chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site anaesthesia
Clinical narrative: it went up to her neck; she was still feeling weak; numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site); heart palpitations; lightheadedness; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)), PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness), DYSPNOEA (short of breath) and HYPOAESTHESIA (it went up to her neck) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Wheezing (for 7-8 months), Productive cough (for 7-8 months) and Weakness (for 7-8 months). Concurrent medical conditions included Familial mediterranean fever.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)), PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness) and DYSPNOEA (short of breath). On an unknown date, the patient experienced HYPOAESTHESIA (it went up to her neck) and ASTHENIA (she was still feeling weak). On 20-Aug-2021, VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)) outcome was unknown. At the time of the report, PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness), DYSPNOEA (short of breath), HYPOAESTHESIA (it went up to her neck) and ASTHENIA (she was still feeling weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Laboratory data was mentioned as   ECG was normal, BP was 125 , heart rate was 120, Troponin level was  normal. No concomitant medications were provided by the reporter. Treatment information was mentioned  as IV fluid , Corvalol 30 drops 2 doses, Valeriana pills -3, Colchicine.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events are not medically significant and case is non-serious.  While patient states a systolic BP of 125 is high for them, this is not an abnormally high reading and no event captured for it.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events are not medically significant and case is non-serious.  While patient states a systolic BP of 125 is high for them, this is not an abnormally high reading and no event captured for it
Sex: U
Vaccine: COVID19
Symptoms: Stiff person syndrome
Clinical narrative: Stiff-Person Syndrome attack more often but on a very irregular pattern; This spontaneous case was reported by a consumer and describes the occurrence of STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stiff person syndrome.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) (seriousness criterion medically significant). At the time of the report, STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) outcome was unknown.            Patient had Stiff-Person Syndrome before vaccinated it was controllable and attacks was on regular basis but after getting the first dose then the second dose it attack more often but on a very irregular pattern Concomitant product use was not provided. Treatment information was not provided.  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.  The patient reported the existence of the stiff person syndrome from already before receiving the first dose of vaccination. However, following both vaccinations, the syndrome worsened.; 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.  The patient reported the existence of the stiff person syndrome from already before receiving the first dose of vaccination. However, following both vaccinations, the syndrome worsened.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: diagnosed with stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (diagnosed with stroke) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included MELATONIN for Difficulty sleeping, METFORMIN, ROSUVASTATIN, ESCITALOPRAM, QUETIAPINE, BUPROPION, VITAMIN D NOS and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (diagnosed with stroke) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was treated with RIVAROXABAN (XARELTO) for Stroke, at a dose of 20 mg once a day. At the time of the report, CEREBROVASCULAR ACCIDENT (diagnosed with stroke) outcome was unknown.            Patient drove to the nearest hospital and  where she was diagnosed with a stroke. she was airlifted to a hospital where she stayed overnight and next evening she was moved to another hospital where she stayed for 15-19 days for therapy. On unknown date laboratory tests of  MRI, EKG, and cardiologist might have done an ECHO were performed and results were not reported.  Patient was treated with Blood thinner and some other medicine. she was discharged on antibiotic and florigen for stomach, change from pravastatin to rosuvastatin 20 mg  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.  Further information is expected.; 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.  Further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paralysis, Transient ischaemic attack
Clinical narrative: paralyzed; felt like a stroke; fell on floor; could not take pants down; bowels emptied; woozy; sweating profusely; she had some soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralyzed), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke), FALL (fell on floor) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 030L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken ankle.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021 at 2:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PARALYSIS (paralyzed) (seriousness criterion medically significant), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke) (seriousness criterion medically significant), FALL (fell on floor) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down) (seriousness criterion medically significant), ANAL INCONTINENCE (bowels emptied), DIZZINESS (woozy), HYPERHIDROSIS (sweating profusely) and PAIN IN EXTREMITY (she had some soreness in her arm). At the time of the report, PARALYSIS (paralyzed), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke), FALL (fell on floor), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down), ANAL INCONTINENCE (bowels emptied), DIZZINESS (woozy), HYPERHIDROSIS (sweating profusely) and PAIN IN EXTREMITY (she had some soreness in her arm) outcome was unknown.            Patient had her first Moderna vaccine on 27Jan2021 with no side effects. Patient experienced a low grade fever and a slight headache that lasted about 7 hours. Patient had a broken ankle and was on a scooter in the night she got on her scooter to go to the bathroom and urinate. Patient had never experienced anything like this before.  Her cognitive function was fine and so was her speech. Patient gave consent to be contacted by email or phone.  No relevant concomitant medications were reported.  No treatment information was provided.  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. Further information has been requested.   This case was linked to MOD-2021-298153 (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 events, a causal relationship cannot be excluded. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: fluttering in her heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering in her heart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced CARDIAC FLUTTER (fluttering in her heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering in her heart) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drug information provided.  Patient stated that fluttering in her heart was ongoing, at the time of this report.  Patient did not take any concomitant medications. She had no history of myocarditis/COVID-19.  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.; 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Chest discomfort, Fall, Haemorrhage, Heart rate
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) and HAEMORRHAGE (Found herself in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included AFib. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HAEMORRHAGE (Found herself in blood) (seriousness criterion medically significant), FALL (Fell down  and  hit the pole) and HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose). On an unknown date, the patient experienced BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) (seriousness criterion medically significant) and CHEST DISCOMFORT (feeling of tightness in her chest). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose), HAEMORRHAGE (Found herself in blood), FALL (Fell down  and  hit the pole), HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose) and CHEST DISCOMFORT (feeling of tightness in her chest) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low heart rate below 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per report patient went to a cardiologist where he performed several tests and everything came normal and could not figure out the cause for patient's low heart rate.  No treatment medication information provided.  Company comment: 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. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.   This case was linked to MOD-2021-300180 (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 events, a causal relationship cannot be excluded. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Loss of consciousness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) and HAEMORRHAGE (Found herself in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included AFib. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HAEMORRHAGE (Found herself in blood) (seriousness criterion medically significant), FALL (Fell down  and  hit the pole) and HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose). On an unknown date, the patient experienced BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) (seriousness criterion medically significant) and CHEST DISCOMFORT (feeling of tightness in her chest). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose), HAEMORRHAGE (Found herself in blood), FALL (Fell down  and  hit the pole), HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose) and CHEST DISCOMFORT (feeling of tightness in her chest) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low heart rate below 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per report patient went to a cardiologist where he performed several tests and everything came normal and could not figure out the cause for patient's low heart rate.  No treatment medication information provided.  Company comment: 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. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.   This case was linked to MOD-2021-300180 (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 events, a causal relationship cannot be excluded. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection, Blood pressure high and High cholesterol. Concomitant products included BENZOIC ACID, METHENAMINE, SALICYLATE SODIUM (CYSTEX [BENZOIC ACID;METHENAMINE;SALICYLATE SODIUM]) for Urinary tract infection, VITAMIN D [VITAMIN D NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication of the patient also included medication to treat her blood pressure and cholesterol. The had been taking her concomitant medications since a long time ago.  No treatment information was 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. However, patient's age and med HX of HTN and high cholesterol are possible confounding factors.; 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. However, patient's age and med hx of HTN and high cholesterol are possible confounding factors.; Reported Cause(s) of Death: unknown cause of death
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anticipatory anxiety, Kidney infection
Clinical narrative: Kidney infection; very anxious and started to feel panic; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZLA or L:039AZlA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety. Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and ANTICIPATORY ANXIETY (very anxious and started to feel panic). The patient was treated with ALPRAZOLAM for Anxiety, at an unspecified dose and frequency. At the time of the report, KIDNEY INFECTION (Kidney infection) had resolved and ANTICIPATORY ANXIETY (very anxious and started to feel panic) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant products also included Supplements for an unknown indication. Treatment information included unspecified Antibiotics for kidney infection for 14 days.  Patient stated that she was not sure of what happened or if her defenses went down.  Company Comment: Very limited information regarding the event Kidney Infection has been provided at this time.  Further information has been requested. There is at least a timely relationship between the event and the vaccination date. The event Anticipatory Anxiety is rather related to the patient´s medical history of anxiety.; Sender's Comments: Very limited information regarding the event Kidney Infection has been provided at this time.  Further information has been requested. There is at least a timely relationship between the event and the vaccination date. The event Anticipatory Anxiety is rather related to the patient´s medical history of anxiety.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Euphoric mood, Feeling abnormal, Nausea
Clinical narrative: feels weak; nausea; wasn't feeling right; chills; within 15 minutes of shot felt high for about an hour after; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak), EUPHORIC MOOD (within 15 minutes of shot felt high for about an hour after), NAUSEA (nausea), CHILLS (chills) and FEELING ABNORMAL (wasn't feeling right) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced EUPHORIC MOOD (within 15 minutes of shot felt high for about an hour after). On 16-Aug-2021, the patient experienced ASTHENIA (feels weak), NAUSEA (nausea) and CHILLS (chills). 16-Aug-2021, the patient experienced FEELING ABNORMAL (wasn't feeling right). On 14-Aug-2021, EUPHORIC MOOD (within 15 minutes of shot felt high for about an hour after) had resolved. At the time of the report, ASTHENIA (feels weak), NAUSEA (nausea), CHILLS (chills) and FEELING ABNORMAL (wasn't feeling right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Haematemesis, Vomiting
Clinical narrative: Vomiting, and the vomit had visible blood cloths; This spontaneous serious Safety Report was received by Agency on 18-AUG-2021 and forwarded to Agency on 20-AUG-2021 from a health care professional.  A 2-month-old patient, with an unknown medical history, had been vaccinated with Vaxelis (dosing number and batch number unknown) on an unspecified date for prophylaxis.  The following co-suspect vaccinations were reported: Rotateq and Prevnar 13.   On 17-AUG-2021, the patient experienced vomiting, and the vomit had visible blood clots. The patient was admitted to the hospital and was hospitalized for one day on an unknown date.  The action taken with Vaxelis was unknown.  The outcome of the event was resolved on an unspecified date.   The reporter assessed the causal relationship between Vaxelis and the reported event of vomit had visible blood clots as not related.   Further information is expected.  Company comment:  Haematemesis was assessed as serious (hospitalization).  Haematemesis is unlisted for Vaxelis, as per the Agency.    Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Haematemesis was assessed as serious (hospitalization).  Haematemesis is unlisted for Vaxelis, as per the Agency.    Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain assessment
Clinical narrative: headache for 7 days; This consumer reported for a 35-year-old male patient (husband) that: A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination was 35-year-old) as dose 1, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. Caller states her husband received the Pfizer Covid vaccine. On an unspecified date, the caller's husband had a headache for 7 days since 1st vaccine dose. He states that headache goes away with a pill and then comes back. The headache pain is 5/10. Asking, when should he go to the emergency room and how long will the headache last. Caller calling on behalf of her husband who reported headaches after the first dose of Pfizer Covid 19 vaccine. Stated that she wanted to know if this is something to be expected after first dose. Agent stated that she was provided with Medical Information department phone number. Clarified that she wanted to know is it regular to have a headache after the first one or does she have to go emergency room. The patient underwent lab tests and procedures which included pain assessment: 5/10, headache pain is 5/10 on an unspecified date. Treatment received for the event. Outcome of the event was not recovered.   Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Eye pain, Eye swelling, Headache
Clinical narrative: scared it can be an allergic reaction; this morning it is a little swollen, her left eye; Headache; night her eye kind of hurt, it felt like a stye coming; night her eye kind of hurt, it felt like a stye coming; crying; scared; This is a spontaneous report from a contactable consumer (reported for herself). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration, administered in arm left on 18Jul2021 11:30 (age at vaccination was 27-year-old) as dose 2, single for covid-19 immunisation. Vaccine was not administered at military facility. None other additional vaccine was administered on same date of the Pfizer suspect. The patient medical history was not reported. There were no concomitant medications. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: Unknown), via an unspecified route of administration, administered in arm left on 26Jun2021 14:00 (age at vaccination was 27-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Jul2021, the patient was crying as was scared after the second dose of vaccination. On 18Jul2021, evening the patient developed left eye pain. The patient states that on 18Jul2021, night her eye kind of hurt, it felt like a stye coming and she thought that's weird. On 19Jul2021, morning (7:00) when the patient woke up with little swelling to her left eye. The patient also had headache on the 19Jul2021. On an unknown date, the patient states that she googled it and feels it could be normal but was scared it can be an allergic reaction. She wants to know if she should expect this or if it's an allergic reaction. The patient did not visit emergency room and physician office. The outcome of the events was unknown.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Hypersensitivity
Clinical narrative: scared it can be an allergic reaction; this morning it is a little swollen, her left eye; Headache; night her eye kind of hurt, it felt like a stye coming; night her eye kind of hurt, it felt like a stye coming; crying; scared; This is a spontaneous report from a contactable consumer (reported for herself). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration, administered in arm left on 18Jul2021 11:30 (age at vaccination was 27-year-old) as dose 2, single for covid-19 immunisation. Vaccine was not administered at military facility. None other additional vaccine was administered on same date of the Pfizer suspect. The patient medical history was not reported. There were no concomitant medications. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: Unknown), via an unspecified route of administration, administered in arm left on 26Jun2021 14:00 (age at vaccination was 27-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Jul2021, the patient was crying as was scared after the second dose of vaccination. On 18Jul2021, evening the patient developed left eye pain. The patient states that on 18Jul2021, night her eye kind of hurt, it felt like a stye coming and she thought that's weird. On 19Jul2021, morning (7:00) when the patient woke up with little swelling to her left eye. The patient also had headache on the 19Jul2021. On an unknown date, the patient states that she googled it and feels it could be normal but was scared it can be an allergic reaction. She wants to know if she should expect this or if it's an allergic reaction. The patient did not visit emergency room and physician office. The outcome of the events was unknown.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Pain, Weight decreased
Clinical narrative: intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when I eat; debilitating pain; lost 20 lbs; This is a spontaneous report from contactable consumer (patient) via the Regulatory Authority. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 08Apr2021 13:30 (lot numbers: EW0150 also reported as EN6205; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for COVID-19 immunisation. Medical history included reactive arthritis from food poisoning. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Concomitant medications included ibuprofen, acetaminophen, and gabapentin, and more (unspecified). On 24Apr2021, the patient experienced intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when he eats. It manifests in the corners of the intestine and can cause debilitating pain. He had a weekend of "normal" reactions then intestines started cramping 2 weeks after that. He had lost 20 lbs since April and shows no signs of slowing down. The patient did not receive treatment for the events. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. Outcome of the event lost 20 lbs was unknown, while for the other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my left arm hurt for about 2 days; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 05May2021 as single dose for COVID-19 immunisation. Medical history included at the tender age of 40 (unspecified units), diagnosed with chickenpox. The patient had itching and discomfort on the chest and throughout the body. The patient concomitant medications were not reported. The patient previously received shingle shots for immunization. It was reported that 20 years later after chicken pox, the patient heard about shingle shots. Patient learned that people who have had chickenpox carried the same "virus" and decided to get vaccinated. As the pharmacist gave the injection, the patient felt a brief itching sensation, exactly the same location where the patient had the chickenpox, mainly on the chest and all over the body. That lasted only a few minutes and then disappeared. On 05May2021, the patient received first vaccination in left arm. About 8 hours after the vaccination (May2021), left arm hurt for about 2 days and that was all the patient experienced. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neuromyopathy, Neuropathy peripheral
Clinical narrative: ulnar neuropathy; Nerve and muscle problem in my right hand; My lively hood depend on my hand. I am a pianist; This is a spontaneous report received from a contactable consumer, the patient. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. On an unspecified date, the patient experienced nerve and muscle problem in right hand, ulnar neuropathy and he reported that lively hood depend on my hand. i am a pianist. Consumer stated, I have absolute muscle problem and I am a pianist. I went to the regular doctor so; I don't have the exact diagnosis yet but its looks like the ulnar neuropathy. When paraphrased the above concern, consumer sated, It's not muscle, its nerve and muscle problem in my right hand after the first shot. My doctor said it's most likely ulnar neuropathy (Consumer was unsure hence not captured as event) after the vaccine. Consumer stated, I do require a medical assistance because my lively hood depend on my hand. I am a pianist. The outcome of events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: vaccine was not diluted; received his first dose of the Pfizer BioNTech Covid 19 vaccine today 30Jul2021 but the vaccine was undiluted; This is a spontaneous report from a contactable nurse. This Nurse reported for a 58-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, via an unspecified route of administration, administered in Deltoid Right on 30Jul2021 (Batch/Lot Number: FA6780; Expiration Date: 26Aug2021) as dose 1, 0.3 ml single (at the age of 58) for COVID-19 immunization. The patient no medical history and no concomitant medications. The patient had no prior vaccination. The administered vaccine was undiluted. Vaccination facility type was workplace clinic. The outcome was unknown.  Amendment: This follow up is being submitted in order to update the narrative  Follow-up (23Aug2021): New information reported from a contactable nurse includes: medical history and vaccination details.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: My whole arm hurts it doesn't feel like it's getting better; My fingers are like I got to be say numb and hard to move, like I move it and it just feels so unnatural; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, expiration date: unknown), dose 2 via an unspecified route of administration on an unspecified date in Jul2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine, the patient received first dose BNT162B2, dose 1 on an unspecified date as single for COVID-19 immunisation. On an unspecified date in Jul2021 the patient's whole arm hurted, it didn't feel like it's getting better and fingers were like patient got to be say numb and hard to move, like if patient move it and it just felt so unnatural. Outcome of the event patient's whole arm hurted, it didn't felt like it's getting better was not resolved and patient's fingers were like, patient got to be say numb and hard to move, like if patient move it and it just felt so unnatural was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dysstasia, Electromyogram, Gait inability
Clinical narrative: Tremors; I can't walk; I can't properly walk or hold myself upright; I had persecution in my muscles in my upper body and lower body; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EX3294) via an unspecified route of administration on 23Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX). On an unspecified date in 2021, a week later patient stated that I got tremors and I can't walk, I can't properly walk or hold myself upright and I wanted to know if there are common cases like this. I can go upright, I just can't walk properly or hold myself, but I can't support my body, climb upstairs, I can't go upstairs. So I did all my testing. I got all my medical testing blood is fine, EMG, MRI, CAT Scan and I am doing a brain MRI tomorrow, but everything has come out clear and the only difference is 12Apr2021 my psychiatrist added 5mg of Trintellix and then on 23Apr2021, I have my vaccination that's the only difference that I did before I had persecution in my muscles in my upper body and lower body. Upon follow-up (24Aug2021), patient questioned do you know how many people have this adverse events, is there a place where I can read about this adverse events, how many reports do you have about people taking Pfizer's vaccine who cannot walk and which are the most common adverse events. At the time of this report, the outcome of all the events was unknown.   No follow-up attempts possible. No further information expected.  Follow up (24Aug2021): New information was received from a contactable consumer. This consumer reported in response to Non-HCP letter via telephonic follow-up activity that included addition of clinical information.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Myalgia, Tremor
Clinical narrative: Tremors; I can't walk; I can't properly walk or hold myself upright; I had persecution in my muscles in my upper body and lower body; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EX3294) via an unspecified route of administration on 23Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX). On an unspecified date in 2021, a week later patient stated that I got tremors and I can't walk, I can't properly walk or hold myself upright and I wanted to know if there are common cases like this. I can go upright, I just can't walk properly or hold myself, but I can't support my body, climb upstairs, I can't go upstairs. So I did all my testing. I got all my medical testing blood is fine, EMG, MRI, CAT Scan and I am doing a brain MRI tomorrow, but everything has come out clear and the only difference is 12Apr2021 my psychiatrist added 5mg of Trintellix and then on 23Apr2021, I have my vaccination that's the only difference that I did before I had persecution in my muscles in my upper body and lower body. Upon follow-up (24Aug2021), patient questioned do you know how many people have this adverse events, is there a place where I can read about this adverse events, how many reports do you have about people taking Pfizer's vaccine who cannot walk and which are the most common adverse events. At the time of this report, the outcome of all the events was unknown.   No follow-up attempts possible. No further information expected.  Follow up (24Aug2021): New information was received from a contactable consumer. This consumer reported in response to Non-HCP letter via telephonic follow-up activity that included addition of clinical information.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: muscle problems in one of his legs and one of his arms; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route, on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated my son is experiencing muscle problems in one of his legs and one of his arms. I think he got Pfizer as well, but I am not sure. You are coming out with a follow up shot but it makes me very uncomfortable getting it. It is a little bit frightening not knowing what is causing this. On an unknown date, patient was reported experiencing muscle problems in one of his legs and one of his arms. The outcome of the event was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Body aches; Headache; Chills; Left arm pain; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 31Jul2021 08:00 (Batch/Lot Number: EW0217) (at the age of 31-years-old) as SINGLE for covid-19 immunization and administered at School. It was reported that known allergies as no and other medical history as no. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Jul2021 08:00 (Batch/Lot Number: EW0217) (at the age of 31-years-old) as SINGLE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Also, the patient did not receive any other medication within two weeks. The patient noticed that her 1st dose and 2nd dose have the same lot number and she wants to know if it's normal to have the same lot number for the 1st and 2nd dose. On 31Jul2021 at 21:00 patient experienced fever, body aches, headache, chills and left arm pain. The reporter considered the events as non-serious as no hospitalization is reported. The patient did not received any treatment. The outcome of all the events was recovering.    Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Pain; Fever; numbness on right side of shoulder and then going down now the area is expanding; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (reporter's wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unknown date in 2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain, fever and numbness on right side of shoulder and then going down now the area is expanding. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994036 same reporter/ AE/ drug, different patient;US-PFIZER INC-202100993856 same reporter/ AE/ drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Had a persistent metallic taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 28Jul2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On 28Jul2021 the patient experienced had a persistent metallic taste in her mouth. She is asking if this side effect is common and /or reported by other patients. Outcome of events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.