chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: people who got the shingles after getting the shingle shot /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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. 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 provided as follows: The age at vaccination was not reported. The reporter know the people who got the shingles after getting the shingle shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: get the shot, but I got it /suspected vaccination failure; got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles).   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 provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles, doctor told to get the shot. I did but I got it a second time. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: shingrix vaccines with the adjuvant only; shingrix vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 age at vaccination was not reported. The reporter was a other health professional.  The reporter stated that, the patient received shingrix vaccines with the adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They took inventory yesterday and had 3 shingrix antigens left. The reporter was not sure which patients received full dose and which patients received the adjuvant only.  The reporter stated that, all the patients that received Shingrix would have to get revaccinated. The doctor's office reported this to clinical disease centre. No other information available. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178145:same reporter US-GLAXOSMITHKLINE-US2021AMR178137:same reporter US-GLAXOSMITHKLINE-US2021AMR178136: US-GLAXOSMITHKLINE-US2021AMR178146:same reporter
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent portion; received only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had received only the diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine. Patient data was not available at the moment. HCP reported it was administered without the powder. No further clarifications were made. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiac flutter, Chills, Dysphagia, Hyperhidrosis
Clinical narrative: Heart is fluttering; Feeling that the room is rotating/Cannot move the head; Feeling sick the entire day; Sweating; Cannot drink water; Stomach is like killing her; Felt like the vaccine gave her a flu; Shaking; Cannot drink water; Tingling in the hand and toes; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea, Paraesthesia, Tremor
Clinical narrative: Heart is fluttering; Feeling that the room is rotating/Cannot move the head; Feeling sick the entire day; Sweating; Cannot drink water; Stomach is like killing her; Felt like the vaccine gave her a flu; Shaking; Cannot drink water; Tingling in the hand and toes; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting, Water pollution
Clinical narrative: Heart is fluttering; Feeling that the room is rotating/Cannot move the head; Feeling sick the entire day; Sweating; Cannot drink water; Stomach is like killing her; Felt like the vaccine gave her a flu; Shaking; Cannot drink water; Tingling in the hand and toes; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer via a company representative concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. No past medical history or concurrent conditions were reported. All patients (some 3%) received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown)1 total, dose and 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 patients experienced myocarditis and pericarditis. The myocarditis were in men with a median age of 36 years old. The median age for the pericarditis cases was 59 years. The action taken with covid-19 vaccine was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849032-COVID-19 VACCINE AD26.COV2.S - myocarditis and pericarditis. These events are considered unassessable. The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Suspected COVID-19, Therapy non-responder, Vaccination failure
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 1808609, expiry: unknown) dose was not reported, 1 total, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. Patient was not pregnant at the time of report. On APR-2021, patient took 3 rapid tests at work which were negative. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative (for three rapid test). On 30-APR-2021, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure. she went to the doctor, they performed another rapid test which was positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. On 15-JUL-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative for antibodies. Patient visited to doctors office. The action taken with covid-19 vaccine was not applicable. The patient recovered from suspected covid-19 infection, and had not recovered from suspected clinical vaccination failure, and confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190943.; Sender's Comments: V0:20210851545 -COVID-19 VACCINE AD26.-Suspected clinical vaccination failure, Confirmed immunoloical 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: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure increased, Blood pressure measurement, Cough, Eating disorder
Clinical narrative: COUGH; HEAD HURTS SO BAD; FEVER; BLOOD PRESSURE WENT UP; COULD NOT EAT; GOT A LOT OF THINGS WRONG; ARMS BLACK AND BLUE; LOST WEIGHT; GOT SICK; This spontaneous report received from a patient concerned an 8-decade old female, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hole in chest, clotted artery in heart/ blood clot in artery, intestinal problem, sick, and possible bronchitis, and concurrent conditions included: diabetic, kidney cancer, and antibiotic allergy. The patient was previously treated with azithromycin, doxycycline; and experienced almost died when treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 24-AUG-2021 ,13:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin glargine for diabetes, and insulin Lispro for diabetes. On an unspecified date last year, the patient stated her blood pressure was190/120 units unspecified. The patient stated that after vaccination she felt fine, could not pass out. On 24-Aug-2021, around 17:00 to 18:00 she stated that her head hurts bad, blood pressure went up and got sick. The patient experienced headache, fever and she could not eat. The patient stated that she got lots of thing wrong with her. The patient took Tylenol, and extra blood pressure medicine at night and was able to sleep. The Laboratory data included: Blood pressure (NR: not provided) 188, 186/79/83, 123/54, 186. The patient stated her arms are black and blue. On 25-AUG-2021, the patient experienced cough. Laboratory data included: Blood glucose (NR: not provided) 100, and Blood pressure (NR: not provided) 186/79. The action taken with covid-19 vaccine was not applicable. The patient was recovering from head hurts so bad, and the outcome of cough, blood pressure went up, arms black and blue, fever, lost weight, could not eat, got a lot of things wrong and got sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851803-COVID-19 VACCINE AD26.COV2.S-blood pressure went up. 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: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia, Skin discolouration, Unevaluable event
Clinical narrative: COUGH; HEAD HURTS SO BAD; FEVER; BLOOD PRESSURE WENT UP; COULD NOT EAT; GOT A LOT OF THINGS WRONG; ARMS BLACK AND BLUE; LOST WEIGHT; GOT SICK; This spontaneous report received from a patient concerned an 8-decade old female, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hole in chest, clotted artery in heart/ blood clot in artery, intestinal problem, sick, and possible bronchitis, and concurrent conditions included: diabetic, kidney cancer, and antibiotic allergy. The patient was previously treated with azithromycin, doxycycline; and experienced almost died when treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 24-AUG-2021 ,13:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin glargine for diabetes, and insulin Lispro for diabetes. On an unspecified date last year, the patient stated her blood pressure was190/120 units unspecified. The patient stated that after vaccination she felt fine, could not pass out. On 24-Aug-2021, around 17:00 to 18:00 she stated that her head hurts bad, blood pressure went up and got sick. The patient experienced headache, fever and she could not eat. The patient stated that she got lots of thing wrong with her. The patient took Tylenol, and extra blood pressure medicine at night and was able to sleep. The Laboratory data included: Blood pressure (NR: not provided) 188, 186/79/83, 123/54, 186. The patient stated her arms are black and blue. On 25-AUG-2021, the patient experienced cough. Laboratory data included: Blood glucose (NR: not provided) 100, and Blood pressure (NR: not provided) 186/79. The action taken with covid-19 vaccine was not applicable. The patient was recovering from head hurts so bad, and the outcome of cough, blood pressure went up, arms black and blue, fever, lost weight, could not eat, got a lot of things wrong and got sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851803-COVID-19 VACCINE AD26.COV2.S-blood pressure went up. 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: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: COUGH; HEAD HURTS SO BAD; FEVER; BLOOD PRESSURE WENT UP; COULD NOT EAT; GOT A LOT OF THINGS WRONG; ARMS BLACK AND BLUE; LOST WEIGHT; GOT SICK; This spontaneous report received from a patient concerned an 8-decade old female, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hole in chest, clotted artery in heart/ blood clot in artery, intestinal problem, sick, and possible bronchitis, and concurrent conditions included: diabetic, kidney cancer, and antibiotic allergy. The patient was previously treated with azithromycin, doxycycline; and experienced almost died when treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 24-AUG-2021 ,13:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin glargine for diabetes, and insulin Lispro for diabetes. On an unspecified date last year, the patient stated her blood pressure was190/120 units unspecified. The patient stated that after vaccination she felt fine, could not pass out. On 24-Aug-2021, around 17:00 to 18:00 she stated that her head hurts bad, blood pressure went up and got sick. The patient experienced headache, fever and she could not eat. The patient stated that she got lots of thing wrong with her. The patient took Tylenol, and extra blood pressure medicine at night and was able to sleep. The Laboratory data included: Blood pressure (NR: not provided) 188, 186/79/83, 123/54, 186. The patient stated her arms are black and blue. On 25-AUG-2021, the patient experienced cough. Laboratory data included: Blood glucose (NR: not provided) 100, and Blood pressure (NR: not provided) 186/79. The action taken with covid-19 vaccine was not applicable. The patient was recovering from head hurts so bad, and the outcome of cough, blood pressure went up, arms black and blue, fever, lost weight, could not eat, got a lot of things wrong and got sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851803-COVID-19 VACCINE AD26.COV2.S-blood pressure went up. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Initial insomnia, Injection site pain, Injection site swelling
Clinical narrative: SO OFTEN LEFT SIDE  NUMBNESS IN HER LEG AS IF HER  LEG WANTED TO GO TO SLEEP WHICH  LASTED GOOD 15 MIN AND RETURNED  SAME THING IN THE EVENING; VERY BAD STRONG HEADACHE; THE SMALL HIVES; HARD TIME TO SLEEP; ITCH IN BACK, ARM, AND LEGS; SCRATCHING THE BUMPS; HEAVINESS; TINGLING FEELING TRAVELING FROM HAND UP TO ARM; SWELLING IN  ARM  IN THE INJECTION SITE; PAIN IN  ARM IN THE  INJECTION SITE; COLD TRAVELING FROM THE LEFT HAND UP  LIKE NUMBNESS, GOING BACK AND FORTH; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-alcoholic, non-smoker, and hypertension, and other pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced cold traveling from the left hand up like numbness, going back and forth. On 02-APR-2021, the patient experienced heaviness. On 02-APR-2021, the patient experienced tingling feeling traveling from hand up to arm. On 02-APR-2021, the patient experienced swelling in arm in the injection site. On 02-APR-2021, the patient experienced pain in arm in the injection site. On 03-APR-2021, the patient experienced hard time to sleep. On 03-APR-2021, the patient experienced itch in back, arm, and legs. On 03-APR-2021, the patient experienced scratching the bumps. On 03-APR-2021, the patient experienced the small hives. On 08-APR-2021, the patient experienced very bad strong headache. On 09-APR-2021, the patient experienced so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold traveling from the left hand up like numbness, going back and forth, heaviness, and tingling feeling traveling from hand up to arm, itch in back, arm, and legs on 04-MAY-2021, and so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening on 11-APR-2021, and the outcome of swelling in arm in the injection site, hard time to sleep, scratching the bumps, very bad strong headache, pain in arm in the injection site and the small hives was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia, Peripheral coldness, Pruritus, Scratch
Clinical narrative: SO OFTEN LEFT SIDE  NUMBNESS IN HER LEG AS IF HER  LEG WANTED TO GO TO SLEEP WHICH  LASTED GOOD 15 MIN AND RETURNED  SAME THING IN THE EVENING; VERY BAD STRONG HEADACHE; THE SMALL HIVES; HARD TIME TO SLEEP; ITCH IN BACK, ARM, AND LEGS; SCRATCHING THE BUMPS; HEAVINESS; TINGLING FEELING TRAVELING FROM HAND UP TO ARM; SWELLING IN  ARM  IN THE INJECTION SITE; PAIN IN  ARM IN THE  INJECTION SITE; COLD TRAVELING FROM THE LEFT HAND UP  LIKE NUMBNESS, GOING BACK AND FORTH; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-alcoholic, non-smoker, and hypertension, and other pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced cold traveling from the left hand up like numbness, going back and forth. On 02-APR-2021, the patient experienced heaviness. On 02-APR-2021, the patient experienced tingling feeling traveling from hand up to arm. On 02-APR-2021, the patient experienced swelling in arm in the injection site. On 02-APR-2021, the patient experienced pain in arm in the injection site. On 03-APR-2021, the patient experienced hard time to sleep. On 03-APR-2021, the patient experienced itch in back, arm, and legs. On 03-APR-2021, the patient experienced scratching the bumps. On 03-APR-2021, the patient experienced the small hives. On 08-APR-2021, the patient experienced very bad strong headache. On 09-APR-2021, the patient experienced so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold traveling from the left hand up like numbness, going back and forth, heaviness, and tingling feeling traveling from hand up to arm, itch in back, arm, and legs on 04-MAY-2021, and so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening on 11-APR-2021, and the outcome of swelling in arm in the injection site, hard time to sleep, scratching the bumps, very bad strong headache, pain in arm in the injection site and the small hives was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SO OFTEN LEFT SIDE  NUMBNESS IN HER LEG AS IF HER  LEG WANTED TO GO TO SLEEP WHICH  LASTED GOOD 15 MIN AND RETURNED  SAME THING IN THE EVENING; VERY BAD STRONG HEADACHE; THE SMALL HIVES; HARD TIME TO SLEEP; ITCH IN BACK, ARM, AND LEGS; SCRATCHING THE BUMPS; HEAVINESS; TINGLING FEELING TRAVELING FROM HAND UP TO ARM; SWELLING IN  ARM  IN THE INJECTION SITE; PAIN IN  ARM IN THE  INJECTION SITE; COLD TRAVELING FROM THE LEFT HAND UP  LIKE NUMBNESS, GOING BACK AND FORTH; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-alcoholic, non-smoker, and hypertension, and other pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced cold traveling from the left hand up like numbness, going back and forth. On 02-APR-2021, the patient experienced heaviness. On 02-APR-2021, the patient experienced tingling feeling traveling from hand up to arm. On 02-APR-2021, the patient experienced swelling in arm in the injection site. On 02-APR-2021, the patient experienced pain in arm in the injection site. On 03-APR-2021, the patient experienced hard time to sleep. On 03-APR-2021, the patient experienced itch in back, arm, and legs. On 03-APR-2021, the patient experienced scratching the bumps. On 03-APR-2021, the patient experienced the small hives. On 08-APR-2021, the patient experienced very bad strong headache. On 09-APR-2021, the patient experienced so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold traveling from the left hand up like numbness, going back and forth, heaviness, and tingling feeling traveling from hand up to arm, itch in back, arm, and legs on 04-MAY-2021, and so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening on 11-APR-2021, and the outcome of swelling in arm in the injection site, hard time to sleep, scratching the bumps, very bad strong headache, pain in arm in the injection site and the small hives was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Body temperature, Diarrhoea, Fatigue
Clinical narrative: WATERY DIARRHEA; VOMITING; MUSCLE ACHES ALL OVER; FEVER 99.7 DEGREES FAHRENHEIT; NAUSEA; TIREDNESS; FELT LIKE BLOOD SUGAR DROPPED; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 110 pounds, and height was 70 inches. The patient's concurrent conditions included: diet controlled diabetic, pancreatitis issues, anemia, and allergic to contrast ct dye, and other pre-existing medical conditions included: Patient had no daily medications. The patient experienced drug allergy when treated with morphine, and ondansetron.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced felt like blood sugar dropped. On 25-AUG-2021, the patient experienced tiredness. Laboratory data included: Blood glucose (NR: not provided) dropped. On 26-AUG-2021, the patient experienced watery diarrhea. On 26-AUG-2021, the patient experienced vomiting. On 26-AUG-2021, the patient experienced muscle aches all over. On 26-AUG-2021, the patient experienced fever 99.7 degrees fahrenheit. On 26-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.7 F. Treatment medications (dates unspecified) included: tizanidine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt like blood sugar dropped on 25-AUG-2021, and fever 99.7 degrees fahrenheit, was recovering from watery diarrhea, had not recovered from tiredness, muscle aches all over, and nausea, and the outcome of vomiting was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: WATERY DIARRHEA; VOMITING; MUSCLE ACHES ALL OVER; FEVER 99.7 DEGREES FAHRENHEIT; NAUSEA; TIREDNESS; FELT LIKE BLOOD SUGAR DROPPED; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 110 pounds, and height was 70 inches. The patient's concurrent conditions included: diet controlled diabetic, pancreatitis issues, anemia, and allergic to contrast ct dye, and other pre-existing medical conditions included: Patient had no daily medications. The patient experienced drug allergy when treated with morphine, and ondansetron.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced felt like blood sugar dropped. On 25-AUG-2021, the patient experienced tiredness. Laboratory data included: Blood glucose (NR: not provided) dropped. On 26-AUG-2021, the patient experienced watery diarrhea. On 26-AUG-2021, the patient experienced vomiting. On 26-AUG-2021, the patient experienced muscle aches all over. On 26-AUG-2021, the patient experienced fever 99.7 degrees fahrenheit. On 26-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.7 F. Treatment medications (dates unspecified) included: tizanidine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt like blood sugar dropped on 25-AUG-2021, and fever 99.7 degrees fahrenheit, was recovering from watery diarrhea, had not recovered from tiredness, muscle aches all over, and nausea, and the outcome of vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITION; VACCINE ADMINISTERED 2 DAYS AFTER ITS BEYOND USE DATE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced incorrect product storage, administration of vaccine which was stored outside of recommended storage condition, and vaccine administered 2 days after its beyond use date. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage, administration of vaccine which was stored outside of recommended storage condition and vaccine administered 2 days after its beyond use date was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE THAT WAKES HIM UP; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced severe headache that wakes him up. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache that wakes him up. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Oropharyngeal pain, Pain
Clinical narrative: SORE THROAT; BODY ACHES; CHEST IS HURTING; HAVING DIFFICULTY BREATHING; HEADACHE; This spontaneous report received from a patient concerned a 24 year old male. The patient's weight was 140 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol use, and smoker, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sore throat. On 26-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced chest is hurting. On 26-AUG-2021, the patient experienced having difficulty breathing. On 26-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms, Pyrexia
Clinical narrative: FEVER; MUSCLE CRAMPING WORSEN AS THE DAY PROGRESSED; HEAVY LEGS WORSEN AS THE DAY PROGRESSED; This spontaneous report received from a patient concerned an adult 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) dose was not reported, administered on 16-AUG-2021 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 AUG-2021, the patient experienced muscle cramping worsen as the day progressed. On AUG-2021, the patient experienced heavy legs worsen as the day progressed. On 16-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from heavy legs worsen as the day progressed, and muscle cramping worsen as the day progressed. This report was non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Immunology test, Pemphigoid
Clinical narrative: Bullous pemphigoid; This literature-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    The patient's past medical history included Atopic dermatitis (Childhood).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (Bullous pemphigoid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: abnormal (abnormal) Intraepidermal spongiotic  vesicles with  eosinophilic  spongiosis. In 2021, Immunology test: abnormal (abnormal) linear deposition of C3 and weak linear deposition of Immunoglobulin (IgG) along the dermoepidermal junction confirming a diagnosis of bullous pemphigod.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PEMPHIGOID (Bullous pemphigoid) to be possibly related.    Concomitant medications were not provided by the reporter.   It was reported that the clinical and histopathologic features of delayed cutaneous adverse reactions from 12 patients after receiving an mRNA COVID-19 vaccine. Patient reported no recent medication changes who developed a widespread eruption of erythematous papules and plaques, some with vesiculation two week after second dose of Moderna vaccine  Treatment drug included topical corticosteroids.  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.   This case was linked to MOD-2021-276439, MOD-2021-276440, MOD-2021-276441, MOD-2021-276442, MOD-2021-276443, MOD-2021-276444, MOD-2021-276445, MOD-2021-276353, MOD-2021-278847 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Chills, Electrocardiogram, Limb mass
Clinical narrative: lump in arm and neck; knee went out; lump in arm and neck; rash; arthritic pain; fever; chills; Myocardial infarction; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LIMB MASS (lump in arm and neck), ARTHROPATHY (knee went out), NECK MASS (lump in arm and neck), RASH (rash), ARTHRALGIA (arthritic pain), PYREXIA (fever) and CHILLS (chills). In 2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Myocardial infarction), LIMB MASS (lump in arm and neck), ARTHROPATHY (knee went out), NECK MASS (lump in arm and neck), RASH (rash), ARTHRALGIA (arthritic pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: myocardial infarction (abnormal) myocardial infarction.   The physician scheduled echo on 17-Sep-2021. No concomitant medications was provided. No treatment medications was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-027089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received on 20-AUG-2021.event and lab data were added.; 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.