chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received her second Shingrix shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2nd dose received 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received her second Shingrix shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The pharmacist reported that a female customer just informed her that she never received her second Shingrix shot. The patient had the first shot over 2 years ago.  No further details were obtained as pharmacist wanted to get her call transferred to GlaxoSmithKline medical information department. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Pt is 37 weeks pregnant.; Pt was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received Arexvy (intramuscular, left arm). On 05-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Pt was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pt is 37 weeks pregnant.). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 02-NOV-2023 The patient was 37 weeks pregnant.  The patient did not have any adverse reaction after vaccine was administered. The patient was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy, which led to wrong vaccine administration. A35 year old patient received Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pharmacist calling requesting data on the administration of 3 doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Pharmacist calling requesting data on the administration of 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist requested data on the administration of 3 doses of Shingrix.  She stated that she believed some years back a patient may had received a 3rd dose of Shingrix, but was not totally certain. The health care professional (HCP) had no additional details regarding the event. Declined follow up as she could not remember all the details of the event. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 02-NOV-2023, the patient received Boostrix. On 02-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired drug used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired drug used was unknown.   Additional Information: GSK receipt date: 03-NOV-2023 The Medical Assistant reported they inadvertently administered an expired Boostrix (expiry 27th October 2023) dose to a patient yesterday on 2nd November 2023, which led expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was given a dose of SHINGRIX with only the adjuvant component; patient was given a dose of SHINGRIX with only the adjuvant component; This non-serious case was reported by a pharmacist 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 an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given a dose of SHINGRIX with only the adjuvant component) and inappropriate dose of vaccine administered (Verbatim: patient was given a dose of SHINGRIX with only the adjuvant component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-NOV-2023 The reporter stated that a patient was given a dose of Shingrix with only the adjuvant component. The patient was not given the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: HPV9
Symptoms: Immunosuppression, Incomplete course of vaccination, Induration, Rash
Clinical narrative: patient is currently immunosuppressed; hard, painful rash down the injected arm for several weeks; Patient never finished the GARDASIL 9 series.; This spontaneous report was received from nurse and refers to female patient who was 34-year-old at the reporting time. The patient concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2015, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) into arm as a routine vaccination (strength, dose, frequency, route of administration, lot#, expiry date were not reported).  On an unknown date, the patient experienced a hard, painful rash down the injected arm for several weeks. Moreover, patient never finished the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (Incomplete course of vaccination). Healthcare professional (HCP) also stated that patient was immunosuppressed at the reporting time. On an unknown date, the patient recovered from rash (also reported as the rash subsided after a few weeks). The outcome of immunosuppression was not reported. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was drug withdrawn.  The reporter considered that immunosuppression was not related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The causal relationship between rash and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event immunosuppression was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine and the reported event of immunosuppression cannot be established. Additional information regarding the patient's medical history, concurrent conditions, concomitant therapies, clarification of vaccination date, event onset date, the detailed clinical course, diagnostic workup results, and outcome is needed for further assessment.  Company Comment- No changes to the GARDASIL 9 product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a physician concerned an elderly 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, start therapy date were not reported, 1 total was 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 experienced stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231110448-Stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Hypoacusis, Pain, Presyncope
Clinical narrative: chills; aches; I feel faint; had a lump form at the site of injection; now it's just sore/ vaccination site sore; I believe my reaction was due to the manner in which it was administered; lump form at the site of injection immediately and it bled; shaky; Sweat; hearing gets muffled; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled) and PAIN (aches) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203G23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Oct-2023, the patient experienced VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled), PRESYNCOPE (I feel faint), VACCINATION SITE MASS (had a lump form at the site of injection), VACCINATION SITE PAIN (now it's just sore/ vaccination site sore) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (I believe my reaction was due to the manner in which it was administered). On 31-Oct-2023, the patient experienced PAIN (aches) and CHILLS (chills). At the time of the report, VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled), PRESYNCOPE (I feel faint) and VACCINATION SITE MASS (had a lump form at the site of injection) had resolved, PAIN (aches), CHILLS (chills) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (I believe my reaction was due to the manner in which it was administered) outcome was unknown and VACCINATION SITE PAIN (now it's just sore/ vaccination site sore) had not resolved.            No concomitant medication was reported.  Patient reported that, after receiving Spikevax, the pharmacist seemed to have trouble with the injection. Patient had a lump formed at the site of injection immediately and it bled. Patient sometimes have trouble when giving blood. Patient got shaky, sweat, hearing gets muffled, and felt faint. This happened when patient received the vaccine.  Although, patient believed the reaction was due to the manner in which it was administered and his/her reaction to it, patient wanted to be sure and report it. Patient sat for several minutes and had some juice and was able to walk around the store for 10 minutes and then went home. On the reporting day, patient had had some chills and aches, but the injection site was fine. The lump went down and now it was just sore.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vaccination site haemorrhage, Vaccination site mass, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: chills; aches; I feel faint; had a lump form at the site of injection; now it's just sore/ vaccination site sore; I believe my reaction was due to the manner in which it was administered; lump form at the site of injection immediately and it bled; shaky; Sweat; hearing gets muffled; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled) and PAIN (aches) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203G23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Oct-2023, the patient experienced VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled), PRESYNCOPE (I feel faint), VACCINATION SITE MASS (had a lump form at the site of injection), VACCINATION SITE PAIN (now it's just sore/ vaccination site sore) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (I believe my reaction was due to the manner in which it was administered). On 31-Oct-2023, the patient experienced PAIN (aches) and CHILLS (chills). At the time of the report, VACCINATION SITE HAEMORRHAGE (lump form at the site of injection immediately and it bled), TREMOR (shaky), HYPERHIDROSIS (Sweat), HYPOACUSIS (hearing gets muffled), PRESYNCOPE (I feel faint) and VACCINATION SITE MASS (had a lump form at the site of injection) had resolved, PAIN (aches), CHILLS (chills) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (I believe my reaction was due to the manner in which it was administered) outcome was unknown and VACCINATION SITE PAIN (now it's just sore/ vaccination site sore) had not resolved.            No concomitant medication was reported.  Patient reported that, after receiving Spikevax, the pharmacist seemed to have trouble with the injection. Patient had a lump formed at the site of injection immediately and it bled. Patient sometimes have trouble when giving blood. Patient got shaky, sweat, hearing gets muffled, and felt faint. This happened when patient received the vaccine.  Although, patient believed the reaction was due to the manner in which it was administered and his/her reaction to it, patient wanted to be sure and report it. Patient sat for several minutes and had some juice and was able to walk around the store for 10 minutes and then went home. On the reporting day, patient had had some chills and aches, but the injection site was fine. The lump went down and now it was just sore.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: Itching; Fever; extreme headaches; Chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection). At the time of the report, PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 3rd patient out of 5 patients as described by the reporter.  Concomitant and treatment medications were not reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects. Three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748404, US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received that contains significant information: Batch number and event details were updated. On 03-Nov-2023: Live follow-up received that contains non-significant information: Reporter information and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Patient 1 out of 3 US-MODERNATX, INC.-MOD-2023-748404:same reporter Patient 5 US-MODERNATX, INC.-MOD-2023-748403:same reporter Patient 4 US-MODERNATX, INC.-MOD-2023-748342:same reporter Patient 2 US-MODERNATX, INC.-MOD-2023-748215:Reporters case
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: about hour later was rushed to hospital with seizure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Nov-2023 and was forwarded to Moderna on 06-Nov-2023.      This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (about hour later was rushed to hospital with seizure) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2022, the patient experienced SEIZURE (about hour later was rushed to hospital with seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in January 2022 due to SEIZURE. At the time of the report, SEIZURE (about hour later was rushed to hospital with seizure) outcome was unknown.            No concomitant medications were reported.  It was reported that about a year ago patient had vaccine and about hour later was rushed to hospital with seizure. Had 4 seizures in a month after the vaccine. Patient states it was the Moderna vaccine and patient was afraid to get another vaccine because of that. Patient was in the hospital for 5 days and they did tests on Went to the emergency room a couple times. Patient states got the vaccine some time in Jan-2022 and had 4 seizures early Feb-2022 also patient had same shot and had no problem.  No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient (unknown gender and unknown age), with no medical history reported, who experienced the unexpected, serious (medically significant and hospitalization) AESI seizure. The event was described as occurring "about one hour" after an unspecified dose number of Spikevax NOS (COVID-19 Vaccine, mRNA). The report stated that the patient was hospitalized for 5 days and that the patient also had 4 seizures in the month after the vaccine which required going to the emergency room a couple times No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax NOS (COVID-19 Vaccine, mRNA) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Corneal disorder
Clinical narrative: the patient was scheduled for a corneal transplant on 28-NOV-2023; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL DISORDER (the patient was scheduled for a corneal transplant on 28-NOV-2023) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Corneal transplant (The patient reported that he had 5 corneal transplants before and he was prescribed steroids to prevent graft-host rejection.).   On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CORNEAL DISORDER (the patient was scheduled for a corneal transplant on 28-NOV-2023). At the time of the report, CORNEAL DISORDER (the patient was scheduled for a corneal transplant on 28-NOV-2023) outcome was unknown. Not Provided          No Concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid within the last 2 years; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine.  Treatment information was not provided.  This case contains information about patient 2nd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748503:Master case (patient 1)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid within the last 2 years; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine. No treatment information was provided. This case is reported for patient 3 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748503:Master case (patient 1)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 013F21A, 016B21A and 029A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LATANOPROST for Ocular discomfort.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 04-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 16-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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-Jul-2022, SARS-CoV-1 test: Positive.         No treatment information was reported.   This case was linked to MOD-2023-747291 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Off label use, Renal pain, Retching
Clinical narrative: Kidneys were also hurting too; burning sensation; OFF label use; she had heaves for a little bit; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation), RENAL PAIN (Kidneys were also hurting too), OFF LABEL USE (OFF label use) and RETCHING (she had heaves for a little bit) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (lot number 025520-2A) on 07-Jan-2021, COVID-19 Vaccine (lot number 008C214) on 19-Oct-2021 and Flu shot 1 week ago; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (lot number 029L20A) on 08-Feb-2021 and Moderna bivalent (lot number AS7165B) on 05-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 vaccine, Flu shot 1 week ago, Moderna COVID-19 vaccine and Moderna bivalent.    On 02-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OFF LABEL USE (OFF label use). On 02-Nov-2023 at 8:00 PM, the patient experienced BURNING SENSATION (burning sensation). On an unknown date, the patient experienced RENAL PAIN (Kidneys were also hurting too) and RETCHING (she had heaves for a little bit). At the time of the report, BURNING SENSATION (burning sensation), RENAL PAIN (Kidneys were also hurting too) and RETCHING (she had heaves for a little bit) had resolved and OFF LABEL USE (OFF label use) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had no medications or treatments taken. She felt like she needed to get an antiacid pill and also felt that her symptoms were due to the quantity of dose that she received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Injection site erythema, Injection site pain
Clinical narrative: The next day 3 of them had called out sick from work.; itching; The site of the injection, the redness has widened; fever; headaches; chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever) and HEADACHE (headaches) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Nov-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection). At the time of the report, ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that five other employees that were given shot same morning all having had adverse side effects, three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748404 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live significant follow up received: Batch/lot number, new events and reference numbers were added. On 06-Nov-2023: Non-significant information received: Reporter details and reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748342:Patient 2 out of 3 US-MODERNATX, INC.-MOD-2023-748352:Patient 3 out of 3 US-MODERNATX, INC.-MOD-2023-748215:Reporter's case US-MODERNATX, INC.-MOD-2023-748404:Patient 5
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: The next day 3 of them had called out sick from work.; itching; The site of the injection, the redness has widened; fever; headaches; chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever) and HEADACHE (headaches) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Nov-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection). At the time of the report, ILLNESS (The next day 3 of them had called out sick from work.), PRURITUS (itching), INJECTION SITE ERYTHEMA (The site of the injection, the redness has widened), PYREXIA (fever), HEADACHE (headaches), CHILLS (chills) and INJECTION SITE PAIN (very sore at site of injection) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that five other employees that were given shot same morning all having had adverse side effects, three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748404 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live significant follow up received: Batch/lot number, new events and reference numbers were added. On 06-Nov-2023: Non-significant information received: Reporter details and reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748342:Patient 2 out of 3 US-MODERNATX, INC.-MOD-2023-748352:Patient 3 out of 3 US-MODERNATX, INC.-MOD-2023-748215:Reporter's case US-MODERNATX, INC.-MOD-2023-748404:Patient 5
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: T-cell lymphoma
Clinical narrative: Angioimmunoblastic T-cell lymphoma and underwent chemotherapy; This spontaneous case was reported by a consumer and describes the occurrence of T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma and underwent chemotherapy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma and underwent chemotherapy) (seriousness criteria death and medically significant). The reported cause of death was angioimmunoblastic t-cell lymphoma and underwent chemotherapy and Rash. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported. Date of death was reported as 09-Aug-2022. After five months of horrific, nightmarish ordeal, our beloved husband, father, and brother died of this aggressive, vaccine-induced cancer. It is unknown if the patient experienced any additional symptoms/events. Patient has 1st dose of Moderna vaccine (received both shots a month apart).  Additionally reported events vaccine-induced cancer, rash over the legs and body, pain sensation/Swollen neck with pain developed, facial numbness, tingling and enlarged lymph nodes were considered as signs and symptoms of the final diagnosis Angioimmunoblastic T-cell lymphoma.  Company Comment: This is a Spontaneous case concerning a 59-year-old male patient with no medical history reported, who experienced the fatal unexpected event of T-cell lymphoma (Angioimmunoblastic T-cell lymphoma) (medically significant) which occurred on the same day after a dose of mRNA-1273 received as the first dose for COVID-19 Vaccination. It was reported that after vaccination the patient experienced events of rash over the legs and body, pain sensation/Swollen neck with pain developed, facial numbness, tingling and enlarged lymph nodes which were considered as signs and symptoms of the final diagnosis Angioimmunoblastic T-cell lymphoma. It was also reported as a vaccine-induced cancer. The patient received chemotherapy (not specified) and died after 5 months. The reported cause of death was angioimmunoblastic t-cell lymphoma and underwent chemotherapy and Rash. It was unknown if an autopsy was performed. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Angioimmunoblastic T-cell lymphoma and underwent chemotherapy; Rash
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: dermatographia; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (dermatographia) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis.     The patient did not report any medical history or condition. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1, batch no- EN5318) on 29-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 2, batch no-GV6201) on 21-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 3, batch no-3D1308A) on 31-Aug-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 4, batch no-FK9896) on 13-Feb-2022, PFIZER BIONTECH COVID-19 VACCINE (dose 5, batch no-GH9702) on 08-Sep-2022, PFIZER BIONTECH COVID-19 VACCINE (dose 6, batch no-GJ3670) on 12-May-2023, INFLUENZA VACCINE in September 2023 and RSV in September 2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and RSV.    On 16-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced MECHANICAL URTICARIA (dermatographia). The patient was treated with PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (dermatographia) was resolving.            No concomitant medication was reported. The dosage text was reported as unknown. The patient had been having symptoms for 3 weeks and a solid 2 weeks of the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: had a shot yesterday for the vaccine and I'm having chest pains; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 05-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains). At the time of the report, CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Dosage text for suspect product was given as Unknown,  Treatment medication not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Migraine with aura
Clinical narrative: migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue; Her taste bud feels off; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1st dose 077M20A) on 27-Jan-2021, Moderna COVID-19 vaccine (2nd dose 001A21A) on 24-Feb-2021 and Moderna COVID-19 vaccine (3rd dose 033F21A) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 21-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off). At the time of the report, MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off) had not resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Caller stated they got the 2023 COVID-19 vaccine she had very strange symptoms. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 70-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of Ageusia, which occurred within the first 2 weeks after SPIKEVAX 2023-2024 vaccine, administered as fourth dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19/ had little fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ had little fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013F21A, 020B21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-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 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (covid 19/ had little fever). At the time of the report, COVID-19 (covid 19/ had little fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2023, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  It was reported that patient was taking care of her husband who was a cancer patient. She was concerned that she will transmit the COVID to her sick husband. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID three days after getting the booster shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID three days after getting the booster shot) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID three days after getting the booster shot). At the time of the report, COVID-19 (tested positive for COVID three days after getting the booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received. Reference numbers updated.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Biopsy breast, Biopsy lymph gland, Injection site hypoaesthesia, Injection site pain
Clinical narrative: I am still experiencing some numbness and pain in my left arm, where I received the vaccination; I am still experiencing some numbness and pain in my left arm, where I received the vaccination; pain in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit). At the time of the report, INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy breast: two biopsies recently in the left breast and left armpit (lymph node) - both benign.. On an unknown date, Biopsy lymph gland: two biopsies recently in the left breast and left armpit (lymph node) - both benign..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2023: Significant Live follow-up received on 05-Nov-23: Reference numbers added