chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The health care professional (HCP) reported that a 3 month old received the Kinrix. No other reactions were reported. The vaccine administration facility was the same as primary reporter The reporter consent to follow up. Additional Supportive Information: 3 months old patient received Kinrix, which led to inappropriate age at vaccine administration. Note: As per case narrative patients age was given as 4 months but by the calculation form date of birth to vaccination date the patient was 3 month old.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Overdose, Wrong product administered
Clinical narrative: administered Engerix-B and Pediarix at the same visit; Pediarix (instead of Pentacel); This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-week-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 26th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B. On 26th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: The nurse reported a patient was administered Engerix-B and Pediarix (instead of Pentacel) at the same visit.  The patient received two doses of Hepatitis B in same visit.  The consent to follow up was granted via email. Additional Supportive Information: As patient had Engerix-B and Pediarix having same antigen on the same day, which led to overdose of hepatitis B component. As patient received Pediarix instead of Pentacel, which led to wrong vaccine administered.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received Havrix pediatric; Adult patient received Havrix pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 29-year-old male patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 26th August 2022, the patient received Havrix pediatric (intramuscular) .5 ml. On 26th August 2022, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 26-AUG-2022 Reporter's Comments: Adult patient was given 0.5mL pediatric dose of Havrix in the right arm. Call was transferred for further assistance.  The reporter consented to follow up. Additional Supportive Information: Adult patient received pediatric dose of Havrix which led to underdose and adult use of a child product.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix) (batch number 75C45, expiry date 19th August 2022) for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Havrix. On 26th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The office Manager reported that the patient was administered 1st dose of Havrix on 26th August 2022, which had an expiration date of 19th August 2022.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient didn't receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received about 2 years ago, 0.5 mg/ml in left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 26-Aug-2022:  Reporter's comments: This case was self reported by the patient. The patient received the first dose of Shingrix. The patient did not received second dose yet. The patient did not have any further information regarding the vaccine. The reporter did not consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 76-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The pharmacist reported that male patient received a dose of Twinrix and was expired on 7th Aug 2022.  The vaccine administration facility was the same as primary reporter The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: PAIN IN HANDS DUE TO RHEUMATOID ARTHRITIS; This spontaneous report received from a patient concerned an adult female. 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 01-APR-2021 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 in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced pain in hands due to rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from pain in hands due to rheumatoid arthritis. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer via social media (J&J Corporate) via a company representative concerned a female of unspecified age 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, expiry: unknown) dose 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 died from unknown cause of death after vaccination. It was unknown if autopsy was performed or not. Reporter stated "So frustrated with the loss of my sister after taking J&J". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0: 20220853278-covid-19 vaccine ad26.cov2.s-Loss of sister. 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.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included: fatigue, and concurrent conditions included: drug allergy (Not reported), and sleep apnea, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had other lifelong issues which causes her to normally deal with excessive daytime sleepiness. The patient was previously treated with modafinil, methylphenidate hydrochloride, and amfetamine aspartate/amfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate for fatigue. 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, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medication included duloxetine hydrochloride. 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 included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The patient received non-company suspect drug included: Paxlovid (form of admin, route of admin, and batch number were not reported), dose, administered on 14-AUG-2022 for covid-19 treatment. Last dose of administration was 19-AUG-2022. On 15-AUG-2022, patient had insomnia due to Paxlovid (dose number in series 2) and was not getting sleepy and now that patient was on it and could only get herself to fall asleep if patient took a NyQuil to knock herself out. The patient could easily let 24 hours go by without feeling tired at all. The patient had noticed to be more mentally alert and sensitive (bothered by) sensations like a clothing tag or stray hay or blade of grass poking or brushing against patient. Paxlovid was far more effective than those were at keeping me awake and alert painlessly. But it was too effective at it. The patient did not need to sleep at night for good health and really could not because of the Paxlovid. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with Paxlovid drug was discontinued. The patient had not recovered from insomnia, and the outcome of suspected covid-19 infection was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Headache, Muscle spasms, Pain, Systemic lupus erythematosus
Clinical narrative: LUPUS ERYTHEMATOSUS; STOMACH UPSET; SPASM MUSCLE; BODYACHE; HEADACHE; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned an adult female of an unspecified age, 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, intramuscular, batch number: unknown and expiry: Unknown) dose was not reported, 1 total (Dose 1), start therapy date was 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 in pre-filled pen, subcutaneous, batch number: 1164824 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported.  On an unspecified date, the patient experienced lupus erythematosus, could not handle the heat, sick, depressed, angry, stomach upset, spasm muscle, headache, and body ache. The patient experienced spasms throughout her whole body in her muscles, when she received covid vaccination it really made her sick for a day and experienced a massive headache, entire body ached and her stomach was upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from lupus erythematosus, and the outcome of sickness and stomach upset was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220853574-covid-19 vaccine ad26.cov2.s-lupus erythematosus. 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: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex (local case ID# Unknown). 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 03-DEC-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. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaemia, Diarrhoea, Gastric haemorrhage, Stress
Clinical narrative: BLEEDING OF THE STOMACH; CLOT IN LEFT LEG AND RIGHT KNEE; STOMACH CRAMPS; STRESS; ANEMIA; LOOSE STOOL/BOWELS; This spontaneous report received from a patient via other manufacturer concerned a 6 decade old adult female of an unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, first dose, 1 total administered on 22-JUL-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 56 years old. No concomitant medications were reported. The patient also received non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported and expiry: Unknown) dose, frequency and therapy dates were not reported for moderate to severe ulcerative colitis.  On an unspecified date, the patient experienced bleeding of the stomach, clot in left leg and right knee, stomach cramps, stress, anemia and loose stool/bowels (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from clot in left leg and right knee, and stomach cramps, had not recovered from bleeding of the stomach, stress, and anemia, and the outcome of loose stool/bowels was not reported. The patient also additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, second dose, 1 total administered on 29-OCT-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220859758-covid-19 vaccine ad26.cov2.s-bleeding of stomach. 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.  20220859758-covid-19 vaccine ad26.cov2.s- Clot in left leg and right knee. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLEEDING OF THE STOMACH; CLOT IN LEFT LEG AND RIGHT KNEE; STOMACH CRAMPS; STRESS; ANEMIA; LOOSE STOOL/BOWELS; This spontaneous report received from a patient via other manufacturer concerned a 6 decade old adult female of an unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, first dose, 1 total administered on 22-JUL-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 56 years old. No concomitant medications were reported. The patient also received non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported and expiry: Unknown) dose, frequency and therapy dates were not reported for moderate to severe ulcerative colitis.  On an unspecified date, the patient experienced bleeding of the stomach, clot in left leg and right knee, stomach cramps, stress, anemia and loose stool/bowels (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from clot in left leg and right knee, and stomach cramps, had not recovered from bleeding of the stomach, stress, and anemia, and the outcome of loose stool/bowels was not reported. The patient also additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, second dose, 1 total administered on 29-OCT-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220859758-covid-19 vaccine ad26.cov2.s-bleeding of stomach. 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.  20220859758-covid-19 vaccine ad26.cov2.s- Clot in left leg and right knee. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. 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 and has been requested. No concomitant medications were reported. On 14-AUG-2022, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis was suspected but not confirmed; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis was suspected but not confirmed) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis was suspected but not confirmed) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis was suspected but not confirmed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided Company comment This is a Spontaneous case reported by a physician, concerning a female patient of an unknown age, who had no medical history reported and experienced the expected, serious, medically significant, AESI of Myocarditis and received a dose of mRNA-1273 vaccine. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Myocarditis was suspected but not confirmed. No further information regarding course of the event, lab tests, cardiac studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a physician, concerning a female patient of an unknown age, who had no medical history reported and experienced the expected, serious, medically significant, AESI of Myocarditis and received a dose of mRNA-1273 vaccine. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Myocarditis was suspected but not confirmed. No further information regarding course of the event, lab tests, cardiac studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (NO adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053b22a) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (NO adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (NO adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (NO adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture) and PRODUCT STORAGE ERROR (Product storage error). Concomitant medication details were not reported by the reporter. It was reported that patient received second booster dose. It was reported that the vial was initially stored in refrigerator on 04-Aug-2022. On 23-AUG-2022 at 9:40 AM, vial was first punctured. The vial was stored at room temperature post puncture for 25 hours and did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case was linked to MOD-2022-633802 (E2B Linked Report). Sender's Comments: MOD-2022-633802: Other patient case.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided by reporter.  It was reported that the boss got a heart attack.  No treatment medication was provided by reporter.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest, Myocardial Infarction which was medically significant as reported by the regulatory authority and occurred on an unknown date after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest, Myocardial Infarction which was medically significant as reported by the regulatory authority and occurred on an unknown date after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant products were not reported. The reporter's causality for Humira with event 'felt that Humira was not working' was reported as not provided and no reasonable possibility for event 'Covid'. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Treatment medications were not reported. Company Comment: This spontaneous case concerns an adult female patient who received the non-company product, co-suspect drug Adalimumab for hidradenitis suppurative and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation including SARS-CoV-2 test, and treatment information were not provided in the report. The event has not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient who received the non-company product, co-suspect drug Adalimumab for hidradenitis suppurative and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation including SARS-CoV-2 test, and treatment information were not provided in the report. The event has not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Heart rate, Palpitations
Clinical narrative: Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    There was no reported medical history.  The patient's past medical history included Staphylococcal infection (stapf infection after surgery) in 2015 and Surgery in 2015.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 125 to 140 beats.         No concomitant medication details were provided. No treatment medication details were provided.   Dosage form for HUMIRA was given as solution for injection in pre-filled pen.  The reporter's causality for the event was not provided with HUMIRA.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ABDOMINAL PAIN UPPER (Stomach pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Ankylosing spondylitis. Concurrent medical conditions included Rheumatoid arthritis and Ankylosing spondylitis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced COVID-19 (COVID-19). On 03-Jun-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). In 2022, COVID-19 (COVID-19) and ABDOMINAL PAIN UPPER (Stomach pain) had resolved. No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of COVID-19, stomach pain was not reported for co-suspect Humira. No treatment medications were reported. Company comment: This spontaneous case concerns a 20 year old female patient with concurrent rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving the booster dose of mRNA1273. Further details regarding the clinical course, additional diagnostic or imaging test done and treatment were not provided. The patient's compromised immune system due to concurrent rheumatoid arthritis and use of co-suspect drug adalimumab (Humira) may be considered as risk factors for COVID-19. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 20 year old female patient with concurrent rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving the booster dose of mRNA1273. Further details regarding the clinical course, additional diagnostic or imaging test done and treatment were not provided. The patient's compromised immune system due to concurrent rheumatoid arthritis and use of co-suspect drug adalimumab (Humira) may be considered as risk factors for COVID-19. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) had not resolved. No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. All doses of vaccine including booster were given one in once. It was reported that the patient did not see a lot of help with it. No treatment information was provided. The reporter's causality for the event of Rinvoq was not working with Rinvoq (Upadacitinib) was a reasonable possibility. Company Comment: This spontaneous case concerns an elderly, female patient who received the co-suspect product Rinvoq (upadacitinib) for an unknown indication and also received the third (booster) dose of the mRNA-1273 vaccine on unspecified dates. On an unknown date, it was reported that the patient did not see a lot of help with Rinvoq and it was not working. The event drug ineffective was reported and the mRNA-1273 vaccine was also considered as a suspect product. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns an elderly, female patient who received the co-suspect product Rinvoq (upadacitinib) for an unknown indication and also received the third (booster) dose of the mRNA-1273 vaccine on unspecified dates. On an unknown date, it was reported that the patient did not see a lot of help with Rinvoq and it was not working. The event drug ineffective was reported and the mRNA-1273 vaccine was also considered as a suspect product. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (after the first three shots, she felt body aches, soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes (20 years ago). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (after the first three shots, she felt body aches, soreness). At the time of the report, PAIN (after the first three shots, she felt body aches, soreness) outcome was unknown. Concomitant medication details were not reported by the reporter. Patient never tested COVID positive. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. The adverse event had not caused the patient to seek any form of medical care. Treatment details was not reported by the reporter. This case was linked to MOD-2022-635783 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLOOD GLUCOSE INCREASED (after second booster, her sugar levels went out of whack/there is moment on the day that it goes very high) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient had no allergies to medication, food and other products. The patient had never been diagnosed or tested positive for COVID-19. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccination. Concurrent medical conditions included Diabetes (started 20 years ago). On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (after second booster, her sugar levels went out of whack/there is moment on the day that it goes very high). At the time of the report, BLOOD GLUCOSE INCREASED (after second booster, her sugar levels went out of whack/there is moment on the day that it goes very high) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: sugar levels went out of whack and on some moment on the day, it goes very high. Concomitant medication information was not provided. After receiving the second booster dose, the patient's sugar levels went out of whack, and there were moments in the day that it went very high, and the physician reported that it could be due to the vaccine. The adverse event had not caused the patient to seek any form of medical care. The patient had not experienced a similar event in the past. Treatment information was not provided. This case was linked to MOD-2022-635407 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    It was reported that patient received second booster dose. Concomitant drugs were not reported. It was reported that the vial was moved from freezer to room temperature to be thawed on 23-Aug-2022. The vial did not undergo any temperature excursions. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-635822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635822:2 of 2 Patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medication was not provided.  The patient was in hospital with Covid 19 and had been in there for a few days.  CC: This spontaneous case concerns a 61 year old female patient, with concomitant use of adalimumab for rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) Adverse Event of Special Interest of COVID-19, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The patient was hospitalized with Covid 19 and had been in there for a few days and was treated with REMDESIVIR. The ongoing COVID-19 pandemic and concomitant use of adalimumab (immunosuppressant) for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year old female patient, with concomitant use of adalimumab for rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) Adverse Event of Special Interest of COVID-19, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The patient was hospitalized with Covid 19 and had been in there for a few days and was treated with REMDESIVIR. The ongoing COVID-19 pandemic and concomitant use of adalimumab (immunosuppressant) for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.