency room/department or urgent care. Patient received treatment with prednisone for the events. On an unspecified date in 2021, events recovered.  Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Malaise
Clinical narrative: Chills; Tired; Light headed; General not feeling well; This is a spontaneous report from a contactable consumer (patient).  A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 23Jan2021 at 09:50 (Batch/Lot Number: EL9263) as 1st dose, single for covid-19 immunization. Patient's medical history included, light-headed, hormone therapy, goiter, blood pressure and water pill (water retention), all were ongoing. It was mentioned that she was lightheaded before the vaccination and light-headedness was still ongoing. Patient's family history was reported as none. The vaccine was not administered in military facility. Concomitant medication(s) included amlodipine (AMLODIPINE) (ongoing since several years) at 5mg (one and one-half) daily orally for blood pressure, lisinopril (LISINOPRIL) (ongoing since several years) at 20mg take once daily orally for blood pressure, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) (ongoing since 8 months or a year) at 25mg (one and one-half) daily orally as water pill, levothyroxine (LEVOTHYROXINE) (ongoing since few years) at 25mcg (one-half) once daily orally for goitre, estrogens conjugated (PREMARIN) (ongoing since long time) at 0.03 mg five times a week orally for hormone therapy and also Vitamins since an unspecified date. The patient previously took clindamycin and experienced allergic reaction to an antibiotic. It was some years ago that a doctor gave her clindamycin and she had a reaction. Had no product or information to provide NDC, lot or expiration date for the clindamycin she took. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced Light headed and not feeling well and on 25Jan2021, the patient experienced chills and tired. It was reported that patient had a vaccine shot on 23Jan2021 and she had chills and a general not feeling well and she was tired. The patient noticed about 24 hours later, she felt the chills really bad on 25Jan2021 monday morning. She had chills all day monday (25Jan2021) and Tuesday(26Jan2021). She also started to feel tired on Monday also mentioned she told the pharmacist and he suggested she got up too quickly. She was scheduled to take the second dose of the vaccine 13Feb2021.The outcome of the event chills was recovered on 28Jan2021 and outcome for the event tired was recovering, outcome for all other events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; when she moves her arm, it hurts; This is a spontaneous report from a contactable consumer or other non hcp. A 29-year-old Female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 28Jan2021 15:55 as SINGLE DOSE for COVID-19 immunization. (Age at vaccination is 29-Year-old). Medical history included ongoing fibromyalgia, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for hypersensitivity, start and stop date were not reported. Within an hour of receiving the vaccine, her arm was becoming sore and she took 400mg of Advil. patient wants to know is the efficacy of the vaccine effected by taking the Advil. Patient stated that she had to wait 15 minutes after receiving the vaccine. It started hurting like a normal vaccine would but within the hour when she got home, her arm started hurting more. She also has fibromyalgia, so she doesn't know if this contributed to the soreness. Patient stated she honestly does not know if the Advil helped. The soreness kind of stayed the same and moving her arm, hurts. She tried to move her arm because it says to exercise it, but it hurts. The patient stated that soreness has remained the same. Therapeutic measures were taken as a result of sore arm when she moves her arm, it hurts with Advil. The outcome for the events were reported as Not Resolved.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Night sweats, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Night sweats; little shortness of breath; white dots on back of throat; Throat pain; bunch of bumps on the back of her tongue/throat; little cough; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EL3248) via an unspecified route of administration in left arm on 12Jan2021 as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that on 12Jan2021 patient took the Pfizer COVID vaccine and 3 days later i.e., on 15Jan2021, she had night sweats and a little shortness of breath, like upstairs, or if she runs too fast, or talks too much, that was pretty much for two weeks now, then the last 2 days she had white dots, white dots in the back of her throat, and she went to urgent care and it was negative for strep, she was prone to strep. They said it was not strep, she was having throat pain, and now that morning, she had a bunch of bumps on the back of her tongue, and she was given Clindamycin, she wondered if the throat pain was related to the vaccine, she got tested for strep, and they said it was negative so now maybe it was related to the vaccine. Night sweats outcome: if she puts on a fleece blanket, which she loves to as she was always cold, but now she cannot unless she was waking up with a drenching sweat, and she did not sweat. She did not call about the sweats, since she thought she was 41, and it maybe that, but then with more thought it could be the vaccine. She did light jogs up and down stairs, she walked all over the hospital, and never got out of breath, and now she had to stop and breathe in deep. She had a little cough every now and then, and when she went to urgent care, because of the cough and her throat hurting, they did a COVID test, and it was negative. She told them she got vaccinated, they said they would still do the test, it was a rapid COVID, in the office strep and they put strep in the lab for 3 days. For white dots: her throat was hurting a while, and she looked with a flashlight and saw white dots, now states this was more than 3 days ago, the test took 3 days, so this was 4 or 5 days since she saw white dots. Last night, she did not see before the bumps in the back of her throat, she thought she had food in the back of her throat, she felt something there, and she looked at it with a flashlight and now she has bumps in the back of her throat, she tried to remove what was in the back of her throat. She did not see the white dots anymore, before the test came in, when they saw white dots. Treatment included clindamycin which was at home and she has not started. On an unspecified date in Jan2021, the patient underwent lab tests and procedures which included rapid COVID test and strep test with results of negative. The outcome of the events was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.