chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Loss of consciousness, Malaise, Pyrexia
Clinical narrative: Loss of consciousness; Malaise; Pyrexia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis, Osteoporosis, GERD, Hypercholesterolemia, Irritable bowel syndrome, Hypothyroidism, Hypertension, Diabetes mellitus and Coronary atherosclerosis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), DOCUSATE SODIUM, BIFIDOBACTERIUM LACTIS, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (FLORAJEN3), GLIPIZIDE, LEVOTHYROXINE, OMEPRAZOLE, INSULIN DEGLUDEC (TRESIBA), VALSARTAN, VITAMIN D3 and ZOLEDRONIC acid for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Pyrexia). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and MALAISE (Malaise). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), MALAISE (Malaise) and PYREXIA (Pyrexia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 142 mg/dl (abnormal) 142 mg/dl. On 26-Feb-2021, Blood pressure measurement: 117/60 (normal) normal, Earlier it was noted to be in the 90s systolic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. On night of 25-Feb-2021. The patient reported running a fever. On 26-Feb-2021, the patient woke up with not feeling well. The patient's blood sugar was checked which was 142 mg/dl and shortly after she passed out. The patient's blood sugar was noted to be in the 90's systolic as taken by her daughter, who was a nurse. On re-checking the patient's blood pressure, it got improved to 117/60. The patient was scheduled to be seen with her primary care provider on 26-Feb-2021 to verify that the patient was stable.  Company Comment: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactoid reaction, Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: Anaphylactoid reaction; Dyspnoea; Swollen tongue; Throat tightness; This case was received via FDA VAERS (Reference number: 1072186) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Egg allergy and Allergy to vaccine (flu vaccine).   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid reaction) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness). At the time of the report, ANAPHYLACTOID REACTION (Anaphylactoid reaction), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. Waiting on the EMS to arrive the patient started having rebound anaphylaxis so was given shot of another EpiPen. Patient was then put into EMS and left for the hospital.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster infection neurological, Ophthalmic herpes zoster, Vaccination failure, Varicella zoster virus infection
Clinical narrative: Suspected vaccination failure; believe I have suffered VZV Opthm / had a more severe outbreak of herpes zoster which included infection of my. Eye; have chronic herpes zoster in my trigeminal nerve; believe I have suffered VZV Opthm / believe I had Vz; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster infection neurological (serious criteria GSK medically significant) and varicella zoster. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient was being treated for an immune deficiency. The patient also asked should he/she get shingles vaccine if he/she has an immune problem. The patient stated that after receiving the Shingrix vaccine, he/she had a more severe outbreak of herpes zoster which included infection of his/her eye. The patient also had chronic herpes zoster in his/her trigeminal nerve and any amount of stress causes an outbreak of varicella zoster virus.  The patient believe he/she had suffered from ophthalmic herpes zoster. The patient also believe he/she had varicella zoster. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for Herpes zoster and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got The Vaccine And 2 Weeks Later Got The Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and got the shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Several of my friends got shingles from the shot/Suspected Vaccination failure; Several of my friends got shingles from the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with vitamin e and lysine. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patients were reporter's friend. The age at vaccination was not applicable to this report. The reporter stated that several of his/her friends (patients) got shingles from the shot and Lysine and Vitamin E stop and prevent it. The reporter stated that you did not need to shoot up poison unless you want to get sick. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I HAD A FRIEND WHO HAD THE SHOT AND GOT IT ANYWAY/ Suspect vaccination failure; HAD THE SHOT AND GOT IT ANYWAY; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose greater than a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than a year before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter stated that 1st dose was greater than year ago and asked do they need to restart the series.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / december of 2019 / wants her to get her second dose now; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient's primary care physician wanted the patient to get her 2nd dose now, it had been approximately a year and a half since 1st dose. The reporter consented to follow up. No further information was provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Only the adjuvant / was given to patient; Only the adjuvant / was given to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number PN2L3, expiry date 7th November 2022) for prophylaxis.   On 21st May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The case was reported by the pharmacy student. The patient received only the adjuvant part of Shingrix, without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No signs and symptoms were reported and limited information was obtained.   The pharmacy also requested a replacement dose.  The reported batch number PH2L3, was not found in sales data sheet, hence was updated to PN2L3.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered with Menveo using another diluent; Patient was administered with Menveo using another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Menveo using another diluent than the one supplied by Glaxo SmithKline, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The information regarding the patient was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: nurse/tech diluted the powder vial with sterile water; nurse/tech diluted the powder vial with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Menveo which was diluted the powder vial with sterile water which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter was asked if patient need to vaccinated. The reporter does not have detail of patient or vaccine. The reporter consented to follow up. This case had been linked with case US2021111552, as reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111552:Same reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood pressure measurement, C-reactive protein, C-reactive protein increased, Headache
Clinical narrative: ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Liver function test, Liver function test increased, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: GOT A BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient got a blood clot in their leg and our vaccine is not good to compare to mRNA Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got a blood clot in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210541027-COVID-19 VACCINE AD26.COV2.S-Got a Blood Clot in Leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total dose administered for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers .No concomitant medications were reported. It was reported that on an unspecified date, the patient died from covid-19 vaccine ad26.cov2.s. The cause of death was unknown. it was unspecified if an autopsy  was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender's Comments: V0: 20210546018-covid-19 vaccine ad26.cov2. s Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0.20210546789-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported and expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-May-2021, the doctor called in for efficacy of the vaccine given to one of his patient (confirmed immunological vaccine failure) experienced on an unspecified date, and measured the spike protein about a month apart. On 19-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody. On 17-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody.  The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210546864-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE DOSE GIVEN AFTER 2 HOUR OF ROOM TEMPERATURE/GIVEN OUTSIDE OF TEMPERATURE RECOMMENDATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation was not reported. This report was non-serious
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cytokine storm, Dyspnoea, Heart rate, Heart rate increased, Hypercoagulation
Clinical narrative: Cytokines Storm; Thickening of the blood; Polycythemia; Extremely Short Of Breath; Elevated Heart Rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.     On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CYTOKINE STORM (Cytokines Storm) (seriousness criteria hospitalization and medically significant), HYPERCOAGULATION (Thickening of the blood) (seriousness criterion hospitalization), POLYCYTHAEMIA (Polycythemia) (seriousness criterion hospitalization), DYSPNOEA (Extremely Short Of Breath) (seriousness criteria hospitalization and intervention required) and HEART RATE INCREASED (Elevated Heart Rate) (seriousness criterion hospitalization). At the time of the report, CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: elevated (High) Elevated.         No treatment related information has been reported.  Since receiving the second vaccine patient visited the ER a total of 4 times. Patient had no medical history of heart disease or Short Breath.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Polycythaemia
Clinical narrative: Cytokines Storm; Thickening of the blood; Polycythemia; Extremely Short Of Breath; Elevated Heart Rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.     On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CYTOKINE STORM (Cytokines Storm) (seriousness criteria hospitalization and medically significant), HYPERCOAGULATION (Thickening of the blood) (seriousness criterion hospitalization), POLYCYTHAEMIA (Polycythemia) (seriousness criterion hospitalization), DYSPNOEA (Extremely Short Of Breath) (seriousness criteria hospitalization and intervention required) and HEART RATE INCREASED (Elevated Heart Rate) (seriousness criterion hospitalization). At the time of the report, CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: elevated (High) Elevated.         No treatment related information has been reported.  Since receiving the second vaccine patient visited the ER a total of 4 times. Patient had no medical history of heart disease or Short Breath.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Oropharyngeal pain, Platelet count
Clinical narrative: Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2EA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat in Neck Area). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) and OROPHARYNGEAL PAIN (Sore Throat in Neck Area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 10,000 (Low) Platelets had dropped to 10,000 and 47,000 (Low) Decreased.         Concomitant medications were not reported.  Patient went to urgent care and blood work revealed that her platelets had dropped to 10,000 and she was directed to the emergency room and was treated with steroids and gamma globulin. She was diagnosed with ITP and treated with 4 infusions of Rituxan and her platelets are still low at 47,000.  Treatment information were included gamma globulin, steroids, 4 infusions of Rituxan at hospital.   Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Echocardiogram, Pericarditis
Clinical narrative: Developed extreme anxiety symptoms after the vaccination, thought it was normal until the onset of extreme chest pains on or around 4/24/2021.   Was diagnosed with Pericarditis on 4/29/2021.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, Nausea, Pain, Sleep disorder
Clinical narrative: I was vaccinated yesterday and woke up in horrible pain and nausea. I vomited and had to go back up so bed since I was so dizzy.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I was vaccinated yesterday and woke up in horrible pain and nausea. I vomited and had to go back up so bed since I was so dizzy.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal motility disorder, Pain, Stool analysis normal
Clinical narrative: The morning after his second vaccine, he had the expected body aches, but he also began having diarrhea, which has fluctuated between diarrhea and constipation......back and forth.......ever since.   Today is May 26, 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Anxiety, Arthralgia, Chills, Depressed mood
Clinical narrative: After the first 15 minutes started to feel very dizzy,  30 minutes after the shot depression and darkness came over me and lasted for about 90 minutes, still dizzy and felt like I was drunk plus my shoulder felt tight and heavy.   Depression left after 1,5 hours , started to feel manic episode for 5 hours with racing thoughts, restlessness, irritation, anger, and not calm.  Still dizzy, had chills.  The next day and the day after that felt fatigued and not well, the place of a shot hurt.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dizziness, Fatigue, Feeling drunk, Injection site pain
Clinical narrative: After the first 15 minutes started to feel very dizzy,  30 minutes after the shot depression and darkness came over me and lasted for about 90 minutes, still dizzy and felt like I was drunk plus my shoulder felt tight and heavy.   Depression left after 1,5 hours , started to feel manic episode for 5 hours with racing thoughts, restlessness, irritation, anger, and not calm.  Still dizzy, had chills.  The next day and the day after that felt fatigued and not well, the place of a shot hurt.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Limb discomfort, Malaise, Mania, Restlessness
Clinical narrative: After the first 15 minutes started to feel very dizzy,  30 minutes after the shot depression and darkness came over me and lasted for about 90 minutes, still dizzy and felt like I was drunk plus my shoulder felt tight and heavy.   Depression left after 1,5 hours , started to feel manic episode for 5 hours with racing thoughts, restlessness, irritation, anger, and not calm.  Still dizzy, had chills.  The next day and the day after that felt fatigued and not well, the place of a shot hurt.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachyphrenia
Clinical narrative: After the first 15 minutes started to feel very dizzy,  30 minutes after the shot depression and darkness came over me and lasted for about 90 minutes, still dizzy and felt like I was drunk plus my shoulder felt tight and heavy.   Depression left after 1,5 hours , started to feel manic episode for 5 hours with racing thoughts, restlessness, irritation, anger, and not calm.  Still dizzy, had chills.  The next day and the day after that felt fatigued and not well, the place of a shot hurt.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph nodes in right armpit
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: beginning about 2.5 weeks after injection site became itchy and a hard amber colored "plug" came out of the site.  It was definitely not a scab.  The same symptom occurred a second time about a week later.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Nausea
Clinical narrative: Big red hot itchy tender painful rash on arm spot of injection. A bad headache, nausea and vomiting, chills, aches and pains all over. Feels like flu coming on.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Skin warm, Tenderness
Clinical narrative: Big red hot itchy tender painful rash on arm spot of injection. A bad headache, nausea and vomiting, chills, aches and pains all over. Feels like flu coming on.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Big red hot itchy tender painful rash on arm spot of injection. A bad headache, nausea and vomiting, chills, aches and pains all over. Feels like flu coming on.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered.  This developed into muscle soreness as I sat through the waiting period before leaving the facility.  (For this reason, I had taken acetaminophen at about 8:30 that morning.)  I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me.  After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection.  It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005.  It was a bit like the tingling I first experienced after the injection, but throughout the injected arm.  As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer.  This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees.  By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head.  I took a third dose of acetaminophen.  My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back.  Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep.  Full-body chills set in soon after, prompting me to turn off my ceiling fan.  I faced some mild nausea as I attempted to get comfortable in bed again.  I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Injection site reaction, Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered.  This developed into muscle soreness as I sat through the waiting period before leaving the facility.  (For this reason, I had taken acetaminophen at about 8:30 that morning.)  I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me.  After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection.  It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005.  It was a bit like the tingling I first experienced after the injection, but throughout the injected arm.  As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer.  This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees.  By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head.  I took a third dose of acetaminophen.  My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back.  Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep.  Full-body chills set in soon after, prompting me to turn off my ceiling fan.  I faced some mild nausea as I attempted to get comfortable in bed again.  I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Sleep disorder
Clinical narrative: Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered.  This developed into muscle soreness as I sat through the waiting period before leaving the facility.  (For this reason, I had taken acetaminophen at about 8:30 that morning.)  I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me.  After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection.  It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005.  It was a bit like the tingling I first experienced after the injection, but throughout the injected arm.  As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer.  This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees.  By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head.  I took a third dose of acetaminophen.  My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back.  Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep.  Full-body chills set in soon after, prompting me to turn off my ceiling fan.  I faced some mild nausea as I attempted to get comfortable in bed again.  I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site red and swollen - very painful. Cold chills.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hormone level abnormal, Malaise
Clinical narrative: I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Night sweats, Vomiting
Clinical narrative: I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antibody test, Blood test, Electromyogram, Endoscopy
Clinical narrative: Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and  painful, I have a constant headache, eyesight worse (blurry even with glasses), all over constant body  throbbing, stomach issues (sharp pains and cramping), constant numbness (the feeling of when you rub  your skin when the novocaine is starting to wear off after a dental procedure) from my feet up to my  waist and the feeling of pins and needles (like when you hand is asleep) from my feet up to my pelvic  area. This all started with just a small vibration in my right hip and has increasing gotten worse over the  last several months.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging, Oesophagogastroduodenoscopy, Pain
Clinical narrative: Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and  painful, I have a constant headache, eyesight worse (blurry even with glasses), all over constant body  throbbing, stomach issues (sharp pains and cramping), constant numbness (the feeling of when you rub  your skin when the novocaine is starting to wear off after a dental procedure) from my feet up to my  waist and the feeling of pins and needles (like when you hand is asleep) from my feet up to my pelvic  area. This all started with just a small vibration in my right hip and has increasing gotten worse over the  last several months.