chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received his 1st dose of Shingrix vaccine 3 years prior to the reporting.) and Covid vaccine (after this vaccine patient got the Covid vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The reporter stated that the patient had his first shot of Shingrix vaccine 3 years prior to the reporting and after this vaccine, the patient had got the Covid vaccine. Reporter stated that the patient did not completed his Shingrix vaccine series. No information was provided for the patient (demographics) or about the vaccine. The reporter had consented to follow-up. Additional supportive information: Until the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving Engerix B and Engerix B 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: 06-OCT-2022 Reporter's Comment: The medical assistant reported that a dose of Engerix B inadvertently given to the patient and it was already expired.  The health care professional declined to provide additional information.  The reporter reported that the patient was a employee. The reporter did not consent to follow up.  Additional Supportive Information: The use of Engerix B dose, which was already expired on 11th September 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant not  reconstitutied with lyophilized component; Onlyliquid adjuvant portion administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) (batch number 99AG4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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: 07-OCT-2022 Reporter's Comment: The registered nurse did not had expiry date on hand at the time of call. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up via email. Additional Supportive Information: The patient was administered the liquid adjuvant portion of Shingrix without reconstituting it with the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site rash, Rash
Clinical narrative: Rash down the arm/Rash around injection site; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and allergic reaction. On an unknown date, the outcome of the rash and allergic reaction were unknown.   It was unknown if the reporter considered the rash and allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comment: Pharmacist reported that the patient had an allergic reaction following the first dose of Shingrix and experienced a rash on around the injection site and down the arm. Pharmacist called to inquired for Shingrix and asked what level of protection the patient would have after only receiving the first dose. The reporter unable to provide any vaccine or patient details. The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain at the injection site; Heat at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Shingrix. On 7th October 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and experienced pain, heat and redness at the injection site. The reporter gave medical disclaimer and referred to health care professional. The reporter spoke per package insert and content and after call survey offered package insert. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2019, 2nd dose in 2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number AY7BP, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose in November 2019).   On 11th October 2022, the patient received the 2nd dose of Shingrix. On 11th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The pharmacy intern reported that the patient did not back for second dose until the date of reporting. The reporter did not had the exact date of the first dose, nor the lot number/expiration date information. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct2019, 2nd 11Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose intramuscularly in October 2019).   On 11th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The pharmacist  gave consent to follow-up by GlaxoSmithKline. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT NEAR LIVER; This spontaneous report received from a consumer via other manufacturer (Abbvie) concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot near liver and was hospitalized (date unspecified). This happened after covid shot. Number of days of hospitalization was unknown. Patient agreed to have MD contacted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from blood clot near liver. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221022007-COVID-19 VACCINE AD26.COV2.S- Blood Clot near liver. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSES OF COVID-19 VACCINE EXPERIENCED TEMPERATURE EXCURSION AND WAS ADMINISTERED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional 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 not reported, batch number: 202F21A expiry: 07-FEB-2023) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced doses of covid-19 vaccine experienced temperature excursion and was administered, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses of covid-19 vaccine experienced temperature excursion and was administered and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Crohn's and Arthritis. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Crohn's and Arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient developed signed and symptoms that lead to a positive COVID test on 16Aug 2022. They were trying to get more clarity if there were further information to support how far after infection a patient who may have these immune variables should wait until getting the bivalent booster (ie the standard recommended at least 3 month wait or possibly sooner if these variables had any evidence of lesser/shorter immune response). Patient had extreme anxiety about how to proceed and what the best way to proceed would be.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Immunisation reaction
Clinical narrative: Had a slight response but was over in a day. Felt worse after senior Flu Shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot). At the time of the report, IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot) outcome was unknown.            No relevant concomitant medications were reported.  Bivalent booster shot was Moderna and was 0.5ml compared to 0.25ml for the previous booster shot. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm swelling; pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (pain in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Benign thyroid nodule and Thyroidectomy (Thyroid removed because she had a benign mass) in 1997. Previously administered products included for Product used for unknown indication: Synthroid (Still had parathyroid Been on Synthroid for many years). Past adverse reactions to the above products included No adverse event with Synthroid. Concurrent medical conditions included Arthritis (Thinks diagnosed in 1995, but is not sure, gets MRIs for back and hips and things like that) since 1995.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (pain in arm). At the time of the report, PERIPHERAL SWELLING (arm swelling) outcome was unknown and PAIN IN EXTREMITY (pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.   Treatment medication was not reported.   This case was linked to MOD-2021-034561 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product monitoring error
Clinical narrative: After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes'; no adverse event; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Oct-2022 and was forwarded to Moderna on 11-Oct-2022.    This spontaneous case was reported by a patient and describes the occurrence of PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event) in a male 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 PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant information provided  Patient was interested to read this leaflet for two reasons. It started that Read all of this leaflet before you receive the vaccine. Patient was given it after receiving the vaccine. It said that during and after each injection of the vaccine, your doctor, nurse, or pharmacist will watch over you for at least 15 minutes. After the vaccine patient was asked if he drove to the vaccination center  On patients reply of yes patient was told to wait in car for 15 minutes. It seemed the vaccination center was not reading the same leaflet.  No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Up all night; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (Up all night) in a male 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 vaccination.     No Medical History information was reported.    On 10-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 10-Oct-2022, the patient experienced INSOMNIA (Up all night). At the time of the report, INSOMNIA (Up all night) outcome was unknown.            Patient was taking unspecified concomitant medication. He received the booster dose. He did not take any treatment medications.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Neck pain
Clinical narrative: Side of her neck is a little sore; Side of her neck is a little sore (Lymph nodes); This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (Side of her neck is a little sore (Lymph nodes)) and NECK PAIN (Side of her neck is a little sore) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Side of her neck is a little sore (Lymph nodes)) and NECK PAIN (Side of her neck is a little sore). At the time of the report, LYMPH NODE PAIN (Side of her neck is a little sore (Lymph nodes)) and NECK PAIN (Side of her neck is a little sore) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that she was schedule to receive the bivalent shot this afternoon. She stated the side of her neck is a little sore (Lymph nodes). She has no fever, no sore throat, and no headache. She wanted to know can she received the Moderna bivalent booster.  No treatment details reported.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen sclerosus
Clinical narrative: Lichens sclerosis; This spontaneous case was reported by a patient and describes the occurrence of LICHEN SCLEROSUS (Lichens sclerosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Flu vaccine (in fall) in 2020 and Flu vaccine (in fall) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine and Flu vaccine. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Hypercholesterolaemia (No changes noticed after vaccination, condition present before vaccination), Arrhythmia (No changes noticed after vaccination, condition present before vaccination) and Arthritis (No changes noticed after vaccination, condition present before vaccination). Concomitant products included SIMVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced LICHEN SCLEROSUS (Lichens sclerosis). At the time of the report, LICHEN SCLEROSUS (Lichens sclerosis) outcome was unknown.            Concomitant medications also included Hidrcor and Clovividol.  For dose 1, the site of vaccination was provided as deltoid muscle. It was reported that the patient thought that the side effect of Lichens Sclerosis might be a side effect of the vaccine because of increased immune activity and enquired whether it was related or not. The patient was referred to a healthcare professional.  No treatment information was provided.   This case was linked to MOD-2022-657551 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Hypophagia, Illness, Pyrexia
Clinical narrative: Quite sick; she had a fever; Stay in bed for 2 days; Did not eat or drink for 2 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Quite sick), BEDRIDDEN (Stay in bed for 2 days), HYPOPHAGIA (Did not eat or drink for 2 days) and PYREXIA (she had a fever) in a 90-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 vaccination.     Concurrent medical conditions included Drug allergy.    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 ILLNESS (Quite sick), BEDRIDDEN (Stay in bed for 2 days), HYPOPHAGIA (Did not eat or drink for 2 days) and PYREXIA (she had a fever). At the time of the report, ILLNESS (Quite sick) and PYREXIA (she had a fever) outcome was unknown and BEDRIDDEN (Stay in bed for 2 days) and HYPOPHAGIA (Did not eat or drink for 2 days) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B, 025J20-2A, 024M20A and 032F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.).    No adverse reactions reported after receiving first, second dose of primary series and first, second booster dose of vaccine. No treatment drug was reported.   This case was linked to MOD-2022-657575 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over body; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash all over body) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A(Sor5)7147B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid19 vaccines (previous had all Pfizer Covid19 vaccines.). Past adverse reactions to the above products included No adverse event with Pfizer Covid19 vaccines.    On 06-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 an unknown date, the patient experienced RASH (rash all over body). The patient was treated with TRIAMCINOLONE ongoing since an unknown date at a dose of 0. 1 percent. At the time of the report, RASH (rash all over body) outcome was unknown.            Patient had no known allergies. Patient was not taking any other medications for any health conditions.  Patient went to a dermatologist and they prescribed Triamcinolone Cream 0.1 percent..
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022; No adverse event; Received the Moderna Covid 19 vaccine after the 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     The patient had no allergy.     On 11-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after the 30-day use by date.) and PRODUCT STORAGE ERROR (The vial was initially on 07-Sep-2022 and administered on 11-Oct-2022).    No concomitant medications were reported.  The monovalent vaccine was initially stored on 07-Sep-2022. The vial size was 2.5 ml. The vial did not underwent any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657740 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657740:Same Reporter
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUA4, PNC20
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Minor Allergic reaction:  Swelling below the injection site, hot, red hard and itching.  This occurred around 8pm the following day (Saturday).  I took  one Benadryl capsule that night and took 2 Zrytec Sunday morning and another Benadryl.  On Monday morning it was better, but a red ring was forming around my arm and it still itched.  I sought care at Urgent Care.  The nurse practioner administered a steriod injection, Dex.  It helped, but the itching and redness continued for several days, but was improving each day.  I believe my reaction was caused by the Prevnar injection.  Rite Aid stacked my injections in the left arm,  the top injection was the senior flu vaccine, followed by the Covid injection and lastly by Prevnar.  The swelling and redness occurrred below the prevnar injection.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUA4, PNC20
Symptoms: Injection site warmth
Clinical narrative: Minor Allergic reaction:  Swelling below the injection site, hot, red hard and itching.  This occurred around 8pm the following day (Saturday).  I took  one Benadryl capsule that night and took 2 Zrytec Sunday morning and another Benadryl.  On Monday morning it was better, but a red ring was forming around my arm and it still itched.  I sought care at Urgent Care.  The nurse practioner administered a steriod injection, Dex.  It helped, but the itching and redness continued for several days, but was improving each day.  I believe my reaction was caused by the Prevnar injection.  Rite Aid stacked my injections in the left arm,  the top injection was the senior flu vaccine, followed by the Covid injection and lastly by Prevnar.  The swelling and redness occurrred below the prevnar injection.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Inflammation
Clinical narrative: Severe back pain, sore hips, shoulders, inflamed chest wall
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arrhythmia, Chest pain, Echocardiogram abnormal, Electrocardiogram, Pericardial fibrosis
Clinical narrative: Pericarditis. Awoke day after vaccine with chest pain, tachycardia, and arrythmia. Echocardiogram shows thickening of pericardium. Unknown whether this is permanent damage, but I understand it to be. Awaiting an MRI next week for more details. I had no adverse reaction to previous three vaccines.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pericarditis, Tachycardia
Clinical narrative: Pericarditis. Awoke day after vaccine with chest pain, tachycardia, and arrythmia. Echocardiogram shows thickening of pericardium. Unknown whether this is permanent damage, but I understand it to be. Awaiting an MRI next week for more details. I had no adverse reaction to previous three vaccines.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arrhythmia, Chest pain, Echocardiogram, Heart rate, Pericardial fibrosis
Clinical narrative: Pericarditis. Awoke day after vaccine with chest pain, tachycardia, and arrythmia. Echocardiogram shows thickening of pericardium. Unknown whether this is permanent damage, but I understand it to be. Awaiting an MRI next week for more details. I had no adverse reaction to previous three vaccines.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue / experienced with previous vaccines; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue / experienced with previous vaccines) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Latex allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Jan-2022, 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 experienced FATIGUE (Fatigue / experienced with previous vaccines). At the time of the report, FATIGUE (Fatigue / experienced with previous vaccines) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had not been diagnosed with tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Patient had no chronic or long-standing health conditions.  The event did not cause the patient to seek medical care.  The patient had experienced similar adverse event in the past and had other potential causes for the event.  Treatment information was not provided.   This case was linked to MOD-2022-654685.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac stress test, Echocardiogram abnormal, Heart rate increased, Mass
Clinical narrative: The next day after the shot on 08/10/2021 i had a big lump behind my head that lasted 3 weeks. Also i started having heart issues. The heart issues got worse within time. To where I ended up in the hospital multiple times. On 10/09/2022 i ended up in the hospital and got diagnosed with SVT. Heart rate of 247. I'm seeing a cardiologist  and now they are talking about possible surgery.  I rapid heart rates about 5 times a week all in the range of 130 and above.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: The next day after the shot on 08/10/2021 i had a big lump behind my head that lasted 3 weeks. Also i started having heart issues. The heart issues got worse within time. To where I ended up in the hospital multiple times. On 10/09/2022 i ended up in the hospital and got diagnosed with SVT. Heart rate of 247. I'm seeing a cardiologist  and now they are talking about possible surgery.  I rapid heart rates about 5 times a week all in the range of 130 and above.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Fatigue, Muscle spasms
Clinical narrative: Significant lower back pain and muscle spasms, fatigue
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Amnesia, Arthralgia, Ataxia, Back pain, Blood test
Clinical narrative: Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Computerised tomogram, Dizziness, Dysphagia, Echocardiogram, Electrocardiogram
Clinical narrative: Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Electrocardiogram ambulatory, Fatigue, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Magnetic resonance imaging, Muscular weakness, Neck pain, Photophobia, Presyncope
Clinical narrative: Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Syncope, Tilt table test, X-ray
Clinical narrative: Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Imaging procedure, Laboratory test normal, Portal vein thrombosis, Ultrasound biliary tract abnormal
Clinical narrative: Developed portal vein thrombosis. Clot was discovered incidentally during a gallbladder ultrasound.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reactions are noted or reported during 15 minute observation period
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Aphonia, Chills, Dyspnoea, Impaired work ability, Influenza like illness
Clinical narrative: Roughly 2 weeks after taking the Flu vaccine at my work place, I became very sick with congestions,  chills and all the flu-like symptoms. could hardly speak out for days, because I lost my voice-- my management at work will testify to this. Initially, the cough was dry-- could not cough-it out, I took over the counter cough tablets and syrups, with pain relievers to decongest my self. currently, I still feel sick. This was not the first time I have experienced this.  in 2019, about 2 weeks after the flu-vaccine, I had shortness of breath, in 2021, I had serious congestions and coughs, I react to this vaccine, but it is mandatory at my work place, but it is also affecting my productivity.
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Malaise, Respiratory tract congestion, Speech disorder
Clinical narrative: Roughly 2 weeks after taking the Flu vaccine at my work place, I became very sick with congestions,  chills and all the flu-like symptoms. could hardly speak out for days, because I lost my voice-- my management at work will testify to this. Initially, the cough was dry-- could not cough-it out, I took over the counter cough tablets and syrups, with pain relievers to decongest my self. currently, I still feel sick. This was not the first time I have experienced this.  in 2019, about 2 weeks after the flu-vaccine, I had shortness of breath, in 2021, I had serious congestions and coughs, I react to this vaccine, but it is mandatory at my work place, but it is also affecting my productivity.
Age: 36.0
Sex: U
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, Lethargy, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: Positive for Covid; Lethargy; Fever; Redness and pain at the injection site; Redness and pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid), LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Lot No EP7533) on 02-Apr-2021 and Pfizer (Lot No ER8735) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site). On 14-Jun-2022, the patient experienced COVID-19 (Positive for Covid). In 2021, LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) had resolved. At the time of the report, COVID-19 (Positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications were not reported.  Patient had regular symptoms observed like fever, lethargy, redness and pain at the injection site for a couple of days. Patient had no allergic reactions in any of the vaccines before. Patient had symptoms as coughing and shortness of breath. Patient was not hospitalized or anything but had a rough case for a week and had to use an inhaler and other medications to improve coughing and shortness of breath.   This case was linked to MOD-2022-657728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow-up received contains no new information
Age: 36.0
Sex: U
Vaccine: COVID19, COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Positive for Covid; Lethargy; Fever; Redness and pain at the injection site; Redness and pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid), LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Lot No EP7533) on 02-Apr-2021 and Pfizer (Lot No ER8735) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site). On 14-Jun-2022, the patient experienced COVID-19 (Positive for Covid). In 2021, LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) had resolved. At the time of the report, COVID-19 (Positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications were not reported.  Patient had regular symptoms observed like fever, lethargy, redness and pain at the injection site for a couple of days. Patient had no allergic reactions in any of the vaccines before. Patient had symptoms as coughing and shortness of breath. Patient was not hospitalized or anything but had a rough case for a week and had to use an inhaler and other medications to improve coughing and shortness of breath.   This case was linked to MOD-2022-657728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow-up received contains no new information