chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: SUDDEN SENSORY NEURAL HEARING LOSS LEFT EAR; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and he had no known allergies and he was not a drug abuse or illicit drug user. 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 on 18-MAR-2021 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced sudden sensory neural hearing loss left ear (ringing in left ear) and which was still ongoing and she visited physician's office. On an unspecified date, the patient experienced ringing in left ear. The patient was treated with prednisone 50 mg first 2 days and taper over 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden sensory neural hearing loss left ear.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210738424 - Covid-19 vaccine ad26.cov2.s-sudden sensory neural hearing loss left ear. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Gait disturbance, Headache, Mental disorder
Clinical narrative: SHORTNESS OF BREATH; HEART ISSUES; TROUBLE USING BATHROOM; MENTALLY NOT OK; HIVES (ITCH ALL THE TIME); SEVERE 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, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On JUL-2021, the subject experienced shortness of breath. On JUL-2021, the subject experienced heart issues. On JUL-2021, the subject experienced trouble using bathroom. On JUL-2021, the subject experienced mentally not ok. On JUL-2021, the subject experienced hives (itch all the time). On JUL-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, hives (itch all the time), heart issues, trouble using bathroom, mentally not ok and severe headache was not reported. 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: Urticaria
Clinical narrative: SHORTNESS OF BREATH; HEART ISSUES; TROUBLE USING BATHROOM; MENTALLY NOT OK; HIVES (ITCH ALL THE TIME); SEVERE 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, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On JUL-2021, the subject experienced shortness of breath. On JUL-2021, the subject experienced heart issues. On JUL-2021, the subject experienced trouble using bathroom. On JUL-2021, the subject experienced mentally not ok. On JUL-2021, the subject experienced hives (itch all the time). On JUL-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, hives (itch all the time), heart issues, trouble using bathroom, mentally not ok and severe headache was not reported. 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Vomiting
Clinical narrative: HEADACHE ALMOST MIGRAINE; MOSTLY SLEEPING; LITTLE TIRED; VOMITING EVERY WHERE; This spontaneous report received from a parent concerned a 25 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vomiting every where. On 03-JUL-2021, the subject experienced mostly sleeping. On 03-JUL-2021, the subject experienced little tired. On 04-JUL-2021, the subject experienced headache almost migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting every where on 04-JUL-2021, and headache almost migraine on JUL-2021, and was recovering from little tired, and mostly sleeping. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement, Blood pressure systolic, Heart rate irregular
Clinical narrative: BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE  DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF  INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pruritus, Rash, Urticaria
Clinical narrative: BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE  DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF  INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE  DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF  INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling hot, Hypoaesthesia
Clinical narrative: OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. 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 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Muscle spasms, Pain
Clinical narrative: OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. 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 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a consumer concerned a 73 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included diabetes and difficulty hearing. Patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 1805018 and expiry: Unknown) dose was not reported, 1 total administered on 18-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the patient experienced sore arm. Patient had sore arm for a day. On an unspecified date (two weeks ago), doctor gave patient a blood test to determine if patient had antibodies. Patient had taken an antibody test and it was negative (confirmed immunological vaccine failure). Reporter did not know the type of antibody test that patient received, just knew it was a blood test. Patient had an upcoming appointment with physician in August and would discuss this with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 19-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186487.; Sender's Comments: V0: 20210739065-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Anxiety, Headache, Illness, Personality change
Clinical narrative: PERSONALITY CHANGED; SICK; SCREAMED TO HIGH HEAVEN FOR 6 HOURS; GOING CRAZY; VERY ANXIOUS; POUNDING HEADACHE; This spontaneous report received from a consumer on 16-JUL-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had regular ongoing medical care that she got. she was taking a couple of pills a day. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced personality changed, sick, screamed to high heaven, going crazy, very anxious, and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from personality changed, sick, pounding headache, screamed to high heaven, going crazy, and very anxious. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: PERSONALITY CHANGED; SICK; SCREAMED TO HIGH HEAVEN FOR 6 HOURS; GOING CRAZY; VERY ANXIOUS; POUNDING HEADACHE; This spontaneous report received from a consumer on 16-JUL-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had regular ongoing medical care that she got. she was taking a couple of pills a day. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced personality changed, sick, screamed to high heaven, going crazy, very anxious, and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from personality changed, sick, pounding headache, screamed to high heaven, going crazy, and very anxious. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE A TRUCK HIT; This spontaneous report received from a consumer 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) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUL-2021, the subject experienced felt like a truck hit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like a truck hit was not reported. This report was non-serious. This case, from the same reporter is linked to 20210738403.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Feeling abnormal, Feeling drunk, Hyperhidrosis
Clinical narrative: OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DRUNK; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, chronic obstructive pulmonary disease, seasonal allergy, non alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-MAR-2021 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 subject experienced trouble sleeping. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced felt drunk. On 13-MAR-2021, the subject experienced sleepy. On 15-MAR-2021, the subject experienced arm pain. On 26-MAR-2021, the subject experienced chest tightness. On 26-MAR-2021, the subject experienced sweaty. On 26-MAR-2021, the subject experienced cough. On APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On an unspecified date, the subject experienced oxygen went down to 92 percent. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 92 %. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen went down to 92 percent, chest tightness on 02-APR-2021, sweaty on 28-MAR-2021, trouble sleeping, and brain fog on 13-MAR-2021, cough on 02-JUN-2021, felt drunk on 12-MAR-2021, and arm pain on 19-MAR-2021, and the outcome of sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432473, 20210738839 and 20210739000.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, SARS-CoV-2 test
Clinical narrative: OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DRUNK; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, chronic obstructive pulmonary disease, seasonal allergy, non alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-MAR-2021 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 subject experienced trouble sleeping. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced felt drunk. On 13-MAR-2021, the subject experienced sleepy. On 15-MAR-2021, the subject experienced arm pain. On 26-MAR-2021, the subject experienced chest tightness. On 26-MAR-2021, the subject experienced sweaty. On 26-MAR-2021, the subject experienced cough. On APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On an unspecified date, the subject experienced oxygen went down to 92 percent. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 92 %. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen went down to 92 percent, chest tightness on 02-APR-2021, sweaty on 28-MAR-2021, trouble sleeping, and brain fog on 13-MAR-2021, cough on 02-JUN-2021, felt drunk on 12-MAR-2021, and arm pain on 19-MAR-2021, and the outcome of sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432473, 20210738839 and 20210739000.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DRUNK; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, chronic obstructive pulmonary disease, seasonal allergy, non alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-MAR-2021 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 subject experienced trouble sleeping. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced felt drunk. On 13-MAR-2021, the subject experienced sleepy. On 15-MAR-2021, the subject experienced arm pain. On 26-MAR-2021, the subject experienced chest tightness. On 26-MAR-2021, the subject experienced sweaty. On 26-MAR-2021, the subject experienced cough. On APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On an unspecified date, the subject experienced oxygen went down to 92 percent. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 92 %. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen went down to 92 percent, chest tightness on 02-APR-2021, sweaty on 28-MAR-2021, trouble sleeping, and brain fog on 13-MAR-2021, cough on 02-JUN-2021, felt drunk on 12-MAR-2021, and arm pain on 19-MAR-2021, and the outcome of sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432473, 20210738839 and 20210739000.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: DECREASED ARTHRITIS PAIN; This spontaneous report received from a health care professional via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis pain. 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 decreased arthritis pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of decreased arthritis pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210740986.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Joint stiffness, Myalgia
Clinical narrative: LACK OF SLEEP; TRICEP PAIN; ELBOW STIFFNESS; ELBOW TENDERNESS/JOINT PAIN/ELBOW PAIN/SHOULDER PAIN; This spontaneous report received from a patient concerned a 53 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced elbow stiffness. On 11-APR-2021, the subject experienced elbow tenderness/joint pain/elbow pain/shoulder pain. On JUL-2021, the subject experienced lack of sleep. On JUL-2021, the subject experienced tricep pain. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elbow stiffness, and elbow tenderness/joint pain/elbow pain/shoulder pain, and the outcome of tricep pain and lack of sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Pyrexia
Clinical narrative: SPENT 12 DAYS IN BED; FEVER OF 102° F OR HIGHER; This spontaneous report received from a patient via a 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 spent 12 days in bed, and fever of 102° f or higher. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102° F OR HIGHER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 102° f or higher and spent 12 days in bed was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SEVERE SHOULDER PAIN (SHOULDER AT THE  INJECTION SITE HURTING); This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 165 pounds, and height was 75 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and was a skinny man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced severe shoulder pain (shoulder at the injection site hurting). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe shoulder pain (shoulder at the injection site hurting). This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: BRAIN FOG; CAN HARDLY HOLD COFFEE CUP DUE TO SHAKING/ KNEES SHAKY; COULD HARDLY STAND UP; SLEEPING A LOT; LEGS RUBBERY; LEGS TINGLY; LEG GAVE OUT; TIREDNESS AND FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned an 83 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: 1805081, and batch number: 1805081 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, can hardly hold coffee cup due to shaking/ knees shaky, could hardly stand up, sleeping a lot, legs rubbery, legs tingly, leg gave out, tiredness and fatigue, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can hardly hold coffee cup due to shaking/ knees shaky, leg gave out, could hardly stand up, weakness, tiredness and fatigue, sleeping a lot, brain fog, legs rubbery and legs tingly was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, Sensory disturbance, Tremor
Clinical narrative: BRAIN FOG; CAN HARDLY HOLD COFFEE CUP DUE TO SHAKING/ KNEES SHAKY; COULD HARDLY STAND UP; SLEEPING A LOT; LEGS RUBBERY; LEGS TINGLY; LEG GAVE OUT; TIREDNESS AND FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned an 83 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: 1805081, and batch number: 1805081 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, can hardly hold coffee cup due to shaking/ knees shaky, could hardly stand up, sleeping a lot, legs rubbery, legs tingly, leg gave out, tiredness and fatigue, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can hardly hold coffee cup due to shaking/ knees shaky, leg gave out, could hardly stand up, weakness, tiredness and fatigue, sleeping a lot, brain fog, legs rubbery and legs tingly was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Paraesthesia
Clinical narrative: FEELING TINGLING IN RIGHT LEG AND LEFT KNEE/ TINGLING MOVED TO THIGH AREA, STOMACH AND CHEST; FEELING WEIRD AFTER EACH EPISODE OF TINGLING AND WEAKNESS; FEELING WEAKNESS IN RIGHT LEG AND LEFT KNEE/ WEAKNESS MOVED TO THIGH AREA, STOMACH, AND CHEST; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre diabetes, and other pre-existing medical conditions included he had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest. On MAY-2021, the subject experienced feeling weird after each episode of tingling and weakness. On MAY-2021, the subject experienced feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest, feeling weird after each episode of tingling and weakness, and feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Irritability, Vertigo
Clinical narrative: WICKED VERTIGO FOR COUPLE OF DAYS; BLAH GROUCHINESS; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative 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, 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 vertigo for couple of days, blah grouchiness, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo for couple of days, chills, headache and blah grouchiness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood uric acid, Gout
Clinical narrative: GOUT (TOE PAIN); This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and muscle pain, and other pre-existing medical conditions included patient does not drinks soda, drinks a lot of water, was physically fit and active. patient thinks that patient shouldn't be having gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205B21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced  gout (toe pain).  On 12-JUL-2021, Laboratory data included: Uric acid (NR: not provided) More than twice than it should be. Normal is 4 and subject had a 9.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gout (toe pain). This report was non-serious. This case, from the same reporter is linked to 20210741152.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: TOE PAIN; This spontaneous report received from a consumer concerned a 50 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced toe pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of toe pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210741144.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: NECK PAIN; ARM PAIN; 40 DEGREE FEVER; STRONG HEADACHE; MUSCLE PAIN; NAUSEA; 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: Unk) dose was not reported, administered on 13-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 neck pain. On JUL-2021, the subject experienced arm pain. On JUL-2021, the subject experienced 40 degree fever. On JUL-2021, the subject experienced strong headache. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 40 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, arm pain, 40 degree fever, strong headache, muscle pain, and nausea on 17-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: NECK PAIN; ARM PAIN; 40 DEGREE FEVER; STRONG HEADACHE; MUSCLE PAIN; NAUSEA; 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: Unk) dose was not reported, administered on 13-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 neck pain. On JUL-2021, the subject experienced arm pain. On JUL-2021, the subject experienced 40 degree fever. On JUL-2021, the subject experienced strong headache. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 40 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, arm pain, 40 degree fever, strong headache, muscle pain, and nausea on 17-JUL-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Headache, Nausea
Clinical narrative: LEFT EAR IS BOTHERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included exposure to covid.  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 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-JUL-2021, the subject experienced nausea. On 18-JUL-2021, the subject experienced headache. On an unspecified date, the subject experienced left ear is bothering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and headache, and the outcome of left ear is bothering was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742023.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: HORRIBLE DIARRHEA/LOOSE STOOL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-JUN-2021, the subject experienced horrible diarrhea/loose stool. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible diarrhea/loose stool. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: BODY WAS IN PAIN; LIGHT HEADED; 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: Unk) 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 body was in pain, and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed and body was in pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: LEFT UPPER ARM DEVELOPED SEVERE WEAKNESS; LEFT UPPER ARM DEVELOPED PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced left upper arm developed severe weakness, and left upper arm developed pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left upper arm developed severe weakness and left upper arm developed pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742246.