chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cleft lip, Foetal exposure during pregnancy
Clinical narrative: FETAL EXPOSURE DURING PREGNANCY; CLEFT LIP; This solicited pregnancy report received from a consumer concerned an infant male of an unspecified age, race and ethnic origin. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registry number: C01653). The patient's weight was 3.26 kilograms, and height was 20 inches. No concurrent conditions were reported. The mother of the baby had no relevant medical history. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered on 12-MAR-2021 for covid-19 immunisation. No concomitant medications were reported.  On 12-MAR-2021, the patient had a cleft lip due to fetal exposure during pregnancy. On an unspecified date in JUL-2021, A Laboratory test was conducted, an Acoustic stimulation tests (NR: not provided) Result: The baby passed the hearing test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cleft lip and fetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy, and cleft lip as not related. Company causality between Covid-19 vaccine ad26.cov2.s and fetal exposure during pregnancy assessed as not related and Cleft lip assessed as related This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210762291.; Sender's Comments: V0: 20210958770-COVID-19 VACCINE AD26.COV2.S-cleft lip. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210958770-COVID-19 VACCINE AD26.COV2.S-fetal exposure during pregnancy. 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
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 56 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959581, 20210959351, 20210958321, 20210958348, 20210958371, 20210958425, 20210958518, 20210958525, 20210958566, 20210958806, 20210958977, 20210958993 and 20210959909.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 33 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959581, 20210958425, 20210959620, 20210959351, 20210958518, 20210958348, 20210958371, 20210958525, 20210958566, 20210958806 and 20210958977. This case, from the Others is linked to 20210958423.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: STUFFED NOSE; SORE THROAT; LEFT EAR ACHE; FEVER OF 103.6 F; This spontaneous report received from a parent concerned an 18 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, intramuscular, batch number: Unknown) dose was not reported, administered on 29-SEP-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 29-SEP-2021, the patient experienced stuffed nose. On 29-SEP-2021, the patient experienced sore throat. On 29-SEP-2021, the patient experienced left ear ache. On 29-SEP-2021, the patient experienced fever of 103.6 f. Laboratory data included: Body temperature (NR: not provided) 103.6 F, 100.8 F. Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 103.6 f, and had not recovered from stuffed nose, sore throat, and left ear ache. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 35 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210960415 and 20210960389.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cellulitis, Dyspepsia, Oropharyngeal pain, Pain
Clinical narrative: CELLULITIS; HEART BURN; SORE THROAT; SENSITIVITY IN UPPER RIGHT QUADRANT OF STOMACH; PETECHIA; BODY ACHES/ ACHING BODY; ACHING TONSILS; This spontaneous report received from a consumer concerned multiple patients of unspecified age, race and ethnic origin. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced heart burn, sore throat, sensitivity in upper right quadrant of stomach, petechia, body aches/ aching body, severe red rash, aching tonsils, severe pain in the right leg, and fever. It was reported that the skin was on fire hot to touch and red and a large, very red spot across the skin was found which later was diagnosed as cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cellulitis, body aches/ aching body, heart burn, sensitivity in upper right quadrant of stomach, petechia, sore throat and aching tonsils was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958657.; Sender's Comments: V0: 20210960441-Covid-19 vaccine ad26.cov2.s- cellulitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Petechiae, Tonsillar disorder
Clinical narrative: CELLULITIS; HEART BURN; SORE THROAT; SENSITIVITY IN UPPER RIGHT QUADRANT OF STOMACH; PETECHIA; BODY ACHES/ ACHING BODY; ACHING TONSILS; This spontaneous report received from a consumer concerned multiple patients of unspecified age, race and ethnic origin. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced heart burn, sore throat, sensitivity in upper right quadrant of stomach, petechia, body aches/ aching body, severe red rash, aching tonsils, severe pain in the right leg, and fever. It was reported that the skin was on fire hot to touch and red and a large, very red spot across the skin was found which later was diagnosed as cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cellulitis, body aches/ aching body, heart burn, sensitivity in upper right quadrant of stomach, petechia, sore throat and aching tonsils was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958657.; Sender's Comments: V0: 20210960441-Covid-19 vaccine ad26.cov2.s- cellulitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN FOR 10 MINUTES; 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, 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 patient experienced injection site pain for 10 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain for 10 minutes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: STOMACH UPSET; CHILLS; HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 08-SEP-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced stomach upset. On 08-SEP-2021, the patient experienced chills. On 08-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, stomach upset, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (DOSE ADMINISTERED WHICH WAS DRAWN UP IN A PRE-FILLED SYRINGE AND STORED AT 65-70 DEGREES FAHRENHEIT FOR 3 HOURS PRIOR TO ADMINISTRATION); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was not known whether the patient had any medical history. 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 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient experienced expired vaccine administered (dose administered which was drawn up in a pre-filled syringe and stored at 65-70 degrees fahrenheit for 3 hours prior to administration). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (dose administered which was drawn up in a pre-filled syringe and stored at 65-70 degrees fahrenheit for 3 hours prior to administration) was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: SLIGHT HEADACHE AT THE BASE OF THE HEAD (WAS STILL LINGERING BUT VERY MILD), THEN IT GOT WORSE; FEELING TIRED; FEVER; BODY ACHES, (WAS LITTLE BIT SORE); CHILLS; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 135 pounds, and height was 64 inches. The patient's concurrent conditions included: fibroids, alcohol consumer, non smoker, and perimenopause, and other pre-existing medical conditions included: The patient had no known allergies, and no any drug abuse/illicit drug usage. Medication for fibroids and perimenopause- vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. Concomitant medications included progesterone for perimenopause, and fibroids.  On 25-SEP-2021, the patient experienced body aches, (was little bit sore). On 25-SEP-2021, the patient experienced chills. On 25-SEP-2021, the patient experienced feeling tired. On 25-SEP-2021, the patient experienced fever. On 26-SEP-2021, the patient experienced slight headache at the base of the head (was still lingering but very mild), then it got worse. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, (was little bit sore) on 27-SEP-2021, and fever on 26-SEP-2021, had not recovered from slight headache at the base of the head (was still lingering but very mild), then it got worse, and feeling tired, and the outcome of chills was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: RECEIVED EXPIRED DOSE OF VACCINE; This spontaneous report received from a pharmacist concerned a 49 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, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced received expired dose of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired dose of vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Throat irritation
Clinical narrative: SCRATCHY THROAT; ABDOMINAL WALL PAINS; TIREDNESS; NAUSEA; HEADACHE; 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 patient experienced scratchy throat, abdominal wall pains, tiredness, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, nausea, headache, scratchy throat and abdominal wall pains was not reported. This report was non-serious.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO 17 YEAR OLD; This spontaneous report received from a health care professional concerned a 17 year old of unspecified 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use. On 26-MAR-2021, the patient experienced vaccine administered to 17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 17 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000796.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Muscle spasms
Clinical narrative: CRAMPS IN LEGS/MUSCLE STRETCH; SLUGGISHNESS; INJECTION SITE BRUISING; CHILLS; PAIN IN ARM/LEG PAIN; FELT VERY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 58 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced cramps in legs/muscle stretch, sluggishness, injection site bruising, chills, pain in arm/leg pain, felt very tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, chills, and felt very tired, and had not recovered from cramps in legs/muscle stretch, pain in arm/leg pain, injection site bruising, and headache. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: CRAMPS IN LEGS/MUSCLE STRETCH; SLUGGISHNESS; INJECTION SITE BRUISING; CHILLS; PAIN IN ARM/LEG PAIN; FELT VERY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 58 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced cramps in legs/muscle stretch, sluggishness, injection site bruising, chills, pain in arm/leg pain, felt very tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, chills, and felt very tired, and had not recovered from cramps in legs/muscle stretch, pain in arm/leg pain, injection site bruising, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SICK WITH COVID/ SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional and concerned multiple patients of an unspecified sex, age, race and ethnic origin. The patients heights and weights were not reported. No 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 and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date post vaccination, the patients developed sickness with Covid (suspected Covid-19 infection and suspected clinical vaccination failure) and were hospitalized (number of days unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and sick with Covid/ suspected Covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194197.; Sender's Comments: V0:20211000706-covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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.  20211000706-covid-19 vaccine ad26.cov2.s -Sick with covid/suspected covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Knee deformity, Limb mass, Loss of personal independence in daily activities
Clinical narrative: TENSE DUE TO CRAMPS; AGGRAVATED  HORRIBLE CRAMPS/COULD NOT STRAIGHTEN HIS FEET AND TOES/CRAMPS IN BOTTOM OF RIB, LIKE LEG CRAMP, AND IN RIGHT HANDS AND ARM; CANNOT SLEEP; BOW LEGGED SOMETIMES THEY WERE ON FRONT OR BACK SOMETIMES FOOT OR LEG, OR BOTH; DOES NOT WANT TO WORK/WALKS; TUCKERED OUT/FATIGUED; FELT A TINY BALL OR DOT FLOATING DOWN LEG, THEN RAPIDLY SPEED UP IN STRAIGHT LINE WITH TOE/DIMPLES IN BOTH SIDE OF LEG UPTO MIDDLE AND SIDES OR BULGE STICKING UP TO HIS GROIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cramps, and concurrent conditions included: bad thumb. 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 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient experienced felt a tiny ball or dot floating down leg, then rapidly speed up in straight line with toe/dimples in both side of leg upto middle and sides or bulge sticking up to his groin. On an unspecified date, the patient experienced tense due to cramps, aggravated horrible cramps/could not straighten his feet and toes/cramps in bottom of rib, like leg cramp, and in right hands and arm, cannot sleep, bow legged sometimes they were on front or back sometimes foot or leg, or both, does not want to work/walks, and tuckered out/fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aggravated horrible cramps/could not straighten his feet and toes/cramps in bottom of rib, like leg cramp, and in right hands and arm, cannot sleep, felt a tiny ball or dot floating down leg, then rapidly speed up in straight line with toe/dimples in both side of leg upto middle and sides or bulge sticking up to his groin, tense due to cramps, bow legged sometimes they were on front or back sometimes foot or leg, or both, and does not want to work/walks, and the outcome of tuckered out/fatigued was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Tension
Clinical narrative: TENSE DUE TO CRAMPS; AGGRAVATED  HORRIBLE CRAMPS/COULD NOT STRAIGHTEN HIS FEET AND TOES/CRAMPS IN BOTTOM OF RIB, LIKE LEG CRAMP, AND IN RIGHT HANDS AND ARM; CANNOT SLEEP; BOW LEGGED SOMETIMES THEY WERE ON FRONT OR BACK SOMETIMES FOOT OR LEG, OR BOTH; DOES NOT WANT TO WORK/WALKS; TUCKERED OUT/FATIGUED; FELT A TINY BALL OR DOT FLOATING DOWN LEG, THEN RAPIDLY SPEED UP IN STRAIGHT LINE WITH TOE/DIMPLES IN BOTH SIDE OF LEG UPTO MIDDLE AND SIDES OR BULGE STICKING UP TO HIS GROIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cramps, and concurrent conditions included: bad thumb. 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 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient experienced felt a tiny ball or dot floating down leg, then rapidly speed up in straight line with toe/dimples in both side of leg upto middle and sides or bulge sticking up to his groin. On an unspecified date, the patient experienced tense due to cramps, aggravated horrible cramps/could not straighten his feet and toes/cramps in bottom of rib, like leg cramp, and in right hands and arm, cannot sleep, bow legged sometimes they were on front or back sometimes foot or leg, or both, does not want to work/walks, and tuckered out/fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aggravated horrible cramps/could not straighten his feet and toes/cramps in bottom of rib, like leg cramp, and in right hands and arm, cannot sleep, felt a tiny ball or dot floating down leg, then rapidly speed up in straight line with toe/dimples in both side of leg upto middle and sides or bulge sticking up to his groin, tense due to cramps, bow legged sometimes they were on front or back sometimes foot or leg, or both, and does not want to work/walks, and the outcome of tuckered out/fatigued was not reported. This report was non-serious.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO 17 YEAR OLD; This spontaneous report received from a health care professional concerned a 17 year old of unspecified 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use. On 26-MAR-2021, the patient experienced vaccine administered to 17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 17 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000660.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO 17 YEAR OLD PATIENT; This spontaneous report received from a health care professional concerned a 17 year old of unspecified 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced off label use. On 26-MAR-2021, the patient experienced vaccine administered to 17 year old subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 17 year old patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000660.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; ABDOMINAL PAINS; TERRIBLE HEADACHE; FATIGUE; 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: Unk) dose was not reported, administered on 28-SEP-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 SEP-2021, the patient experienced sore throat. On SEP-2021, the patient experienced abdominal pains. On SEP-2021, the patient experienced terrible headache. On SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible headache, fatigue, sore throat and abdominal pains was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration
Clinical narrative: TASTE THE VACCINE; FACE BECOME NUMB; NUMBNESS WHOLE LEFT SIDE DOWN ARM; This spontaneous report received from a patient concerned a 60 year old of unspecified 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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced taste the vaccine. On 06-MAR-2021, the patient experienced face become numb. On 06-MAR-2021, the patient experienced numbness whole left side down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face become numb, numbness whole left side down arm and taste the vaccine was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Taste disorder
Clinical narrative: TASTE THE VACCINE; FACE BECOME NUMB; NUMBNESS WHOLE LEFT SIDE DOWN ARM; This spontaneous report received from a patient concerned a 60 year old of unspecified 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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced taste the vaccine. On 06-MAR-2021, the patient experienced face become numb. On 06-MAR-2021, the patient experienced numbness whole left side down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face become numb, numbness whole left side down arm and taste the vaccine was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Body temperature, Chest pain, Chills, Decreased appetite
Clinical narrative: A TYPICAL YEAST INFECTION; HAIR STARTED TO FALL OUT IN THE SHOWER AND WITH BRUSHING; ECZEMA ON BOTH HANDS AND ARMS; HEADACHES ON/OFF LIKE MIGRAINES; CHEST PAIN; LOST APPETITE COMPLETELY AND READY TO PASS OUT FROM HUNGER/NOT EATING.; LIGHTHEADED; EXTREME CHILLS; FEVER; HOT/COLD SENSATIONS; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 196 pounds, and height was 66 inches. The patient's concurrent conditions included: sesame seeds allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient was very healthy, never had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced hot/cold sensations. On 08-SEP-2021, the patient experienced extreme chills. On 08-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 105.0 F. On 09-SEP-2021, the patient experienced lost appetite completely and ready to pass out from hunger/not eating. On 09-SEP-2021, the patient experienced lightheaded. On 10-SEP-2021, the patient experienced chest pain. On 11-SEP-2021, the patient experienced eczema on both hands and arms. On 11-SEP-2021, the patient experienced headaches on/off like migraines. Laboratory data included: Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced hair started to fall out in the shower and with brushing. On 19-SEP-2021, the patient experienced a typical yeast infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, hot/cold sensations, extreme chills, and fever on SEP-2021, was recovering from eczema on both hands and arms, and a typical yeast infection, had not recovered from hair started to fall out in the shower and with brushing, and the outcome of lost appetite completely and ready to pass out from hunger/not eating., headaches on/off like migraines and lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000473.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eczema, Electrocardiogram, Feeling of body temperature change, Fungal infection
Clinical narrative: A TYPICAL YEAST INFECTION; HAIR STARTED TO FALL OUT IN THE SHOWER AND WITH BRUSHING; ECZEMA ON BOTH HANDS AND ARMS; HEADACHES ON/OFF LIKE MIGRAINES; CHEST PAIN; LOST APPETITE COMPLETELY AND READY TO PASS OUT FROM HUNGER/NOT EATING.; LIGHTHEADED; EXTREME CHILLS; FEVER; HOT/COLD SENSATIONS; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 196 pounds, and height was 66 inches. The patient's concurrent conditions included: sesame seeds allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient was very healthy, never had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced hot/cold sensations. On 08-SEP-2021, the patient experienced extreme chills. On 08-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 105.0 F. On 09-SEP-2021, the patient experienced lost appetite completely and ready to pass out from hunger/not eating. On 09-SEP-2021, the patient experienced lightheaded. On 10-SEP-2021, the patient experienced chest pain. On 11-SEP-2021, the patient experienced eczema on both hands and arms. On 11-SEP-2021, the patient experienced headaches on/off like migraines. Laboratory data included: Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced hair started to fall out in the shower and with brushing. On 19-SEP-2021, the patient experienced a typical yeast infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, hot/cold sensations, extreme chills, and fever on SEP-2021, was recovering from eczema on both hands and arms, and a typical yeast infection, had not recovered from hair started to fall out in the shower and with brushing, and the outcome of lost appetite completely and ready to pass out from hunger/not eating., headaches on/off like migraines and lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000473.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: A TYPICAL YEAST INFECTION; HAIR STARTED TO FALL OUT IN THE SHOWER AND WITH BRUSHING; ECZEMA ON BOTH HANDS AND ARMS; HEADACHES ON/OFF LIKE MIGRAINES; CHEST PAIN; LOST APPETITE COMPLETELY AND READY TO PASS OUT FROM HUNGER/NOT EATING.; LIGHTHEADED; EXTREME CHILLS; FEVER; HOT/COLD SENSATIONS; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 196 pounds, and height was 66 inches. The patient's concurrent conditions included: sesame seeds allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient was very healthy, never had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced hot/cold sensations. On 08-SEP-2021, the patient experienced extreme chills. On 08-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 105.0 F. On 09-SEP-2021, the patient experienced lost appetite completely and ready to pass out from hunger/not eating. On 09-SEP-2021, the patient experienced lightheaded. On 10-SEP-2021, the patient experienced chest pain. On 11-SEP-2021, the patient experienced eczema on both hands and arms. On 11-SEP-2021, the patient experienced headaches on/off like migraines. Laboratory data included: Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced hair started to fall out in the shower and with brushing. On 19-SEP-2021, the patient experienced a typical yeast infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, hot/cold sensations, extreme chills, and fever on SEP-2021, was recovering from eczema on both hands and arms, and a typical yeast infection, had not recovered from hair started to fall out in the shower and with brushing, and the outcome of lost appetite completely and ready to pass out from hunger/not eating., headaches on/off like migraines and lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000473.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, SARS-CoV-2 test
Clinical narrative: upset stomach; chills;  Permitted by caller to collect details of call. Caller referenced this case number: MOD-2021-122758. (Current case now crosslinked with Case # MOD21-089750).  Caller compying with request to return call & provide an email address. She does not have an email address. This agent did confirm her mailing address & added minimal update to vaccine information.  "I got the shots of the Moderna Covid-19 vaccine in Jan2021 & Feb2021. It was at the end of the month for both of them."  1st dose: Near end of Jan2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No  2nd dose: Near end of Feb2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No  Consent given for Safety follow up/contact.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Headache, Hypoacusis, Hypoaesthesia
Clinical narrative: Hearing loss-i can't hear as well in the left ear as the right; Ear popping sensation; numbness in lower right ear; sharp pain in the rear left ear canals; ringing ear; headache; 1st dose 14 jul 2021, 2nd dose 25 aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear), EAR PAIN (sharp pain in the rear left ear canals) and TINNITUS (ringing ear) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021). 14-Jul-2021, the patient experienced EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache). At the time of the report, HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache) had not resolved and EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. No treatment information was provided.  About 20 minutes after receiving the Madonna COVID-19 vaccine patient started to experience what one would referred to as hearing loss at ?rst it was a sharp pain in the rear left ear canals. After a couple of weeks the pain has stopped the ringing has stopped but he still can't hear as well in the left ear as the right anymore this has happened since the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up received and updated Patient demographics, second dose information,  and action taken. New events hearing impaired, ear pain and tinnitus, inappropriate schedule of product administered added. Removed event hearing disability
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Hearing loss-i can't hear as well in the left ear as the right; Ear popping sensation; numbness in lower right ear; sharp pain in the rear left ear canals; ringing ear; headache; 1st dose 14 jul 2021, 2nd dose 25 aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear), EAR PAIN (sharp pain in the rear left ear canals) and TINNITUS (ringing ear) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021). 14-Jul-2021, the patient experienced EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache). At the time of the report, HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache) had not resolved and EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. No treatment information was provided.  About 20 minutes after receiving the Madonna COVID-19 vaccine patient started to experience what one would referred to as hearing loss at ?rst it was a sharp pain in the rear left ear canals. After a couple of weeks the pain has stopped the ringing has stopped but he still can't hear as well in the left ear as the right anymore this has happened since the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up received and updated Patient demographics, second dose information,  and action taken. New events hearing impaired, ear pain and tinnitus, inappropriate schedule of product administered added. Removed event hearing disability