chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Facial pain, Laboratory test, Musculoskeletal stiffness
Clinical narrative: On 01/14/21 I  started developing neck and shoulder pain. I reported symptoms to ER. On 01/20/21 I also started developing stiffness and pain on may arms, hands and feet on both sides. I reported symptoms to Urgent Care. Since then the pain has increased and is now worse on my right hand side-arms, feet; leg-up the glutes and face. I was seen on Urgent Care on 01/22/21 and was told to take OTC ibuprofen. Since symptoms worsened I went to ED on 01/24/21 and was told to keep taking ibuprofen and follow-up with my PCP. I saw my PCP on 01/25/21 and was told to continue monitoring symptoms, continue ibuprofen and f/u in week. I was also prescribed an Hydroxyzine to help with anxiety.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Urine analysis
Clinical narrative: On 01/14/21 I  started developing neck and shoulder pain. I reported symptoms to ER. On 01/20/21 I also started developing stiffness and pain on may arms, hands and feet on both sides. I reported symptoms to Urgent Care. Since then the pain has increased and is now worse on my right hand side-arms, feet; leg-up the glutes and face. I was seen on Urgent Care on 01/22/21 and was told to take OTC ibuprofen. Since symptoms worsened I went to ED on 01/24/21 and was told to keep taking ibuprofen and follow-up with my PCP. I saw my PCP on 01/25/21 and was told to continue monitoring symptoms, continue ibuprofen and f/u in week. I was also prescribed an Hydroxyzine to help with anxiety.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Liver injury, Pneumonia
Clinical narrative: According to wife: On 1-21-21 night, the patient began having severe shortness of breath, trouble breathing, cough that wouldn?t stop, light headedness, and sore arm.  On 1-22-21 , wife checked oxygen level and it was at 81%. Called ambulance, and the patient went to ED. The patient was transferred to the emergency room. The patient was  Diagnosed with severe pneumonia and is on a ventilator. Unknown if related to vaccine at this time.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Pain in extremity, Pneumonia
Clinical narrative: According to wife: On 1-21-21 night, the patient began having severe shortness of breath, trouble breathing, cough that wouldn?t stop, light headedness, and sore arm.  On 1-22-21 , wife checked oxygen level and it was at 81%. Called ambulance, and the patient went to ED. The patient was transferred to the emergency room. The patient was  Diagnosed with severe pneumonia and is on a ventilator. Unknown if related to vaccine at this time.
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: welts on her legs and swelling in her hands; welts on her legs and swelling in her hands; This spontaneous report was received from a consumer regarding to herself;  a 66 year old female patient. . Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced welts on her legs (urticaria) and swelling in her hands (peripheral swelling).      The outcome of urticaria and peripheral swelling was reported as recovered.     The reporter considered urticaria and peripheral swelling to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AEs; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist and a consumer concerning to a female patient of unknown age.  The patient's concurrent conditions included chronic lung disease. No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies or concomitant therapies was provided.      On an unspecified date in 2014, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), 1 time dose for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided).             On 11-JAN-2021, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), 1 time dose for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided).  It was reported that the patient's healthcare professional (HCP) recommended and requested that she receive the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) every 5 years (previously reported as ''every 6 years'').
Sex: U
Vaccine: VARZOS
Symptoms: Bronchitis, Herpes zoster, Post herpetic neuralgia
Clinical narrative: bronchitis; post herpetic neuralgia; herpes zoster; Information has been received from a lawyer and a consumer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after being vaccinated, the pt suffered multiple outbreaks of herpes zoster, post herpetic neuralgia and bronchitis. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered bronchitis, post herpetic neuralgia and herpes zoster to be disabling events.
Age: 12.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no AE; product experienced multiple temperature excursions and that some of the product might have been administered to patients; This spontaneous report was received from a medical assistant, referring to a 12 years old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1637648, expiration date 19-JUN-2022 for prophylaxis (strength, route and frequency were not reported). The reporter said the vaccine experienced multiple temperature excursions and that some of the product might have been administered to patients.  The temperature excursion was of -2.09 Centigrade degrees (°C) during 37 hours. A previous temperature excursion occurred of 12.9 °C for 2 hours.A digital data logger was involved. No other adverse events were reported. This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA011510: US-009507513-2101USA011511:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No other AE reported; incorrect product storage; This spontaneous report was received from a person of physician's office, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 07-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1602284, expiration date 26-SEP-2021 for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of 31.2 Centigrade degrees (°C) during 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No other adverse events were reported. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: No other AE reported; report a temperature excursion; This spontaneous report was received from an other type of reporter and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history. On 12-JAN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). However, no adverse events were reported. This temperature excursion occurred on an unknown date, at a 31.2 F temperature for 30 minutes. There was no previous temperature excursion reported and it was confirmed that a digital data logger was involved. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Rotateq was improperly stored and administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 20-JAN-2021, the patient was vaccinated with improperly stored dose of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose, route of administration, anatomical location and vaccine scheme were not provided), lot number: 1687012 has been verified to be a valid lot number, expiration date was on 08-JUL-2021 as prophylaxis (product storage error). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 Fahrenheit (°F), for a time frame of 1 hour.  A digital data logger was involved. There were no previous temperature excursions reported.
Age: 16.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no AE; product experienced multiple temperature excursions and that some of the product might have been administered to patients; This spontaneous report was received from a medical assistant, referring to a 16 years old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 18-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1637648, expiration date 19-JUN-2022 for prophylaxis (strength, route and frequency were not reported). The reporter said the vaccine experienced multiple temperature excursions and that some of the product might have been administered to patients.  The temperature excursion was of -2.09 Centigrade degrees (°C) during 37 hours. A previous temperature excursion occurred of 12.9 °C for 2 hours.A digital data logger was involved. No other adverse events were reported. This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA011511: US-009507513-2101USA009815:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no AE; product experienced multiple temperature excursions and that some of the product might have been administered to patients; This spontaneous report was received from a medical assistant, referring to a 16 years old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 18-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1637648, expiration date 19-JUN-2022 for prophylaxis (strength, route and frequency were not reported). The reporter said the vaccine experienced multiple temperature excursions and that some of the product might have been administered to patients.  The temperature excursion was of -2.09 Centigrade degrees (°C) during 37 hours. A previous temperature excursion occurred of 12.9 °C for 2 hours.A digital data logger was involved. No other adverse events were reported. This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA009815: US-009507513-2101USA011510:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Incomplete course of vaccination, Inflammation, Scar
Clinical narrative: her first dose August 2018 / is unsure that she received the second dose; The area was really inflamed; Scar; swelling went down but nothing else changed.; poison ivy; diagnosed her with shingles; This case was reported by a consumer and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2020, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, inflammation localized, scar, swelling and poison ivy rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were recovered/resolved and the outcome of the inflammation localized, scar, swelling and poison ivy rash were unknown.   It was unknown if the reporter considered the shingles, inflammation localized, scar, swelling and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced area on her left leg that started small and grew. The patient went to urgent care and they quickly diagnosed her with shingles. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient believes that it could have been poison ivy because she was outside, however, her son had a mild case of chicken pox also. The area was really inflamed so they gave her a steroid shot and the overall swelling went down but nothing else changed. The patient still has a scar. The patient had steroid shot. The patient was unsure that she received the second dose because her HCP has no record of a second shot in their system and she cannot recall getting the second dose. The reporter consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: her first dose August 2018 / is unsure that she received the second dose; The area was really inflamed; Scar; swelling went down but nothing else changed.; poison ivy; diagnosed her with shingles; This case was reported by a consumer and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2020, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, inflammation localized, scar, swelling and poison ivy rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were recovered/resolved and the outcome of the inflammation localized, scar, swelling and poison ivy rash were unknown.   It was unknown if the reporter considered the shingles, inflammation localized, scar, swelling and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced area on her left leg that started small and grew. The patient went to urgent care and they quickly diagnosed her with shingles. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient believes that it could have been poison ivy because she was outside, however, her son had a mild case of chicken pox also. The area was really inflamed so they gave her a steroid shot and the overall swelling went down but nothing else changed. The patient still has a scar. The patient had steroid shot. The patient was unsure that she received the second dose because her HCP has no record of a second shot in their system and she cannot recall getting the second dose. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dyspnoea, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Blue lips; Immediately after getting shot she couldn't breath; A spontaneous report was received from a nurse who was also a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced difficulty breathing, blue lips, shortness of breath, and pulmonary embolism.    The patient's medical history included pulmonary embolism. No relevant concomitant medications were reported.   On 30 Dec 2020, moments prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient began to feel like she couldn't breathe, and her lips were blue immediately after receiving the vaccine on 30 Dec 2020. The symptoms resolved within an hour.  On 05 Jan 2021, she developed shortness of breath and experienced pulmonary embolism.  Treatment included apixaban.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, difficulty breathing, blue lips, shortness of breath, and pulmonary embolism, were not reported.; Reporter's Comments: This case concerns a female patient, nurse, of unknown age with medical history of Pulmonary embolism,  who experienced a serious, unexpected event of difficulty breathing, cyanosis and pulmonary embolism. The event of difficulty breathing and cyanosis occurred immediately and pulmonary embolism occurred after 7 days after first dose of mRNA-1273 (lot number 026L20A).  Based on the current available information and temporal association between the use of mRNA-1273 and the start of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Inner ear inflammation
Clinical narrative: Ear infection; Pain in ear; Inflammation in ear; A spontaneous report was received from a consumer concerning a 49-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in ear, inflammation in ear, and ear infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient began experiencing pain and inflammation in his ear and was treating for an ear infection. Treatment for the event included pseudoephedrine, loratadine, ibuprofen, diphenhydramine hydrochloride, and amoxicillin.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, pain in ear, inflammation in ear, and ear infection, were unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of ear infection and non-serious unexpected events of ear pain and inner ear inflammation. The event of ear infection, ear pain, inner ear inflammation occurred 9 days after mRNA-1273 (lot # unknown) administration. Treatment included pseudoephedrine, loratadine, ibuprofen, diphenhydramine hydrochloride, and amoxicillin. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Bad allergic reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a bad allergic reaction.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced a bad allergic reaction. Treatment for the event included epinephrine injection.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, experienced a bad allergic reaction, was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of hypersensitivity.  The event of hypersensitivity occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. She was treated with EpiPen. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Oxygen saturation
Clinical narrative: Anaphylactic response; A spontaneous report was received from a consumer who was a 50-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic response.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, a few minutes after receiving the vaccine, the patient experienced an anaphylactic response.  Her extremities went cold, her mouth was dry, and she couldn't swallow due to her throat being swollen. She was given intravenous fluids and oxygen due to her oxygen saturation being 82 percent. She was also given an epinephrine injection and was taken to the emergency room to be observed for a few hours.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, anaphylactic response, was unknown.; Reporter's Comments: This case concerns a 50-year-old female patient, who experienced a serious unexpected event of Anaphylactic reaction. The event occurred soon after first dose of the study medication administration. The patient was treated with an Epi-pen, Benadryl iv, and oxygen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Body temperature, Chest pain, Electrocardiogram, Pyrexia
Clinical narrative: Mild Chest Pain Worse With Deep Breath/chest pain got worse; Felt warm and his temperature was 100 F; Now I have A-Fib; A spontaneous report was received from a consumer concerning a male 76-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, fever, and atrial fibrillation.   The patient's medical history, as provided by the reporter, included coronary artery disease.  Concomitant medications included carvedilol.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced chest pain that got worse when he took a deep breath.  He also felt warm, and his temperature was 100 degrees Fahrenheit.  The patient visited the emergency room where an electrocardiogram (EKG) was normal and his COVID-19 test were negative.  Because of his history of coronary artery disease, he stayed in the hospital overnight.  On 01 Jan 2021, the hospital cardiologist called it a reaction the vaccine, and he was discharged.  On 05 Jan 2021, on a follow-up visit with another cardiologist, another EKG was performed, and the patient was diagnosed with atrial fibrillation.  The cardiologist increased his carvedilol dose to 6.25 milligram from 3.125 milligram and added apixaban, 5 milligram, twice daily.  At the time of the report, he felt fine.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chest pain and fever, was considered recovered/resolved on 01 Jan 2021.  The outcome of the event, atrial fibrillation, was considered recovering/resolving.; Reporter's Comments: This case concerns a 76-year-old male patient with medical history of coronary artery disease, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of chest pain and atrial fibrillation and the non-serious listed event of fever.  Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. However, the events of chest pain and atrial fibrillation may be explained by the patient's history of coronary artery disease.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Mild Chest Pain Worse With Deep Breath/chest pain got worse; Felt warm and his temperature was 100 F; Now I have A-Fib; A spontaneous report was received from a consumer concerning a male 76-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, fever, and atrial fibrillation.   The patient's medical history, as provided by the reporter, included coronary artery disease.  Concomitant medications included carvedilol.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced chest pain that got worse when he took a deep breath.  He also felt warm, and his temperature was 100 degrees Fahrenheit.  The patient visited the emergency room where an electrocardiogram (EKG) was normal and his COVID-19 test were negative.  Because of his history of coronary artery disease, he stayed in the hospital overnight.  On 01 Jan 2021, the hospital cardiologist called it a reaction the vaccine, and he was discharged.  On 05 Jan 2021, on a follow-up visit with another cardiologist, another EKG was performed, and the patient was diagnosed with atrial fibrillation.  The cardiologist increased his carvedilol dose to 6.25 milligram from 3.125 milligram and added apixaban, 5 milligram, twice daily.  At the time of the report, he felt fine.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chest pain and fever, was considered recovered/resolved on 01 Jan 2021.  The outcome of the event, atrial fibrillation, was considered recovering/resolving.; Reporter's Comments: This case concerns a 76-year-old male patient with medical history of coronary artery disease, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of chest pain and atrial fibrillation and the non-serious listed event of fever.  Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. However, the events of chest pain and atrial fibrillation may be explained by the patient's history of coronary artery disease.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; A spontaneous report was received from a consumer concerning a 34-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for COVID-19 infection prophylaxis.  On 09 Jan 2021, 15 minutes after receiving the mRNA-1273 vaccination, the patient was taken to the hospital for anaphylaxis. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, anaphylaxis, was unknown.; Reporter's Comments: This case concerns a patient who experienced a serious unexpected event of Anaphylaxis. The event occurred 1 day after first dose of mRNA-1273.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Heart rate increased, Malaise, Muscle spasms
Clinical narrative: Hurts when she breathes; Unable to lift arm; On and off chest pain; Spasms; Fast heartbeat; Did not feel good; Headache; Vomiting; A spontaneous report was received from a consumer regarding a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced the events, did not feel good, headache, vomiting, chest pain, spasms, a fast heartbeat, unable to lift arm, and hurts when she breathes.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 09 Jan 2021, approximately 24 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 10 Jan 2021, the patient did not feel well and experienced a headache and vomiting.   On 11 Jan 2021, the patient experienced on and off chest pain, spasms, and a fast heart beat. She was unable to lift her arm and it hurt when she would breathe. An emergency medical technician (EMT) was called to assist the patient. No further details were provided. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, did not feel good, headache, vomiting, chest pain, spasms, a fast heartbeat, unable to lift arm, and hurts when she breathes, was not reported.; Reporter's Comments: This case concerns a female patient, who experienced serious unexpected events of painful breathing, and non-serious unexpected event of vaccination site movement impairment, chest pain, muscle spasm, malaise, and heart rate increased; and non-serious expected events of headache and vomiting. The event of malaise, headache and vomiting occurred 2 days after mRNA-1273 (lot # unknown) administration. The event of painful breathing, vaccination site movement impairment, chest pain, muscle spasms, heart rate increased, occurred day 3 after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Vaccination site movement impairment, Vomiting
Clinical narrative: Hurts when she breathes; Unable to lift arm; On and off chest pain; Spasms; Fast heartbeat; Did not feel good; Headache; Vomiting; A spontaneous report was received from a consumer regarding a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced the events, did not feel good, headache, vomiting, chest pain, spasms, a fast heartbeat, unable to lift arm, and hurts when she breathes.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 09 Jan 2021, approximately 24 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 10 Jan 2021, the patient did not feel well and experienced a headache and vomiting.   On 11 Jan 2021, the patient experienced on and off chest pain, spasms, and a fast heart beat. She was unable to lift her arm and it hurt when she would breathe. An emergency medical technician (EMT) was called to assist the patient. No further details were provided. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, did not feel good, headache, vomiting, chest pain, spasms, a fast heartbeat, unable to lift arm, and hurts when she breathes, was not reported.; Reporter's Comments: This case concerns a female patient, who experienced serious unexpected events of painful breathing, and non-serious unexpected event of vaccination site movement impairment, chest pain, muscle spasm, malaise, and heart rate increased; and non-serious expected events of headache and vomiting. The event of malaise, headache and vomiting occurred 2 days after mRNA-1273 (lot # unknown) administration. The event of painful breathing, vaccination site movement impairment, chest pain, muscle spasms, heart rate increased, occurred day 3 after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellultic response 8 days after receiving the COVID vaccine; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, cellulitis.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed cellulitis 8 days after receiving the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, cellulitis, is considered unknown.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of cellulitis.  Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the onset of the event 8 days after vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Hypersensitivity
Clinical narrative: Anaphylactic Reaction; Significant angioedema; Severe allergic reaction; A spontaneous report was received from a nurse, who was also a 28-year old, female patient who received Moderna's COVID-19 vaccine and experienced an anaphylactic reaction, a severe allergic reaction, and significant angioedema.   The patient's medical history, as provided by the reporter, included Hashimoto's disease and thyroid disease. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced an anaphylactic reaction, significant angioedema and a severe allergic reaction. Treatment for the events included epinephrine, unspecified antihistamines and unspecified intravenous fluids.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered not resolved.; Reporter's Comments: This case concerns a 28 year old, female patient with medical history of autoimmune disorders including Hashimotos disease and thyroid disease, who experienced a serious unexpected event of anaphylactic reaction, angioedema and hypersensitivity reaction. The event occurred on an unspecified date after first dose mRNA-1273 ((Lot# 039K20-2A) administration. The subject's concomitant medication was not provided. The event was treated with epinephrine, iv fluids and anti-histamines. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site appeared 9 days after injection 1.5? x 2?
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: Hives, itching, tongue swelling
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Muscle tightness, Nausea
Clinical narrative: Tingling in extremity after 10 minutes of administering vaccine.  Jaw tightness, dizziness, nausea and chills for two days.  Occasional low grad fever for two days.  Fatigue for 5 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Tingling in extremity after 10 minutes of administering vaccine.  Jaw tightness, dizziness, nausea and chills for two days.  Occasional low grad fever for two days.  Fatigue for 5 days.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Limb discomfort, Sneezing, Vision blurred
Clinical narrative: Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves.  Feels "heavy" some sneezing too.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Diarrhoea, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Respiratory tract congestion, Taste disorder
Clinical narrative: Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing in am
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: scattered rash on chest and upper abdomen, asymptomatic
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Fatigue
Clinical narrative: "extremely fatigue" and "feeling high".
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 12Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, from a contactable physician (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 02Jan2020. Medical history and concomitant medication were not reported. The patient received his first dose of BNT162B2 and experienced side effects afterwards. He started coming down with a fever took paracetamol (TYLENOL) to help with the fever (from Jan2021). Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Pyrexia
Clinical narrative: Mild Fever (99.6 F), severe headache, hot flashes, chills, fatigue. Started the morning following the vaccination, continued for approximately 24 hours. Spent the whole day in bed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram normal, Pain in jaw, White blood cell count decreased
Clinical narrative: Right sided jaw to chest pain. Right sided chest pain was intermittent and became severe enough to go into ER.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Pruritus, Rash, Vulvovaginal mycotic infection
Clinical narrative: Red bumps on lower legs (possibly Poiser Oak)-- itchy, noticed when I awoke day after vaccine vaginal yeast infection (noticed 2 days after vaccine and still have) irritated stomach/colon
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Headache
Clinical narrative: Temp 101, then 100, joint pain, headaches and chills
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started to experience slight swelling and itching at injection site on day 8 after vaccination. 4-5 cm area around injection site is warm to touch and flushed. Level of itching is about the same as a mosquito bite. Swelling is a 1-1.5 cm bump at injection site.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Extreme muscle aches, rate 9 on scale of 1 to 10.
Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: 1 week after vaccination, started itching on the site,  next day developed rash around the vaccination site with itching.  Next day developed a very pink place below the site about two inches in diameter and also itched.  This continued for 4 days.  On 1/25/21 the itch is gone and the rash and pink spot are fading.