chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Vx pushed back into the syringe barrel; Unaware how much of the vx was administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong injection technique in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) and (batch number Z4J77, expiry date unknown) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 15th February 2022, unknown after receiving Shingrix, the patient experienced wrong injection technique and incomplete dose administered. On an unknown date, the outcome of the wrong injection technique and incomplete dose administered were unknown.  Additional details were provided as follows: The reporter stated that, when she was administering 2nd dose of Shingrix to the patient in left deltoid, most of the vaccine was seen pushed back and being capture in the syringe barrel rather than going forward, which led to wrong injection technique and incomplete dose administered. The reporter was unaware how much of the vaccine was administered to the patient, if any. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The case was reported by the Medical assitant. The reporter stated that, the patient received an expired dose of Kirinx, which led to expired vaccine used. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: pain on the back of the neck; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). In February 2022, less than a day after receiving Shingrix, the patient experienced neck pain. The patient was treated with paracetamol (Tylenol) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the neck pain was not recovered/not resolved.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in left arm and on date of reporting (16th February 2022) around 3:00 am, the patient experiencing pain on the back of neck. The patient stated the pain had been about the same, it had not gotten better or worse. The patient took Tylenol and Aspirin due to pain. The patient did not have lot/expiry date of Shingrix. The patient did not had any contact information, except health care professional's name and facility's name. The reporter consented to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number y537x, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09th September 2020) and Shingrix (received 2nd dose on 11th November 2020).   On 15th February 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 15th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient inadvertently received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: the dose has expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The patient received a dose of Bexsero that had expired on 30th January 2022, which led to expired vaccine used. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient did not have any lot numbers for the vaccines, the date in which he got the vaccines, and he could not remember which arm he received the vaccines in. The patient stated that he got his Covid booster and first Shingrix vaccine on the same day on unknown arm at his local. The patient said that since getting these vaccines (Covid booster and Shingrix) a few months prior to the reporting date, patient had experienced extreme fatigue that had not resolved.   Spoke per content, gave medical disclaimer, and referred to health care professional for follow up. The reporter did not consent to follow up. No health care professional for follow up. It was unknown if the reporter considered the fatigue to be related to Covid booster.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that patient experienced pain in her arm for 3 to 4 days after Shingrix dose.  The patient stated that the pain in her arm was the worst on the first night.  The reporter did not consent to follow up. This case has been linked to the US2022028948 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022028948:same reporter
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 15 month old patient was administered kinrix vaccine inadvertently; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient inadvertently received a dose of Kinrix at the age of 15 months, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   On 16th February 2022, the patient received Engerix B. On 16th February 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On 16th February 2022, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Swelling
Clinical narrative: Knots on feet; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2022, the patient received the 1st dose of Shingrix (intramuscular). In February 2022, 1 week after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on left arm. She states that approximately one week after her Shingrix dose, she experienced knots on both of her feet.  The bigger ones were the size of golf balls.  The left foot had cleared completely but the right foot still had some knots. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Wrong product administered
Clinical narrative: Patient got Engerix-B instead of Pediarix; Patient got Engerix-B instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 20th October 2021, the patient received Engerix B. On 8th September 2021, the patient received Engerix B. On 8th September 2021, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On 20th October 2021, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The reporter intended to give the patient 2 doses of Pediarix, but inadvertently gave Engerix B instead, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 30-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Healthcare professional wanted to remain anonymous as she was doing a clinical rotation there.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 in 2020, is back for another dose; This case was reported by a other health professional 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 in year 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter enquired that, if the patient got one dose of Shingrix in 2020 and was back on 16th February 2022 for another dose, did the patient require a 3rd dose in the 2 to 6 months time frame. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional disconnected the chat before call center representative could ask for demographics.  No additional information was available. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Twinrix and Twinrix 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 details were provided as follows: The patient inadvertently received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Came for 2nd dose 15 months after 1st; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd October 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix on 02nd October 2020 and came in pharmacy on 16th February 2022 for his 2nd dose, 15 months later instead of 2 to 6 months as outlined in PI.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked if the patient needed to restart the series or needed a third dose. Call center representative provided information as per content and CDC guidelines.  The reporter did not consent to follow up. VAERS details pertained to 1st dose of Shingrix.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: VACCINE DID NOT WORK; This spontaneous report received from a patient via media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. 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 reported vaccine did not work (Lack of drug effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine did not work was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint: 90000216653. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from department on 16-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event. 20220220931-COVID-19 VACCINE AD26.COV2.S-Vaccine didn't work. Follow-up received regarding Clinical Details. 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: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with 2 doses of covid-19 vaccine from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, (dose number in series was 1), administered for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, (Dose number in series was 2) start therapy date were not reported administered 1 in total  for prophylactic vaccination. 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 suspected clinical vaccination failure, and suspected covid-19 infection (Dose number in series was 2) "we had different brand but 2 plus Booster and still got Covid Variant But Dr. said would be much worse , if not had vaccine but was still very sick. Thank God for the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217076.; Sender's Comments: V0:20220227500-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via media concerned multiple patients of unspecified sex, age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 suspected clinical vaccination failure, and suspected covid-19 infection. The reporter reported that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They are not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side affects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217227. This case, from the same reporter is linked to 20220230277 and 20220230393.; Sender's Comments: V0: 20220230299-COVID-19 VACCINE AD26.COV2.S-Suspected 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: COVID-19
Clinical narrative: COVID; 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. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217340. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as no covid symptoms experienced) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220240603.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported and batch number were not reported, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose not reported, administered on an unspecified date for prophylactic vaccination. 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 covid-19 and became violently ill after receiving vaccines and all booster shots (suspected clinical vaccination failure and suspected covid-19 infection) (both events with dose number in series 2). The consumer reported that, "I caught covid from someone who had vaccine and all booster shots. He became violently ill and I contracted it from him. It's like the vaccine caused the virus to mutate into something worse. I am lucky to still be alive and if the vaccine worked all that would have never happened."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000217481. This case, from the same reporter is linked to 20220234819.; Sender's Comments: V0-20220234118- covid-19 vaccine ad26.cov2.s-Suspected 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: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; VIRUS HAD EFFECTED THE WALLS OF HER HEART; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported hearing a radio news (social media) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient was a cardiologist. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient got covid-19 (coded as suspected covid-19 infection and suspected clinical vaccination failure). The patient was very sick and there was a diagnosis that the virus had affected the walls of her heart, which made difficult to breath long term (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, virus had effected the walls of her heart and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000217755.; Sender's Comments: V0: 20220237050-covid-19 vaccine ad26.cov2.s-suspected 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: Atrial fibrillation
Clinical narrative: A-FIB; This spontaneous report received from a patient via a company representative through media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 was having A-Fib (Atrial fibrillation) since the second shot (dose number in series 2). Patient posted that "I have been having A-Fib since the second shot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a-fib. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220237598-COVID-19 VACCINE AD26.COV2.S-a-fib. The event(s) has a compatible/suggestive 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: Death, Thrombosis
Clinical narrative: DIED; CLOTS BLOOD; This spontaneous report received from a consumer via a company representative through media  concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 01 total was administered for prophylactic vaccination. 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 after vaccination, the patient developed blood clots, and on an unspecified date, 04 weeks after vaccination, the patient died due to unknown cause. It was unspecified if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date, and the outcome of clots blood was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:202202239471-Covid-19 vaccine ad26.cov2.s-Died,clots blood.The event(s) has a compatible/suggestive 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date the patient had Covid-19 (Dose number in series 1). The outcome of Covid-19 was not reported. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. 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 had Covid-19 (Dose number in series 2) and patient further stated that the patient did not believe the shots were ready to be used. It was reported "I have had COVID twice with all the shots. I don't believe the shots are ready to be used". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217340. The suspected product quality complaint has been confirmed to be voided (this report indicates medical adverse events for the patient, there was no product quality issue described in the information reported.) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220231689.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: 201A21A, expiry: 21-SEP-2022) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: post-menopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 171808, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20220242180.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: VAGINAL BLEEDING; This spontaneous report received from a health care professional (registered nurse) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: post-menopause. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 171808 and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. The patient experienced side effects after her first shot (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: unknown) dose was not reported, 1 total administered at left arm on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-FEB-2022, the patient experienced vaginal bleeding (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaginal bleeding was not reported. This report was non-serious. This case, involving the same patient is linked to 20220242139.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diplopia, Dysphagia, Furuncle, Gait disturbance
Clinical narrative: DIFFICULTY WALKING; DOUBLE VISION; DIFFICULTY CHEWING; DIFFICULTY SWALLOWING; BOIL; SKIN RASH; WEAKNESS; TINGLING ARMS/LEGS/HANDS; This spontaneous report received from a consumer concerned a 61 year old. The patient's weight was 200 pounds, and height was 67 inches. The patient's concurrent conditions included diabetes, hypertension, prostate cancer, and allergies but it was unknown what allergies patient had. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 for prophylactic vaccination. 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, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 03-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Patient's son reported on behalf of himself who had experienced the adverse effects, which began on DEC-2021 (approximately a week or two after getting the booster), the patient experienced difficulty walking, double vision, difficulty chewing, difficulty swallowing, weakness, tingling arms, legs and hands. The patient also experienced skin dysfunction or skin issues which included boil and skin rash (all events with dose number in series 2). Son reported that his father experienced the same at the time of reporting, and had been sent to an outside medical facility because of his medical history at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, tingling arms/legs/hands, difficulty walking, double vision, difficulty chewing, difficulty swallowing, boil, and skin rash. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mastication disorder, Paraesthesia, Rash
Clinical narrative: DIFFICULTY WALKING; DOUBLE VISION; DIFFICULTY CHEWING; DIFFICULTY SWALLOWING; BOIL; SKIN RASH; WEAKNESS; TINGLING ARMS/LEGS/HANDS; This spontaneous report received from a consumer concerned a 61 year old. The patient's weight was 200 pounds, and height was 67 inches. The patient's concurrent conditions included diabetes, hypertension, prostate cancer, and allergies but it was unknown what allergies patient had. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 for prophylactic vaccination. 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, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 03-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Patient's son reported on behalf of himself who had experienced the adverse effects, which began on DEC-2021 (approximately a week or two after getting the booster), the patient experienced difficulty walking, double vision, difficulty chewing, difficulty swallowing, weakness, tingling arms, legs and hands. The patient also experienced skin dysfunction or skin issues which included boil and skin rash (all events with dose number in series 2). Son reported that his father experienced the same at the time of reporting, and had been sent to an outside medical facility because of his medical history at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, tingling arms/legs/hands, difficulty walking, double vision, difficulty chewing, difficulty swallowing, boil, and skin rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT STORAGE OF PRODUCT/TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced out of specification product use, and incorrect storage of product/temperature excursions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect storage of product/temperature excursions was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: RACING HEART AND WERE REQUIRED HEART MEDS; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 racing heart and were required heart meds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of racing heart and were required heart meds was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Fainted; Profusely sweat; severely sick; dont feel the same; Dizzy; Fatigue; Vomit; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient received unknown medication for high blood pressure).    On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), DIZZINESS (Dizzy), FATIGUE (Fatigue) and VOMITING (Vomit). At the time of the report, SYNCOPE (Fainted), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), FATIGUE (Fatigue) and VOMITING (Vomit) outcome was unknown and DIZZINESS (Dizzy) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  Company comment: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-480584 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.