chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Mitral valve incompetence, Palpitations, Pulmonary valve incompetence, Sinus rhythm
Clinical narrative: I got my first Moderna vaccine on 9/22 /21 . After receiving the shot I became extremely flushed and had to lie down . An hour later my blood pressure was 87/52. I drank fluids to raise my blood pressure. A week later I began to experience heart palpitations. I considered it was possibly dehydration so I continued to drink fluids . The palpitations continued . I decided to go to the urgent care . They did an EKG that showed sinus  Rhythm with possible ischemia. I went to the ER for a repeat EKG and blood work ..My bloodwork was normal . The palpitations have continued with a run of SVT at 148 beats .
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Supraventricular tachycardia, Ultrasound scan
Clinical narrative: I got my first Moderna vaccine on 9/22 /21 . After receiving the shot I became extremely flushed and had to lie down . An hour later my blood pressure was 87/52. I drank fluids to raise my blood pressure. A week later I began to experience heart palpitations. I considered it was possibly dehydration so I continued to drink fluids . The palpitations continued . I decided to go to the urgent care . They did an EKG that showed sinus  Rhythm with possible ischemia. I went to the ER for a repeat EKG and blood work ..My bloodwork was normal . The palpitations have continued with a run of SVT at 148 beats .
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Asthenia, Asthma, Blood pressure increased, Dyspnoea
Clinical narrative: Immediately after the shot on Friday Jan 22 I experienced a heavy leg feeling  lasting 4 hours. Saturday and Sunday, 1 and 2 days after the shot I experienced very extreme fatigue. Like I had no energy to even eat or drink water. I had light vertigo for 5 days after the shot. I had a sore arm til one week after the shot, nothing unusual or unusually painful. I had highly fluctuating heart rates. On Saturday and Sunday following Jan 22 as tracked by a blood-ox monitor: At the lowest I measured it in the upper 40s/low 50s. Generally it would race to 96, then drop to 76. Saturday night I experienced 8 hours of raspy, shallow breathing. All symptoms resolved by Wednesday the following week. Approximately three weeks after the shot around the late afternoon of Feb 7, I noted my heart felt like it was beginning to pound in my chest and beat fast. On a whim I checked my bp using a home bp monitor and noted it was elevated at around 141/not remembered diastolic. As the week progressed I had fluctuating blood pressure and heart beats where I could feel it rising and falling, but always trending higher than previous highs. On evening of Feb 11 I measured my bp at 192/unremembered diastolic and checked into an urgent care facility. My bp and heart palpitations continued to remain generally high with 2 other random and sudden spikes happening in April and June. Also by June I was experiencing sudden shortness of breath with physical activity and was diagnosed with pulmonary arterial hypertension. With medical treatment my symptoms feel like they resolved by late August/early September, but I will know for sure next year when the cardiologist does another echo gram of my heart.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Fatigue, Heart rate irregular, Hypopnoea
Clinical narrative: Immediately after the shot on Friday Jan 22 I experienced a heavy leg feeling  lasting 4 hours. Saturday and Sunday, 1 and 2 days after the shot I experienced very extreme fatigue. Like I had no energy to even eat or drink water. I had light vertigo for 5 days after the shot. I had a sore arm til one week after the shot, nothing unusual or unusually painful. I had highly fluctuating heart rates. On Saturday and Sunday following Jan 22 as tracked by a blood-ox monitor: At the lowest I measured it in the upper 40s/low 50s. Generally it would race to 96, then drop to 76. Saturday night I experienced 8 hours of raspy, shallow breathing. All symptoms resolved by Wednesday the following week. Approximately three weeks after the shot around the late afternoon of Feb 7, I noted my heart felt like it was beginning to pound in my chest and beat fast. On a whim I checked my bp using a home bp monitor and noted it was elevated at around 141/not remembered diastolic. As the week progressed I had fluctuating blood pressure and heart beats where I could feel it rising and falling, but always trending higher than previous highs. On evening of Feb 11 I measured my bp at 192/unremembered diastolic and checked into an urgent care facility. My bp and heart palpitations continued to remain generally high with 2 other random and sudden spikes happening in April and June. Also by June I was experiencing sudden shortness of breath with physical activity and was diagnosed with pulmonary arterial hypertension. With medical treatment my symptoms feel like they resolved by late August/early September, but I will know for sure next year when the cardiologist does another echo gram of my heart.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Limb discomfort, Pain in extremity, Palpitations, Pulmonary arterial hypertension
Clinical narrative: Immediately after the shot on Friday Jan 22 I experienced a heavy leg feeling  lasting 4 hours. Saturday and Sunday, 1 and 2 days after the shot I experienced very extreme fatigue. Like I had no energy to even eat or drink water. I had light vertigo for 5 days after the shot. I had a sore arm til one week after the shot, nothing unusual or unusually painful. I had highly fluctuating heart rates. On Saturday and Sunday following Jan 22 as tracked by a blood-ox monitor: At the lowest I measured it in the upper 40s/low 50s. Generally it would race to 96, then drop to 76. Saturday night I experienced 8 hours of raspy, shallow breathing. All symptoms resolved by Wednesday the following week. Approximately three weeks after the shot around the late afternoon of Feb 7, I noted my heart felt like it was beginning to pound in my chest and beat fast. On a whim I checked my bp using a home bp monitor and noted it was elevated at around 141/not remembered diastolic. As the week progressed I had fluctuating blood pressure and heart beats where I could feel it rising and falling, but always trending higher than previous highs. On evening of Feb 11 I measured my bp at 192/unremembered diastolic and checked into an urgent care facility. My bp and heart palpitations continued to remain generally high with 2 other random and sudden spikes happening in April and June. Also by June I was experiencing sudden shortness of breath with physical activity and was diagnosed with pulmonary arterial hypertension. With medical treatment my symptoms feel like they resolved by late August/early September, but I will know for sure next year when the cardiologist does another echo gram of my heart.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Vertigo
Clinical narrative: Immediately after the shot on Friday Jan 22 I experienced a heavy leg feeling  lasting 4 hours. Saturday and Sunday, 1 and 2 days after the shot I experienced very extreme fatigue. Like I had no energy to even eat or drink water. I had light vertigo for 5 days after the shot. I had a sore arm til one week after the shot, nothing unusual or unusually painful. I had highly fluctuating heart rates. On Saturday and Sunday following Jan 22 as tracked by a blood-ox monitor: At the lowest I measured it in the upper 40s/low 50s. Generally it would race to 96, then drop to 76. Saturday night I experienced 8 hours of raspy, shallow breathing. All symptoms resolved by Wednesday the following week. Approximately three weeks after the shot around the late afternoon of Feb 7, I noted my heart felt like it was beginning to pound in my chest and beat fast. On a whim I checked my bp using a home bp monitor and noted it was elevated at around 141/not remembered diastolic. As the week progressed I had fluctuating blood pressure and heart beats where I could feel it rising and falling, but always trending higher than previous highs. On evening of Feb 11 I measured my bp at 192/unremembered diastolic and checked into an urgent care facility. My bp and heart palpitations continued to remain generally high with 2 other random and sudden spikes happening in April and June. Also by June I was experiencing sudden shortness of breath with physical activity and was diagnosed with pulmonary arterial hypertension. With medical treatment my symptoms feel like they resolved by late August/early September, but I will know for sure next year when the cardiologist does another echo gram of my heart.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation reaction, Nodule, Pain
Clinical narrative: "aching, Knot," describing area where  immunization was given. "sore today  per employee.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear discomfort, Headache, Malaise, SARS-CoV-2 test negative
Clinical narrative: 11/1/2021 Temp 99; headache. Right sinus and ears clogged, postnasal drip, malaise, no energy. 11/1 Augmentin prescribed by PCP. Previous headache right sinus infection, malaise, no energy after 2nd COVID injection. 4/9 Augmentin prescribed by PCP.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Upper-airway cough syndrome
Clinical narrative: 11/1/2021 Temp 99; headache. Right sinus and ears clogged, postnasal drip, malaise, no energy. 11/1 Augmentin prescribed by PCP. Previous headache right sinus infection, malaise, no energy after 2nd COVID injection. 4/9 Augmentin prescribed by PCP.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on 12/3/21 resolved with Benadryl
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, New daily persistent headache
Clinical narrative: Good afternoon, I had a hard attack on Jun 27th .2021, around 12 weeks after my 2nd dose of the Pfizer Vaccine. I received the booster on November 22nd, 2021 and a week after I developed a pain headache that only goes away after taking Excedrin. The problem is that it has been a week and I have the headache every single day and I am afraid to continue taking Excedrin as I am taking several medications that may be impares or perhaps or the perhaps cause me either an aneurisma to burst or a serotonine syndrome. I will appreciate if someone from FDA or CDC or the Pfizer team can reach out with informed advice on how should I proceed. Perhaps I need an MRI of my brain to discard an aneurysm or brain swollen that is happening as an undocumented adversed reaction to the Pfizer booster vaccine. Here is the list and time of the medications I am taking: 08:00am- Escitalopram 10mg 09:00am- Metropolol succinate 25mg 12:00pm- Aspirin 81mg and Clopidogrel 75mg 04:30pm- Dinner 09:00pm- Synthroid 112mcg 10:00pm- Losartan 25mg 11:00pm- Atorvastatin 80mg
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: DEC2021 (SINCE LAST WEEK) Pt Had Covid vaccine and went to hospital with tightening in chest. Pt also missed 1 dose due to pharmacy delay.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Injection site swelling, Loss of consciousness, Lymph node pain
Clinical narrative: I got the Moderna booster at the pharmacy yesterday afternoon, Monday, 12/06/2021. Was sick yesterday evening and today (aches, lymph pain, swelling at the injection site), and today I had to leave work early after only an hour and a half due to wooziness. When I got home, I fell asleep right away. On waking, I tried to eat, and immediately passed out in the kitchen. I am still trying to figure out whether to go to the ER or not.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: I got the Moderna booster at the pharmacy yesterday afternoon, Monday, 12/06/2021. Was sick yesterday evening and today (aches, lymph pain, swelling at the injection site), and today I had to leave work early after only an hour and a half due to wooziness. When I got home, I fell asleep right away. On waking, I tried to eat, and immediately passed out in the kitchen. I am still trying to figure out whether to go to the ER or not.
Sex: F
Vaccine: COVID19
Symptoms: Gastritis, Multiple organ dysfunction syndrome, Renal failure
Clinical narrative: spontaneous call. spoke with patient during orenitram consult. patient stated that she was not doing well after receiving her booster of covid-19 Pfizer vaccine on 11/4/21. as a result, she was in the hospital from 11/9/21 to 11/14/2021 due to kidney failure and issues with her organs shutting down. she was not able to take the orentiram while in the hospital. she had to restart the medication and titrate at a slower rate due to inflammation in the stomach. current dose is 1.5mg by mouth three times daily. her doctor is aware of the situation there is no other information known.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased
Clinical narrative: Patient she is currently on hold from Prolia until she is given the ok from prescriber to resume in February. Prescriber wants her on hold until she is finished both her covid shots. Patient had covid this year and was in the hospital for 5 days, which damaged her lungs and heart and now on a pacemaker. She got her first covid shot last saturday 12/4/21 and her BP dropped to 66, she went to hospital to make sure it wasn't her pacemaker.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Hypotension
Clinical narrative: Pt stated two days after receiving Moderna Covid Booster vaccine, she experienced hypotension, weakness, and dehydration resulting in hospitalization.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cardiac monitoring, Chest discomfort, Dysphagia, Dyspnoea
Clinical narrative: Patient is a 46-year-old female presenting today via EMS after being referred by med express for suspected allergic reaction. The culprit is suspected to be the second dose of COVID vaccine as administered to her around 2:30 PM yesterday (12/2/21). She reports she felt totally fine until that occurred. Since, she reports increasing fatigue with a mild scratchy throat and nasal congestion. She says around noon today, she felt like her throat was swelling, had difficulty swallowing with tightness in her chest and shortness of breath which prompted her visit to urgent care. She was then giving the medications were report her symptoms have overall improved. She has nausea vomiting. Mild abdominal pain. No current chest pain. She has any hives-like rash. She has history to allergic reactions in the past and did feel she needed an EpiPen. She has not prescribed one at home. She has history of diabetes. Non-smoker. She received her first Covid vaccine, Pfizer, 3 weeks ago reports she had significant fatigue and myalgias but no other reaction. She denies any new exposures, soaps, lotions, foods etc. that would have been different for her today. she does note taking p.o. Benadryl 25mg at around noon today. Arrived via EMS, referred by med express for possible anaphylactic reaction, given EpiPen as well as Solu-Medrol prior to arrival. On arrival, the patient's vital signs are stable. There is no current signs of allergic reaction. Her lungs are clear and she speaking full sentences. We will continue monitoring. She likely got the EpiPen around 3 PM. Differential including anaphylaxis, allergic reaction, Covid vaccine adverse reaction. She will be given Benadryl and Pepcid. Pulse oximetry monitoring cardiac monitoring. States this feels similar to when she had anaphylaxis prior.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Myalgia, Nasal congestion, Nausea
Clinical narrative: Patient is a 46-year-old female presenting today via EMS after being referred by med express for suspected allergic reaction. The culprit is suspected to be the second dose of COVID vaccine as administered to her around 2:30 PM yesterday (12/2/21). She reports she felt totally fine until that occurred. Since, she reports increasing fatigue with a mild scratchy throat and nasal congestion. She says around noon today, she felt like her throat was swelling, had difficulty swallowing with tightness in her chest and shortness of breath which prompted her visit to urgent care. She was then giving the medications were report her symptoms have overall improved. She has nausea vomiting. Mild abdominal pain. No current chest pain. She has any hives-like rash. She has history to allergic reactions in the past and did feel she needed an EpiPen. She has not prescribed one at home. She has history of diabetes. Non-smoker. She received her first Covid vaccine, Pfizer, 3 weeks ago reports she had significant fatigue and myalgias but no other reaction. She denies any new exposures, soaps, lotions, foods etc. that would have been different for her today. she does note taking p.o. Benadryl 25mg at around noon today. Arrived via EMS, referred by med express for possible anaphylactic reaction, given EpiPen as well as Solu-Medrol prior to arrival. On arrival, the patient's vital signs are stable. There is no current signs of allergic reaction. Her lungs are clear and she speaking full sentences. We will continue monitoring. She likely got the EpiPen around 3 PM. Differential including anaphylaxis, allergic reaction, Covid vaccine adverse reaction. She will be given Benadryl and Pepcid. Pulse oximetry monitoring cardiac monitoring. States this feels similar to when she had anaphylaxis prior.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Throat irritation, Vomiting
Clinical narrative: Patient is a 46-year-old female presenting today via EMS after being referred by med express for suspected allergic reaction. The culprit is suspected to be the second dose of COVID vaccine as administered to her around 2:30 PM yesterday (12/2/21). She reports she felt totally fine until that occurred. Since, she reports increasing fatigue with a mild scratchy throat and nasal congestion. She says around noon today, she felt like her throat was swelling, had difficulty swallowing with tightness in her chest and shortness of breath which prompted her visit to urgent care. She was then giving the medications were report her symptoms have overall improved. She has nausea vomiting. Mild abdominal pain. No current chest pain. She has any hives-like rash. She has history to allergic reactions in the past and did feel she needed an EpiPen. She has not prescribed one at home. She has history of diabetes. Non-smoker. She received her first Covid vaccine, Pfizer, 3 weeks ago reports she had significant fatigue and myalgias but no other reaction. She denies any new exposures, soaps, lotions, foods etc. that would have been different for her today. she does note taking p.o. Benadryl 25mg at around noon today. Arrived via EMS, referred by med express for possible anaphylactic reaction, given EpiPen as well as Solu-Medrol prior to arrival. On arrival, the patient's vital signs are stable. There is no current signs of allergic reaction. Her lungs are clear and she speaking full sentences. We will continue monitoring. She likely got the EpiPen around 3 PM. Differential including anaphylaxis, allergic reaction, Covid vaccine adverse reaction. She will be given Benadryl and Pepcid. Pulse oximetry monitoring cardiac monitoring. States this feels similar to when she had anaphylaxis prior.
Sex: M
Vaccine: FLUX
Symptoms: Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: During a refill call for Stelara, the patient's mother reported that the patient was hospitalized due to a reaction to a flu shot. He experienced a rapid heart rate, sweating, and nausea. The flu shot information was not provided. Note that the following product information reflects the last dispense by pharmacy (delivered 28 Oct 2021) and was not provided by the primary reporter.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient received two dose of COVID -19 vaccine with one additional dose. Only removed a vial from the freezer and put in the refrigerator the day before administered. The vaccines were not in the fridge for more than a day unless patients did not appear for vaccination.  No concomitant medications reported. No treatment reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia & Arthralgia
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Diarrhoea, Lung opacity
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 06/01 CR impression: 1. Nonspecific subtle left suprahilar increased opacity. 2. Similar left rib deformities. 07/03 Extremity impression: 1. No sonographic evidence of deep venous thrombosis in the left lower extremity. 2. Superficial thrombosis involving the left lesser saphenous vein. 3. Varicose veins involving the left mid thigh and left mid calf. The above results were communicated to PA at 1:42 PM on 7/3/2021 with read back verification. 08/23 Extremity Impression: 1. No LEFT femoropopliteal venous system deep vein thrombosis. 2. Previously noted superficial venous thrombosis of the left lesser saphenous vein is no longer visualized. 3. Patent superficial varicosities in the left mid calf in the area of reported pain. 11/22 COVID swab, result; detected 11/20 pt cc: cough, diarrhea, rhinitis, sore throat exposure: unknown 11/22 SARS-COV-S Variant Sequencing result: pending
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Rhinitis, SARS-CoV-2 test positive, Superficial vein thrombosis
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 06/01 CR impression: 1. Nonspecific subtle left suprahilar increased opacity. 2. Similar left rib deformities. 07/03 Extremity impression: 1. No sonographic evidence of deep venous thrombosis in the left lower extremity. 2. Superficial thrombosis involving the left lesser saphenous vein. 3. Varicose veins involving the left mid thigh and left mid calf. The above results were communicated to PA at 1:42 PM on 7/3/2021 with read back verification. 08/23 Extremity Impression: 1. No LEFT femoropopliteal venous system deep vein thrombosis. 2. Previously noted superficial venous thrombosis of the left lesser saphenous vein is no longer visualized. 3. Patent superficial varicosities in the left mid calf in the area of reported pain. 11/22 COVID swab, result; detected 11/20 pt cc: cough, diarrhea, rhinitis, sore throat exposure: unknown 11/22 SARS-COV-S Variant Sequencing result: pending
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, Varicose vein
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 06/01 CR impression: 1. Nonspecific subtle left suprahilar increased opacity. 2. Similar left rib deformities. 07/03 Extremity impression: 1. No sonographic evidence of deep venous thrombosis in the left lower extremity. 2. Superficial thrombosis involving the left lesser saphenous vein. 3. Varicose veins involving the left mid thigh and left mid calf. The above results were communicated to PA at 1:42 PM on 7/3/2021 with read back verification. 08/23 Extremity Impression: 1. No LEFT femoropopliteal venous system deep vein thrombosis. 2. Previously noted superficial venous thrombosis of the left lesser saphenous vein is no longer visualized. 3. Patent superficial varicosities in the left mid calf in the area of reported pain. 11/22 COVID swab, result; detected 11/20 pt cc: cough, diarrhea, rhinitis, sore throat exposure: unknown 11/22 SARS-COV-S Variant Sequencing result: pending
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Myalgia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection following COVID vaccine series 03/25/2021, Moderna , dose #1 Non-Facility 04/22/2021 Moderna, dose #2 Non-Facility 08/25/2020 COVID swab, result: not detected 08/09 COVID swab, result: not detected 11/22 SARS-COV-2 Variant Sequencing result: pending 11/22 COVID swab, result: detected 11/19 pt cc: myalgias, rhinorrhea, loss of taste exposure: unknown
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head normal, Electrocardiogram, Headache, Hypertension
Clinical narrative: got severe headache, lasted for about 36 hrs and then was gone completely; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 13:30 (Lot number: EL0140) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN. Past drug history included: Emycin, reaction(s): "Known allergies: emycin/codeine"; Codeine, reaction(s): "Known allergies: emycin/codeine". The following information was reported: HEADACHE (non-serious) with onset 15Jan2021, outcome "recovered" (Jan2021), described as "got severe headache, lasted for about 36 hrs and then was gone completely".  Additional information: Facility type vaccine was . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. Other medical history was reported as none. Patient received vaccine and about 3 hrs later got severe headache, lasted for about 36 hrs and then was gone completely.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine
Clinical narrative: got severe headache, lasted for about 36 hrs and then was gone completely; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 13:30 (Lot number: EL0140) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN. Past drug history included: Emycin, reaction(s): "Known allergies: emycin/codeine"; Codeine, reaction(s): "Known allergies: emycin/codeine". The following information was reported: HEADACHE (non-serious) with onset 15Jan2021, outcome "recovered" (Jan2021), described as "got severe headache, lasted for about 36 hrs and then was gone completely".  Additional information: Facility type vaccine was . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. Other medical history was reported as none. Patient received vaccine and about 3 hrs later got severe headache, lasted for about 36 hrs and then was gone completely.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: got severe headache, lasted for about 36 hrs and then was gone completely; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 13:30 (Lot number: EL0140) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN. Past drug history included: Emycin, reaction(s): "Known allergies: emycin/codeine"; Codeine, reaction(s): "Known allergies: emycin/codeine". The following information was reported: HEADACHE (non-serious) with onset 15Jan2021, outcome "recovered" (Jan2021), described as "got severe headache, lasted for about 36 hrs and then was gone completely".  Additional information: Facility type vaccine was . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. Other medical history was reported as none. Patient received vaccine and about 3 hrs later got severe headache, lasted for about 36 hrs and then was gone completely.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Respiratory distress, Wheezing
Clinical narrative: Couldn't breathe 45 min after the vaccine. Was sent home after taking steroids from the hospital facility.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Couldn't breathe 45 min after the vaccine. Was sent home after taking steroids from the hospital facility.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: sore arm and headache; sore arm and headache; Caller's son was "given too much"; 0.3mL of the vaccine that wasn't diluted was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 19May2021, outcome "unknown", described as "Caller's son was "given too much""; PRODUCT PREPARATION ERROR (non-serious) with onset 19May2021, outcome "unknown", described as "0.3mL of the vaccine that wasn't diluted was administered"; PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 20May2021, outcome "not recovered" and all described as "sore arm and headache". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: Caller stated that her fourteen year old son received the first dose of COVID vaccine and that same day they have received a call from pharmacy that they had given too much of the vaccine to him, apparently it is about 0.3 milliliter dose so not diluted, So, they are asking her to never to kindly come to receive the second dose.  So she was wondering if she should even go through with that or if perhaps there might be some issues to look at for in regards to that. Reporter stated, they said that just keep a eye on him, then his arm might hurt more and that he would not need the second shot. So caller just calling as a concerned parent. Will patient need that second dose. Caller mentioned that her son had a sore arm and headache today means on 20May2021 other than that he said he feels ok.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm and headache; sore arm and headache; Caller's son was "given too much"; 0.3mL of the vaccine that wasn't diluted was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 19May2021, outcome "unknown", described as "Caller's son was "given too much""; PRODUCT PREPARATION ERROR (non-serious) with onset 19May2021, outcome "unknown", described as "0.3mL of the vaccine that wasn't diluted was administered"; PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 20May2021, outcome "not recovered" and all described as "sore arm and headache". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: Caller stated that her fourteen year old son received the first dose of COVID vaccine and that same day they have received a call from pharmacy that they had given too much of the vaccine to him, apparently it is about 0.3 milliliter dose so not diluted, So, they are asking her to never to kindly come to receive the second dose.  So she was wondering if she should even go through with that or if perhaps there might be some issues to look at for in regards to that. Reporter stated, they said that just keep a eye on him, then his arm might hurt more and that he would not need the second shot. So caller just calling as a concerned parent. Will patient need that second dose. Caller mentioned that her son had a sore arm and headache today means on 20May2021 other than that he said he feels ok.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Ophthalmic herpes zoster, Pain in extremity, Product supply issue
Clinical narrative: issues with eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious) with onset 01Mar2021, outcome "unknown", described as "issues with eye". The event "issues with eye" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of eye disorder.  Additional information: The patient was prescribed with acyclovir 400mg ten days for the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder
Clinical narrative: issues with eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious) with onset 01Mar2021, outcome "unknown", described as "issues with eye". The event "issues with eye" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of eye disorder.  Additional information: The patient was prescribed with acyclovir 400mg ten days for the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Skin discolouration, Throat tightness
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Scan with contrast
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bell's palsy, Chills, Fatigue, Glossodynia
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Medial tibial stress syndrome, Muscle tightness, Muscular weakness, Paraesthesia
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Rash, Skin tightness
Clinical narrative: Patient presented with bilateral upper extremity numbness and tingling followed by progressive weakness in both lower extremities and gait instability. Assessed at our institution for suspicious progressive weakness after COVID-19 vaccine and found to have signs compatible with Guillain-Barré Syndrome on an MRI of the Lumbar Spine. Patient was treated with 5 days of Intravenous Immunoglobulin after which she improved and was discharged home.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Hyperhidrosis, Hypoaesthesia, Throat tightness
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Arrhythmia, Blood bilirubin increased, Blood test abnormal
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram abdomen, Dehydration, Dyspnoea, Echocardiogram
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Hyperhidrosis, Hypoaesthesia, Myocardial injury
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Ultrasound biliary tract, Ultrasound kidney, Ventricular extrasystoles, Vitamin B12 decreased
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin D decreased, White blood cell count increased
Clinical narrative: About 5 minutes after receiving the second dose of Pfizer vaccine I had a severe anaphylactic reaction. I couldn't breathe was sweating my throat was closing. I was in ministered the EpiPen in the doctor's office and was rushed to the local ER. Posterial oropharyngeal a Arrhythmia.  Benadryl injection 25 mg pepcid injection 20 mg saline 9% bolus 1000 ml Benadryl injection,  Tylenol.  Was told to follow up with my PCP in 2 days. So my PCP on November 10th.  Was in urgent Care on the 12th - EKG performed November 14th return to the ER with severe abdominal pain, chest pains, shortness of breath numbness of the fingers and hands and severe dehydration.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: feeling chills; low grade fever; significant swelling; painful realm of reported adverse events; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; a 7 year old patient was accidently administered an adult Pfizer COVID 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer program (159558), other case identifier(s) US-PFIZER INC-202101548778 (PFIZER).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:40 (Lot number: 30155BA, Expiration Date: 31Dec2021) at the age of 7 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included FLU VACCINE taken for immunisation, start date: 08Nov2021, stop date: 08Nov2021. The following information was reported OVERDOSE (non-serious), PRODUCT USE ISSUE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 08Nov2021, outcome unknown; CHILLS (non-serious) with onset 09Nov2021, outcome unknown; PYREXIA (non-serious) with onset 09Nov2021, outcome unknown; SWELLING (non-serious) with onset 09Nov2021, outcome unknown; PAIN (non-serious) with onset 09Nov2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section.  No History of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect flu vaccine yesterday in right arm. No AE required a visit to Emergency Room or Physician Office. HCP indicated adult was administered to 7-year-old female yesterday at 17:40. First dose, flu shot in one arm. Mother was present and due to receive dose, HCP administered to patient. Patient was at home today feeling chills, low grade fever, significant swelling, painful realm of reported adverse events. School nurse indicated to for mother to ask about cardiac, cardiomyopathy occurrences in those receiving purple cap dose in pediatric population.  Follow-up attempts are completed. No further information is expected.