chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous report received from a patient, concerned a female of unspecified age. The patient's concomitant medications, height and weight not reported. The patient's medical conditions included difficulty swallowing pills. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose: not reported, administered May 13, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On May 13, 2021, patient felt a little achy. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from felt little achy on May 13, 2021.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient developed a rash. Treatment medications (dates unspecified) included hydrocortisone and diphenhydramine hydrochloride. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Patient recovered from the rash.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report received from a patient, concerned a 56 year old male. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported), at the age of 56, dose: not reported, on May 21, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On May 21, 2021, patient experienced arm hurting. Treatment medications included: ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from arm hurting. This case (same patient) linked to 20210546840.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot  number: not reported) dose: not reported, on Apr 28, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. Apr 2021, patient experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of fever: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Delusion, Pain, Pyrexia
Clinical narrative: DELUSIONS/THE IMPOSSIBILITY OF DISTINGUISHING BETWEEN REALITY AND DELUSIONAL DREAMS; PAIN; FEVERISH; This spontaneous report received from a patient via social media (Janssen ) 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, 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 delusions/the impossibility of distinguishing between reality and delusional dreams, pain, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feverish, pain and delusions/the impossibility of distinguishing between reality and delusional dreams was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: SWOLLEN THROAT; 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, 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 swollen throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pruritus, Rash
Clinical narrative: ITCHINESS; RASH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAY-2021, dose was not reported, administered on 06-MAY-2021, and dose was not reported, administered on 06-MAY-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 06-MAY-2021, the patient experienced itchiness, rash, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, itchiness, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and ethnic origin. 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, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total 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, 4 weeks after the vaccination, the patient experienced confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) No antibodies. 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 case is associated with a product quality complaint number 90000225275. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the  evaluation/investigation performed. Sender's Comments: V0:20220417828-COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SOME PAIN ON SHOULDER; 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, 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 some pain on shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some pain on shoulder was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product use complaint, Pyrexia
Clinical narrative: CAN'T SWALLOW PILLS; FEVER; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 fever, and can't swallow pills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and can't swallow pills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned 12 multiple patients of an unspecified sex, age, race and ethnicity. 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 and has been requested. No concomitant medications were reported. On an unspecified date, after receiving vaccine the 12 multiple patients died from an unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210320422.; Sender's Comments: 20220419102 -covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered Unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Inflammation, Pain in extremity, Tinnitus
Clinical narrative: BODY GOT INFLAMED; CHEST TIGHTNESS/CHEST FELT PAINFULLY TIGHT WHEN COUGHING; PERSISTENT COUGH; ARM PAIN; RINGING IN THE EARS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had surgery years ago. The patient was using rescue inhaler. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 30-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Age at time of vaccination 61 years old. No concomitant medications were reported.  On 20-AUG-2021, the patient experienced arm pain, and ringing in the ears. On 27-AUG-2021, the patient experienced chest tightness/chest felt painfully tight when coughing, and persistent cough. On an unspecified date, the patient experienced body got inflamed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain on 01-OCT-2021, had not recovered from chest tightness/chest felt painfully tight when coughing, ringing in the ears, and persistent cough, and the outcome of body got inflamed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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. Non-company suspect drugs included: upadacitinib (prolonged-release tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included adalimumab. On FEB-2022, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The patient recovered from sickness on FEB-2022. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned a 6 decade 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 was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from covid-19. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Flushing, Pain, Pain in extremity
Clinical narrative: APPETITE LOST; SINUS INFECTION; PAIN IN ARM; FEVERISH ABOUT 24-48 HOURS; FATIGUED; SLIGHT FLUSHED; ACHES AND PAINS/ACHINESS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis.  Non-company suspect vaccine included: aciclovir (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 2021, and dose was not reported, administered on 11-NOV-2021 for prophylaxis for shingles. Age at time of vaccination 60 years old.  No concomitant medications were reported.  On APR-2021, the patient experienced aches and pains/achiness. On an unspecified date, the patient experienced slight flushed, appetite lost, sinus infection, pain in arm, feverish about 24-48 hours, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from feverish about 24-48 hours, and the outcome of pain in arm, aches and pains/achiness, slight flushed, appetite lost, sinus infection and fatigued was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: APPETITE LOST; SINUS INFECTION; PAIN IN ARM; FEVERISH ABOUT 24-48 HOURS; FATIGUED; SLIGHT FLUSHED; ACHES AND PAINS/ACHINESS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis.  Non-company suspect vaccine included: aciclovir (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 2021, and dose was not reported, administered on 11-NOV-2021 for prophylaxis for shingles. Age at time of vaccination 60 years old.  No concomitant medications were reported.  On APR-2021, the patient experienced aches and pains/achiness. On an unspecified date, the patient experienced slight flushed, appetite lost, sinus infection, pain in arm, feverish about 24-48 hours, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from feverish about 24-48 hours, and the outcome of pain in arm, aches and pains/achiness, slight flushed, appetite lost, sinus infection and fatigued was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: CHEST TIGHTNESS; This spontaneous report received from a parent 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 chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest tightness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220419225.
Sex: U
Vaccine: COVID19
Symptoms: Injection site infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: INFECTIONS ON THE RIGHT SIDE WHERE THE SHOT WAS GIVEN; VACCINATION SITE SWELLING; VACCINATION SITE PAIN; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced infections on the right side where the shot was given, vaccination site swelling, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the infections on the right side where the shot was given, vaccination site swelling and vaccination site pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220421592.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; THE VACCINE WAS STORE FROZEN UNTIL RECEIVED SINCE 19-NOV-2021; This spontaneous report received from a physician 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: 213D21A expiry: UNKNOWN) dose was not reported, administered on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-DEC-2021, the patient experienced the vaccine was store frozen until received since 19-nov-2021. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and the vaccine was store frozen until received since 19-nov-2021 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220421741. This report was associated with product quality complaint: 90000225540.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Eye irritation, International normalised ratio, Nasal discomfort, Oropharyngeal pain
Clinical narrative: BURNING OF THE EYES; PRESSURE IN THE EARS; SORE THROAT; IRRITATION OF NASAL PASSAGES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: deep vein thrombosis (The patient stated he experienced the following events prior to vaccination. The patient felt something was pierced up through the body and right into the lung after he woke up from the nap. Patient went to dermatologist first thinking it was an insect since there was a mark on his calf. Dermatologist diagnosed patient with Deep vein thrombosis (DVT) and sent patient to emergency room (ER) immediately. Patient did not receive any procedures in ER. It was not concluded that he had any internal injury or internal bleeding.). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. Concomitant medications included warfarin for deep vein thrombosis. On an unspecified date, the patient experienced burning of the eyes, pressure in the ears, sore throat, and irritation of nasal passages. Laboratory data (dates unspecified) included: normalized ratio (NR: not provided) 1.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning of the eyes, pressure in the ears, sore throat, and irritation of nasal passages. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS NOT STORED PROPERLY; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 12-APR-2022. 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: 213D21A, expiry: unknown) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced poor quality vaccine administered. On an unspecified date, the patient experienced vaccine was not stored properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was not stored properly and poor quality vaccine administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000225546. The suspected product quality complaint has been confirmed to be voided. Product was stored frozen until 19-NOV-2021 (when product was received) and then was not properly stored after that. On 07-APR-2022, the shelf life for the vaccine has been extended from 9 months to 11 months refrigerated (stored at 2-8 degree C). It is not clear how the product was stored after it was received. There is no product quality issue described in the information reported as the product was not within Janssen custody during this potential temperature excursion. Based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220421157.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARMS WERE STILL HURTING; 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, 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 arms were still hurting. 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 arms were still hurting. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Colitis ulcerative, Diabetes mellitus, Pain
Clinical narrative: This spontaneous report received from a consumer via other manufacturer (RA) concerned a 6 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis.  Age at time of vaccination 52 years old. No concomitant medications were reported. On an unspecified date, the patient experienced diabetes, ache, colitis ulcerative aggravated/ flare up, and chills. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the chills, diabetes, ache and colitis ulcerative aggravated/flare up was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220424725-COVID-19 VACCINE AD26.COV2.S-colitis ulcerative aggravated/flare up. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20220424725-COVID-19 VACCINE AD26.COV2.S- diabetes. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash, Suspected COVID-19
Clinical narrative: HIVE LIKE RASH TURNED INTO BRUISES ON BUTTOCKS AND LOWER EXTREMITIES (BOTH) AND THESE SYMPTOMS RECURRING EVERY COUPLE OF WEEKS; SYMPTOMS STARTED LIKE A SPIDER VENOM BITE AND DEVELOPED A HIVE LIKE RASH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a former occupational therapist. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced suspected covid-19 infection. On 15-MAR-2021, the patient experienced hive like rash turned into bruises on buttocks and lower extremities (both) and these symptoms recurring every couple of weeks, and symptoms started like a spider venom bite and she developed a hive like rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms started like a spider venom bite and she developed a hive like rash, and hive like rash turned into bruises on buttocks and lower extremities (both) and these symptoms recurring every couple of weeks, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: PAIN IN ARM; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 74 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: primary immunodeficiency disease. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  The patient reported that on an unspecified date after vaccine administration she had minor and expected reactions including headache, pain in arm, and fatigue for couple of days (dose number in series 1). The patient also reported that, she was told by her doctors that the vaccine would not be 100 percent effective for her because of her existing medical conditions.  The patient recovered from pain in arm, headache, and fatigue. The patient additionally received booster of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26. cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 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 an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MODERATE HEADACHE (APPROXIMATELY) 1 HOUR AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and allergy to penicillin. The patient 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 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 moderate headache (approximately) 1 hour after vaccination. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from moderate headache 1 hour after vaccination. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered over12hs after thawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The year of birth of patient was reported. Reporter stated that the pharmacist administered a dose of the Moderna vaccine over 12 hours after thawed to patient who requested a booster shoot. Treatment medications were not reported.
Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to patient below approval age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient below approval age) in a 17-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient below approval age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient below approval age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient received one dose of the moderna COVID-19 vaccine as part of a research trial on 29 Nov 2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received some Moderna COVID19 doses that were expired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient had additional dose.The vial was initially stored in the refrigerator on 31 Aug 2021.The vial  did not undergo any temperature excursions.  No treatment medication was reported   This case was linked to MOD-2022-534284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up was received and contains  non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received the expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received the expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received the expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received the expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received expired dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (patient received expired dose). At the time of the report, administered expired product (patient received expired dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccine was actually expired five days ago, but given to a patient. Most recent follow-up information incorporated: On Apr 7, 2022: Follow-up received on Apr 7, 2022, included no new information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Hypertension, Pain
Clinical narrative: High blood pressure / after the vaccine it has been hitting 200/105; Hurts; Feel horrible; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure / after the vaccine it has been hitting 200/105), PAIN (Hurts), FEELING ABNORMAL (Feel horrible) and HEADACHE (Bad headaches) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no past medical history of any allergies and neither tested positive for covid test or diagnosis.  The patient's past medical history included Heart disorder (even before the moderna vaccine and had underlying issues). Concomitant products included CARVEDILOL and IVABRADINE HYDROCHLORIDE (CORLANOR) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure / after the vaccine it has been hitting 200/105), PAIN (Hurts), FEELING ABNORMAL (Feel horrible) and HEADACHE (Bad headaches). At the time of the report, HYPERTENSION (High blood pressure / after the vaccine it has been hitting 200/105), PAIN (Hurts), FEELING ABNORMAL (Feel horrible) and HEADACHE (Bad headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 108/64 for many years even before the moderna vaccine and 200/105 after the vaccine and believed it was the vaccine.         Concomitant medications also included bunch of medications, nitro patches to lower blood pressure.  Patient had no past medical history of any allergies and neither tested positive for covid test or diagnosis.The patient stated that he had been trying to get the blood pressure down and stated that the medications had not helped a lot. The blood pressure had been too high and stated that he did not want the vaccine to stay in his body for the rest of his life.  The patient reported for underlying issues and received both doses in the recommended time frame.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experiencing really weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing really weird side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing really weird side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing really weird side effects) had not resolved.            No concomitant details was provided. Patient had second booster on Thursday March 31 and  experienced really weird side effects. it was reported that not really have much of a reaction to any of the others, may be patient didn't felt it on the first day, but it was is very different and it is the same thing for both husband and wife. No treatment information was provided.   This case was linked to MOD-2022-535485 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: tonight have a fever not a big one 100 and a half; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (tonight have a fever not a big one 100 and a half) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced PYREXIA (tonight have a fever not a big one 100 and a half). At the time of the report, PYREXIA (tonight have a fever not a big one 100 and a half) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2022, Body temperature: 100 fever not a big one 100 and a half.         Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient had no known drug allergies and chronic or long-standing health conditions. The patient had never been diagnosed or tested positive for COVID-19.     On 30-Mar-2022 at 10:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date).    No concomitant medications were reported. The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a health department that they inadvertently administered the expired Moderna COVID-19 vaccines to 17 patients on 30-Mar-2022 with expiration date was 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions. No treatment medications were reported.