chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, COVID-19, Chills, Dyspnoea, Hallucination
Clinical narrative: Oxygen saturation low; Difficulty breathing; Hallucinating; Incoherent; Wheezing; does not recall anything after that for the next 12 hours; Extreme Painful L arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing) and HALLUCINATION (Hallucinating) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not reported.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. Concomitant products included INSULIN ASPART and INSULIN DETEMIR (LEVEMIR) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), HALLUCINATION (Hallucinating) (seriousness criterion hospitalization), INCOHERENT (Incoherent), WHEEZING (Wheezing), AMNESIA (does not recall anything after that for the next 12 hours), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills). On 21-Mar-2021, OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing), HALLUCINATION (Hallucinating), INCOHERENT (Incoherent), WHEEZING (Wheezing), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills) had resolved. At the time of the report, AMNESIA (does not recall anything after that for the next 12 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: negative (Negative) Negative. On 17-Mar-2021, Oxygen saturation decreased: abnormal (abnormal) oxygen 72.     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.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incoherent, Oxygen saturation decreased, Pain in extremity, Wheezing
Clinical narrative: Oxygen saturation low; Difficulty breathing; Hallucinating; Incoherent; Wheezing; does not recall anything after that for the next 12 hours; Extreme Painful L arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing) and HALLUCINATION (Hallucinating) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not reported.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. Concomitant products included INSULIN ASPART and INSULIN DETEMIR (LEVEMIR) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), HALLUCINATION (Hallucinating) (seriousness criterion hospitalization), INCOHERENT (Incoherent), WHEEZING (Wheezing), AMNESIA (does not recall anything after that for the next 12 hours), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills). On 21-Mar-2021, OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing), HALLUCINATION (Hallucinating), INCOHERENT (Incoherent), WHEEZING (Wheezing), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills) had resolved. At the time of the report, AMNESIA (does not recall anything after that for the next 12 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: negative (Negative) Negative. On 17-Mar-2021, Oxygen saturation decreased: abnormal (abnormal) oxygen 72.     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.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Inappropriate schedule of product administration, Lymphoedema
Clinical narrative: CHF; lymphedema; did not receive 2nd Dose within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days). The patient was hospitalized from 10-Mar-2021 to 07-Apr-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF) and LYMPHOEDEMA (lymphedema) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.; Sender's Comments: This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Fatigue, Mobility decreased, Nausea
Clinical narrative: Severe  arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe  arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue,  fever off and on, and sometimes I feel weak
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Severe headaches, lasting ~1+ week; Severe joint pain (~7 on scale of 1-10), lasting ~1-2 weeks
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in right arm to start followed by chills and tiredness. The next day much the same. Now 3 days later still feeling nausea and fever and chills.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Diplopia, Extraocular muscle disorder, Magnetic resonance imaging
Clinical narrative: Vision became double; Muscles in my rayed no longer work together; This is a spontaneous report from a contactable consumer (patient). This 68-year-old, non-pregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2, via an unspecified route of administration, administered in left arm on 17Feb2021 at 01:00 PM (age at vaccination of 68 years; lot number: EL6201) as single dose for COVID-19 immunization. Medical history included "IND" from an unknown date, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, vestibular vertigo from an unknown date and unknown if ongoing, and type 2 diabetes from an unknown date and unknown if ongoing. Patient had allergies to benzoic acid, vancomycin, moxifloxacin hydrochloride (AVELOX), sulfa, azithromycin (ZITHROMAX), and tree pollen. Patient had not experienced COVID or tested positive for COVID prior to vaccination. Concomitant medication(s) included pravastatin sodium (PRAVASTIN) taken for an unspecified indication, start and stop date were not reported; glimepiride taken for an unspecified indication, start and stop date were not reported; insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported; vitamin D taken for an unspecified indication, start and stop date were not reported; and famotidine (PEPCID AC) taken for an unspecified indication, start and stop date were not reported. Patient had received no other vaccine in four weeks. Patient received the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration, as a single dose (batch/lot number: unknown) on an unknown date for COVID-19 immunization. The patient reported that three days after her second dose her vision became double on 21Fe2021 at 2:00 PM. She had three MRI's, two MRA's, and blood test and they could not find a cause. The muscles in her "rayed" no longer work together but vision was fine and no diabetic damage. She had not received treatment for vision became double. Not sure if it's from the vaccine but wanted someone to know if it might help. The patient was not recovered from vision became double and muscles in her "rayed" no longer work together.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Fibrin D dimer decreased
Clinical narrative: Chest pain, Elevated blood pressure, elevated cardiac enzymes,  Acute myocarditis
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Myocardial necrosis marker increased, Myocarditis, Scan with contrast normal, Ventilation/perfusion scan
Clinical narrative: Chest pain, Elevated blood pressure, elevated cardiac enzymes,  Acute myocarditis
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Injection site rash
Clinical narrative: Chest pain, throat tightening, pain with deep breath, dizziness, chills, fever, arm rash under injection site, muscle pains throughout back/legs/neck, lightheadedness, fatigue, nausea, difficulty holding head up. Several Sx lasted up to five days.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pleurisy, Throat tightness
Clinical narrative: Chest pain, throat tightening, pain with deep breath, dizziness, chills, fever, arm rash under injection site, muscle pains throughout back/legs/neck, lightheadedness, fatigue, nausea, difficulty holding head up. Several Sx lasted up to five days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Loss of consciousness, Pain in extremity, Skin abrasion
Clinical narrative: Hypoesthesia in left arm & hand. Intermittent hypoesthesia in lips and jaw within 15 minutes of vaccination.  Dizziness and vision impairment after 35 minutes. I attempted to return to the store and fell over twice while walking there due to dizziness/blacking out.  Scraped my knees and chin.  Was helped by store employees, they checked my blood pressure and cleaned the wounds on my knees (from falling). Hypotension (88/50) upon returning to the store. Drank fluid, ate, was taken to urgent care. At urgent care, normal blood sugar (104),  still hypotensive (86/56) approximately 2 hours after vaccination but I felt less dizzy, no vision abnormalities since being helped at the store. Remained at urgent care for over 2 hours, blood pressure was 99/62 at release.  Prior to release hypoesthesia largely resolved and was left with only arm pain.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period started 14 days too soon.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Nausea, Vertigo
Clinical narrative: Sever vertigo; nausea; dehydrated; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had received first dose on unspecified date. Nine days later had "sever vertigo/nausea" on unspecified date. The patient thought it was his own stupidity doing yard work and getting dehydrated on unspecified date. The clinical outcome of vertigo/nausea and dehydrated was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: 39 y/o reports painful/burning rash after vaccine. States he received his second dose of the Moderna vaccine on Friday 16 April. Friday he developed chills, arm pain/redness at injection site, headache and felt feverish but didn't check his temperature. He also developed a painful rash on his left mid-upper back that has now spread to under his arm along his side and to his chest, consistent with Shingles. States he is also experiencing like he inhaled smoke, like a burning sensation when he inhales. Denies any SOB, chest pain, wheezing, coughing.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: 39 y/o reports painful/burning rash after vaccine. States he received his second dose of the Moderna vaccine on Friday 16 April. Friday he developed chills, arm pain/redness at injection site, headache and felt feverish but didn't check his temperature. He also developed a painful rash on his left mid-upper back that has now spread to under his arm along his side and to his chest, consistent with Shingles. States he is also experiencing like he inhaled smoke, like a burning sensation when he inhales. Denies any SOB, chest pain, wheezing, coughing.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went away after ~15 min, and came back off and on a few times over next few days; extremely swollen lymph node on left side, noticed ~45 min after shot, went away by next day; headache, minor aches in joints for 1 night
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: Sore left shoulder 24 hours; Flu like symptoms beginning  24 hours after second injection
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness, redness, slight swelling of injection area; No treatment; Has continued for 3 days following initial reaction
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizzy; headache; This is a spontaneous report received from a contactable female consumer, the patient. A 29-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced dizzy and headache, both on an unspecified date. The patient received the first dose on 06Mar2021, and on Wednesday, the patient started experiencing a headache and felt dizzy. The patient went to the doctor who said he was normal. The first day after receiving the vaccine, the patient felt normal but on Wednesday, she started with a headache and was told these can also be symptoms for a COVID infection. Clinical outcome of the events dizzy and headache was unknown.  Information about lot/batch no. has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: LUMP IN LEFT LYMPH NODE IN MY NECK
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus ringing of the ears continuous
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red spots began to appear on both arms and neck; This is a spontaneous report from a contactable consumer, the patient. This 76-year-old female patient that reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 14Feb2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Mar2021; both via unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that on 17Feb2021, red spots began to appear on both arms and neck. She was like that for two weeks and they disappeared (unspecified date). She went for the second dose on 12Mar2021. She got the little spots again last night and the day before (estimated as Mar2021), outcome reported as unknown. The clinical outcome of red spots on both arms and neck was recovered on unspecified date.  No follow-up attempts are possible; no request for batch number will be pursued.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthma, Fall, Head injury, Headache
Clinical narrative: asthma is worse; left knee was a little swollen; left knee was a little swollen and hurts a little bit; hitting her head and left knee on the concrete; hitting her head and left knee on the concrete; splinter in right hand; fell; startled; arm was weak; little bit of a pain in my arm; headache; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for four patients. The is the first of four reports. This 57-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included cerebral palsy, epilepsy, asthma, pacemaker, postural orthostatic tachycardia syndrome, and obese. Concomitant medications were not reported. The patient reported that when she first got the shot, she had no pain in her arm or anything. The next day (28Feb2021) she had a little bit of a pain in her arm and a headache. She did not have any flu symptoms.  About 4 days after the shot (estimated as Mar2021), her dominant arm was weak; no pain but just really weak. She stated that she has cerebral palsy and tends to do a lot of things with one arm. She had to use both arms to take a tray of cookies out of the oven. On 15Mar2021, she was carrying a bag of shredded paper and someone honked their car, which startled her and she fell, hitting her head and left knee on the concrete and got a splinter in her right hand when she landed from the fall. She also had a headache.  Her left knee was a little swollen and hurts a little bit but she did not get hurt bad when she fell. On 16Mar2021, she let the dogs in and her husband yelled and startled her so she fell and hit the the counter in the bathroom but did not get hurt. She did not get hurt the third time she fell either. The patient reported that she thinks her asthma was worse but stated has had terrible weather; it has been dusty since she lives in (State). The patient was scheduled to get her second shot on 18Mar2021. She reported that she has have never had arm weakness or experienced falling when startled; these are new since receiving the vaccine. The outcome of the events pain in arm, headache, arm was weak, startled, fell, hitting head and left knee on the concrete and got a splinter in right hand, left knee was a little swollen and hurts a little bit, and asthma is worse was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint injury, Joint swelling, Muscular weakness, Nervousness, Pain in extremity
Clinical narrative: asthma is worse; left knee was a little swollen; left knee was a little swollen and hurts a little bit; hitting her head and left knee on the concrete; hitting her head and left knee on the concrete; splinter in right hand; fell; startled; arm was weak; little bit of a pain in my arm; headache; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for four patients. The is the first of four reports. This 57-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included cerebral palsy, epilepsy, asthma, pacemaker, postural orthostatic tachycardia syndrome, and obese. Concomitant medications were not reported. The patient reported that when she first got the shot, she had no pain in her arm or anything. The next day (28Feb2021) she had a little bit of a pain in her arm and a headache. She did not have any flu symptoms.  About 4 days after the shot (estimated as Mar2021), her dominant arm was weak; no pain but just really weak. She stated that she has cerebral palsy and tends to do a lot of things with one arm. She had to use both arms to take a tray of cookies out of the oven. On 15Mar2021, she was carrying a bag of shredded paper and someone honked their car, which startled her and she fell, hitting her head and left knee on the concrete and got a splinter in her right hand when she landed from the fall. She also had a headache.  Her left knee was a little swollen and hurts a little bit but she did not get hurt bad when she fell. On 16Mar2021, she let the dogs in and her husband yelled and startled her so she fell and hit the the counter in the bathroom but did not get hurt. She did not get hurt the third time she fell either. The patient reported that she thinks her asthma was worse but stated has had terrible weather; it has been dusty since she lives in (State). The patient was scheduled to get her second shot on 18Mar2021. She reported that she has have never had arm weakness or experienced falling when startled; these are new since receiving the vaccine. The outcome of the events pain in arm, headache, arm was weak, startled, fell, hitting head and left knee on the concrete and got a splinter in right hand, left knee was a little swollen and hurts a little bit, and asthma is worse was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Splinter
Clinical narrative: asthma is worse; left knee was a little swollen; left knee was a little swollen and hurts a little bit; hitting her head and left knee on the concrete; hitting her head and left knee on the concrete; splinter in right hand; fell; startled; arm was weak; little bit of a pain in my arm; headache; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for four patients. The is the first of four reports. This 57-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included cerebral palsy, epilepsy, asthma, pacemaker, postural orthostatic tachycardia syndrome, and obese. Concomitant medications were not reported. The patient reported that when she first got the shot, she had no pain in her arm or anything. The next day (28Feb2021) she had a little bit of a pain in her arm and a headache. She did not have any flu symptoms.  About 4 days after the shot (estimated as Mar2021), her dominant arm was weak; no pain but just really weak. She stated that she has cerebral palsy and tends to do a lot of things with one arm. She had to use both arms to take a tray of cookies out of the oven. On 15Mar2021, she was carrying a bag of shredded paper and someone honked their car, which startled her and she fell, hitting her head and left knee on the concrete and got a splinter in her right hand when she landed from the fall. She also had a headache.  Her left knee was a little swollen and hurts a little bit but she did not get hurt bad when she fell. On 16Mar2021, she let the dogs in and her husband yelled and startled her so she fell and hit the the counter in the bathroom but did not get hurt. She did not get hurt the third time she fell either. The patient reported that she thinks her asthma was worse but stated has had terrible weather; it has been dusty since she lives in (State). The patient was scheduled to get her second shot on 18Mar2021. She reported that she has have never had arm weakness or experienced falling when startled; these are new since receiving the vaccine. The outcome of the events pain in arm, headache, arm was weak, startled, fell, hitting head and left knee on the concrete and got a splinter in right hand, left knee was a little swollen and hurts a little bit, and asthma is worse was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: asthma is worse; left knee was a little swollen; left knee was a little swollen and hurts a little bit; hitting her head and left knee on the concrete; hitting her head and left knee on the concrete; splinter in right hand; fell; startled; arm was weak; little bit of a pain in my arm; headache; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for four patients. The is the first of four reports. This 57-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included cerebral palsy, epilepsy, asthma, pacemaker, postural orthostatic tachycardia syndrome, and obese. Concomitant medications were not reported. The patient reported that when she first got the shot, she had no pain in her arm or anything. The next day (28Feb2021) she had a little bit of a pain in her arm and a headache. She did not have any flu symptoms.  About 4 days after the shot (estimated as Mar2021), her dominant arm was weak; no pain but just really weak. She stated that she has cerebral palsy and tends to do a lot of things with one arm. She had to use both arms to take a tray of cookies out of the oven. On 15Mar2021, she was carrying a bag of shredded paper and someone honked their car, which startled her and she fell, hitting her head and left knee on the concrete and got a splinter in her right hand when she landed from the fall. She also had a headache.  Her left knee was a little swollen and hurts a little bit but she did not get hurt bad when she fell. On 16Mar2021, she let the dogs in and her husband yelled and startled her so she fell and hit the the counter in the bathroom but did not get hurt. She did not get hurt the third time she fell either. The patient reported that she thinks her asthma was worse but stated has had terrible weather; it has been dusty since she lives in (State). The patient was scheduled to get her second shot on 18Mar2021. She reported that she has have never had arm weakness or experienced falling when startled; these are new since receiving the vaccine. The outcome of the events pain in arm, headache, arm was weak, startled, fell, hitting head and left knee on the concrete and got a splinter in right hand, left knee was a little swollen and hurts a little bit, and asthma is worse was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthma, Fall, Head injury, Headache
Clinical narrative: pain in the arm/Arm Pain; flu symptoms/Flu Like Symptoms; This is a spontaneous report from a contactable consumer reporting for 4 patients (herself, husband, mom, and brother-in-law). This report is for her brother-in-law. A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 27Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced pain in the arm/ arm pain and the next day they had flu symptoms/ flu like symptoms. The outcome of the events pain in the arm/ arm pain and flu symptoms/ flu like symptoms was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295120 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint injury, Joint swelling, Muscular weakness, Nervousness, Pain in extremity
Clinical narrative: pain in the arm/Arm Pain; flu symptoms/Flu Like Symptoms; This is a spontaneous report from a contactable consumer reporting for 4 patients (herself, husband, mom, and brother-in-law). This report is for her brother-in-law. A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 27Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced pain in the arm/ arm pain and the next day they had flu symptoms/ flu like symptoms. The outcome of the events pain in the arm/ arm pain and flu symptoms/ flu like symptoms was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295120 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splinter
Clinical narrative: pain in the arm/Arm Pain; flu symptoms/Flu Like Symptoms; This is a spontaneous report from a contactable consumer reporting for 4 patients (herself, husband, mom, and brother-in-law). This report is for her brother-in-law. A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 27Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced pain in the arm/ arm pain and the next day they had flu symptoms/ flu like symptoms. The outcome of the events pain in the arm/ arm pain and flu symptoms/ flu like symptoms was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295120 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: pain in the arm/Arm Pain; flu symptoms/Flu Like Symptoms; This is a spontaneous report from a contactable consumer reporting for 4 patients (herself, husband, mom, and brother-in-law). This report is for her brother-in-law. A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 27Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced pain in the arm/ arm pain and the next day they had flu symptoms/ flu like symptoms. The outcome of the events pain in the arm/ arm pain and flu symptoms/ flu like symptoms was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295120 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303394 as same reporter/drug, different AE/patients.;US-PFIZER INC-2021303396 as same reporter/drug, different AE/patients.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: headache; lightheaded; chills; tingling; flushed face; hot flashes; fatigue; feeling unwell; This is a spontaneous report received from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included the patient was allergic to 23 medicines and got hives from them. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient called her physician before the first shot and her physician thought that the patient should not taking diphenhydramine hydrochloride before the first shot and she followed his advice and she did not take it. The patient did have some reactions on the 3rd and the 4th in Mar2021; headache, lightheaded, chills, tingling, flushed face. After 2 days it was okay and the patient was fine. The patient stated that yesterday it was all back again for no reason and the patient felt lightheaded and had a headache, hot flashes and fatigue in Mar2021. The patient had a bad night and she tried ibuprofen (ADVIL) and then she switched to acetaminophen (TYLENOL) as she was feeling unwell in Mar2021. The outcome of events, headache, lightheaded, chills, tingling, flushed face, hot flashes, fatigue and feeling unwell was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Malaise, Paraesthesia
Clinical narrative: headache; lightheaded; chills; tingling; flushed face; hot flashes; fatigue; feeling unwell; This is a spontaneous report received from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included the patient was allergic to 23 medicines and got hives from them. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient called her physician before the first shot and her physician thought that the patient should not taking diphenhydramine hydrochloride before the first shot and she followed his advice and she did not take it. The patient did have some reactions on the 3rd and the 4th in Mar2021; headache, lightheaded, chills, tingling, flushed face. After 2 days it was okay and the patient was fine. The patient stated that yesterday it was all back again for no reason and the patient felt lightheaded and had a headache, hot flashes and fatigue in Mar2021. The patient had a bad night and she tried ibuprofen (ADVIL) and then she switched to acetaminophen (TYLENOL) as she was feeling unwell in Mar2021. The outcome of events, headache, lightheaded, chills, tingling, flushed face, hot flashes, fatigue and feeling unwell was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Feeling abnormal, Pain in extremity
Clinical narrative: put me out of whack; just has a sore arm; Patient's blood pressure has gone down enough; This is a spontaneous report from a contactable consumer, based on information received by Pfizer  (manufacturer control number: EC-2021-088255), for BNT162B2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 11Feb2021 to 11Mar2021, at 10 mg, daily, for endometrial cancer.  The patient medical history included endometrial cancer. The patient's concomitant medications were not reported.  The patient experienced feeling "out of whack", sore arm and blood pressure increased on unknown dates. It was reported the patient's blood pressure had gone down enough, and if it stays stable then her physician might increase her dose of lenvatinib mesilate. The patient also had a COVID shot (manufacturer Pfizer) on Monday, 08Mar2021, which "put me out of whack" but she's feeling better, just has a sore arm.  The action taken in response to the event for lenvatinib mesilate was unknown. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Blood sodium decreased, Constipation, Oedema peripheral
Clinical narrative: bilateral foot/ankle edema; bilateral foot/ankle edema; constipation; lowered sodium levels; This is a spontaneous report from a contactable consumer, the patient, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-089103). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE: Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization; and lenvatinib mesilate (LENVIMA) from 26Feb2021 to 04Mar2021, via an unspecified route of administration, at 14 mg daily for differentiated thyroid cancer. Medical history included differentiated thyroid cancer and hypertension, both from an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced bilateral foot/ankle edema, constipation, lowered sodium levels. The cardiologist increased the patient's hydrochlorothiazide from 25 mg once daily to 50 mg once daily for the foot/ankle edema. The patient was not sure if the events were related to lenvatinib mesilate or the vaccine. The patient was advised to temporarily hold lenvatinib mesilate therapy until 05Apr2021, starting 05Mar2021 and continuing for one week after receiving the second vaccination on 29Mar2021, pending no side effects from the second vaccination. At that time, the patient will resume lenvatinib mesilate 10 mg daily. The action taken in response to the events for lenvatinib mesilate was unknown. The clinical outcome of bilateral foot/ankle edema, constipation, lowered sodium levels was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, SARS-CoV-2 test
Clinical narrative: nauseous; feel tired; This is a spontaneous report from a contactable consumer.   An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced nauseous on an unspecified date with outcome of unknown and patient stated "feel tired" on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results.     Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This is a spontaneous report from a contactable consumer (patient's brother)  A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE  ), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included haemochromatosis, weakened immune systems, low platelets, low immunoglobulin and has thrombocytopenia. Also fatty liver and iron overload. He also mentioned that he got senior shots of the pneumonia vaccine because he only has75% immunization. Concomitant medications were not reported.  Because he has fatty liver and iron overload, are scheduled for a blood draw. The patient had a swollen lymph node. He was  concerned since only got the first dose of the vaccine a week ago. He was afraid that it would decrease the amount of antibodies in his system. He wanted to know if it is safe to give blood / phlebotomy a week after the shot. The patient was so happy that he did not have major adverse events with the vaccine. He mentioned that he didn't have any discomfort after the shot. The outcome of the swollen lymph node was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: flu symptoms; pain in the arm; This is a spontaneous report received from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced pain in the arm on 27Feb2021 with outcome of unknown , flu symptoms on 28Feb2021 with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: little soreness on the arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This 74-year-old patient of unspecified gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO) via an unspecified route of administration from an unknown date at an unknown dosage for an unknown indication. Medical history and concomitant medications were not reported. The patient previously received estrogens conjugated, medroxyprogesterone acetate in 2019 for an unknown indication and experienced an automobile accident on the freeway. The patient called seeking assistance with estrogens conjugated, medroxyprogesterone acetate and stated that the patient and the patient's husband got their vaccines and had a little soreness on the arm. The action taken with estrogens conjugated, medroxyprogesterone acetate was unknown. The clinical outcome of little soreness on the arm was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little soreness on the arm; This is a spontaneous report received from a contactable consumer via a Pfizer sponsored program. A male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that they and their husband received their vaccines, and both had a little soreness on the arm. The clinical outcome of little soreness on the arm was unknown.   Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable healthcare professional via a Pfizer sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called to inquire what to do as her patient had received her first dose from Pfizer in early Jan2021 but missed the second vaccine due to a severe case of shingles. The clinical outcome of shingles was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.