chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix 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: 20-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, they inadvertently administered an expired Kinrix dose to a patient in their facility. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, they inadvertently administered an expired Kinrix dose to a patient in their facility, which led to expired vaccine used.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Rash
Clinical narrative: Neck pain; rash in neck, upper back and chest; Headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number h7at2, expiry date 28th August 2023) for prophylaxis.   On 1st October 2022, the patient received the 1st dose of Shingrix. On 1st October 2022, less than a day after receiving Shingrix, the patient experienced headache. On 6th October 2022, the patient experienced neck pain and rash. On an unknown date, the outcome of the headache, neck pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain and rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter who was reporting on behalf of a patient.  She stated that, the patient received Shingrix.  He started to experience a headache on the same day.  On 6th October 2022, the patient experienced neck pain followed by a rash on the left side of his neck which extended to his upper back and his chest.  The symptoms had not yet resolved.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix administered without the powder; Shingrix administered without the powder; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2022, the patient received the 2nd dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, 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: 20-OCT-2022 Reporter's Comment:The reporter was looking on information because, a colleague administered a Shingrix to a patient without the powder. The reporter did not consent to follow-up. Additional Supportive Information: The reporter was looking on information because, a colleague administered a Shingrix to a patient without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administration of Shingrix at 56 day.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2022, the patient received the 2nd dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Oct 2022 Reporter's comment: The pharmacist reported the administration of Shingrix at 56 days mark to the patient. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule. As per reported information it seems that the reporter was reporting about second dose therefore case was kept valid for second dose and meanwhile query raised for the clarification.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder reconstituted with non approved diluent/ only diluent received; powder reconstituted with non approved diluent/only diluent received; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022AMR152100:Same reporter US-GSK-US2022AMR152101:Same reporter
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: had all his Dtap, also received Boostrix and Tdap on 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Dtap vaccine  (received all Dtap vaccines, with the last being administered in 2015) and Boostrix (received Boostrix on 25th August 2022).   On 17th October 2022, the patient received Tdap Vaccine. On 17th October 2022, unknown after receiving Tdap Vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The reporter did not think that was Boostrix that was administered by the other health care professional, but rather another Tdap or TD based on the lot number provided.  The reporter checked the lot number and it did not match a GlaxoSmithKline vaccine.  The reporter consented to follow up via postal. Additional supportive information: The licensed vocation nurse stated that they administered Boostrix to a patient and then received another Tdap (or possibly TD) from his provider, which led to extra dose administered. The case was kept valid in worst approach considering the suspect was potential GSK one, as in whole source document there was no lot number was reported regarding which reporter was mentioning that it did not match with GSK vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Nausea, Pyrexia, Vomiting
Clinical narrative: fever with most vaccines and antibiotics; nausea with most vaccines and antibiotics; vomiting with most vaccines and antibiotics; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Tdap vaccine with an associated reaction of hypersensitivity (about 40 years ago).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced fever, nausea and vomiting. On an unknown date, the outcome of the fever, nausea and vomiting were unknown.   It was unknown if the reporter considered the fever, nausea and vomiting to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR151776   Additional Information: GSK Receipt Date: 20-Oct-2022 Reporter's comment: The patient reported she would like to get protected with Tdap vaccine but she could not find one that did not had the tetanus portion in it.  She stated that she had a severe allergic reaction to a Tdap vaccine about 40 years ago.  She also mentioned her last flu vaccine (not sure of manufacture or date) and she experienced fever, nausea and vomiting with most vaccines and antibiotics. The reporter did not consent to follow-up. The adverse event was filed with limited information. Additional Supportive Information: This case was linked with case US2022AMR151776, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR151776:same reporter
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered on 19Oct2022, expiration 30Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 19th October 2022, the patient received the 2nd dose of Havrix. On 19th October 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: 20-Oct-2022 Reporter's comment: This was the patient's second dose in the series. At the time of reporting, a repeat dose has not been administered. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havirx, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: FLUR3, PNC, TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis and INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix, Boostrix, Boostrix Pre-Filled Syringe Device, PREVNAR and FLUBLOK. In October 2022, less than 3 weeks after receiving Shingrix and Boostrix and less than a month after starting Boostrix Pre-Filled Syringe Device, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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, Boostrix and Boostrix 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: 20-OCT-2022 Reporter's Comment: The reporter stated that, a patient received the Shingrix along with 3 other vaccines (Boostrix, Prevnar, and Flublok) and got shingles within the month.  He received the first dose of Shingrix, along with the mentioned vaccines.  A prescription for Valtrex was sent over to the pharmacy on 4th October 2022, but she stated that, other medications (that were not named) were sent on 3rd October 2022 (diagnosis could have been on 3rd October 2022 or 4th October 2022). It was unknown if the reporter considered the shingles to be related to Prevnar and Flublok. The reporter consented to follow up via postal.
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: medical assistant inadvertently gave a BOOSTRIX vaccine instead of a Flu vaccine; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Tdap vaccine (In 2015 received).   On an unknown date, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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:  20-OCT-2022 Reporters comment: The reporter reported that medical assistant inadvertently given a boostrix vaccine instead of a flu vaccine in left deltoid age was unknown. No other information provided The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, medical assistant inadvertently given a boostrix vaccine instead of a flu vaccine , which led to Wrong vaccine administered.
Age: 11.0
Sex: U
Vaccine: UNK
Symptoms: Overdose
Clinical narrative: patient received 2 dose of flulaval on the same visit on 14th OCT 2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 14th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and FLULAVAL QUADRIVALENT, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 21-OCT-2022 Reporter's comment: Registered nurse had reported that the patient had received 2 dose of flulaval on the same visit on 14th October 2022. Hcp was ok for safety team to team call back for further information. The reporter had consented to follow up. Additional supportive information: The patient had received 2 dose of Flulaval on the same day, which had led to overdose.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Impaired work ability
Clinical narrative: GOT FIRED FOR CONTINUALLY BEING  DISABLED; SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-MAR-2021, the patient experienced severe side effects. On an unspecified date, the patient experienced got fired for continually being disabled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe side effects and got fired for continually being disabled was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a male of 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, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had blood clots. It was reported as "My dad died from the vaccine injury from Johnson and Johnson. Blood clots". On an unspecified date, the patient died from blood clots. 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- 20221051939-covid-19 vaccine ad26.cov2.s-Blood clot. 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.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer by a company representative via social media   and concerned a male of 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, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total (first dose), start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. Reporter reported that " Ummm, no. You dirty rats killed my uncle with your clot shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221052157- 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: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 7 decade old female of an unspecified 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 date were not reported) dose was not reported, 1 in total was administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced myalgia and also stated that a physician had mentioned Guillain-Barre syndrome (GBS). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221054971-covid-19 vaccine ad26.cov2.s -guillain-barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: POOL OF BLOOD IN EYE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-MAR-2022 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 MAR-2022, the patient experienced pool of blood in eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pool of blood in eye was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness
Clinical narrative: DIzziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIzziness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia.   On an unknown date, the patient received 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 IBRUTINIB (IMBRUVICA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (DIzziness). At the time of the report, DIZZINESS (DIzziness) had resolved.            No concomitant medication information was provided.  On an unknown date, the patient received booster dose of Moderna COVID-19 vaccine.  The reporter's causality for the event of dizziness with Ibrutinib was reported as no reasonable possibility.  The route of administration of Ibrutinib was reported as subcutaneous.    It was unknown if patient was enrolled in COVID-19 vaccine trial or not.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided.  Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraines) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced MIGRAINE (Migraines). At the time of the report, MIGRAINE (Migraines) had not resolved.            No concomitant product use was reported.  The patient stated that due to the weather patient was having migraines and wanted to know if a migraine medication with codeine would interfere with the vaccine as patient received the bivalent booster on 24-Oct-2022 in the morning.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell down/fell down at home again/fell down twice; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down/fell down at home again/fell down twice) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell down/fell down at home again/fell down twice). At the time of the report, FALL (fell down/fell down at home again/fell down twice) outcome was unknown.     No concomitant medications was reported. The reporter states that, the patient fell down. The patient had to go to the hospital. Then on the way back from hospital, patient fell down at home again. Patient also took the last booster. No treatment medications was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nasopharyngitis
Clinical narrative: Feel like I have a cold; Hoarse voice; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice). At the time of the report, NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication provided.  Patient called with a hoarse voice and apologized saying it was due to the COVID shot. Feels like a cold as well.  No treatment information mentioned.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Macule, Pruritus, Skin disorder, Skin exfoliation
Clinical narrative: skin changes after Moderna Bivalent vaccine; 4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area; It was dry; scaly texture; patient feels warm; patient feels itchy/spreading; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture) and SKIN WARM (patient feels warm) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading). The patient was treated with BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was a healthy with no known allergy or skin issues. HCP stated that he had never seen such reaction before because the vaccine was new. Concomitant medications were not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: skin changes after Moderna Bivalent vaccine; 4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area; It was dry; scaly texture; patient feels warm; patient feels itchy/spreading; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture) and SKIN WARM (patient feels warm) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading). The patient was treated with BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was a healthy with no known allergy or skin issues. HCP stated that he had never seen such reaction before because the vaccine was new. Concomitant medications were not reported.
Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Psoriasis, Pyrexia
Clinical narrative: upset stomach a couple doses back; after injection he was running a fever; Psoriasis flare; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare), ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 06-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever). In March 2021, the patient experienced PSORIASIS (Psoriasis flare). At the time of the report, PSORIASIS (Psoriasis flare), ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever) was resolving.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient had never experienced any symptoms or flares prior to the Covid vaccine. A few days after his first dose he broke out in a major flare. Physician advised him that he was either a carrier or he wasn't.  No treatment information was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fall, Malaise, Syncope
Clinical narrative: Fainted twice; Fell on the floor; Feels out of sorts; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainted twice) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 24-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. In October 2022, the patient experienced MALAISE (Feels out of sorts). On 25-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced SYNCOPE (Fainted twice) (seriousness criterion medically significant) and FALL (Fell on the floor). At the time of the report, SYNCOPE (Fainted twice), FALL (Fell on the floor) and MALAISE (Feels out of sorts) outcome was unknown.            The patient was not taking any medications for any conditions. Patient received first dose on 22-Mar-2021 with Lot number 939903 and second dose on 21-Apr-2021. Patient got the Moderna booster and the flu shot at the same time. Patient got the high dose flu shot. Patient says she was told to really hydrate and take it easy. Patient felt great last night. Patient was not really dizzy but just feels out of sorts.  Patient put ice on her forehead and toes.  No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 70-year-old female patient with no reported medical history, who experienced the expected serious (medically significant) event of syncope among other non-serious events. The event occurred 2 days after the third dose of mRNA-1273.222 vaccine. It is reported that patient took Flu vaccine at the same time. Patient reported that she fainted twice. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no reported medical history, who experienced the expected serious (medically significant) event of syncope among other non-serious events. The event occurred 2 days after the third dose of mRNA-1273.222 vaccine. It is reported that patient took Flu vaccine at the same time. Patient reported that she fainted twice. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness in his arm; swelling in his arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (itchiness in his arm) and VACCINATION SITE SWELLING (swelling in his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness in his arm) and VACCINATION SITE SWELLING (swelling in his arm). At the time of the report, VACCINATION SITE PRURITUS (itchiness in his arm) and VACCINATION SITE SWELLING (swelling in his arm) outcome was unknown.            Concomitant medication was not reported. Treatment drug was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Immunisation reaction
Clinical narrative: Had minor reactions to each of those shots; Diagnosed with alpha-gal allergy in July 2022; This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022) and IMMUNISATION REACTION (Had minor reactions to each of those shots) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022). On an unknown date, the patient experienced IMMUNISATION REACTION (Had minor reactions to each of those shots). At the time of the report, FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022) and IMMUNISATION REACTION (Had minor reactions to each of those shots) outcome was unknown.            It was reported that patient could not eat red meat because of this condition. Patient wanted to know if the vaccine contained materials of animal origin.  Patient stated that she was planning to get her Pfizer COVID-19 Bivalent booster dose for Omicron on Thursday 27-Oct-2022. Patient had Alpha Gal allergy but never had anaphylaxis. Patient talked about how rare the disorder was and out of the small percentage of the population with this allergy a smaller percentage react negatively to the bone char. Patient was aware that the product does contain sucrose and wanted to verify if the sucrose has been filtered with the Bone Char. Patient stated that she was previously vaccinated but with Moderna and had minor reactions to each of those shots, however this was prior to her being diagnosed with Alpha Gal as well.  Patient did note that it was scary enough already that animal derived products were used in production, although noted to not be in the final end product. The patient did request to have further specified in regards with the Bone Char.  No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow-up document received on 26-Oct-2022 from Pfizer with Event added and I-narrative supplement updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm which she has gotten with all her vaccinations.; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm which she has gotten with all her vaccinations.) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.     The patient had no allergies. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine. There were no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No Medical History information was reported.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm which she has gotten with all her vaccinations.). At the time of the report, PAIN IN EXTREMITY (sore arm which she has gotten with all her vaccinations.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient had dose 1 on 17 Mar 2021 with Lot number as 047A21A via unknown route and dose 2 on 14 Apr 2021 with lot number as 040B21A via unknown route. No treatment medication reported.   This case was linked to MOD-2022-656967, MOD-2022-656961 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no known allergies.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) single dose pen. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   The reporters causality for event of pain with Adalimumab solution for injection was reasonable possibility (probable).   It was unknown if patient was enrolled in a clinical trial.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Odynophagia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Voice is Hoarse; Hurts to swallow; Had a sore throat and became worse throughout the day; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day), DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (fourth dose) on 06-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Oct-2022, the patient experienced OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day). On 25-Oct-2022, the patient experienced DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Had a sore throat and became worse throughout the day), DYSPHONIA (Voice is Hoarse) and ODYNOPHAGIA (Hurts to swallow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2022, SARS-CoV-2 test: Negative.         No concomitant medications were provided. The patient had received 5 doses of COVID-19 vaccines by intramuscular injection. Patient received her first dose on 17-Mar-2021 with lot number 031A21A, second dose on 14-Apr-2021 with lot number 029A21A, third dose on 3-Nov-2021with lot number 032F21A and fourth dose Pfizer on 6-Apr-2022.  The patient was out of the country and returned last week Monday. Patient tested negative for COVID-19 on Tuesday prior to receiving her most recent vaccine on Saturday. Patient has been taking acetaminophen and ibuprofen.