chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dyspnoea, Fibromyalgia, Neuralgia
Clinical narrative: arm swelling; tongue swelling; nerve pain; joint pain; pain in the center of her back; trouble breathing; fibromyalgia; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular). In May 2022, less than a week after receiving Shingrix, the patient experienced fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia. The patient was treated with ambiguous medication nos (Neurontin (Nos)), epinephrine (Epi Pen) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved and the outcome of the fibromyalgia was unknown.   It was unknown if the reporter considered the fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine last week and experienced fever, arm swelling, tongue swelling, nerve and joint pain, pain in the center of her back and trouble breathing. The patient used Epi pen and Benadryl to treat her symptoms.  Fever resolved after 3 days and all other symptoms had also resolved except the swelling in her left arm which extends from an area right below the injection site to her elbow. The outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved in May 2022   The patient stated that she never had any reactions to other vaccines. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Swollen tongue
Clinical narrative: arm swelling; tongue swelling; nerve pain; joint pain; pain in the center of her back; trouble breathing; fibromyalgia; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular). In May 2022, less than a week after receiving Shingrix, the patient experienced fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia. The patient was treated with ambiguous medication nos (Neurontin (Nos)), epinephrine (Epi Pen) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved and the outcome of the fibromyalgia was unknown.   It was unknown if the reporter considered the fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine last week and experienced fever, arm swelling, tongue swelling, nerve and joint pain, pain in the center of her back and trouble breathing. The patient used Epi pen and Benadryl to treat her symptoms.  Fever resolved after 3 days and all other symptoms had also resolved except the swelling in her left arm which extends from an area right below the injection site to her elbow. The outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved in May 2022   The patient stated that she never had any reactions to other vaccines. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Nausea, Rash pruritic
Clinical narrative: Felt nauseated; Loose stools; Itchy rash, concerned might be shingles; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (had before).   On 3rd May 2022, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. In May 2022, less than a week after receiving Shingrix, the patient experienced nausea, loose stools and itchy rash. On an unknown date, the outcome of the nausea and loose stools were recovered/resolved and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the nausea, loose stools and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in her right arm and unspecified pneumonia shot in her left arm and less than a week after vaccination, for the first couple of days she felt nauseated and had loose stools and then resolved. 10 days after the immunizations she developed an itchy rash on her left lower chest that she was concerned might be shingles.  The rash had not resolved. The patient had not seen a doctor yet regarding this rash. She said she did not feel bad and did not had a fever. It was unknown if the reporter considered the nausea, loose stools and itchy rash to be related to unspecified pneumonia vaccine. The reporter consented to follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 17 year old received a extra dose of  meningococcal; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA603a, expiry date 11th September 2022) for prophylaxis.   On 11th May 2022, the patient received Menveo. On 11th May 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Clinic manager reporting that 17-year-old received an extra dose of Menveo. Adverse event report contained all information provided by healthcare professional at the time of reporting.  The reporter consented for safety team follow up. Additional supportive information: The patient received an extra dose of Menveo, which led to extra dose administered.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered a dose of SHINGRIX to a patient with a sterile water solution instead of SHINGRIX adjuvant; Administered a dose of SHINGRIX to a patient with a sterile water solution instead of SHINGRIX adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2022, the patient received Shingrix. On 7th May 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Reporter was clinic manager who reported that, a medical assistant at the office administered a dose of Shingrix to the patient with a sterile water solution instead of Shingrix adjuvant.  No symptoms were reported.  She stated, she realized on the day of reporting as she was doing inventory that they had an extra adjuvant vial with no antigen and were able to trace the administration.  Referred to healthcare professional, provided phone number for provider to contact. The reporter consented to follow up. Additional supportive information: The patient received Shingrix with a sterile water solution instead of Shingrix adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old male patient who received HAB (Twinrix) 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 8th May 2022, the patient received the 1st dose of Twinrix (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 9th May 2022, 1 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Twinrix and Twinrix Pre-Filled Syringe Device. 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: 16-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Twinrix vaccine and developed a headache the next day. The event headache was continued. The reporter consented to follow-up. The patient had nothing else to report.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 11yo patient received an adult dose; 11yo patient received an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix 1440) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th May 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 16th May 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: 11-year-old patient received an adult dose of Havrix. The reporter consented to follow up. Additional supportive information: 11-year-old patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: wanted to receive 3rd dose, second dose was administered in April 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 2nd dose in April 2021) and Engerix B (received 1st dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Registered pharmacist reported that, there was a patient at the facility who wanted to receive 3rd dose of Engerix B but second dose was administered in April 2021.  It had been more than 6 months between doses and healthcare professional wanted to know how to proceed in this situation. Healthcare professional did not have neither lot number or expiration date of 2nd dose.  Additional supportive information: Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: MA reporting giving 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA654A, expiry date unknown) for prophylaxis.   On 14th May 2022, the patient received Menveo. On 14th May 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Medical assistant reporting giving 3rd dose of Menveo to the patient. Healthcare professional did not have expiration date available.  Adverse event report contained all reported adverse event information by healthcare professional at the time of reporting.  Healthcare professional gave consent for safety to follow up. Additional supportive information: The patient received 3rd dose of Menveo, which led to extra dose administered.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered a dose reconstituted with sterile water; Administered a dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA603A, expiry date 30th September 2022) for prophylaxis.   On 10th May 2022, the patient received Menveo. On 10th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: The patient received a dose of the lyophilized powder vial of Menveo reconstituted with sterile water. The reporter consented to follow up. Additional supportive information: The patient received a dose of the lyophilized powder vial of Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th 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 21st April 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st April 2022, an unknown time 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.   It was unknown if the reporter considered the expired vaccine used to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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: 16-MAY-2022 Reporters comment: Pharmacy technician reported that, the patient received a dose of Twinrix that had expired on 28th February 2022. The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient has had residual pain since receiving the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of residual pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced residual pain. On an unknown date, the outcome of the residual pain was unknown.   It was unknown if the reporter considered the residual pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: Pharmacist reported that a patient had residual pain since receiving the Shingrix vaccine. The pharmacist wanted to know how to proceed after an event like this had occurred. The reporter consented to follow-up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient who received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd January 2022 with batch number C43KM and expiry date 10th April 2023) and Shingrix (received 2nd dose on an unknown date ).   On 13th May 2022, the patient received the 3rd dose of Shingrix. On 13th May 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 Information: GSK receipt date: 16-May-2022 Reporter's comment: Registered pharmacist requesting information for a patient who received 3 doses of Shingrix. The 1st dose was administered by the reporter (as well as the 3th dose) but the 2nd dose in another facility (health care professional was not aware). The reporter consented to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered. Note: No assumption were applied for 2nd dose as no information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via a company representative via Social media concerned 14 patients 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 patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, 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 reporter stated that, " thanks to the poison vaccines I have 14 dead relatives and friends ". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20220527210. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126174, 20220126211, 20220126582, 20220126614 and 20220126701.  Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. The following information was updated and incorporated into the case narrative: social media added as source, reporter added, patients number updated from 12 to 14 in narrative.; Sender's Comments: V1: Additional information received is regarding Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number and social media added as source, reporter added, patients number updated from 12 to 14 in narrative. This follow up information received does not alter the assessment of prior company causality of previously reported event.  20220126708-COVID-19 VACCINE AD26.COV2.S-Dead. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via a company representative via other company (Pfizer, Inc) concerned a 32 year old male of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 16-MAY-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions. On an unspecified date, the patient previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, (Dose number in series 1), 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination (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: 213D21A and expiry date was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On 26-APR-2022, the patient experienced suspected Covid-19 infection (suspected clinical vaccination failure), (Dose number in series 2), and had a fever of 102 degree F. constant with symptoms progressing to the chest area and throat. He was prescribed with Paxlovid 3 days later and the next day on 30-APR-2022, the symptoms seemingly dissolved within 24 hours after taking the Paxlovid. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected Covid-19 infection on 30-APR-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230988. Sender's Comments: V0-20220526805-Covid-19 vaccine ad26.CoV-2.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.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Liver function test, Liver function test abnormal, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; LIVER FUNCTION TEST ABNORMAL; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old female of an unspecified race and ethnicity. Initial information processed with additional information received from the department on 17-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (recovered). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, first dose (1 in 1 once) administered on JUN-2021 (date unspecified) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs included: Upadacitinib (Rinvoq) (form of admin unknown, oral, batch number: Unknown and expiry: Unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 23-AUG-2021, the patient experienced covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On 30-NOV-2021 and 01-FEB-2022, the patient experienced covid-19. On an unspecified date, the patient experienced liver function test abnormal. Laboratory data (dates unspecified) included: Liver function test / liver levels (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from suspected covid-19 infection on 2022, and the outcome of liver function test abnormal and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000230989. 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.; Sender's Comments: V0: 20220526854 -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: Abdominal discomfort, Chills, Headache, Pain in extremity
Clinical narrative: UPSET STOMACH; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female 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 (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced upset stomach, sore arm, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach, and chills on 08-AUG-2021, and headache on 07-AUG-2021, and had not recovered from sore arm. This report was non-serious. This case, involving the same patient is linked to 20220531923.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (company representative), a 30 year old female of unspecified ethnic origin. Initial information was processed with additional information received on 16-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 16-FEB-2022) dose was not reported, 1 total administered in the right arm on 08-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 additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: unknown) dose was not reported, 1 total administered on 30-NOV-2021 (possibly in left arm but reporter was unsure) for prophylactic vaccination. No concomitant medications were reported. The patient reported her symptoms included vomiting, diarrhea, lethargy, small headache and flu like symptoms. The patient reported she tested covid positive on a rapid test as of 31-JAN-2022 (suspected covid-19 infection) (dose number in series 2). The patient developed COVID-19 as of 31-JAN-2022 which resulted in suspected clinical vaccination failure (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, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231044.; Sender's Comments: V0: 20220528464- 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: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: INSTANTLY DIED; MASSIVE HEART ATTACK; This spontaneous potential legal report received from a parent via a company representative concerned a 55 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, first dose, dose, start therapy date were not reported 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 previously received with covid-19 vaccine ad26. cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, second dose, dose, start therapy date were not reported for prophylactic vaccination, which was an off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, booster dose, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Parent said that his son had a massive heart attack 2 weeks after receiving his covid booster. He was on his way home from basketball game when he pulled off the side of the road and instantly died. Parent was considered calling a lawyer to file a wrongful death case (dose number in series 3). On an unspecified date, the patient died from unknown cause of death. It was unspecified if autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of instantly died on an unspecified date, and the outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition). This case, involving the same patient is linked to 20220526608 (dose series 2 case).; Sender's Comments: V0: 20220529749-COVID-19 VACCINE AD26.COV2.S- instantly died, massive heart attack . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via another manufacturer (Pfizer) via company representative concerned a 53 year old female of an unknown race. Initial information was processed along with the additional information received on 17-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified allergy, and other pre-existing medical conditions included: Patient was on other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 01 total, administered on 01-APR-2021 for prophylactic vaccination at right arm. The batch number was not reported and has been requested. Age at time of vaccination 52 years old. Concomitant medications included bupropion and paxlovid.  On 06-MAY-2022, laboratory data included: COVID-19 (Coronavirus disease) virus test (NR: not provided) Negative. On 08-MAY-2022, patient experienced sore throat (suspected covid-19 infection) and laboratory data included: COVID-19 virus test (NR: not provided) Positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231563.; Sender's Comments: V0:20220530376 -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: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient 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. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 201A21A, expiry unknown) dose was not reported, 1 total, administered on 07-AUG-2021 for prophylactic vaccination. On 07-AUG-2021, the patient experienced chills, headache, sore arm and upset stomach following vaccination with first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient recovered from sore arm on an unspecified date, headache recovered in AUG-2021, chills and upset stomach on 08-AUG-2021.  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total, administered on 06-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient reported that after second dose of covid-19 vaccine, the patient experienced sore arm (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on NOV-2021. This report was non-serious. This case, involving the same patient is linked to 20220528160.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: SINUS ISSUES (SNEEZING, COUGHING); This spontaneous report received from a patient 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. The patient was received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on MAR-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 booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sinus issues (sneezing, coughing) that has been diagnosed (dose number in series 2). Patient did not mention if it was related to J&J covid 19 vaccine primary and booster shots or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus issues (sneezing, coughing) was not reported. This report was non-serious. This case is a duplicate of 20220531526.  It was determined that Manufacturer Case Number 20220531526 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220531993.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SEVERE JOINT PAIN; This spontaneous report received from a patient via another manufacturer (Pfizer) of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Cipro). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 07-APR-2020 at 12:00 PM in left arm for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 31-DEC-2021 in left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-APR-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose not reported for treatment of COVID-19. The patient discontinued Paxlovid treatment on 01-MAY-2022.  On 03-MAY-2022 at 12:00, The patient experienced severe joint pain (dose number in series 2) for 5 days.  After finishing the Paxlovid, patient felt well. 3 days later the severe joint pain returned for 4 more days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe joint pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via company representative through social 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 previously received pfizer covid-19 vaccine (tozinameran) (dose number in series 1) (form, route of administration, batch number, dose were not reported, expiry: unknown) for prophylactic vaccination.  No adverse events were reported following vaccination with pfizer covid-19 vaccine (dose number in series 1). The patient additionally received booster dose 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) 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, according to the patient, covid smell loss was fixed by the vaccine (coded as unexpected therapeutic benefit) (dose number in series 2).  Patient reported that, "I got your vaccine (as a booster after my Pfizer vaccine) and I truly believe it fixed my COVID smell loss". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE AT FLUCTUATED TEMPERATURE BETWEEN 19 TO 43 FAHRENHEIT; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect product storage at fluctuated temperature between 19 to 43 fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage at fluctuated temperature between 19 to 43 fahrenheit and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220534309.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: TINNITUS OR EAR RINGING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient never had hearing problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced tinnitus or ear ringing. Laboratory data (dates unspecified) included: Hearing test (NR: not provided) hearing was fine, and Hearing test (NR: not provided) hearing was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus or ear ringing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Fatigue, Platelet count, Platelet count decreased
Clinical narrative: EXTREME FATIGUE; LOW PLATELET COUNT; BRUISING IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: tumour from neck, and concurrent conditions included: tumour removed (In Sep-2021, the patient had a tumor removed from her neck). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced bruising in arm. On SEP-2021, the patient experienced low platelet count. Laboratory data included: Blood test (NR: not provided) platelet count of 22, and Platelet count (NR: not provided) 22. On 24-JAN-2022, Laboratory data included: Platelet count (NR: not provided) 35. On 06-MAY-2022, Laboratory data included: Platelet count (NR: not provided) 51. On an unspecified date, the patient experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low platelet count, extreme fatigue and bruising in arm was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Developed blood clots after the second dose/got blood clot after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant medications were reported.  8 other women all aged 60 and up developed blood clots after the second dose. Also stated as this was a very serious situation that requires investigation. Reporter states that she knows other women in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No treatment medications were reported. COMPANY COMMENT: COMPANY COMMENT: This is an spontaneous case concerning a  7-decade-old female patient with no  medical history who experienced the unexpected  AESI (seriousness criterion IME ) events   of THROMBOSIS  and CEREBROVASCULAR ACCIDENT unknown days after  receiving the  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566828, MOD-2022-566718, MOD-2022-566813, MOD-2022-566839, MOD-2022-566821, MOD-2022-566814 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow-up received with added reporter Information, verbatim for event thrombosis and new event stroke.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  7-decade-old female patient with no  medical history who experienced the unexpected  AESI (seriousness criterion IME ) events   of THROMBOSIS  and CEREBROVASCULAR ACCIDENT unknown days after  receiving the  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.