chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 5 years ago from reporting).   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: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The pharmacist asked if the patient needed to restart the series. The reporter did not provide information about the first Shingrix dose (lot number, expiry date, date of administration). The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an adult received a pediatric dose of Engerix-B; an adult received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 01-MAR-2024) for prophylaxis.   On 15-AUG-2023, the patient received Engerix B pediatric. On 15-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: an adult received a pediatric dose of Engerix-B) and underdose (Verbatim: an adult received a pediatric dose of Engerix-B).     The outcome of the inappropriate age at vaccine administration and underdose were unknown.   Additional Information: GSK receipt date: 17th August 2023 The nurse reported that nurse reported that an adult received a pediatric dose of Engerix-B, received inappropriate age at vaccine administration and underdose. The reporter consented to follow up.
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Kinrix was administered subcutaneously instead of intramuscularly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 5-year-old patient who received DTPa-IPV (Kinrix) (batch number C6002BA) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix (subcutaneous). On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Kinrix was administered subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter stated that Kinrix was administered subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. Lot number provided did not identify as a GSK vaccine. The reporter did not have initials or gender at the time of call. The reporter consented to follow up via postal.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product administration error, Product preparation error
Clinical narrative: MenA Lyophilized Conjugate Component mixed with just plain sterile water; MenA Lyophilized Conjugate Component mixed with just plain sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   On 14-AUG-2023, the patient received Menveo (left deltoid). On 14-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: MenA Lyophilized Conjugate Component mixed with just plain sterile water) and inappropriate dose of vaccine administered (Verbatim: MenA Lyophilized Conjugate Component mixed with just plain sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The Menveo was reconstituted improperly with sterile water instead of provided liquid conjugate component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter called to report an administration error for the Menveo Vaccine and he gave only the MenA Lyophilized Conjugate Component mixed with just plain sterile water to a patient in the left deltoid (Inappropriate Reconstitution Technique). The reporter consented to follow-up.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: maladministration of Infanrix to a 12 year old patient; Infanrix was administered instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 16-AUG-2023, the patient received Infanrix. On 16-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: maladministration of Infanrix to a 12 year old patient) and wrong vaccine administered (Verbatim: Infanrix was administered instead of Tdap).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 17-AUG-2023 The healthcare professional (HCP) was not sure, but she thoughts Infanrix was administered to 12-year-old patient instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The HCP asked if the patient had to be re-vaccinated. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo was administered instead of Men B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a adolescent female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA791A, expiry date 03-SEP-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo was administered instead of Men B). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 08-AUG-2023 Certified medical assistant (CMA) stated Menveo was administered instead of Men B (month or 2 ago), which led to Wrong vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 2nd dose of Menveo 5 weeks apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A) for prophylaxis.   Concomitant products included MENVEO.   On 10-AUG-2023, the patient received Menveo. On 10-AUG-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2nd dose of Menveo 5 weeks apart).     The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 An office manager called to inform that an 18-year-old patient that received the 1st dose of Menveo on 7th July 2023, received a second dose of Menveo on 10th August 2023 which led to extra dose administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: a female 1 year old patient received Kinrix instead of meningococcal vaccine; a female 1 year old patient received Kinrix instead of meningococcal vaccine; previously got 3 doses of Dtap and IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Dtap (previously got 3 doses of Dtap on an unknown date) and IPV (previously got 3 doses of IPV on an unknown date).   On 18-AUG-2023, the patient received Kinrix. On 18-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a female 1 year old patient received Kinrix instead of meningococcal vaccine), wrong vaccine administered (Verbatim: a female 1 year old patient received Kinrix instead of meningococcal vaccine) and inappropriate schedule of vaccine administered (Verbatim: previously got 3 doses of Dtap and IPV).     The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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: 18-AUG-2023 Medical assistant informed 1 year old patient received Kinrix instead of meningococcal vaccine and the patient previously got 3 doses of Dtap and IPV, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: after the shot he is having 150/85 for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (left arm). On 16-AUG-2023, less than a day after receiving Shingrix, the patient experienced increased blood pressure (Verbatim: after the shot he is having 150/85 for 2 days). The outcome of the increased blood pressure was not resolved.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.     It was unknown if the company considered the increased blood pressure to be related to Shingrix.   Additional Information: Receipt date: 18-AUG-2023 The reporter was the patient. The patient received Shingrix first dose last Wednesday and his blood pressure was normally 120 by 70 but after the shot he was having 150 by 85 for 2 days now (at the time of reporting). The patient was referred to health care professional (HCP). The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 3 years ago and never got the second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix 3 years ago and never got the second dose.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The health care professional (HCP) asked if the patient has to restart the series. The reporter did not provide information about the first dose of Shingrix. The pharmacist reported that a patient received the first dose of Shingrix 3 years ago and never got the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a patient was administered a dose of Havrix that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 23-JUN-2023, the patient received Havrix. On 23-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a patient was administered a dose of Havrix that was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter was a Medical Assistant. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter reported that a patient was administered a dose of Havrix that was expired, which led to expired vaccine used.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: She stated that a two month old received Kinrix [DTaP + polio] injection instead of Infanrix on 24-Jul-2023; 2 month patient received Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-week-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 24-JUL-2023, the patient received Kinrix (intramuscular, left thigh). On 24-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: She stated that a two month old received Kinrix [DTaP + polio] injection instead of Infanrix on 24-Jul-2023) and inappropriate age at vaccine administration (Verbatim: 2 month patient received Kinrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter was a medical assistant. The reporter reported that the 2 month old patient received Kinrix vaccine instead of Infanrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter reported that, they were intending to administered Infanrix and inadvertently administered Kinrix instead of Infanrix, which led to wrong vaccine administered. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: supposed to receive a dose of Menveo on 17Aug2023 but was inadvertently given a dose of Bexsero instead; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Bexsero. On 17-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: supposed to receive a dose of Menveo on 17Aug2023 but was inadvertently given a dose of Bexsero instead).     The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2023 Practice Manager reports the patient was supposed to receive a dose of Menveo on 17th August 2023 but was inadvertently given a dose of Bexsero instead which led to Wrong vaccine administered.  The patient had not previously had any Bexsero dosing.  The correct Menveo dosing has not yet been administered. the vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Shingrix to a patient who was 37 weeks pregnant; he inadvertently administered Shingrix to a patient who was 37 weeks pregnant; 26 year old patient received shingrix; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number M9F2T, expiry date 06-AUG-2024) for prophylaxis.   On 21-AUG-2023, the patient received Shingrix. On 21-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: he inadvertently administered Shingrix to a patient who was 37 weeks pregnant) and inappropriate age at vaccine administration (Verbatim: 26 year old patient received shingrix). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administered Shingrix to a patient who was 37 weeks pregnant). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Shingrix): 37 Weeks Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-AUG-2023 Pharmacist reported he inadvertently administered Shingrix to a patient who was 37 weeks pregnant. She was supposed to get Boostrix which led to wrong vaccine administered, inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA928A, expiry date 31-MAR-2025) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received a third dose of Menveo).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The reporter reported that a patient that received a third dose of Menveo, which led to extra dose administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Cerebrovascular accident, Neoplasm malignant, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; DOUBLE STROKE; CANCER DIAGNOSIS; This solicited report received from a consumer via social media PPSCVM000196 Account concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received first and second dose of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, batch number, expiry was not reported) dose was not reported, administered on unspecified date for a covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first and second dose of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number, expiry date were not reported) dose was not reported, 1 total administered on unspecified date for a covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received fourth dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (unspecified manufacturer) (suspension for injection, route of admin, batch number, expiry date were not reported) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in JUL-2023, the patient experienced double stroke, cancer diagnosis (dose number in series 3). The patient visited emergency room (ER).  The reporter stated that "Visited a friend who was rushed to ER last month double strokes and a cancer diagnosis (4x jabbed) ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the double stroke, cancer diagnosis, off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and double stroke, cancer diagnosis, off label dosing frequency, and revaccination with different covid-19 vaccine was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230838087-Double stroke, Cancer diagnosis. 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 not related.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Panic attack
Clinical narrative: Had a feeling of a panic attack with sweating; After injection nauseated and weak.; After injection nauseated and weak.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.) in a 9-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.). At the time of the report, PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Patient was in her mid-80's. After the first injection patient was needed to lay down and had a feeling of a panic attack with sweating. After the second dose of injection patient was nauseated and weak. Needed to stay in bed a couple of weeks.   Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperacusis, Injection site pain, Myalgia
Clinical narrative: I was sensitive to noise; felt weak; 4 hours after my vaccine I felt an intense pain in my left arm on injection site; Chills; Mild body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (I was sensitive to noise), ASTHENIA (felt weak), INJECTION SITE PAIN (4 hours after my vaccine I felt an intense pain in my left arm on injection site), CHILLS (Chills) and MYALGIA (Mild body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (unspecified drug).    On 14-Jul-2021 at 3:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021 at 8:30 PM, the patient experienced HYPERACUSIS (I was sensitive to noise), ASTHENIA (felt weak), INJECTION SITE PAIN (4 hours after my vaccine I felt an intense pain in my left arm on injection site), CHILLS (Chills) and MYALGIA (Mild body aches). In July 2021, HYPERACUSIS (I was sensitive to noise), ASTHENIA (felt weak), INJECTION SITE PAIN (4 hours after my vaccine I felt an intense pain in my left arm on injection site), CHILLS (Chills) and MYALGIA (Mild body aches) had resolved.            No concomitant medication was reported.  It was reported that 4 hours after vaccination patient felt an intense pain in left arm on injection site. It made it difficult to simply put on deodorant or pick up a cup. Had mild body aches and chills that lasted 2 days on and off. Patient was sensitive to noise and felt weak. The symptoms all together lasted for about 3 days.  On 10-Aug-2023, Patient received paxlovid 150(X2) for treatment of COVID-19  No treatment was received.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I've had the Pfizer and Moderna. They suck. Covid sucks so much more though/ had side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I've had the Pfizer and Moderna. They suck. Covid sucks so much more though/ had side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I've had the Pfizer and Moderna. They suck. Covid sucks so much more though/ had side effects). At the time of the report, IMMUNISATION REACTION (I've had the Pfizer and Moderna. They suck. Covid sucks so much more though/ had side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: All 3 of them are sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (All 3 of them are sick) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (All 3 of them are sick). At the time of the report, ILLNESS (All 3 of them are sick) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737864, US-MODERNATX, INC.-MOD-2023-737836 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For Brother case (same reporter) US-MODERNATX, INC.-MOD-2023-737864:For 1st sister (same reporter) US-MODERNATX, INC.-MOD-2023-737836:nephew case
Sex: F
Vaccine: COVID19-2
Symptoms: Tenderness
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (sore arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (sore arm). At the time of the report, TENDERNESS (sore arm) outcome was unknown.        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 medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737570 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737570:Same patient (Booster dose)
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Diagnosed with Covid) in August 2022. Concurrent medical conditions included Chronic obstructive pulmonary disease and Emphysema.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (Slight fever) outcome was unknown.     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.  The patient stated that she has had all 3 Moderna vaccines and had with no reactions except for a slight fever and a sore arm.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737310:Monovalent case
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Wrong vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong vaccine administered).    Concomitant medication was not reported.  Patient went back to the pharmacy for the 2nd dose of the bivalent vaccine on 12-Aug-2023, they were told that they should wait 8 weeks after the 1st dose. When further enquired it was found patient received first dose from pink cap vial and not from blue cap vial which was recommended. Reporter stated that patient was okay. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737804 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2023: Event and narrative were added. On 16-Aug-2023: Upon internal review on 21-Aug-2023, it was identified that the information in the case MOD-2023-737804 is a follow-up to the existing case MOD-2023-737496. Hence, the case MOD-2023-737496 will be retained for further follow-up and all the information from the duplicate case MOD-2023-737804 has been incorporated into the retained case MOD-2023-737496. The case MOD-2023-737804 will be nullified and deleted from the safety database.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737804:Non Retain case
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: itching; sore arm; Hives/Welts; all over body rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis.     The patient's past medical history included Chronic obstructive pulmonary disease (had to take infusion and had a really hard time, with breathing.), Emphysema (had to take infusion and had a really hard time, with breathing.) and COVID-19 in August 2022.    On 04-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Aug-2023, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash). At the time of the report, PRURITUS (itching), PAIN IN EXTREMITY (sore arm), URTICARIA (Hives/Welts) and RASH (all over body rash) was resolving.        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.  Patient received dose 1 on 02-Feb-2021 lot number unknown, dose 2 on 12-Mar-2021 lot number unknown and dose 3 on 12-Nov-2021 lot number 019F21A of Moderna.  Patient had a reaction that never had with the other 3. It started the day after on 05-Aug-2023. Patient had an all over body rash. Patient was miserable for 7 days with severe itching, welts, hives were breaking out everywhere, literally everywhere. Patient thought it was a mosquito bite at first, but it got worse and worse. Patient went to doctor and saw the Physician Assistant they didn't address it at all. Patient barely had a sore arm with the Bivalent in comparison with the other 3. Patient was not breaking out as bad, and every day she got 2 or 3 but it was getting better each day. Last Friday (date not provided), patient to the doctor for the rash and they insisted on a covid test which was positive. Later patient repeated the test for 5 times, but it was negative. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738199:Monovalent case
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Lower-than-authorized dose administered; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Lower-than-authorized dose administered) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INCORRECT DOSE ADMINISTERED (Lower-than-authorized dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Lower-than-authorized dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Lower-than-authorized dose administered).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Patient received unspecified antibiotics and steroid drugs.  The patient's past medical history included Foot surgery (surgeries in her feet/bones) in 2017 and Bone operation (surgeries in her feet/bones) in 2017. Concurrent medical conditions included Hypothyroidism.    On 07-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 an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the 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 provided.  patient did not remember if she received any other vaccine in the 4 weeks prior to receiving the Moderna vaccines.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737707:Monovalent Dose
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 10 JUL 2023 and Dose administered after 30-day Use by Date on 14 Aug 2023; No adverse event; patient received expired 2nd booster dose Moderna COVID-19 vaccine 5 days after 30-day Use By Date, on 14AUG2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired 2nd booster dose Moderna COVID-19 vaccine 5 days after 30-day Use By Date, on 14AUG2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 10 JUL 2023 and Dose administered after 30-day Use by Date on 14 Aug 2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. 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 EXPIRED PRODUCT ADMINISTERED (patient received expired 2nd booster dose Moderna COVID-19 vaccine 5 days after 30-day Use By Date, on 14AUG2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 10 JUL 2023 and Dose administered after 30-day Use by Date on 14 Aug 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired 2nd booster dose Moderna COVID-19 vaccine 5 days after 30-day Use By Date, on 14AUG2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 10 JUL 2023 and Dose administered after 30-day Use by Date on 14 Aug 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired 2nd booster dose Moderna COVID-19 vaccine 5 days after 30-day Use By Date, on 14AUG2023) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 10 JUL 2023 and Dose administered after 30-day Use by Date on 14 Aug 2023).    No concomitant medications were provided.  The vial did not undergo any temperature excursions.  Dosage text for suspect product was reported as unknown.  No treatment medication was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: mild cases of Covid every time he traveled and this happened after getting the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055B22F) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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 an unknown date, received fourth 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 and third 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 COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine). At the time of the report, COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient had 5 Moderna Covid-19 vaccines, 2 original and 3 boosters.  On an unknown dates patient receives 2 monovalent doses of Moderna Covid-19 vaccine.   Patient had mild cases of Covid every time he traveled and this happened after getting the vaccine.  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023; No adverse event; Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 Vaccine Moderna on 27-Sep-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Moderna.    On 16-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 14-Jul-2023. The vial did not undergo temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737983 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737983:Same Reporter