chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: no antigen, adjuvant-only used; Administration of adjuvant-only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter reported administering Shingrix adjuvant only (no antigen) to patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (no antigen) to patient , inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193690:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022AMR194824:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193680:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter reported administering Shingrix adjuvant only (no antigen) to patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (no antigen) to patient, inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193680:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022AMR194824:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter reported administering Shingrix adjuvant only (no antigen) to patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (no antigen) to patient, inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022193690:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reported that administering adjuvant only (no antigen) to 9 total patients.  Three patients were unidentified, 6 were identified. The AE (adverse event) filed separately for the 3 unidentified patients.  The reporter consented to follow up. This is 1 of the 7 cases reported by the same reporter. Additional Supportive Information: The patient received Shingrix vaccine without antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193690:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reported that administering adjuvant only (no antigen) to 9 total patients.  Three patients were unidentified, 6 were identified. The AE (adverse event) filed separately for the 3 unidentified patients.  The reporter consented to follow up. This is 1 of the 7 cases reported by the same reporter. Additional Supportive Information: The patient received Shingrix vaccine without antigen,  which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid portion; Received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 28-DEC-2022. Reporter's Comment: Nurse reported unknown patient received only the liquid portion of Menveo at an unknown date.  No additional adverse event details available per HCP. HCP gave consent for safety team follow up. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Pain
Clinical narrative: Body pain and aches, could not stand up /get out car; could not stand up /get out car; This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 19th October 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and difficulty in standing. On an unknown date, the outcome of the pain and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the pain and difficulty in standing to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter was a pharmacy technician.  The reporter declined to provide DOB (date of birth) and initials of the patient as he was not given and consented to do so. The reporter stated that patient received Shingrix in right arm. The patient experienced body pain and aches which became gradually more intense to the point where he could not stand up getting out of the car. The reporter reported provided limited information. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Haemorrhage, Injection site erythema
Clinical narrative: Blood on the band-aid adhesive; Hurt during injection; Injection site was red; Injection site was puffy; Possible medication running down arm; Possible medication running down arm; concerned that she not have received the full dose; This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 557b3, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Flu vaccine (received Flu shots on an unknown date) and Covid vaccine (received on an unknown date).   On 28th December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 28th December 2022, less than a day after receiving Shingrix, the patient experienced hemorrhage (serious criteria GSK medically significant), injection site pain, injection site erythema, injection site swelling, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. On an unknown date, the outcome of the hemorrhage, injection site pain, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   The reporter considered the hemorrhage, injection site pain, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The patient self-reported this case. The patient reported that she received 1st dose of Shingrix vaccine on arm. The patient stated that the injection hurt so she moved and upon moving she felt another jab. The patient felt that something was running down her arm but did not look or ask whether what she was feeling was blood or medication.   The patient was concerned that she might not had received the full dose.  The pharmacy records indicated that she did receive the full dose.  The patient upon removing the band aid she was noted blood on the adhesive on the pad.   In addition, when she examined her arm, she noted that her arm at the injection site was red and puffy. The reporter did consent to follow up. Additional supportive information: The patient stated that she felt something running down her arm but did know feeling was blood or medication and she was concerned that she may not have received the full dose which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. As per reported the patient felt something running down her arm was blood or medication so conservatively exposure via skin contact, inadvertent exposure to vaccine and accidental underdose events captured.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Blood on the band-aid adhesive; Hurt during injection; Injection site was red; Injection site was puffy; Possible medication running down arm; Possible medication running down arm; concerned that she not have received the full dose; This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 557b3, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Flu vaccine (received Flu shots on an unknown date) and Covid vaccine (received on an unknown date).   On 28th December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 28th December 2022, less than a day after receiving Shingrix, the patient experienced hemorrhage (serious criteria GSK medically significant), injection site pain, injection site erythema, injection site swelling, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. On an unknown date, the outcome of the hemorrhage, injection site pain, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   The reporter considered the hemorrhage, injection site pain, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The patient self-reported this case. The patient reported that she received 1st dose of Shingrix vaccine on arm. The patient stated that the injection hurt so she moved and upon moving she felt another jab. The patient felt that something was running down her arm but did not look or ask whether what she was feeling was blood or medication.   The patient was concerned that she might not had received the full dose.  The pharmacy records indicated that she did receive the full dose.  The patient upon removing the band aid she was noted blood on the adhesive on the pad.   In addition, when she examined her arm, she noted that her arm at the injection site was red and puffy. The reporter did consent to follow up. Additional supportive information: The patient stated that she felt something running down her arm but did know feeling was blood or medication and she was concerned that she may not have received the full dose which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. As per reported the patient felt something running down her arm was blood or medication so conservatively exposure via skin contact, inadvertent exposure to vaccine and accidental underdose events captured.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th December 2022, unknown after receiving Havrix and Havrix 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: 28-DEC-2022 Reporter's Comments: The nurse reported expired Havrix had been administered to a patient. The health care professional (HCP) did not provide information of the patient due to patient privacy. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired Havrix vaccine, which led to expired vaccine used.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HBV (Engerix B) (batch number PD4DJ5, expiry date 15th December 2022) for prophylaxis.   On 29th December 2022, the patient received Engerix B. On 29th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 30-DEC-20 22 Reporters comment: The health care professional reported that a patient received expired (15 December 2022) vaccine. The reporter consent to follow up. Additional Supportive information: The patient received expired Engerix B vaccine, which led to expired vaccine used.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAV (Havrix 1440 adult) (batch number 2ba99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th December 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 29th December 2022, unknown after receiving Havrix 1440 adult and Havrix 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: 30-Dec-2022. Reporter's Comment: The reporter was a medical assistant. The patient received an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired dose which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: LIGHT RUNNY NOSE; This spontaneous report received from a patient 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 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced light runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light runny nose. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: IT DIAGNOSED AFTER THE COVID SHOT (ADVERSE EVENT UNSPECIFIED); This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 it diagnosed after the covid shot (adverse event unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it diagnosed after the covid shot (adverse event unspecified) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Illness
Clinical narrative: BY THAT EVENING WAS STARTING TO GET SICK; COULDN'T GET OUT OF BED EXCEPT FOR BATHROOM NEEDS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of 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, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on JUN-2022 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 JUN-2022, the patient by that evening was starting to get sick. On 2022, the next morning, patient couldn't get out of bed except for bathroom needs (Dose number in series 2). It was reported as " I feel the same way. My last booster was in June, and by that evening I was starting to get sick. By the next morning I couldn't get out of bed except for bathroom needs. I was like that for 2 weeks and a couple more to feel half way back to normal ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the by that evening was starting to get sick and couldn't get out of bed except for bathroom needs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: BEING REAL SICK; This spontaneous report received from a patient via a company representative through social media and concerned a patient of unspecified age, sex, 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administrated 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 being really sick, and after being sick for a week, patient visited physician's office. The physician informed that the body was trying to adjust to it (dose number in series 1).  The reporter stated "I did the same thing and ended up at the drs office after a week of being real sick. He explained it was because my body was trying to adjust to it and that was a good thing for if I had got Covid-19 I probably wouldn't survive it. I then got the booster shot and did ok. I'm glad I did get then shots." The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administrated 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 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of being real sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient 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 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 shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Age: 90.0
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a 10 decades old patient of an unspecified sex, race and ethnic origin. 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) (Unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and 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. Age at time of vaccination 10 decade old. No concomitant medications were reported.  On FEB-2022, the patient experienced suspected covid-19 infection which was like having a stuffy cold and patient was suggested to take a booster dose by doctor (Dose number in series 1). Reporter stated that, "I had the shots. I didn't think I needed them and didn't know what the airlines required. In Feb this year I had covid. It was like having a stuffy cold. Then my Dr wanted me to have the booster because it helps get over any side effects. I did and here I am. 92 years old and feeling strong" The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 01 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s, but the patient felt strong after booster dose (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with product quality complaint:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait inability, Headache, Herpes virus infection
Clinical narrative: HEART PALPITATIONS LASTED ALMOST 5 MONTHS; COULD NOT EVEN WALK ONE MILE AFTER BEING VACCINATED; DIZZINESS IF TRIED TO EXERT LASTED ALMOST 5 MONTHS / DIZZY IF ANYTHING THAT ACCELERATED HEART RATE; CHIN WAS ONE BIG HERPES SORE; COULD NOT MOVE THE INJECTED ARM AWAY FROM BODY FOR MONTHS WITHOUT PAIN; NAUSEOUS IF ANYTHING THAT ACCELERATED HEART RATE; HEADACHE STARTING 2 HOURS POST VACCINATION LASTING ALMOST 2 WEEKS; FATIGUE WAS DEBILITATING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient walked 8 miles in the mountains just prior to the vaccination. 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 heart palpitations lasted almost 5 months, could not even walk one mile after being vaccinated, dizziness if tried to exert lasted almost 5 months / dizzy if anything that accelerated heart rate, chin was one big herpes sore, could not move the injected arm away from body for months without pain, nauseous if anything that accelerated heart rate, headache starting 2 hours post vaccination lasting almost 2 weeks, and fatigue was debilitating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations lasted almost 5 months, dizziness if tried to exert lasted almost 5 months / dizzy if anything that accelerated heart rate, could not move the injected arm away from body for months without pain, and headache starting 2 hours post vaccination lasting almost 2 weeks, and the outcome of could not even walk one mile after being vaccinated, fatigue was debilitating, chin was one big herpes sore and nauseous if anything that accelerated heart rate was not reported. This report was non-serious. This case, from the same reporter is linked to 20230103826.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Palpitations
Clinical narrative: HEART PALPITATIONS LASTED ALMOST 5 MONTHS; COULD NOT EVEN WALK ONE MILE AFTER BEING VACCINATED; DIZZINESS IF TRIED TO EXERT LASTED ALMOST 5 MONTHS / DIZZY IF ANYTHING THAT ACCELERATED HEART RATE; CHIN WAS ONE BIG HERPES SORE; COULD NOT MOVE THE INJECTED ARM AWAY FROM BODY FOR MONTHS WITHOUT PAIN; NAUSEOUS IF ANYTHING THAT ACCELERATED HEART RATE; HEADACHE STARTING 2 HOURS POST VACCINATION LASTING ALMOST 2 WEEKS; FATIGUE WAS DEBILITATING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient walked 8 miles in the mountains just prior to the vaccination. 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 heart palpitations lasted almost 5 months, could not even walk one mile after being vaccinated, dizziness if tried to exert lasted almost 5 months / dizzy if anything that accelerated heart rate, chin was one big herpes sore, could not move the injected arm away from body for months without pain, nauseous if anything that accelerated heart rate, headache starting 2 hours post vaccination lasting almost 2 weeks, and fatigue was debilitating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations lasted almost 5 months, dizziness if tried to exert lasted almost 5 months / dizzy if anything that accelerated heart rate, could not move the injected arm away from body for months without pain, and headache starting 2 hours post vaccination lasting almost 2 weeks, and the outcome of could not even walk one mile after being vaccinated, fatigue was debilitating, chin was one big herpes sore and nauseous if anything that accelerated heart rate was not reported. This report was non-serious. This case, from the same reporter is linked to 20230103826.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: pain and trouble; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain and trouble), HEADACHE (headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shot from them that they gave me, Which was less than two weeks after I got my Moderna shot) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PAIN (pain and trouble) and HEADACHE (headaches). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shot from them that they gave me, Which was less than two weeks after I got my Moderna shot). At the time of the report, PAIN (pain and trouble) and HEADACHE (headaches) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shot from them that they gave me, Which was less than two weeks after I got my Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient had steroids within two days after had the Moderna shot. And patient have not been the same since patient been suffering very much since May the 13th 2021 when she did that without asking me if I had. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: my brother had a heart attack after they got the modernist shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (my brother had a heart attack after they got the modernist shot) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (my brother had a heart attack after they got the modernist shot) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (my brother had a heart attack after they got the modernist shot) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of myocardial infarction. The event occurred approximately three weeks after a dose of mRNA-1273 bivalent BA.4/BA.5. No information about dose number or vaccination schedule was provided. As reported, patient had a heart attack after they got the modernist shot. No further information about the event was provided, including any diagnostic findings. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-689938, US-MODERNATX, INC.-MOD-2022-693527 (Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of myocardial infarction. The event occurred approximately three weeks after a dose of mRNA-1273 bivalent BA.4/BA.5. No information about dose number or vaccination schedule was provided. As reported, patient had a heart attack after they got the modernist shot. No further information about the event was provided, including any diagnostic findings. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report. US-MODERNATX, INC.-MOD-2022-689938:Daughter case US-MODERNATX, INC.-MOD-2022-693527:Sister case
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: My sister got blood clots in her legs all three weeks after they got the modernist shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) AESI of Thrombosis (blood clots in legs) which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details are not reported for medical review. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report   This case was linked to US-MODERNATX, INC.-MOD-2022-689938 (Linked Report).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) AESI of Thrombosis (blood clots in legs) which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details are not reported for medical review. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report US-MODERNATX, INC.-MOD-2022-689938:Daughter case
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Muscle weakness in my legs; Unable to stand; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand) 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 15-Dec-2022, 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 16-Dec-2022, the patient experienced MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that, after vaccination on Thursday afternoon, by Friday patient was on the floor because of muscle weakness in legs unable to stand. Had to have the fire dept come to get patient up. Patient was lucky that son was there, because patient live alone. Patient had to have someone with patient for the next four days before patient could stand by self and use walker.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) in an adult patient of an unknown 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 GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Guillain-Barre syndrome, which occurred on an unknown date related to an unspecified dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report.     This case was linked to US-MODERNATX, INC.-MOD-2022-692416 (Linked Report).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Guillain-Barre syndrome, which occurred on an unknown date related to an unspecified dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-692416:master case
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Cough, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: Coughing; Sneezing; Runny nose; Throat scratchy too; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too) 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 Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too). At the time of the report, COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too) outcome was unknown.        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 product use was provided by the reporter.   No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction, Tinnitus
Clinical narrative: Tinnitus; Super sick; Moderna Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Super sick), IMMUNISATION REACTION (Moderna Side effects) and TINNITUS (Tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Flu shot (Patient get a flu shot every year when they're available). Past adverse reactions to the above products included No adverse event with Flu shot.   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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Super sick), IMMUNISATION REACTION (Moderna Side effects) and TINNITUS (Tinnitus). At the time of the report, ILLNESS (Super sick) and IMMUNISATION REACTION (Moderna Side effects) had resolved and TINNITUS (Tinnitus) had not resolved.            No concomitant medication details was reported.  Patient got 2 moderna vaccines and 2 moderna boosters. Patient experienced tinnitus within 8 hours and tinnitus could last 6 months, a year or forever.  No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Cough, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: Coughing; sneezing; runny nose; throat scratchy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy) 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 Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Flu.    Concurrent medical conditions included Flu.   In October 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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy). At the time of the report, COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   Concomitant medication was not reported.  No treatment medication was reported.