chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. Initial information was processed with the additional information received on 26-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no known allergies and did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient had a COVID symptoms of bowel issues and a sore throat after being exposed to a friend/coworker who tested positive on 19-AUG-2021 while on break without masks (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191140.; Sender's Comments: V0: 20210852508- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. 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 expiry: UNKNOWN) dose, start therapy date were not reported, 1 total, administered 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 myocarditis and the patient would like to know if booster dose going to heal myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852593- COVID-19 VACCINE AD26.COV2.S-myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pain, Pyrexia
Clinical narrative: BODY ACHES; DRY COUGH; FEVER OF 98 TO 101; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's past medical history included: flu like symptoms, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced body aches. On 23-AUG-2021, the patient experienced dry cough. On 23-AUG-2021, the patient experienced fever of 98 to 101. Laboratory data included: Body temperature (NR: not provided) 98-101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, dry cough and fever of 98 to 101 was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 58 year old white not Hispanic or Latino 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: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUL-2021, the patient did Sars-Cov-2 Antibody(Ab), IgGX test which was negative (confirmed immunological vaccine failure) and the patient stated that he was worried that he received a fraudulent dose of the vaccine. The patient said that he was additionally suspicious because the pharmacy was a very small facility that he found on the CDC website at a time where no other location had the Janssen Covid-19 Vaccine. The patient also said that he rebooked his original appointment to several weeks later and the facility still had a supply, during a time when other facilities were running out within days. The patient stated that he did not see the dose get drawn up in front of him from a vial and also he did not experienced any side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000191025.; Sender's Comments: V0:20210852955-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypotension, Nausea, Overdose, Pyrexia
Clinical narrative: RECEIVED FULL VIAL OF VACCINE (5 TIMES OF THE NORMAL DOSE); HYPOTENSION; CHILLS; VOMITING; FEVER; NAUSEA; This spontaneous report received from a physician 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced received full vial of vaccine (5 times of the normal dose). On 25-AUG-2021, the patient experienced hypotension. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced vomiting. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypotension, fever, chills, nausea, and vomiting, and the outcome of received full vial of vaccine (5 times of the normal dose) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: RECEIVED FULL VIAL OF VACCINE (5 TIMES OF THE NORMAL DOSE); HYPOTENSION; CHILLS; VOMITING; FEVER; NAUSEA; This spontaneous report received from a physician 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced received full vial of vaccine (5 times of the normal dose). On 25-AUG-2021, the patient experienced hypotension. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced vomiting. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypotension, fever, chills, nausea, and vomiting, and the outcome of received full vial of vaccine (5 times of the normal dose) was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: FEELING ACHY; FEVER; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight was 350 pounds, and height was 80 inches. The patient's concurrent conditions included: non smoker, alcohol use, blood pressure, and atrial fibrillation, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse/illicit drug use. The patient had no past medical history. 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 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced feeling achy. On 25-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104.1 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling achy, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED A DOSE OF THE VACCINE 46 MINUTES AFTER THE 6 HOUR TIME FOR HOLDING; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 18-SEP-2021) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-AUG-2021, the patient experienced administered a dose of the vaccine 46 minutes after the 6 hour time for holding. On 09-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered a dose of the vaccine 46 minutes after the 6 hour time for holding and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210849094.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 01-APR-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 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on 02-APR-2021. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: INADVERTENT ADMINISTRATION OF 1ML OF COVID-19 VACCINE; This spontaneous report received from a physician concerned a 40 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 (suspension for injection, route of admin not reported, batch number: Unknown) 1 ml, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced inadvertent administration of 1ml of covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of inadvertent administration of 1ml of covid-19 vaccine was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL STORED IN REFRIGERATION BEYOND THE RECOMMENDED 6 HOURS; ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced punctured vial stored in refrigeration beyond the recommended 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and punctured vial stored in refrigeration beyond the recommended 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855201 and 20210855614.
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Influenza like illness, Paraesthesia, Vomiting
Clinical narrative: HAS NOT EATEN; COULD NOT KEEP ANYTHING DOWN; SYMPTOMS LIKE THE FLU/ HEADACHE/ BODY ACHES/ GOT SICK/ FEELS AN ACHY, FLUISH FEELING; SPARKS RUNNING THROUGH JOINTS, HANDS, LOWER LEGS, FEET, TOES, WRISTS, FINGERS/LITTLE SHOCKS/NERVE SHOCKS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was not reported and height was 64 inches. The patient's past medical history included: bilateral total knee replacement, and concurrent conditions included: alcohol consumer, non smoker, and allergy to pain medicine, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient sometimes take vitamins. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling. On 24-AUG-2021, the patient experienced sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks. On 25-AUG-2021, the patient experienced has not eaten. On 25-AUG-2021, the patient experienced could not keep anything down. The action taken with covid-19 vaccine was not applicable. The outcome of the symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling, sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks, could not keep anything down and has not eaten was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: CHILLS; ARM HURTS; HEADACHE; FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced arm hurts. On 25-AUG-2021, the patient experienced headache. On 25-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm hurts, headache, and fever on 25-AUG-2021, and had not recovered from chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ARM FEELS A BIT OF PAIN; HUGE FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-AUG-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 24-AUG-2021, the patient experienced arm feels a bit of pain. On 24-AUG-2021, the patient experienced huge fever. The action taken with covid-19 vaccine was not applicable. The outcome of the huge fever and arm feels a bit of pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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 (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 chills, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED IN A 16 YEAR OLD; This spontaneous report received from a pharmacist concerned a 16 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the patient experienced vaccine administered in a 16 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered in a 16 year old was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE MESSED UP/SIDE EFFECT; 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 (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 vaccine messed up/side effect. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine messed up/side effect was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Hyperhidrosis, Pain
Clinical narrative: SWEATS; CONGESTION; BLAZING HEADACHE; TEMPERATURE WAS 99.8; BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced sweats. On 26-AUG-2021, the patient experienced congestion. On 26-AUG-2021, the patient experienced blazing headache. On 26-AUG-2021, the patient experienced temperature was 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8. The action taken with covid-19 vaccine was not applicable. The outcome of the sweats, body aches, blazing headache, congestion and temperature was 99.8 was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: SWEATS; CONGESTION; BLAZING HEADACHE; TEMPERATURE WAS 99.8; BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced sweats. On 26-AUG-2021, the patient experienced congestion. On 26-AUG-2021, the patient experienced blazing headache. On 26-AUG-2021, the patient experienced temperature was 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8. The action taken with covid-19 vaccine was not applicable. The outcome of the sweats, body aches, blazing headache, congestion and temperature was 99.8 was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Pyrexia
Clinical narrative: NOT ABLE TO SLEEP ALL NIGHT; FELT LIKE RUN OVER BY A TRUCK; TEMPERATURE, BURNING UP; BAD HEADACHE; This spontaneous report received from a parent concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, ulcer, non smoker, and non alcohol, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug use and have no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced felt like run over by a truck. On AUG-2021, the patient experienced temperature, burning up. On AUG-2021, the patient experienced bad headache. On 25-AUG-2021, the patient experienced not able to sleep all night. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine was not applicable. The outcome of the not able to sleep all night, temperature, burning up, bad headache and felt like run over by a truck was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF A VACCINE DOSE FROM A PUNCTURED VIAL THAT WAS KEPT AT ROOM  TEMPERATURE FOR LONGER THAN TWO HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 administration of a vaccine dose from a punctured vial that was kept at room temperature for longer than two hours, and incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a vaccine dose from a punctured vial that was kept at room temperature for longer than two hours and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Antibody test (NR: not provided) Positive. On 24-AUG-2021, the patient experienced aches. On 24-AUG-2021, the patient experienced chills. On 24-AUG-2021, the patient experienced fever. On 24-AUG-2021, the patient experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, aches, chills, and fatigue. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS GIVEN AFTER THE 2 HOURS LIMIT; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 41 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 (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccine was given after the 2 hours limit. On 25-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was given after the 2 hours limit and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854907.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: possible covid-19 infection. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-JUN-2021 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 felt tired. The action taken with covid-19 vaccine was not applicable. The outcome of felt tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE TEMPERATURE EXCRUSION FROM 3.1 C TO 0.77 C TO 3.0 C WITHIN 30 MINUTES; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes, and incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blepharospasm, Herpes zoster, Neuralgia
Clinical narrative: CLOTHES AND BODY NERVE PAIN; RIGHT EYELID TREMBLING FOR 3 WEEKS; INTENSE PAIN IN LOWER BACK; DIAGNOSED WITH HERPES ZOSTER; INTENSE PAIN IN WAIST; LEG PAIN; 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 (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 clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, intense pain in waist, and leg pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from leg pain, clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, and intense pain in waist. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CLOTHES AND BODY NERVE PAIN; RIGHT EYELID TREMBLING FOR 3 WEEKS; INTENSE PAIN IN LOWER BACK; DIAGNOSED WITH HERPES ZOSTER; INTENSE PAIN IN WAIST; LEG PAIN; 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 (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 clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, intense pain in waist, and leg pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from leg pain, clothes and body nerve pain, right eyelid trembling for 3 weeks, intense pain in lower back, diagnosed with herpes zoster, and intense pain in waist. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 76 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 26-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854749 and 20210855614.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Oropharyngeal pain, Pain in extremity
Clinical narrative: MIGRAINES; SORE THROAT; SORE LEFT ARM; TIRED; This spontaneous report received from a patient concerned a 30 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 (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced tired. On 20-AUG-2021, the patient experienced migraines. On 20-AUG-2021, the patient experienced sore throat. On 20-AUG-2021, the patient experienced sore left arm. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tired, sore throat, migraines, and sore left arm. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: BODY ACHES; FELT EXTREMELY TIRED OR FATIGUE; FELT NAUSEOUS; HEADACHE; SORENESS IN ARM; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: acid reflux, and insomnia, and concurrent conditions included: migraines, cholesterol, thyroid, occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced soreness in arm. On 25-AUG-2021, the patient experienced felt nauseous. On 25-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen. On 26-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced felt extremely tired or fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from soreness in arm, felt nauseous, and headache on AUG-2021, and had not recovered from body aches, and felt extremely tired or fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in excellent health. 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 joint pain, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units not given). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and joint pain was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Paraesthesia, Spinal X-ray, X-ray
Clinical narrative: Tingling in hands/random tingle in my arm/elbow area; Numb fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     No medical history was reported by reporter.    On 12-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers). At the time of the report, PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood test: unknown (normal) blood work tests to rule out Lymes Disease and other potiential issues and she found nothing unexpected. On 13-May-2021, Spinal X-ray: negative (Negative) X-rays of spine and neck, all showed negative. On 13-May-2021, X-ray: negative (Negative) X-rays of spine and neck, all showed negative.         Concomitant medication reported : Men's Daily vitamin-once daily by mouth and indication for use is Health. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Significant follow up: Patient demographic details, vaccine facility center details, , concomitant details,new event were added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus (right ear) and ear pain in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046B21A and 032M20A) for COVID-19 immunization. No medical history reported. On Mar 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced tinnitus (right ear) and ear pain. At the time of the report, tinnitus (right ear) and ear pain outcome: unknown. No concomitant medication or treatment information reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Wrong technique in device usage process; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Wrong technique in device usage process) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Wrong technique in device usage process). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Wrong technique in device usage process) outcome was unknown.            Patient is overweight. Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    This case was linked to MOD-2021-231771 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Vaccination site pain
Clinical narrative: Sore arm; Rash; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and RASH (Rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had missed 2-3 weeks of Dupilumab doses over 1-month ego.  Patient reported the onset of event as May 2021.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment medication was not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C antibody, Lichen planus, Macule, Pruritus, Vaccination site reaction
Clinical narrative: multiple violaceous or erythematous papules with Wickham's striae and pigmented papules; macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.; with itching; Possible side-effect of Moderna COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules), MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.), PRURITUS (with itching) and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE, LEVOTHYROXINE, LOSARTAN and METRONIDAZOLE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules), MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.), PRURITUS (with itching) and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine). The patient was treated with CLOBETASOL at a dose of UNK UNK, bid and PREDNISONE at an unspecified dose and frequency. At the time of the report, LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules) and MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.) had not resolved, PRURITUS (with itching) had resolved and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatitis C antibody: unknown (Negative) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable Patient's physician prescribed sunscreen with SPF 30 or greater and vitamin D rich healthy diet including supplements. Also NB-UVB phototherapy has been planned.