chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY PAIN/BODY ACHES; This spontaneous report received from a patient concerned a male 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 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body pain/body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body pain/body aches was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Headache, Insomnia, Muscular weakness
Clinical narrative: MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oxygen saturation, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Headache, Nausea, Rash
Clinical narrative: NAUSEA; EYES ARE HURTING/OCULAR PAIN; A RASH ON HER LEFT FOOT AND RIGHT ARM A FEW HOURS POST VACCINATION, ALMOST LIKE THE BLOOD HAD COME TO THE SURFACE; RECURRING HEADACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and several antibiotic allergies, and other pre-existing medical conditions included patient had taking aspirin occasionally as a blood thinner. no previous reactions to injections and/or immunizations.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner. On 11-JUN-2021, the subject experienced eyes are hurting/ocular pain. On 11-JUN-2021, the subject experienced a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface. On 11-JUN-2021, the subject experienced recurring headaches. On 12-JUN-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface on 13-JUN-2021, and nausea on 12-JUN-2021, and had not recovered from recurring headaches, and eyes are hurting/ocular pain. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Diarrhoea, Headache, Rash
Clinical narrative: NAUSEA; EYES ARE HURTING/OCULAR PAIN; A RASH ON HER LEFT FOOT AND RIGHT ARM A FEW HOURS POST VACCINATION, ALMOST LIKE THE BLOOD HAD COME TO THE SURFACE; RECURRING HEADACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and several antibiotic allergies, and other pre-existing medical conditions included patient had taking aspirin occasionally as a blood thinner. no previous reactions to injections and/or immunizations.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner. On 11-JUN-2021, the subject experienced eyes are hurting/ocular pain. On 11-JUN-2021, the subject experienced a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface. On 11-JUN-2021, the subject experienced recurring headaches. On 12-JUN-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface on 13-JUN-2021, and nausea on 12-JUN-2021, and had not recovered from recurring headaches, and eyes are hurting/ocular pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: VERY TIRED; HEADACHE (ABOVE THE EYE); LIGHTHEADEDNESS/DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the subject experienced lightheadedness/dizziness. On 17-JUL-2021, the subject experienced very tired. On 17-JUL-2021, the subject experienced headache (above the eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness/dizziness, very tired, and headache (above the eye). This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: ITCHING ALL OVER, DEEP ITCH ON THE  HANDS, FEET, STOMACH, HEAD, LEGS; FLU LIKE SYMPTOMS; HURTING ALL OVER/ACHY; MUSCLE ACHES; FEVER (DID NOT TAKE TEMP); NAUSEA; TIRED; SORENESS TO LEFT ARM INJECTION SITE; LIGHT HEADED; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis neck shoulders, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. takes muscle relaxer and med to lose weight.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included lidocaine for arthritis. On 16-JUL-2021, the subject experienced light headed. On 16-JUL-2021, the subject experienced flu like symptoms. On 16-JUL-2021, the subject experienced hurting all over/achy. On 16-JUL-2021, the subject experienced muscle aches. On 16-JUL-2021, the subject experienced fever (did not take temp). On 16-JUL-2021, the subject experienced nausea. On 16-JUL-2021, the subject experienced tired. On 16-JUL-2021, the subject experienced soreness to left arm injection site. On 18-JUL-2021, the subject experienced itching all over, deep itch on the hands, feet, stomach, head, legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fever (did not take temp), nausea, tired, light headed, itching all over, deep itch on the hands, feet, stomach, head, legs, soreness to left arm injection site, flu like symptoms, and hurting all over/achy. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: ITCHING ALL OVER, DEEP ITCH ON THE  HANDS, FEET, STOMACH, HEAD, LEGS; FLU LIKE SYMPTOMS; HURTING ALL OVER/ACHY; MUSCLE ACHES; FEVER (DID NOT TAKE TEMP); NAUSEA; TIRED; SORENESS TO LEFT ARM INJECTION SITE; LIGHT HEADED; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis neck shoulders, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. takes muscle relaxer and med to lose weight.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included lidocaine for arthritis. On 16-JUL-2021, the subject experienced light headed. On 16-JUL-2021, the subject experienced flu like symptoms. On 16-JUL-2021, the subject experienced hurting all over/achy. On 16-JUL-2021, the subject experienced muscle aches. On 16-JUL-2021, the subject experienced fever (did not take temp). On 16-JUL-2021, the subject experienced nausea. On 16-JUL-2021, the subject experienced tired. On 16-JUL-2021, the subject experienced soreness to left arm injection site. On 18-JUL-2021, the subject experienced itching all over, deep itch on the hands, feet, stomach, head, legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fever (did not take temp), nausea, tired, light headed, itching all over, deep itch on the hands, feet, stomach, head, legs, soreness to left arm injection site, flu like symptoms, and hurting all over/achy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Night sweats
Clinical narrative: NIGHT SWEATS; CHILLS; 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 covid. 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 night sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night sweats and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: SORENESS; MINOR FATIGUE; This spontaneous report received from a consumer 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-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 JUL-2021, the subject experienced soreness. On JUL-2021, the subject experienced minor fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor fatigue and soreness was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site pain, Insomnia, Oropharyngeal pain, Pain
Clinical narrative: INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced injection site pain.  On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced injection site pain.  On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Muscle twitching
Clinical narrative: MUSCLE TWITCHES NEAR THE SHOT AREA; BACK ACHE; 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. 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, 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 muscle twitches near the shot area, and back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle twitches near the shot area and back ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Grimacing, Influenza, Tooth fracture
Clinical narrative: FLU SYMPTOMS; CHIPPED TOOTH FROM SHIVERING; GRIMACING OF FACE; This spontaneous report received from a patient 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 was previously treated with influenza vaccine for prophylactic vaccination. 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 flu symptoms, chipped tooth from shivering, and grimacing of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and the outcome of chipped tooth from shivering and grimacing of face was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; .This spontaneous report received from a consumer via a company representative concerned a male 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 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 headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210740675.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Tremor, Vision blurred
Clinical narrative: SHAKING FROM THE HANDS; VISION SEEMED TO BE BLURRED; SPASMS IN UPPER ARM REGION; This spontaneous report received from a patient concerned a 47 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, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced shaking from the hands. On 12-APR-2021, the subject experienced vision seemed to be blurred. On 12-APR-2021, the subject experienced spasms in upper arm region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking from the hands, vision seemed to be blurred, and spasms in upper arm region. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Migraine, Muscle spasms
Clinical narrative: PAINFUL MIGRAINE HEADACHE; LIPS NUMB; CRAMPS ON EYES MOUTH AND FINGERS; FINGER NUMB; STRONG HEADACHE; This spontaneous report received from a patient 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 16-JUL-2021 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 JUL-2021, the subject experienced painful migraine headache. On JUL-2021, the subject experienced lips numb. On JUL-2021, the subject experienced cramps on eyes mouth and fingers. On JUL-2021, the subject experienced finger numb. On JUL-2021, the subject experienced strong headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, painful migraine headache, lips numb, cramps on eyes mouth and fingers and finger numb was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Pain
Clinical narrative: GUILLAIN-BARRE SYNDROME; PAIN; This spontaneous social media report via Johnson and Johnson was received from a consumer via a company representative and concerned a female patient of unspecified age, race and ethnicity. The patient's weight, height and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number unknown), dose and vaccination date not reported, for prophylactic vaccination. The company is unable to perform follow-up to obtain the batch number. No concomitant medications were reported. The consumer reported that, on unspecified dates, that their aunt 'after days of pain and sending her home 3 times' (not reported what type of facility sent the patient home), she was diagnosed with Guillain-Barre syndrome 'as a reaction to the vaccine'.. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the pain and Guillain-Barre syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from a consumer via social media concerns a female of unknown age, race, and ethnicity who was diagnosed with Guillain-Barre syndrome (GBS) an unspecified period of time after receiving the Janssen Covid-19 vaccine.  Medical history, concomitant medications, clinical symptoms, diagnostic testing, corrective treatment, and outcome were not reported. Information is limited in this case. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. More information will be requested if contact information is available.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS WERE EXAGGERATED; This spontaneous report received from a patient via a company representative concerned a male 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-JUL-2021 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 JUL-2021, the subject experienced side effects were exaggerated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from side effects were exaggerated. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dyspnoea, Gait inability, Headache, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: NUMBNESS IN RIGHT HAND AND FINGERTIPS OF RIGHT HAND; FEELING FATIGUE INTERMITTENTLY; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling fatigue intermittently. On 31-MAY-2021, the subject experienced numbness in right hand and fingertips of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigue intermittently, and numbness in right hand and fingertips of right hand. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Neck pain, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Stroke; Neck aches; Itching at the injection site; Soreness at the injection site; Random headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches). On 18-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received on 19-JUL-2021 updated new event-Stroke and outcome of the event.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Chest discomfort, Headache, Hypertension
Clinical narrative: Her blood pressure was also elevated 186/119; Headache; Anaphylactic reaction; Hives all over her body; Tightness in her chest; Fever; Nausea; Vomiting; Body aches; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). 30-Mar-2021, the patient experienced URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body aches). On an unknown date, the patient experienced HYPERTENSION (Her blood pressure was also elevated 186/119) and HEADACHE (Headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Blood pressure measurement: 186/119 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) to be related.    Patient received treatment in the emergency department (unspecified).  No concomitant medication was reported.  Company Comment: Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 and included relevant medical history, outcome of events and Causality. On 16-Jul-2021: Follow-up received on 16-JUL-2021 and included events (anaphylactic reaction and hypertension); Sender's Comments: Based on 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Her blood pressure was also elevated 186/119; Headache; Anaphylactic reaction; Hives all over her body; Tightness in her chest; Fever; Nausea; Vomiting; Body aches; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). 30-Mar-2021, the patient experienced URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body aches). On an unknown date, the patient experienced HYPERTENSION (Her blood pressure was also elevated 186/119) and HEADACHE (Headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Blood pressure measurement: 186/119 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) to be related.    Patient received treatment in the emergency department (unspecified).  No concomitant medication was reported.  Company Comment: Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 and included relevant medical history, outcome of events and Causality. On 16-Jul-2021: Follow-up received on 16-JUL-2021 and included events (anaphylactic reaction and hypertension); Sender's Comments: Based on 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Psoriasis, Rash
Clinical narrative: Hypersensitivity reaction; Redness; Rash in her trunk and torso upper area/ Rash in her kness; Psoriasis worsened; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis since 02-Jan-1975, Hypertension since 03-Jan-1995 and Vitamin D3 deficiency. Concomitant products included ESTRADIOL for Hormone replacement therapy, AMLODIPINE, LOSARTAN and CHLORTHALIDONE for Hypertension, VITAMIN D3 for Vitamin D3 deficiency.   On 11-Feb-2021 at 6:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (Psoriasis worsened). On 22-Mar-2021, the patient experienced RASH (Rash in her trunk and torso upper area/ Rash in her kness). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion medically significant) and ERYTHEMA (Redness). The patient was treated with PREDNISONE for Rash, at a dose of 60 mg and CLOBETASOL (topical) for Psoriasis, at an unspecified dose and frequency. On 01-Jul-2021, ERYTHEMA (Redness) had resolved. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PSORIASIS (Psoriasis worsened) and RASH (Rash in her trunk and torso upper area/ Rash in her kness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15-APR-2021, the patient went to a dermatologist and was prescribed a longer term prednisone therapy.  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. The patient's medical history of Psoriasis is a possible confounding factor.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up information received on 15 Apr 2021and new treatment information is reported. On 16-Jul-2021: Follow-up information received and information about Patient demographics, Medical history, Concomitants, and New Event is reported; 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. The patient's medical history of Psoriasis is a possible confounding factor.