chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hemiplegia, Hypoaesthesia, Hypoaesthesia oral, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Initially after vaccination the patient experienced nausea, vomiting, chills(no fever), rash, hives, c/o left lower leg and calf pain famotidine 20mg, dexamethasone 10mg, lactated ringers Bolus 1000mL  On 1/30/21 patient experienced tongue numbness, L facial numbness, L drift, L arm weakness. Stroke code was activated in triage  On 3/31/21 patient had MG US Breast limited BI and MG Mammo Diag with TOMO BI. Oval circumscribed mass measuring 1.4 x 0.8 x 0.8 cm with cortical thickness of 0.5 cm was suspected to be related to the reaction to the COVID-19 vaccine.   On 4/20/21 patient experienced macular papular lesions to B/L legs. Noted as being a dermatitis fare on account of an autoimmune reaction. Antihistamines were prescribed   To this day patient still experiences rashes and skin irritation.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Initially after vaccination the patient experienced nausea, vomiting, chills(no fever), rash, hives, c/o left lower leg and calf pain famotidine 20mg, dexamethasone 10mg, lactated ringers Bolus 1000mL  On 1/30/21 patient experienced tongue numbness, L facial numbness, L drift, L arm weakness. Stroke code was activated in triage  On 3/31/21 patient had MG US Breast limited BI and MG Mammo Diag with TOMO BI. Oval circumscribed mass measuring 1.4 x 0.8 x 0.8 cm with cortical thickness of 0.5 cm was suspected to be related to the reaction to the COVID-19 vaccine.   On 4/20/21 patient experienced macular papular lesions to B/L legs. Noted as being a dermatitis fare on account of an autoimmune reaction. Antihistamines were prescribed   To this day patient still experiences rashes and skin irritation.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Tremor, Urticaria, Vomiting
Clinical narrative: Initially after vaccination the patient experienced nausea, vomiting, chills(no fever), rash, hives, c/o left lower leg and calf pain famotidine 20mg, dexamethasone 10mg, lactated ringers Bolus 1000mL  On 1/30/21 patient experienced tongue numbness, L facial numbness, L drift, L arm weakness. Stroke code was activated in triage  On 3/31/21 patient had MG US Breast limited BI and MG Mammo Diag with TOMO BI. Oval circumscribed mass measuring 1.4 x 0.8 x 0.8 cm with cortical thickness of 0.5 cm was suspected to be related to the reaction to the COVID-19 vaccine.   On 4/20/21 patient experienced macular papular lesions to B/L legs. Noted as being a dermatitis fare on account of an autoimmune reaction. Antihistamines were prescribed   To this day patient still experiences rashes and skin irritation.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Culture, Ear pain, Fatigue, Gram stain
Clinical narrative: Right ear infection; headaches with jaw pain; headaches with jaw pain; This is a spontaneous report from a contactable other health care professional. A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular, administered in left arm on 23Dec2020 17:30 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunisation. Medical history included Polycystic ovary, asthma and eczema and known allergies to a yellow mushroom from overwatering house plants. Concomitant medication included triamcinolone acetonide ( 0.1% cream) topical. Other medications in two weeks: topical triamcinolone acetonide 0.1% cream; On 05Jan2021 12:00, Patient had right ear infection with right sided headaches 2 weeks after the first dose. Worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when I removed ear wax. The patient received treatment includes ear wax removal and "neomycin and polymyxin b sulfates and hydrocortisone 1% otic suspension. Patient not had covid prior vaccination; not tested covid post vaccination. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hyperacusis, Hypoacusis, Muscle spasms, Pain in extremity
Clinical narrative: Right ear infection; headaches with jaw pain; headaches with jaw pain; This is a spontaneous report from a contactable other health care professional. A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular, administered in left arm on 23Dec2020 17:30 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunisation. Medical history included Polycystic ovary, asthma and eczema and known allergies to a yellow mushroom from overwatering house plants. Concomitant medication included triamcinolone acetonide ( 0.1% cream) topical. Other medications in two weeks: topical triamcinolone acetonide 0.1% cream; On 05Jan2021 12:00, Patient had right ear infection with right sided headaches 2 weeks after the first dose. Worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when I removed ear wax. The patient received treatment includes ear wax removal and "neomycin and polymyxin b sulfates and hydrocortisone 1% otic suspension. Patient not had covid prior vaccination; not tested covid post vaccination. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in jaw
Clinical narrative: Right ear infection; headaches with jaw pain; headaches with jaw pain; This is a spontaneous report from a contactable other health care professional. A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular, administered in left arm on 23Dec2020 17:30 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunisation. Medical history included Polycystic ovary, asthma and eczema and known allergies to a yellow mushroom from overwatering house plants. Concomitant medication included triamcinolone acetonide ( 0.1% cream) topical. Other medications in two weeks: topical triamcinolone acetonide 0.1% cream; On 05Jan2021 12:00, Patient had right ear infection with right sided headaches 2 weeks after the first dose. Worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when I removed ear wax. The patient received treatment includes ear wax removal and "neomycin and polymyxin b sulfates and hydrocortisone 1% otic suspension. Patient not had covid prior vaccination; not tested covid post vaccination. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear infection, Headache, Pain in jaw
Clinical narrative: Right ear infection; headaches with jaw pain; headaches with jaw pain; This is a spontaneous report from a contactable other health care professional. A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular, administered in left arm on 23Dec2020 17:30 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunisation. Medical history included Polycystic ovary, asthma and eczema and known allergies to a yellow mushroom from overwatering house plants. Concomitant medication included triamcinolone acetonide ( 0.1% cream) topical. Other medications in two weeks: topical triamcinolone acetonide 0.1% cream; On 05Jan2021 12:00, Patient had right ear infection with right sided headaches 2 weeks after the first dose. Worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when I removed ear wax. The patient received treatment includes ear wax removal and "neomycin and polymyxin b sulfates and hydrocortisone 1% otic suspension. Patient not had covid prior vaccination; not tested covid post vaccination. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia, Throat irritation, Throat tightness
Clinical narrative: general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Pruritus, Throat tightness
Clinical narrative: general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Pruritus, Throat tightness
Clinical narrative: general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Erythema, Pruritus, Rash
Clinical narrative: Skin rashes on chest, arms, abdomen, legs, backs, and difficulty of breathing. These symptoms would disappear 5 or 10 minutes after taking Allergy Relief.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Skin rashes on chest, arms, abdomen, legs, backs, and difficulty of breathing. These symptoms would disappear 5 or 10 minutes after taking Allergy Relief.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Mobility decreased, Oropharyngeal pain, Pain
Clinical narrative: 2 white blisters in the back of throat; sore throat.; cough; fatigue; head congestion; body aches; couldn't move my left arm; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotto's. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included levothyroxine sodium (UNITHROID), liothyronine and venlafaxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On24Feb2021, the patient experienced, patient couldn't move left arm without assistance. on 25Feb2021, at 06:00, the patient experienced fatigue, head congestion, and body aches progressively got worse as the day continued. On 26Feb2021, (second night after vaccination) patient developed a severe cough and sore throat. It was reported that patient not been sick or even had a mild cold since 2009. The patient had undergone rapid covid and PCR covid test on 26Feb2021 and resulted in negative. It was reported that the symptoms continued getting worse. The patient did not have fever. The fatigue was the worst by Saturday (as reported). The patient throat still causing a lot of pain and the coughing had gotten progressively worse by Monday (as reported). On 01Mar2021, the patient undergone Nasal Swab/ Rapid covid test which resulted in negative and PCR test results were pending. On 02Mar2021 the patient woke up with 2 white blisters in the back of throat. It was reported that patient haven't been around anyone with strep recently and haven't had strep as an adult. The patient visited physician office and emergency room. The patient received counter cough medicine, Zpak and lozenges as a treatment for the events. The outcome of all the events was not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event throat blister and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test negative, Viral test
Clinical narrative: 2 white blisters in the back of throat; sore throat.; cough; fatigue; head congestion; body aches; couldn't move my left arm; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotto's. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included levothyroxine sodium (UNITHROID), liothyronine and venlafaxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On24Feb2021, the patient experienced, patient couldn't move left arm without assistance. on 25Feb2021, at 06:00, the patient experienced fatigue, head congestion, and body aches progressively got worse as the day continued. On 26Feb2021, (second night after vaccination) patient developed a severe cough and sore throat. It was reported that patient not been sick or even had a mild cold since 2009. The patient had undergone rapid covid and PCR covid test on 26Feb2021 and resulted in negative. It was reported that the symptoms continued getting worse. The patient did not have fever. The fatigue was the worst by Saturday (as reported). The patient throat still causing a lot of pain and the coughing had gotten progressively worse by Monday (as reported). On 01Mar2021, the patient undergone Nasal Swab/ Rapid covid test which resulted in negative and PCR test results were pending. On 02Mar2021 the patient woke up with 2 white blisters in the back of throat. It was reported that patient haven't been around anyone with strep recently and haven't had strep as an adult. The patient visited physician office and emergency room. The patient received counter cough medicine, Zpak and lozenges as a treatment for the events. The outcome of all the events was not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event throat blister and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Head discomfort, Injected limb mobility decreased, Oropharyngeal blistering
Clinical narrative: 2 white blisters in the back of throat; sore throat.; cough; fatigue; head congestion; body aches; couldn't move my left arm; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotto's. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included levothyroxine sodium (UNITHROID), liothyronine and venlafaxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On24Feb2021, the patient experienced, patient couldn't move left arm without assistance. on 25Feb2021, at 06:00, the patient experienced fatigue, head congestion, and body aches progressively got worse as the day continued. On 26Feb2021, (second night after vaccination) patient developed a severe cough and sore throat. It was reported that patient not been sick or even had a mild cold since 2009. The patient had undergone rapid covid and PCR covid test on 26Feb2021 and resulted in negative. It was reported that the symptoms continued getting worse. The patient did not have fever. The fatigue was the worst by Saturday (as reported). The patient throat still causing a lot of pain and the coughing had gotten progressively worse by Monday (as reported). On 01Mar2021, the patient undergone Nasal Swab/ Rapid covid test which resulted in negative and PCR test results were pending. On 02Mar2021 the patient woke up with 2 white blisters in the back of throat. It was reported that patient haven't been around anyone with strep recently and haven't had strep as an adult. The patient visited physician office and emergency room. The patient received counter cough medicine, Zpak and lozenges as a treatment for the events. The outcome of all the events was not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event throat blister and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: 2 white blisters in the back of throat; sore throat.; cough; fatigue; head congestion; body aches; couldn't move my left arm; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotto's. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included levothyroxine sodium (UNITHROID), liothyronine and venlafaxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On24Feb2021, the patient experienced, patient couldn't move left arm without assistance. on 25Feb2021, at 06:00, the patient experienced fatigue, head congestion, and body aches progressively got worse as the day continued. On 26Feb2021, (second night after vaccination) patient developed a severe cough and sore throat. It was reported that patient not been sick or even had a mild cold since 2009. The patient had undergone rapid covid and PCR covid test on 26Feb2021 and resulted in negative. It was reported that the symptoms continued getting worse. The patient did not have fever. The fatigue was the worst by Saturday (as reported). The patient throat still causing a lot of pain and the coughing had gotten progressively worse by Monday (as reported). On 01Mar2021, the patient undergone Nasal Swab/ Rapid covid test which resulted in negative and PCR test results were pending. On 02Mar2021 the patient woke up with 2 white blisters in the back of throat. It was reported that patient haven't been around anyone with strep recently and haven't had strep as an adult. The patient visited physician office and emergency room. The patient received counter cough medicine, Zpak and lozenges as a treatment for the events. The outcome of all the events was not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event throat blister and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: she has an autoimmune disease called Guillain Barre syndrome; Severely ill; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she became severely ill on an unspecified date after receiving the vaccine. The patient stated that she had an autoimmune disease called Guillain Barre syndrome on an unspecified date. The outcome of the events was unknown.   Information on the batch/lot number is requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Malaise
Clinical narrative: she has an autoimmune disease called Guillain Barre syndrome; Severely ill; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she became severely ill on an unspecified date after receiving the vaccine. The patient stated that she had an autoimmune disease called Guillain Barre syndrome on an unspecified date. The outcome of the events was unknown.   Information on the batch/lot number is requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Euphoric mood, Sensory loss, Tremor
Clinical narrative: CONVULSING; ELEVATED BLOOD PRESSURE 190; FELT BAD; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included bee stings allergy, and concurrent conditions included occasionally drinks beer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  After vaccination on March 11th 2021 after 30 minutes later Blood Pressure went up (190) and then convulsion started ,so they called ambulance.They took to the emergency room. after that patient underwent lab test. they gave him (Alban) Intravenous. The patient was in the hospital for few hours and then it calm down. He felt pretty bad for few days after 4to 5 days he feel normal. Currently, patient was back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure 190, and convulsing on 11-MAR-2021, and felt bad on 16-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-convulsion, blood pressure high. These event(s) are considered unassessable. The event(s) have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Hypertension
Clinical narrative: CONVULSING; ELEVATED BLOOD PRESSURE 190; FELT BAD; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included bee stings allergy, and concurrent conditions included occasionally drinks beer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  After vaccination on March 11th 2021 after 30 minutes later Blood Pressure went up (190) and then convulsion started ,so they called ambulance.They took to the emergency room. after that patient underwent lab test. they gave him (Alban) Intravenous. The patient was in the hospital for few hours and then it calm down. He felt pretty bad for few days after 4to 5 days he feel normal. Currently, patient was back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure 190, and convulsing on 11-MAR-2021, and felt bad on 16-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-convulsion, blood pressure high. These event(s) are considered unassessable. The event(s) have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram head, Confusional state, Dysarthria, Electrocardiogram normal
Clinical narrative: CONVULSING; ELEVATED BLOOD PRESSURE 190; FELT BAD; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included bee stings allergy, and concurrent conditions included occasionally drinks beer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  After vaccination on March 11th 2021 after 30 minutes later Blood Pressure went up (190) and then convulsion started ,so they called ambulance.They took to the emergency room. after that patient underwent lab test. they gave him (Alban) Intravenous. The patient was in the hospital for few hours and then it calm down. He felt pretty bad for few days after 4to 5 days he feel normal. Currently, patient was back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure 190, and convulsing on 11-MAR-2021, and felt bad on 16-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-convulsion, blood pressure high. These event(s) are considered unassessable. The event(s) have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count normal, Mental status changes, Metabolic function test, Muscular weakness
Clinical narrative: CONVULSING; ELEVATED BLOOD PRESSURE 190; FELT BAD; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included bee stings allergy, and concurrent conditions included occasionally drinks beer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  After vaccination on March 11th 2021 after 30 minutes later Blood Pressure went up (190) and then convulsion started ,so they called ambulance.They took to the emergency room. after that patient underwent lab test. they gave him (Alban) Intravenous. The patient was in the hospital for few hours and then it calm down. He felt pretty bad for few days after 4to 5 days he feel normal. Currently, patient was back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure 190, and convulsing on 11-MAR-2021, and felt bad on 16-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-convulsion, blood pressure high. These event(s) are considered unassessable. The event(s) have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: CONVULSING; ELEVATED BLOOD PRESSURE 190; FELT BAD; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included bee stings allergy, and concurrent conditions included occasionally drinks beer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  After vaccination on March 11th 2021 after 30 minutes later Blood Pressure went up (190) and then convulsion started ,so they called ambulance.They took to the emergency room. after that patient underwent lab test. they gave him (Alban) Intravenous. The patient was in the hospital for few hours and then it calm down. He felt pretty bad for few days after 4to 5 days he feel normal. Currently, patient was back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure 190, and convulsing on 11-MAR-2021, and felt bad on 16-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-convulsion, blood pressure high. These event(s) are considered unassessable. The event(s) have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood thyroid stimulating hormone increased, Echocardiogram, Electrocardiogram abnormal, Fibrin D dimer increased
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Flushing, Palpitations, Sinus tachycardia, Thyroxine normal, Troponin normal
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea, Echocardiogram normal
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Flushing, Heart rate increased, Loss of consciousness, Palpitations
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.