chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administered a pediatric dose of Engerix-B to 44 year old female patient; administered a pediatric dose of Engerix-B to 44 year old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 44-year-old female patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On 18-OCT-2023, the patient received the 1st dose of Engerix B pediatric. On 18-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Engerix-B to 44 year old female patient) and adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to 44 year old female patient). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter was a medical assistant. The reporter reported that another Medical Assistant administered a pediatric dose of Engerix-B to a patient, which led to underdose and adult use of a child product.  At the time of reporting, no additional doses have been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: pregnant 40 year old patient was administered a dose of Arexvy; pregnant 40 year old patient was administered a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t3n4m, expiry date 05-MAR-2025) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: pregnant 40 year old patient was administered a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant 40 year old patient was administered a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacist reported that a pregnant 40 year old patient was administered a dose of Arexvy which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient that received the 1st dose of Shingrix back in 2019 hadn't received the 2nd dose yet.; This non-serious case was reported by a other health professional 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 (1st dose received in 2019).   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: a patient that received the 1st dose of Shingrix back in 2019 hadn't received the 2nd dose yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacy intern called to inform that a patient that received the 1st dose of Shingrix back in 2019 hadn't received the 2nd dose yet. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility is the same as primary reporter for the 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix B + pediatric dose administered to adult patient.; Engerix B + pediatric dose administered to adult patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 26-SEP-2023, the patient received Engerix B pediatric. On 26-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix B + pediatric dose administered to adult patient.) and adult use of a child product (Verbatim: Engerix B + pediatric dose administered to adult patient.). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Engerix B pediatric dose administered to adult patient, which led to underdose and adult use of a child product. Same lot number and expiration date for both vaccines. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023145302 reported by the same reporter.; Sender's Comments:  US-GSK-US2023145302:another adult patient.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: he noted a lump at the injection site; arm swollen; arm warm; elevated pulse 15 beats per minute over normal; feeling very tired; sleeping most of the time; arm pain at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac operation (Previous cardiac surgery).   On 17-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 17-OCT-2023, 5 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm pain at the injection site), injection site erythema (Verbatim: redness at the injection site), swelling arm (Verbatim: arm swollen), skin warm (Verbatim: arm warm), pulse increased (Verbatim: elevated pulse 15 beats per minute over normal), tiredness (Verbatim: feeling very tired) and sleepiness (Verbatim: sleeping most of the time). On 18-OCT-2023, the patient experienced injection site lump (Verbatim: he noted a lump at the injection site). The outcome of the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-OCT-2023 The patient reported that he received his first Shingrix shot on Tuesday (from the reporting day) and within 5 minutes of the vaccination he started experiencing arm pain and redness at the injection site. About 12 hours later (after vaccination) patient began feeling very tired, sleeping most of the time. His pulse has been elevated about 15 beats per minute above what was normal for him. The next day after vaccination, he noted a lump at the injection site. All symptoms were ongoing till the time of reporting. No consent, as patient had not yet consulted with his doctor. The reporter did not consent to follow-up. Note: Events from entire source document had been captured, even if it was not reported into the narrative description and clarification raised for its confirmation.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Somnolence
Clinical narrative: he noted a lump at the injection site; arm swollen; arm warm; elevated pulse 15 beats per minute over normal; feeling very tired; sleeping most of the time; arm pain at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac operation (Previous cardiac surgery).   On 17-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 17-OCT-2023, 5 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm pain at the injection site), injection site erythema (Verbatim: redness at the injection site), swelling arm (Verbatim: arm swollen), skin warm (Verbatim: arm warm), pulse increased (Verbatim: elevated pulse 15 beats per minute over normal), tiredness (Verbatim: feeling very tired) and sleepiness (Verbatim: sleeping most of the time). On 18-OCT-2023, the patient experienced injection site lump (Verbatim: he noted a lump at the injection site). The outcome of the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-OCT-2023 The patient reported that he received his first Shingrix shot on Tuesday (from the reporting day) and within 5 minutes of the vaccination he started experiencing arm pain and redness at the injection site. About 12 hours later (after vaccination) patient began feeling very tired, sleeping most of the time. His pulse has been elevated about 15 beats per minute above what was normal for him. The next day after vaccination, he noted a lump at the injection site. All symptoms were ongoing till the time of reporting. No consent, as patient had not yet consulted with his doctor. The reporter did not consent to follow-up. Note: Events from entire source document had been captured, even if it was not reported into the narrative description and clarification raised for its confirmation.
Age: 80.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Upset stomach; Dizziness; Weakness; Tiredness; Nausea; Vomiting; This spontaneous report received from a consumer concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: enzalutamide (capsule, oral, batch number: 1739968 expiry: 28-FEB-2023) 160 mg, 1 time every 1 day from 19-JAN-2021 to JUN-2021 for prostate cancer.  Age at time of vaccination 80 years old. No concomitant medications were reported. On JUN-2021, the patient experienced upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with enzalutamide was withdrawn on JUN-2021. The patient had not recovered from upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: Upset stomach; Dizziness; Weakness; Tiredness; Nausea; Vomiting; This spontaneous report received from a consumer concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: enzalutamide (capsule, oral, batch number: 1739968 expiry: 28-FEB-2023) 160 mg, 1 time every 1 day from 19-JAN-2021 to JUN-2021 for prostate cancer.  Age at time of vaccination 80 years old. No concomitant medications were reported. On JUN-2021, the patient experienced upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with enzalutamide was withdrawn on JUN-2021. The patient had not recovered from upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. This report was non-serious.
Sex: F
Vaccine: UNK
Symptoms: Thrombosis
Clinical narrative: Adverse event of clotting after COVID-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     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 THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis which occurred in the context of SPIKEVAX 2023-2024 dose administration, which was unidentifiable dose in COVID-19 vaccination schedule. Latency cannot be calculated due to event date and vaccination date unknown. No further clinical information or details on clinical course, concurrent diseases, concomitant medications, any accompanying circumstances or risk factors, etiologic and diagnostic work up with treatment were provided for medical review. Thrombosis outcome was unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-746627.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746627:same reporter
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic fatigue syndrome
Clinical narrative: It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine). At the time of the report, POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine, lasting several months.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and non-serious AESI of Post viral fatigue syndrome, which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product includes Pfizer vaccine for COVID-19. As reported, patient experienced ME/CFS (Myalgic encephalomyelitis/chronic fatigue syndrome) and had severe fatigue reactions, lasting several months. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: The patient received about half the dose due to syringe leak; The patient received about half the dose due to syringe leak; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection 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 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The patient received about half the dose due to syringe leak) and SYRINGE ISSUE (The patient received about half the dose due to syringe leak).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The patient received about half the dose due to syringe leak) and SYRINGE ISSUE (The patient received about half the dose due to syringe leak).    No concomitant medications were reported.  The Device problem code for Spikevax syringe include FDA code 1250, RA code A050401 which include Fluid Leak. The Spikevax syringe device was malfunctioned, and the type was CIRM.  The nurse practitioner called to report that the patient had not got the full dose as the syringe leaked and hence the patient received about half the dose. Patient wanted to re-vaccinate and the reporter asked whether it will be fine if the patient would be revaccinated since the patient had not received the full dose. The vaccine had been quarantined.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (mild sore arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 006M20A, 046C21A and 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild sore arm). At the time of the report, VACCINATION SITE PAIN (mild sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.  The patient had mild sore arm.   This case was linked to MOD-2023-746996, MOD-2023-747013.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: mild sore arm/mild sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 060F22A and 020H224) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm). At the time of the report, VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The patient received the vaccine in his left arm and had mild sore arm after fifth and sixth doses of vaccine.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746996, US-MODERNATX, INC.-MOD-2023-747010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746996:Dose 7 US-MODERNATX, INC.-MOD-2023-747010:Monovalent case
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested COVID Positive; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Tested COVID Positive) 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)) (batch no. AS7164B) for COVID-19 prophylaxis.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (LOT number EP7534) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (LOT number ER8737) on 22-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (LOT number PE3592  (Booster)) on 30-Aug-2021 and PFIZER BIONTECH COVID-19 VACCINE (LOT number FJ4991 (Second Booster)) on 11-May-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included ATORVASTATIN and OMEPRAZOLE for an unknown indication.  On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Tested COVID Positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 14-Aug-2023 for COVID-19, at a dose of UNK, bid, 3 pills. On 19-Aug-2023, COVID-19 (Tested COVID Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2023, SARS-CoV-2 test: Positive. On 19-Aug-2023, SARS-CoV-2 test: (Negative) No symptoms. On 26-Aug-2023, SARS-CoV-2 test: (Positive) Rebound covid. On 08-Sep-2023, SARS-CoV-2 test: Negative.   On 14-Aug-2023 Patient tested positive and on 19-Aug-2023 after 5 days, tested negative and on 26-Aug-2023 patient again tested positive (rebound COVID) and on 08-Sep-2023, tested negative after 13 days.
Age: 93.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 93-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741758.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741758:Mother's Case
Age: 86.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 86-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741758.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741758:Husband's case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Sleep apnoea syndrome
Clinical narrative: Achy; sleep apnea; Fever; Very very tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), SLEEP APNOEA SYNDROME (sleep apnea), PYREXIA (Fever) and FATIGUE (Very very tired) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergies: Advil, and Ibuprofen, Codeine, Definity (Perflutren Lipid Microsphere) , Latex sensitive, Nexium, Sulfa and Esomeprazole magnesium.  Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Latex allergy, Drug allergy, Sulfonamide allergy and Drug allergy.    On 24-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 24-Oct-2023, the patient experienced PAIN (Achy), SLEEP APNOEA SYNDROME (sleep apnea), PYREXIA (Fever) and FATIGUE (Very very tired). The patient was treated with PARACETAMOL (TYLENOL) on 24-Oct-2023 for Fever, at a dose of took 2 tylenol. At the time of the report, PAIN (Achy) and FATIGUE (Very very tired) outcome was unknown and SLEEP APNOEA SYNDROME (sleep apnea) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2023, Body temperature: 9.7. On 25-Oct-2023, Body temperature: Temp was 99.5.         Concomitant medication was not reported.  The patient had no problems with first two Moderna dose.  The patient took fluids.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Pain, Pyrexia
Clinical narrative: fever; crudy; body aches; lethargic; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 014M20A, 012F21A and 048L21A) for COVID-19 prophylaxis.     The patient's past medical history included Cough in 2020, Ache in 2020, Fever in 2020, Flu like symptoms in 2020 and Feeling abnormal in 2020. Concurrent medical conditions included Drug allergy (Amoxicilin allergy).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic). At the time of the report, PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient took 5th dose: Moderna AS7144B - 07Sep2022, 6th dose: Moderna AS7644C - 11Aug2023; patient involved. Patient says she received Spikevax on 11 Oct 2023 and then she felt like a little weak, no major deal. She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic for a day or so, and it goes away 2nd bivalent: she had no reaction at all, so she was very optimistic with the Spikevax After receiving.   This case was linked to MOD-2023-747062 (Patient Link).
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: Today he took a covid home antibody test which came back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Today he took a covid home antibody test which came back positive) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (He has received every pfizer dose available to him prior to a Moderna Spikevax vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Today he took a covid home antibody test which came back positive). At the time of the report, COVID-19 (Today he took a covid home antibody test which came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, SARS-CoV-2 antibody test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       He had received every Pfizer dose available to him prior to a Moderna Spikevax vaccine on 12 OCT 2023, lot number unknown. He started experiencing symptoms 2 days ago, feeling like he had a severe cold with a runny nose. On 20 Oct 2023 he took a covid home antibody test which came back positive. He had not taken any medications or treatments for his symptoms.
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia
Clinical narrative: severe headache; chills; muscle and body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CHILLS (chills) and MYALGIA (muscle and body aches) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 22-Oct-2023, the patient experienced HEADACHE (severe headache), CHILLS (chills) and MYALGIA (muscle and body aches). At the time of the report, HEADACHE (severe headache), CHILLS (chills) and MYALGIA (muscle and body aches) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Sex: U
Vaccine: UNK
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.; Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) 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 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.). At the time of the report, VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) had not resolved.        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.  This has remained to this day. It was smaller, less hot but still sore. Patient was asking what this meant and when will it go away.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2023: Live follow-up received: Reference number added.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he tested positive to COVID-19 on 24OCT2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he tested positive to COVID-19 on 24OCT2023) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient tested positive to COVID-19 on 24OCT2023.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Oct-2023, the patient experienced COVID-19 (he tested positive to COVID-19 on 24OCT2023). At the time of the report, COVID-19 (he tested positive to COVID-19 on 24OCT2023) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. It was reported that patient stated he previously received Moderna COVID-19 Vaccines (dates and number of vaccines not specified), and he tested positive to COVID-19 on 24-Oct-2023, he had an appointment to get the new Moderna shot scheduled on 29-Oct-2023 but due to COVID-19 he would cancel it.  Treatment information was not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: tiredness; fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness) and PYREXIA (fever). At the time of the report, FATIGUE (tiredness) and PYREXIA (fever) had resolved.        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.   No concomitant medication was reported. It was reported that patient received second dose on 27-Mar-2021 039A21A, third dose on 03-Nov-2021 66F21A and 4th dose on 05-Apr-2022 048L21A. Patient experienced side effects with her previous doses. After first dose her arm didn´t swell up until 8 days after the vaccine. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746975 (Patient Link).
Sex: F
Vaccine: UNK
Symptoms: Skin discolouration, Vaccination site reaction
Clinical narrative: Pink arm; other side effects that lasted a day and then it was over.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Pink arm) and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.) in a female patient of an unknown age 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 SKIN DISCOLOURATION (Pink arm) and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.). At the time of the report, SKIN DISCOLOURATION (Pink arm) outcome was unknown and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.) had resolved.        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. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747000 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747000:Patient 2
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain
Clinical narrative: felt a little warm; shivering; headache; Achiness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness), FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache) in an 82-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031897) for COVID-19 prophylaxis.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: RSV in September 2023 and Flu Vaccine on 06-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu Vaccine and RSV.   On 23-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 23-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PAIN (Achiness). On an unknown date, the patient experienced FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache). At the time of the report, PAIN (Achiness), FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was tumbling, rolling, turning, all night. It was also reported that patient had not taken any medications or treatments at this time. He had received 6 previous doses of COVID-19 vaccines but none Moderna.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Nervousness, SARS-CoV-2 antibody test positive
Clinical narrative: Very shaky feeling inside; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Very shaky feeling inside) in an 84-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:A number of allergies to medicines.  Previously administered products included for COVID-19 vaccination: Moderna (Dose 1: Lot number:004M20A , Expiry date: Unknown.) on 25-Jan-2021, Moderna (Dose 2: Lot number: 001A21A, expiry date was unknown.) on 23-Feb-2021, Moderna (Dose 3: Lot number: 020F21A, expiry date was unknown.) on 13-Sep-2021, Moderna (Dose 4: Lot number: AS7162B and expiry date was unknown.) on 01-Oct-2022; for an unreported indication: FLU VACCINE VII on 08-Sep-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Very shaky feeling inside). At the time of the report, TREMOR (Very shaky feeling inside) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2023, SARS-CoV-2 antibody test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  After Administration of Spikevax, 3 days later the patient started having a very shaky felting inside, as if she had taken 10 cups of coffee. The felting was still there today. It's been a month; she was getting tired of felting this way. She did not feel better. As HCP suggested, she waited a little bit until doing any tests. The patient was wondering if it may be due to the vaccine received was so soon after having COVID. Nobody asked her in the pharmacy if she had COVID recently.
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Pain in extremity, Pyrexia
Clinical narrative: sore arm for 3-4 days; feeling "a bit woozy; 99.4 temp about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 3-4 days), DIZZINESS (feeling "a bit woozy) and PYREXIA (99.4 temp about 24 hours) in a female patient of an unknown age 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 3-4 days), DIZZINESS (feeling "a bit woozy) and PYREXIA (99.4 temp about 24 hours). At the time of the report, PAIN IN EXTREMITY (sore arm for 3-4 days) and DIZZINESS (feeling "a bit woozy) had resolved and PYREXIA (99.4 temp about 24 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 temp.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Sex: U
Vaccine: UNK
Symptoms: Chills, Headache, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: sore throat; itching; chills; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Cataract.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). In October 2023, PYREXIA (fever) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) to be related.    No relevant concomitant medications were reported. Patient did run a fever on day one and two. Felt so on day 3. On day 4,5 &6 patient did not had fever but chills, sore throat, headache and itching. On the day of reporting patient was feeling better. Patient was having cataract surgery on Thursday morning and do not want to cancel. Patient do not feel sick-sick which was why patient was wondering if it was the shot. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2023: Follow-up information included no new information.