chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: do not remember whether they got the 1 and/or 2 doses / got vaccinated was 3-4 years ago.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 or 4 years ago from 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 reported as follows: The case was reported by the patient's husband. The age at vaccination was not applicable for this report. The health care professional reported that the patient wanted to have it might be a 3rd dose of Shingrix as she did not remember whether she got the 1st and/or 2 doses of the vaccine which led to incomplete course of vaccination.  The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with US2021149594 reported by same reporter. Note: This case was conservatively kept valid with event incomplete course of vaccination as it was not clear if patient had received 2nd dose of Shingrix or not. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149594:Same reporter
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal, Nail growth abnormal, Therapeutic response unexpected
Clinical narrative: POSITIVE SIDE EFFECT; HAIR GROWTH; NAIL GROWTH; This spontaneous report received from a patient concerned an 80 year old male. The patient's weight was 150 pounds, and height was 71 inches. The patient's past medical history included malignant melanoma removed, and food poisoning, and concurrent conditions included nail fungus, and other pre-existing medical conditions included took black walnut husk and it affected gut flora, so patient started taking a probiotic as well. The patient was previously treated with juglans nigra fruit for food poisoning, influenza vaccine for prophylactic vaccination; and experienced asthma, edema and high eosinophil count when treated with naproxen sodium, and severe allergy/anaphylactic when treated with diethyltoluamide.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805031, and expiry:10-JUL-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced hair growth. On 26-MAR-2021, the subject experienced nail growth. On an unspecified date, the subject experienced positive side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hair growth, nail growth and positive side effect was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Peripheral swelling, Thrombosis
Clinical narrative: SORE ALL OVER THE BODY; WEAKNESS IN BODY; HEADACHES; POSSIBLE BLOOD CLOT IN RIGHT LEG; SWELLING IN BOTH FEET; This spontaneous report received from a patient concerned a 57 year old. The patient's height, and weight were not reported. The patient's past medical history included accident affected right leg in 2010 and concurrent conditions included penicillin allergy (happened when patient was when very young) and severe back pain (from accident).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZ1A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-JUN-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  In JUN-2021 (week and a half after getting the vaccine), the patient had swelling in both feet but mostly in the right foot. The right foot swelled up during the day and then shrunk back down in the night. The skin looked pink and red and felt hot (warmth). The patient started noticing it when he started to experience pain in shins and then it got sore and then started to swell. The patient started noticing puffiness, soreness and warmth after. By 2 weeks it was very puffy and sore. The patient was able to walk and it was the right foot that was mainly bothering. The patient had not seen any health care professional during this time. The patient was concerned that he might had blood clot in right leg due to the fact that it was swollen, red and warm, as per the symptoms they read about. The patient had some headaches in the beginning, took aspirin, and it had improved. The patient also felt weak (weakness in body) and sore all over the body. These all had resolved except the right leg issue.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore all over the body, weakness in body, and headaches, and had not recovered from swelling in both feet, and possible blood clot in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713160-covid-19 vaccine ad26.cov2.- Possible blood clot in right leg. 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: VACCINE WAS NOT HANDLED RIGHT BEFORE ADMINISTRATION; 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 ad26.cov2.s (suspension for injection, route of admin not reported) 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 was not handled right before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was not handled right before administration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED TO TWO PATIENTS WAS AT ROOM TEMPERATURE FOR FOUR HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  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: 201A21A, and expiry: 04-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vaccine administered to two subjects was at room temperature for four hours. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to two patients was at room temperature for four hours and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; HUGE HEADACHE; MINI FEVER; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUL-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 07-JUL-2021, the subject experienced arm pain. On 07-JUL-2021, the subject experienced huge headache. On 07-JUL-2021, the subject experienced mini fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, huge headache, and mini fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE RANGED FROM 24.8 DEGREES F FROM TO 35 DEGREES F; TEMPERATURE EXCURSION; This spontaneous report received from a health care professional 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) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced temperature ranged from 24.8 degrees f from to 35 degrees f. On 28-JUN-2021, the subject experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature ranged from 24.8 degrees f from to 35 degrees f and temperature excursion was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced poor quality vaccine administered. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722914.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: 28-JUL-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate dose of vaccine administered was not reported. This report was non-serious.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia, Nasopharyngitis, Tremor
Clinical narrative: CANNOT STOP SHAKING; COLD; BACK HURTS; MUSCLES HURTING/MUSCLES ACHE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old of unspecified sex. The patient's weight was 275 kilograms, and height was 76 inches. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced cannot stop shaking. On 10-JUL-2021, the subject experienced cold. On 10-JUL-2021, the subject experienced back hurts. On 10-JUL-2021, the subject experienced muscles hurting/muscles ache. On 10-JUL-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot stop shaking, cold, back hurts, muscles hurting/muscles ache, and headache. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced administration of expired vaccine. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722813.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced administration of expired vaccine. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722813.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Feeling drunk, Inappropriate affect, Oropharyngeal pain
Clinical narrative: SEVERE BODY ACHE; GIGGLES; HIGH ANXIETY; FEELING DRUNK; LOW GRADE FEVER; MILD AND DRY SORE THROAT; 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 allergic to some topical polyethylene glycol (peg), and hand injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hand injury. On 09-JUL-2021, the subject experienced mild and dry sore throat. On 09-JUL-2021, the subject experienced giggles. On 09-JUL-2021, the subject experienced high anxiety. On 09-JUL-2021, the subject experienced feeling drunk. On 09-JUL-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 98.8. On 10-JUL-2021, the subject experienced severe body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild and dry sore throat, severe body ache, low grade fever, feeling drunk, giggles, and high anxiety. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHE; GIGGLES; HIGH ANXIETY; FEELING DRUNK; LOW GRADE FEVER; MILD AND DRY SORE THROAT; 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 allergic to some topical polyethylene glycol (peg), and hand injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hand injury. On 09-JUL-2021, the subject experienced mild and dry sore throat. On 09-JUL-2021, the subject experienced giggles. On 09-JUL-2021, the subject experienced high anxiety. On 09-JUL-2021, the subject experienced feeling drunk. On 09-JUL-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 98.8. On 10-JUL-2021, the subject experienced severe body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild and dry sore throat, severe body ache, low grade fever, feeling drunk, giggles, and high anxiety. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Product administration error, Rash erythematous
Clinical narrative: AGGRAVATING AN OLD ROTATOR CUFF INJURY; INSANE PAIN; SHOT WAS SLIGHTLY OFF AND WENT DIRECTLY INTO A TENDON; BIG RED BUMP; 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's past medical history included rotator cuff injury. The patient received covid-19 vaccine ad26.cov2.s (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 subject experienced aggravating an old rotator cuff injury, insane pain, shot was slightly off and went directly into a tendon, and big red bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the big red bump, insane pain, shot was slightly off and went directly into a tendon and aggravating an old rotator cuff injury was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Loss of consciousness, Mobility decreased
Clinical narrative: really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided  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.   This case was linked to MOD-2021-248557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site rash
Clinical narrative: really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided  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.   This case was linked to MOD-2021-248557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone cancer.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) (seriousness criterion death). The patient died on 13-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) Elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Very limited information regarding the event has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07 Jul 2021 included relevant history detail (bone cancer), seriousness (death) and outcome of the event (fatal).; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Muscular weakness, Vertigo
Clinical narrative: Guillain barre; Vertigo; Cannot walk at all; weakness in my lower extremities; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain barre) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain barre) (seriousness criteria hospitalization prolonged and medically significant), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities). The patient was hospitalized for 45 days due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain barre), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided. Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraplegia
Clinical narrative: After 1st shot he was paralyzed from waist down; He felt like he lost a good chunk of his life, got screwed; This spontaneous case was reported by a consumer and describes the occurrence of PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAPLEGIA (After 1st shot he was paralyzed from waist down) (seriousness criterion medically significant) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) (seriousness criterion medically significant). At the time of the report, PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  It was noted that the patient lives in a assisted living facility. After the onset of events, the patient reported that he was put in a wheel chair but no longer needs the wheel chair. The patient was also advised by his doctor's not to receive the second shot.   Further information regarding treatment was not reported.  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. Further information has been requested.; 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. Further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Headache, Heavy menstrual bleeding, Loss of consciousness
Clinical narrative: threw up a few times; I actually past out that morning; I woke up 5 AM and I was bleeding very heavy; My right side (side I fell on) of the head still hurts; severe headache/ My right side (side I fell on) of the head still hurts; feel nauseous; I got my period days early from my usual; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (I actually past out that morning) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea and Pain. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, NAPROXEN SODIUM (ALEVE) for Pain.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced MENSTRUAL DISORDER (I got my period days early from my usual). On 29-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (I actually past out that morning) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), FALL (My right side (side I fell on) of the head still hurts), HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous). On an unknown date, the patient experienced VOMITING (threw up a few times). At the time of the report, LOSS OF CONSCIOUSNESS (I actually past out that morning) was resolving, HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), MENSTRUAL DISORDER (I got my period days early from my usual), FALL (My right side (side I fell on) of the head still hurts) and VOMITING (threw up a few times) outcome was unknown and HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient never had any issues with the menstrual cycle and never had this much blood. Patient went to emergency department and ran a few imaging tests like CT scans and others which were turned out as normal. Treatment medication were not reported.  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.Very limited information regarding this event has been provided at this time.; 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.Very limited information regarding this event has been provided at this time
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Nausea, Vomiting
Clinical narrative: threw up a few times; I actually past out that morning; I woke up 5 AM and I was bleeding very heavy; My right side (side I fell on) of the head still hurts; severe headache/ My right side (side I fell on) of the head still hurts; feel nauseous; I got my period days early from my usual; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (I actually past out that morning) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea and Pain. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, NAPROXEN SODIUM (ALEVE) for Pain.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced MENSTRUAL DISORDER (I got my period days early from my usual). On 29-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (I actually past out that morning) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), FALL (My right side (side I fell on) of the head still hurts), HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous). On an unknown date, the patient experienced VOMITING (threw up a few times). At the time of the report, LOSS OF CONSCIOUSNESS (I actually past out that morning) was resolving, HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), MENSTRUAL DISORDER (I got my period days early from my usual), FALL (My right side (side I fell on) of the head still hurts) and VOMITING (threw up a few times) outcome was unknown and HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient never had any issues with the menstrual cycle and never had this much blood. Patient went to emergency department and ran a few imaging tests like CT scans and others which were turned out as normal. Treatment medication were not reported.  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.Very limited information regarding this event has been provided at this time.; 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.Very limited information regarding this event has been provided at this time
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Muscular weakness, Palpitations, Pruritus, Rash macular
Clinical narrative: Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included an unspecified cream for an unknown indication.  A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September.  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-2021-248016 (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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included an unspecified cream for an unknown indication.  A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September.  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-2021-248016 (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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine; Itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 93-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581, Expiration date was unknown, NDC number: 59267-1000-1), via an unspecified route administration, administered in left arm on 11Feb2021 around 09:00 (at last thursday, as per report) as a single dose for covid-19 immunization. The patient had no medical history and did not administered any concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unspecified route administration, administered in left arm around 09:00 on 20Jan2021 as a single dose for covid-19 immunization. Patient was administered his second dose of Pfizer COVID-19 Vaccine on 11Feb2021. Everything went very well no problems. He woke up on 12Feb2021 with redness on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine. He then had onset of itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine. He had no idea why he developed these events. His son was a retired doctor, so patient went over to him retired doctor(son) said it was not shingles which was patient first idea. He and the retired doctor (son) decided it was caused by the Pfizer COVID-19 Vaccine. Patient received some anti-itch cream on the itching on left arm area and he was asked for information about these events and what was the expected duration of the events, enquired whether it was normal, how long will this last. Redness on left arm and Itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine was worsened (increased) for a day or two and then became constant level now and controlled. The outcome of the events was not recovered. The relatedness of the events was confirmed related to Pfizer COVID-19 Vaccine by the reporter and from his son who is a retired doctor.  Follow-up attempts completed. No further information expected.