chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient received Menveo instead of MMR; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 49-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st December 2022, the patient received Menveo. On 1st December 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient was accidently administered a dose of Menveo instead of MMR (manufacturer unknown) at his local pharmacy, which led to wrong vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Neuropathy peripheral
Clinical narrative: NEUROPATHY; LONG TERM SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 01-DEC-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient had long term side effects with JNJ Covid-19 vaccine. On an unspecified date, the patient experienced neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neuropathy and long term side effects was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221206568- Neuropathy- The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VIOLENTLY ILL FROM THE SECOND SHOT; This spontaneous report received from a patient via media through a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. 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 violent illness (Dose number in series 2) after second shot of vaccine. It was reported as "Well, we know. I also ot violently I'll from the second shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill from the second shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20221211945.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DESTROYED LIFE / FIGHTING TO SURVIVE THE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced destroyed life / fighting to survive the effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from destroyed life / fighting to survive the effects. This report was non-serious. This report was associated with a product quality complaint: 90000261900
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SOME PAIN IN ARM FOR A COUPLE OF HOURS; JUST A LITTLE TIRED; 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 pre-existing medical conditions included: The patient had booster and had no side effects from the second one. 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 covid-19 prophylaxis. 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 some pain in arm for a couple of hours, and just a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some pain in arm for a couple of hours, and the outcome of just a little tired was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000261914.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR FEW HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 sore arm for few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for few hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEG; This spontaneous report received from a patient via a company representative through social media (J and J Corporate account) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, 6 months after second shot, the patient experienced blood clots in leg (dose number in series 2) and was on blood thinners. It was reported as, "6 months after my 2nd Johnson and Johnson shot I had blood clots in my leg. Now on blood thinners but does that even do anything for those covid blood clots. Wish I never took it or my kids. I trusted you." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210405- blood clots in leg . The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: AUTOIMMUNE DISORDER; This spontaneous report received from a patient via a company representative through a social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 autoimmune disorder. The reported stated that " Your j and j Covid vaccine caused my autoimmune disorder, how about we start researching that". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210426-autoimmune disorder. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness
Clinical narrative: SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (2) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. On an unspecified date, the patients previously received 2 doses with covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number and expiry date were not reported), dose was not reported (dose number in series 1), for covid-19 prophylaxis. It was unknown whether patients had any adverse event following covid-19 vaccine from unspecified manufacturer (dose number in series 1). The patients received third dose with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). 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 sick (dose number in series 2). It was reported as "My ENTIRE fam has had 1,2,3x's-that's extended fam-their kids-2 teens. ALL jabbed- All sick now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221210598, 20221210961, 20221211116, 20221212903 and 20221210980.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer via a company representative by social media (J and J Corporate) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of blood clot in family. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, form of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient had adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, form of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date (apart a year) for covid-19 prophylaxis. 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 died twice from blood clots in lungs (Dose number in series 2). The patient received CPR (Cardiopulmonary resuscitation) by the medics. The patient was airlifted and now on blood thinners the rest of life.  Laboratory data (dates unspecified) included: Blood test result not reported. The reporter stated that " My sister got 2 J and J Covid shots, about a year apart, died twice from blood clots in her lungs, airlifted and now on Blood Thinners the rest of her life thanks to the COVID J and J vaccine. Thank GOD the medics were close and able to do CPR. No history of blood clots in our family. Oh and the Doc made a comment about her blood test "I've never seen anything like this before". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210582- blood clots in lungs. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19 immunisation, Suspected COVID-19, Tremor
Clinical narrative: UNCONTROLLABLE SHAKES; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19  VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 37 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: adhd, depression, dysthymia, intermittent anxiety, and post orgasmic illness syndrome. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on 24-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested.  The patient additionally received non-company suspect drugs included: tozinameran (dose number in series 2) ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported administered on 11-AUG-2021  for covid-19 prophylaxis; and elasomeran (dose number in series 3) ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for covid-19 prophylaxis. Age at time of vaccination 35 years old. Concomitant medications included atomoxetine, and naltrexone. On 11-AUG-2021, the patient experienced revaccination with different covid-19 vaccine(dose number in series 2) On 11-NOV-2022, the patient experienced suspected covid-19 infection (dose number in series 2). Patient received treatment from unspecified pfizer product for Covid-19 from 20-NOV-2022 to 26-NOV-2022. On 29-NOV-2022 23:00, on day 19 from onset of symptoms patient experienced extreme chills, body aches, and exhaustion. Had uncontrollable shakes for several hours despite being under a warm blanket (dose number in series 2). Treatment medications (dates unspecified) included: diclofenac, and Tylenol(paracetamol) which were taken several hours after symptom onset and symptoms improved but did not abate entirely. On 29-NOV-2022, Laboratory data included: Body temperature Multiple temperature readings 0f 96.2-96.4. Temperature then spike to 100.8 within 30 mins of taking Tylenol and diclofenac The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable and for unspecified pfizer product was drug discontinued. The patient was recovering from suspected covid-19 infection, and uncontrollable shakes, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness
Clinical narrative: SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (3 patients) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number and expiry dates were not reported) dose was not reported, administered on an unspecified dates for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patients received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). 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 patients were sick (dose number in series 2). It was reported as "My entire fam has had 1,2,3x's, All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients had not recovered from sick, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221210446, 20221210961, 20221211116, 20221210980 and 20221212903.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dysgeusia, Suspected COVID-19
Clinical narrative: METALLIC MEDICINE TASTE IN MOUTH CONSTANTLY; STRANGE FEELING IN CHEST; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included: chronic mild bronchitis, 1 level cervical fusion, 2 level laminectomy and 2 level discectomy ((fusion and laminectomy/discectomy cause chronic pain)), and concurrent conditions included: drug allergy. 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 01-APR-2021 11:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported.  On NOV-2022, the patient experienced suspected covid-19 infection. On 23-NOV-2022 17:00, the patient experienced metallic medicine taste in mouth constantly and strange feeling in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic medicine taste in mouth constantly, strange feeling in chest, and suspected covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other company manufacturer (Moderna) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster dose of non-company suspect vaccine Spikevax (Moderna covid-19 vaccine, elasomeran) (dose number in series 2) (injection, intramuscular, batch number: unknown and expiry: unknown) dose not reported, administered on an unspecified date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date, the patient experienced Covid soon after covid (suspected COVID-19 infection) and had it for a week and it was treated with pfizer medication (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness, Off label use
Clinical narrative: SICK; OFF LABEL USE IN UNAPPROVED AGE GROUP; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received 2 doses of covid-19 vaccine (dose number in series 1, unspecified manufacturer) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following covid-19 vaccine (dose number in series 1). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (off label use in unapproved age group) (dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient experienced sick (dose number in series 2). It was reported as "My ENTIRE fam has had 1,2,3x's-that's extended fam-- their kids-2 teens,1 elem. ALL jabbed- All sick now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and the outcome of off label use in unapproved age group and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221210598, 20221210446, 20221210961, 20221211116 and 20221212903. This report was associated with product quality complaint: 90000261949.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness
Clinical narrative: SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (kids) of an unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 06-DEC-2022. The patient's weight, height, and medical history were not reported. The patients previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number and expiry dates were not reported) dose was not reported for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). 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 sick (dose number in series 2). It was reported as "My entire fam has had 1,2,3 xs. On my side adult niece her kids- All jabbed- All sick now".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000261962. The suspected product quality complaint has been confirmed to be voided (no product quality issue and there was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210446, 20221210598, 20221210980 and 20221210961.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19  VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 32 year old, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: nasal allergies, and vocal cord dysfunction and the patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 30 years old. Concomitant medications included bupropion, Zyrtec (cetirizine hydrochloride), Vit d3 (colecalciferol), Sprintec (ethinylestradiol/norgestimate), Lamictal (lamotrigine), and Singulair (montelukast sodium). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine Pfizer (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 33036BD, expiry date: UNKNOWN) dose and frequency were not reported, administered on 27-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with Pfizer (tozinameran) (dose number in series 2). The patient additionally received non-company suspect vaccine Moderna (elasomeran) (dose number in series 3) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported, administered in left arm on 09-SEP-2022 for covid-19 prophylaxis. The patient was revaccinated with different covid-19 vaccine (dose number in series 3).  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 3). The patient received non-company suspect drug included: Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 16-NOV-2022 to 21-NOV-2022 for treatment of Covid-19.  On 23-NOV-2022, the patient experienced rebound covid-19 infection after taking Paxlovid, symptoms started 2 days after last dose of Paxlovid (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Artificial crown procedure, Urticaria
Clinical narrative: CROWN PUT ON TOOTH; RASH LIKE HIVES ON BACK; This spontaneous report received from a patient concerned a 71 year old female. 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 was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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, subcutaneous, batch number: 1160299 expiry: UNKNOWN) .4 ml, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the patient experienced crown put on tooth, and rash like hives on back. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of the rash like hives on back and crown put on tooth was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: CLENCHING JAW 9 DAYS AFTER GETTING THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 clenching jaw 9 days after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clenching jaw 9 days after getting the vaccine. This report was non-serious. This case, from the same reporter is linked to 20221211987.
Sex: F
Vaccine: COVID19
Symptoms: Bruxism
Clinical narrative: BRUXISM; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 bruxism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruxism was not reported. This report was non-serious. This case, from the same reporter is linked to 20221211969.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 3 TIMES; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 covid 3 times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 3 times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000261983. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report states the patient was vaccinated and had covid. There was no product quality issue described in the report and there was insufficient information to determine vaccination failure as there was no timeline for date of vaccination to contracting covid and no confirmatory test or symptoms reported) based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen therapy
Clinical narrative: ON OXYGEN 24/7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 on oxygen 24/7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on oxygen 24/7. This report was non-serious. This case is a duplicate of 20221212212.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness
Clinical narrative: SICK NOW; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned a female of an unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient previously received 2 doses of covid-19 vaccine (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse event following 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). 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 sick (dose number in series 2). It was reported that, "My ENTIRE fam has had 1,2,3x's. On my side my brother, his wife- ALL jabbed- All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick now, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000261955. The suspected product quality complaint has been confirmed to be voided (no product quality issue and there was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210980, 20221210598, 20221210446, 20221210961 and 20221211116.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: No Adverse event; temperature excursions; 2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT).    Concomitant medications were not reported.  The 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines had surfer multiple temperature excursions. The case is for the 4th patient out of 5 patients. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: temperature excursions; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions).    Concomitant medications were not reported.  The 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines had surfer multiple temperature excursions. The case is for the 5th patient out of 5 patients. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: Two patients received bivalent expired doses; Two patients received bivalent expired doses; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses), POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Two patients received bivalent expired doses) and POOR QUALITY PRODUCT ADMINISTERED (Two patients received bivalent expired doses).    It was reported that two patients received bivalent expired doses from lot 030g22b with beyond use date 04 Dec 2022. No concomitant medication were reported. No treatment medication were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Influenza, Insomnia
Clinical narrative: flu; night in early morning i had trouble sleeping after 2 am. in the morning; tired; little appetite; irritation throughout my body as if a flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 13-Aug-2022. Previously administered products included for Product used for unknown indication: Pfizer vaccine (4 shots of Pfizer vaccine) on 19-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Dec-2022, the patient experienced INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu). At the time of the report, INFLUENZA (flu) was resolving and INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: flu; night in early morning i had trouble sleeping after 2 am. in the morning; tired; little appetite; irritation throughout my body as if a flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 13-Aug-2022. Previously administered products included for Product used for unknown indication: Pfizer vaccine (4 shots of Pfizer vaccine) on 19-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Dec-2022, the patient experienced INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu). At the time of the report, INFLUENZA (flu) was resolving and INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.