chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: patient received BEXSERO on 07/22/22 and TRUMENBA on 7/20/22; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 20th July 2022, the patient received TRUMENBA. On 20th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 28-Jul-2022. Reporter's Comment: The reporter was a GSK field rep who stated she had an AE to report. The reporter was confused and thought this AE was already filed. It was not so she was filled now.  The patient received Bexsero on right deltoid at HCP office and received Trumenba (no injection site available). The reporter stated both of those 2 vaccines were not interchangeable. The reporter stated the wrong vaccine was administered, the second dose was supposed to be Bexsero as well. The reporter consented to follow up. Additional Supportive Information: The patient was vaccinated with Bexsero and Trumenba, which led to interchange of vaccine products.
Age: 1.25
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix instead of Pentacel; 15 month old was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 15-AUG-2022 Reporter's Comments: The health care professional reported that the patient was administered Kinrix instead of Pentacel. Additional Supportive Information: The 15 month old patient received Kinrix instead of Pentacel which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Infectious mononucleosis, Injection site reaction
Clinical narrative: Peristalsis at the injection site; Signs of mono; This case was reported by a nurse via call center representative and described the occurrence of injection site muscle reaction in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. In September 2021, 4 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site muscle reaction and mononucleosis. On an unknown date, the outcome of the injection site muscle reaction and mononucleosis were recovered/resolved.   It was unknown if the reporter considered the injection site muscle reaction and mononucleosis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 15-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Bexsero vaccine. The reporter stated that four weeks after received Bexsero vaccine patient experienced peristalsis verified with reporter at the injection site and signs of mono. The patient was not seen by the HCP for the reported side effects, reporter had nothing else to report. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received Shingrix. On 15th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: Nurse reported that a 17 year old patient received Shingrix vaccine. No symptoms reported. The HCP (Health Care Professional) did not have the lot number and expiration date at the time of report. The reporter consented to follow-up. Additional Supportive Information: The 17 year old patient received Shingrix vaccine, which led to inappropriate age at vaccine administration.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 1mL instead of 0.5mL; 18 years patient was given 1mL; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Engerix B (intramuscular) 1 ml. On 12th July 2022, unknown after receiving Engerix B, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 15-Aug-2022 Reporter's comments: The pharmacist reported that another pharmacy in her chain gave an overdose (1mL instead of 0.5mL) of  Engerix-B vaccine. The pharmacist reported that 18 years old patient received dose of Engerix-B vaccine on an unknown arm. Transferred to medical information for further assistance. The reporter consented to follow-up. Additional Supportive Information: The Engerix-B was administered 1ml instead of 0.5 ml to 18 years patient, which led overdose and Inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years ago from the reporting date).   On an unknown date, the patient did not receive 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: 15-AUG-2022 Reporter's Comments: The patient had not receive second dose of Shingrix. The reporter did not have the date or lot number information of the first dose.  At the time of reporting, second dose had not been administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA655A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Aug-2022 Reporter's comments: The pharmacist reported that patient was administered with Menveo reconstituted with sterile water. The reporter consent to follow-up. Additional Supportive Information: Menveo reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Menveo administered intradermally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo (intradermal). On 16th August 2022, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The reporter reported that menveo administered to a patient intradermally. The reporter consented to follow up. Additional supportive information: The patient received menveo intradermally instead of intramuscularly which led to incorrect route of administration.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 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 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th 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: 16-AUG-2022 Reporter's comments: The registered nurse (RN) reported that a Twinrix expired dose was administered to a patient. The consent to follow up was granted by email. Additional Supportive Information: As patient received dose of expired vaccine, which led to expired vaccine used.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid conjugate portion; Administered only the liquid conjugate portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received only the liquid conjugate portion of the Menveo vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient administered only the liquid conjugate portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 9th August 2022, the patient received Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The pharmacist reported that a patient received an expired dose of Boostrix on 9th Aug2022. The Boostrix expired on 5th Jul2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired Boostrix vaccine, which lead to expire vaccine used. This case is linked to the case US2022119632, reported by the same reporter; Sender's Comments:  US-GSK-US2022119632:Same reporter. Patient 1.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after receiving Shingrix; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter stated that the patient developed shingles a few days after receiving Shingrix vaccine. It was unknown if this was the first or second dose. No additional information reported. The reporter consented to follow-up.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received a dose of Havrix on 19 Aug 2022 that had expired on 9 Aug 2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th 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: 19-Aug-2022 Reporter's comment: The nurse reported that the patient received a dose of Havrix on 19th August 2022 that had expired on 09th August 2022. The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP HERE AND THERE (HAND AND WRIST); COVID-19; This spontaneous report received from a patient via other manufacturer (Company) concerned a 60 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose, 1 total 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: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate, prednisone, hydrochloxine and patient took shingles vaccine.  On an unspecified date, the patient experienced rheumatoid arthritis flare up here and there (hand and wrist). On JUN-2022, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from rheumatoid arthritis flare up here and there (hand and wrist), and covid-19 on 2022. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220832304-Covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up here and there (hand and wrist). The event(s) has an unknown/unclear relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer through a company representative via social media 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, batch number and expiry were not reported) 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, the patient died and cause of death was not reported. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220833399-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Malaise, Skin burning sensation, Tinnitus
Clinical narrative: This spontaneous report received from a patient 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 16-AUG-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-AUG-2022, the patient experienced vision became dark and could barely see, feeling extremely hot, skin felt like it was burning or sizzling, feel sick, ears started ringing and gradually sound became muffled, and feeling exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision became dark and could barely see, feeling extremely hot, skin felt like it was burning or sizzling, feel sick, and ears started ringing and gradually sound became muffled on 16-AUG-2022, and had not recovered from feeling exhausted. This report was non-serious. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous report received from a patient 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 16-AUG-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-AUG-2022, the patient experienced vision became dark and could barely see, feeling extremely hot, skin felt like it was burning or sizzling, feel sick, ears started ringing and gradually sound became muffled, and feeling exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision became dark and could barely see, feeling extremely hot, skin felt like it was burning or sizzling, feel sick, and ears started ringing and gradually sound became muffled on 16-AUG-2022, and had not recovered from feeling exhausted. This report was non-serious. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via other manufacturer Novavax concerned a male of unspecified age, race and ethnic origin. Initial information was processed with the additional information received on 18-AUG-2022. 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, batch number and expiry date were not reported) 1 total, dose was not reported, administered on 01-MAY-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of 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, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient had blood tests that showed no antibodies (confirmed immunological vaccine failure) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246992.; Sender's Comments: V0: 20220834612-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report received from a consumer 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 was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis after the 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDITIS (Myocarditis after the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis after the 2nd dose) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Reporter consulted patient's primary care physician and cardiologist. Reporter did not have patient's vaccination details. Treatment information was not provided.  Company comment:  This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced the serious (medically significant) expected AESI of myocarditis after the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not reported; hence latency cannot be properly assessed. No further information on diagnostic tests, clinical course and treatment received was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced the serious (medically significant) expected AESI of myocarditis after the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not reported; hence latency cannot be properly assessed. No further information on diagnostic tests, clinical course and treatment received was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died due to blood clots from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died due to blood clots from the vaccine) in a female patient of an unknown age 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 THROMBOSIS (died due to blood clots from the vaccine) (seriousness criteria death and medically significant). The reported cause of death was died due to blood clots from the vaccine. It is unknown if an autopsy was performed.            No concomitant medication information provided.  The reporter also reported that there were females who died due to blood clots from the vaccine.  No treatment medication information provided.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information provided, who experienced the unexpected serious (fatal) AESI of thrombosis. The event occurred on an unknown date after a dose of mRNA-1273. The reported stated there were females who died due to blood clots from the vaccine. Very limited information was provided. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history information provided, who experienced the unexpected serious (fatal) AESI of thrombosis. The event occurred on an unknown date after a dose of mRNA-1273. The reported stated there were females who died due to blood clots from the vaccine. Very limited information was provided. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died due to blood clots from the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Administration error: second dose was given as half of a dose instead of full dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event) 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose). No concomitant medications were reported.  The HCP (health care professional) stated the patient received a first full dose of Moderna COVID-19 Vaccine. The HCP stated that the patient would be informed about this for them to call back and report an event to Moderna. It was unknown if the patient experienced any symptoms after getting any of the vaccines.  No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Mobility decreased, Pyrexia
Clinical narrative: Could not lift/ could not bend over; could not walk; Was in really bad shape; Physically tired/felt very tired; had a fever; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Could not lift/ could not bend over), GAIT DISTURBANCE (could not walk), FEELING ABNORMAL (Was in really bad shape), FATIGUE (Physically tired/felt very tired) and PYREXIA (had a fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0028821A, 939903, 002M21A and 0402A-21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, the patient experienced FATIGUE (Physically tired/felt very tired) and PYREXIA (had a fever). On 27-Apr-2022, the patient experienced MOBILITY DECREASED (Could not lift/ could not bend over), GAIT DISTURBANCE (could not walk) and FEELING ABNORMAL (Was in really bad shape). In 2022, FATIGUE (Physically tired/felt very tired) and PYREXIA (had a fever) had resolved. At the time of the report, MOBILITY DECREASED (Could not lift/ could not bend over), GAIT DISTURBANCE (could not walk) and FEELING ABNORMAL (Was in really bad shape) had resolved with sequelae.            No concomitant medications were reported.  It was reported that the patient had a fever, felt very tired and had been wasted since then. Patient was very active before the 2nd shot. Patient could not lift, bend over or walk. The patient was in really bad shape.  Adverse event did not cause patient to seek medical care and it was unknown if the patient experienced a similar event in the past. It was reported that the symptoms were improved.  No treatment information was reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Illness
Clinical narrative: Crohn's disease aggravated; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) and ILLNESS (Sickness) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criteria hospitalization prolonged and medically significant) and ILLNESS (Sickness) (seriousness criterion hospitalization prolonged). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated) was resolving and ILLNESS (Sickness) had resolved.            Concomitant medications were not reported. Treatment information was not provided.  The patient experienced really bad crohn's disease bowel flare ups which included nonstop diarrhea that landed them in the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment:  This spontaneous case concerns an adult male patient, with a relevant history of Crohn's disease on adalimumab, who experienced the unexpected, serious (hospitalization, medically significant) adverse event of Crohn's disease aggravated, the serious (hospitalization) event Sickness, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. It was reported that the patient experienced really bad Crohn's disease bowel flare ups which included nonstop diarrhea which led the patient to be hospitalized. Underlying  history of Crohn's disease on adalimumab could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient, with a relevant history of Crohn's disease on adalimumab, who experienced the unexpected, serious (hospitalization, medically significant) adverse event of Crohn's disease aggravated, the serious (hospitalization) event Sickness, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. It was reported that the patient experienced really bad Crohn's disease bowel flare ups which included nonstop diarrhea which led the patient to be hospitalized. Underlying  history of Crohn's disease on adalimumab could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 002A21A, 03821A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) had resolved.            No concomitant medication  was reported. The patient took allergy shots and the patient had no complaints after dose 3. The AE did not cause the patient to seek medical care No treatment information was provided.  Company comment- This is a spontaneous case concerning a 53-year-old female patient with no relevant medical history reported who experienced the serious (medically significant) and unexpected AESI cardiac flutter the following day a second booster dose of mRNA-1273 vaccine was administered. When patient woke up, her smart watch said "Fat burn 88-89 heart rate¨. She felt a little fluttering of her heart, but it cleared up pretty quickly. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-630098 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 53-year-old female patient with no relevant medical history reported who experienced the serious (medically significant) and unexpected AESI cardiac flutter the following day a second booster dose of mRNA-1273 vaccine was administered. When patient woke up, her smart watch said "Fat burn 88-89 heart rate¨. She felt a little fluttering of her heart, but it cleared up pretty quickly. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: cough; chills,shiverings; fever; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number: EN6204, Route: Intramuscular) on 02-Mar-2021, Pfizer (2nd dose, Lot number: ET6955 and Expiration date: 30Jun2021) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cholesterol, Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Morphine), Heart failure (all her life, Recent change in status such as improvement or worsening: she feels very sick), Renal failure (since 3 years ago, Recent change in status such as improvement or worsening: she feels very sick), COPD (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Polyneuropathy (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Diabetes (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick) and Sleep disorder NOS. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified, METOPROLOL for Heart disorder, TRAZODONE for Sleep disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID], ISOSORBIDE and HYDROCODONE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever). On 21-Nov-2021, COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) had resolved.            No treatment medication was provided. Patient did not experienced a similar event in the past. Patient symptoms did not got any better.   This case was linked to MOD-2022-630425 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Asthenia, Decreased appetite, Dizziness, Haemoptysis
Clinical narrative: cough; chills,shiverings; fever; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number: EN6204, Route: Intramuscular) on 02-Mar-2021, Pfizer (2nd dose, Lot number: ET6955 and Expiration date: 30Jun2021) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cholesterol, Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Morphine), Heart failure (all her life, Recent change in status such as improvement or worsening: she feels very sick), Renal failure (since 3 years ago, Recent change in status such as improvement or worsening: she feels very sick), COPD (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Polyneuropathy (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Diabetes (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick) and Sleep disorder NOS. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified, METOPROLOL for Heart disorder, TRAZODONE for Sleep disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID], ISOSORBIDE and HYDROCODONE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever). On 21-Nov-2021, COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) had resolved.            No treatment medication was provided. Patient did not experienced a similar event in the past. Patient symptoms did not got any better.   This case was linked to MOD-2022-630425 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: cough; chills,shiverings; fever; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number: EN6204, Route: Intramuscular) on 02-Mar-2021, Pfizer (2nd dose, Lot number: ET6955 and Expiration date: 30Jun2021) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cholesterol, Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Morphine), Heart failure (all her life, Recent change in status such as improvement or worsening: she feels very sick), Renal failure (since 3 years ago, Recent change in status such as improvement or worsening: she feels very sick), COPD (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Polyneuropathy (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick), Diabetes (since 20 years ago, Recent change in status such as improvement or worsening: she feels very sick) and Sleep disorder NOS. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified, METOPROLOL for Heart disorder, TRAZODONE for Sleep disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID], ISOSORBIDE and HYDROCODONE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever). On 21-Nov-2021, COUGH (cough), CHILLS (chills,shiverings) and PYREXIA (fever) had resolved.            No treatment medication was provided. Patient did not experienced a similar event in the past. Patient symptoms did not got any better.   This case was linked to MOD-2022-630425 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, SARS-CoV-2 test
Clinical narrative: Lichen Planus disease; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Lichen Planus disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 051B22A, 005C21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced LICHEN PLANUS (Lichen Planus disease). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and AMOXICILLIN for Hair loss, at a dose of solution. At the time of the report, LICHEN PLANUS (Lichen Planus disease) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications was reported. It was reported that patient had no allergies. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. Patient height was 5'5". It was stated that patient had rash on her head. She was losing her hair. AE has caused patient to seek medical care: doctor visit, dermatologist. The patient had not experienced a similar event in the past. The patient was treated with some creams.