chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018. No 2nd dose yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: Second dose of Shingrix not yet administered. The reporter give consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.; Sender's Comments: Nurse reporting Shingrix 1st dose administered in 2018. Second dose not yet administered. ~~~~~~~Consented to follow up.Call Notes:Nurse reporting Shingrix 1st dose administered in 2018. Second dose not yet administered. HCP unable to provide additional AE details at this time. HCP gives consent for safety team to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Plantar wart disappeared (burned off before, kept coming back); This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included plantar warts (have had plantar wart which was between her 4th and 5th toe on her right foot ).   On 27th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The patient stated that she had previously had it burned off multiple times before but it kept coming back. Did not consent to follow-up. This case is for 1 of 2 linked patients. Additional supportive information: After receiving the first dose of Shingrix, the patient's plantar wart which was between her 4th and 5th toe on her right foot disappeared, which led to unexpected therapeutic benefit; Sender's Comments:  US-GSK-US2022134443:Same reporter
Age: 10.0
Sex: U
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134437, US2022134439 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134437:Same reporter US-GSK-US2022134439:Same reporter US-GSK-US2022134440:Same reporter
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134438, US2022134439 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134438:Same reporter US-GSK-US2022134439:Same reporter US-GSK-US2022134440:Same reporter
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134437, US2022134438 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134437:Same reporter US-GSK-US2022134438:Same reporter US-GSK-US2022134440:Same reporter
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134437, US2022134438 and US2022134439 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134437:Same reporter US-GSK-US2022134439:Same reporter US-GSK-US2022134438:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose September 2020, second dose June 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   In June 2022, the patient received the 2nd dose of Shingrix. In June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The patient stated he was not able to get his second dose until June 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: first dose three years ago, second administered today; first dose three years ago, second administered today, expiry date 15-Sept-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number GJ549, expiry date 15th September 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose three years ago).   On 19th September 2022, the patient received the 2nd dose of Shingrix. On 19th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used were unknown.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Shingrix (on the day of reporting) later than the recommended interval after the expiration, which led to lengthening of vaccine schedule and expired vaccine used.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a 28 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A, expiry: unknown) dose was not reported, 01 total administered on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 27 years old. The patient additionally received non-company suspect vaccine elasomeran (Moderna) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 012F, expiry: unknown) dose was not reported, administered on 24-OCT-2021 for covid-19 prophylaxis, which was revaccination with different covid-19 vaccine (Dose number in series 2). Concomitant medications included ethinylestradiol/norgestrel (Low-Ogestrel) for birth control, sun genomics as concomitant probiotics product.  On 24-AUG-2022, the patient experienced confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive.  The patient was treated with Paxlovid for COVID-19 (coronavirus disease) from 24-AUG-2022 to 29-AUG-2022.  On 30-AUG-2022, the patient tested negative for COVID-19 virus test. On 08-SEP-2022, the patient again tested positive for COVID-19 virus test (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of revaccination with different covid-19 vaccine and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000252080.; Sender's Comments: V0:20220933468-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: TWO SEIZURES AFTER SHOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of an unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced two seizures after shots, and was hospitalized on an unspecified date for 10 days (Dose number in series 2). As per the reporter,  "Johnson and Johnson I Had two Seizures after shots. 10 days in Hospital". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two seizures after shots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220933526-covid-19 vaccine ad26.cov2.s- two seizures after shots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: DEMENTIA; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dementia and now permanently in a nursing home. It was reported that, "I nearly died from COVID. With all the occurrence of variations, I was TOLD to get the vaccines later. I don't EVER want to go through COVID again, so I got the shots. (I'm a vulnerable adult with NUMEROUS health issues and am allowed to live with my boyfriend if I am in safe living conditions and am compliant with doctor orders) I thankfully didn't suffer from side-effects. I was VERY skeptical because of the newness of the vaccine, but had no choice. All my siblings were ok, too. ONE brother-in-law got VERY sick and now is permanently in a nursing home with dementia. Every vaccine has dangers, even the 'tried and true' we trust. My brother-in-law was one of the unlucky 1 percent who have had a bad reaction. obviously, we are heart-broken for him, but in the bigger picture, MANY lives have been saved because of the vaccine making the COVID experience much less deathly." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dementia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220937541-covid-19 vaccine ad26.cov2.s-Dementia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: LITTLE SORENESS IN ARM; ABOUT 24 HOURS OF MALAISE; This spontaneous report received from a patient via a company representative via social media concerned a 71 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose,1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little soreness in arm, and about 24 hours of malaise (dose number in series 1). It was reported that, " "I am 71 and wife is 79. We both were given J&J with only a little soreness in arm and about 24 hours of malaise. Second injection was without issue. Neither of us have had even a sniffle during the entire covid period. We have been takimg an extensive targeted supplement regiment for over 20 years. We feel that had a great impact on the outcome."  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose,1 total, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether the adverse event reported following to second dose of covid-29 vaccine (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little soreness in arm and about 24 hours of malaise was not reported. This report was non-serious. This case, from the same reporter is linked to 20220939908.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Headache
Clinical narrative: NOT FEELING LIKE MYSELF; BACK ACHES; CONSTANT HEADACHE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. On an unspecified date, the patient experienced not feeling like myself, constant headache, and back aches (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced not feeling like myself, constant headache, and back aches (Dose number in series 2). As per reporter "From I took the COVID shots I'm not  feeling like myself. I have this constant headache and back aches." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling like myself, constant headache and back aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220932895.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: A LITTLE SORENESS IN ARM; ABOUT 24 HOURS OF MALAISE; This spontaneous report received from a consumer via company representative via social media concerned a 79 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered, on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced a little soreness in arm, and about 24 hours of malaise (dose number in series 1) and it was reported as "I am 71 and wife is 79. We both were given J&J with only a little soreness in arm and about 24 hours of malaise. Second injection was without issue. Neither of us have had even a sniffle during the entire covid period. We have been taking an extensive targeted supplement regiment for over 20 years. We feel that had a great impact on the outcome." On an unspecified date patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered, on an unspecified date for covid-19 prophylaxis. The patient had no any adverse events with the following vaccination covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from about 24 hours of malaise, and the outcome of a little soreness in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20220938857.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: LITTLE ACHY LIKE A LIGHT CASE OF FLU; SORE ARM; This spontaneous report received from a consumer via a company representative concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little achy like a light case of flu, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and little achy like a light case of flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: LUMPS ALL OVER MY BODY (THE BREAST MY TWO FEET); This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for Covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for Covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lumps all over my body (the breast my two feet) (Dose number in series 2). The reporter stated "Shots gives me lumps all over my body. The breast my two feet. Will not take none again" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lumps all over my body (the breast my two feet) was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Muscle soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Muscle soreness at injection site) in a 40-year-old male 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 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022, the patient experienced VACCINATION SITE PAIN (Muscle soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Muscle soreness at injection site) was resolving.        No concomitant medications were reported.  The patient had no concomitant disease or risk factor.  It was unknown if the patient experienced any additional symptoms and events.  There were no lab data and results available.  No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Myalgia, Nausea, Neck pain
Clinical narrative: pain in shoulders expanded into my neck; body aches; joint pain in both shoulders/joint pain; nausea; vomiting; lower back on both side with pain a 5 on a 10 point scale/pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2022 at 5:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Sep-2022, the patient experienced BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NAUSEA (nausea) and VOMITING (vomiting). On 18-Sep-2022 at 1:30 AM, the patient experienced MYALGIA (body aches) and ARTHRALGIA (joint pain in both shoulders/joint pain). On an unknown date, the patient experienced NECK PAIN (pain in shoulders expanded into my neck). On 18-Sep-2022, NAUSEA (nausea) had resolved. At the time of the report, BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and VOMITING (vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, Pain assessment: 5 on a 10 point scale, ody aches were more severe and about 7 or 8 on a 10 point scale,, joint pain diminished to a 3-4 on a 10 point pain scale and pain continued at a consistent 7/8 out of 10 pain.         No concomitant medications were reported. The patient reported that at 7am (14H), body aches were more severe and about 7 or 8 on a 10 point scale, pain in shoulders expanded into her neck, mild nausea started. By 10am (17H), nausea increased to full vomiting for about 1 hour. Between 11am and 1pm, nausea and pain continued at a consistent 7/8 out of 10 pain rating, then started to subside. She was able to sleep from 1PM to 3 PM.  When she awoke at 3pm the nausea had gone away and the joint pain diminished to a 3-4 on a 10 point pain scale. It was unknown whether the patient experienced any additional symptoms/events. No treatment medications were reported.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain assessment, Vomiting
Clinical narrative: pain in shoulders expanded into my neck; body aches; joint pain in both shoulders/joint pain; nausea; vomiting; lower back on both side with pain a 5 on a 10 point scale/pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2022 at 5:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Sep-2022, the patient experienced BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NAUSEA (nausea) and VOMITING (vomiting). On 18-Sep-2022 at 1:30 AM, the patient experienced MYALGIA (body aches) and ARTHRALGIA (joint pain in both shoulders/joint pain). On an unknown date, the patient experienced NECK PAIN (pain in shoulders expanded into my neck). On 18-Sep-2022, NAUSEA (nausea) had resolved. At the time of the report, BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and VOMITING (vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, Pain assessment: 5 on a 10 point scale, ody aches were more severe and about 7 or 8 on a 10 point scale,, joint pain diminished to a 3-4 on a 10 point pain scale and pain continued at a consistent 7/8 out of 10 pain.         No concomitant medications were reported. The patient reported that at 7am (14H), body aches were more severe and about 7 or 8 on a 10 point scale, pain in shoulders expanded into her neck, mild nausea started. By 10am (17H), nausea increased to full vomiting for about 1 hour. Between 11am and 1pm, nausea and pain continued at a consistent 7/8 out of 10 pain rating, then started to subside. She was able to sleep from 1PM to 3 PM.  When she awoke at 3pm the nausea had gone away and the joint pain diminished to a 3-4 on a 10 point pain scale. It was unknown whether the patient experienced any additional symptoms/events. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood cholesterol, Menstrual disorder
Clinical narrative: Loses eyesight in her left eye; Women having multiple cycles/Women having unusual cycles; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Loses eyesight in her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reporter by reporter.  Concomitant products included THYROID for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (Loses eyesight in her left eye) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Women having multiple cycles/Women having unusual cycles). At the time of the report, BLINDNESS UNILATERAL (Loses eyesight in her left eye) and MENSTRUAL DISORDER (Women having multiple cycles/Women having unusual cycles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Blood Cholesterol 245.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication use information was not provided by reporter.  On an unknown date  the laboratory exams performed to further understand the event included blood work , 2 magnetic resonance imaging and  done and the results were unknown.  Per reporter, patient had no high blood pressure bloodwork and MRIs showed nothing (results not provided) and planned to visit eye specialist.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information  expected.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followed up received on 8-JUL-2021  No High Blood Pressure and nothing on MRI Blood work. On 08-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information  expected.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were provided. It was reported that patient did not take pfizer/biontech vaccine, instead took moderna vaccines. No treatment information provided.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a dose of mRNA-1273.222  vaccine administration. No diagnostic result or treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: grand mal seizure/he was having a seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) outcome was unknown.            Patient doesn't have family history of seizures.  No concomitant medications were reported.   It was reported that patient was fine after the first two doses, but he had a grand mal seizure after the booster and never had seizures before. Patient went to work at the office, and the next thing he know, was he was having a seizure. The emergency personnel came to check on the patient and patient said that he doesn't know if the Moderna booster was the one that caused it.  No treatment details were reported.  Company comment: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Generalised tonic-clonic seizure that occurred in the context to third dose of mRNA-1273.222vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional details of Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to US-MODERNATX, INC.-MOD-2022-645580 (Linked Report).; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Generalised tonic-clonic seizure that occurred in the context to third dose of mRNA-1273.222vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional details of Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-645580:case
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No concomitant and treatment medications were reported. Patient's husband also received the Moderna bivalent booster vaccine on 12-Sep-2022. Age and Date of  birth was reported as 36 and 14-Feb-1986 respectively.  Company comment: This regulatory authority case concerns a 37-year-old pregnant female patient with gestational age of 36 weeks, with no other relevant medical history, was administered booster dose of mRNA-1273 BIVALENT.222  vaccine. There is no information if patient suffered any adverse event after the vaccination. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 37-year-old pregnant female patient with gestational age of 36 weeks, with no other relevant medical history, was administered booster dose of mRNA-1273 BIVALENT.222  vaccine. There is no information if patient suffered any adverse event after the vaccination. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19, SARS-CoV-1 test
Clinical narrative: breakthrough infection with COVID after having received Moderna vaccinations; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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.   No concomitant and treatment medication were reported.  HCP states that a staff member at her facility tested positive for COVID within the last couple of weeks after having received previous Moderna COVID-19 vaccinations. She wanted to inquire on behalf of this staff member, how soon can they receive the new Moderna COVID-19 bivalent booster after testing positive for COVID. HCP requests for information to be sent via email.  Company Comment: This is a spontaneous case, concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date, in the context of the administration of a dose of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in an unknown scheme of administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case, concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date, in the context of the administration of a dose of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in an unknown scheme of administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.