chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: three patients were administered with only the adjuvant part of Shingrix; three patients were administered with only the adjuvant part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: A medical assistant reported that the patient was administered with only the adjuvant part of Shingrix. The medical assistant discovered the error but she could not provide any details about the patient administered with a partial dose because that information was still not available. There were 3 patients who received only adjuvant part out of total 10 patients. This last situation made that all the patient would be revaccinated, and considering this, 7 patients would receive a third dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered with only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067807:same reporter US-GLAXOSMITHKLINE-US2022AMR071124:same reporter US-GLAXOSMITHKLINE-US2022AMR071123:same reporter
Age: 19.0
Sex: F
Vaccine: MENB
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 19-year-old female patient who received Men B NVS (Bexsero) (batch number abxA87az, 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 17th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th March 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 Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The reporter reported that, the patient received expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the patient received expired dose of Bexsero, which led to expired vaccine used. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068142:Same reporter. US-GLAXOSMITHKLINE-US2022068144:Same reporter.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix 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 54-year-old male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th 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 20th April 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th April 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 Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: Office manager stated that, the patient received expired vaccine. The consent to follow up are given. Additional supportive information: Twinrix expired dose was given to the patient, which leads to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: The reporter stated that there was inappropriate reconstitution technique happened. The patient received only the liquid component. The reporter give consent to follow up. Additional supportive Information: The patient received only the liquid component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a nurse 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 ABXB06AA, expiry date 20th March 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 21st April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 21st April 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 Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: The registered nurse reported that the  patient received an expired dose of Bexsero. The reporter did not consent to follow-up. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Influenza like illness, Injection site erythema, Pain in extremity
Clinical narrative: injection site redness; arm is red, spreading down arm; arm is hot, spreading down arm; SWELLING IN ARM; ARM DISCOLOURATION; TROBBING IN arm; FLU-LIKE SYMPTOMS; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient called back, to report adverse reactions to the 1st dose of Shingrix but she got into an accident during the call and had to disconnect the call. The patient received dose of shingrix vaccine into unknown arm and experienced her arm was red and hot and the redness seems to be spreading down. Later in the evening/the next day she experienced swelling in arm, redness at injection site, arm discolouration, trobbing in arm, flu-like symptoms and fever. The patient stated that the symptoms were still ongoing. The patient would like to know if she should still get the 2nd dose. The reporter did not consent to follow-up. Additional supportive Information: Since it was not specified, events were at injected arm or not, coded injection site redness and arm redness separately. Since patient had arm related events, car accident (probably consequence) was not coded as event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: injection site redness; arm is red, spreading down arm; arm is hot, spreading down arm; SWELLING IN ARM; ARM DISCOLOURATION; TROBBING IN arm; FLU-LIKE SYMPTOMS; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema of extremities, extremities hot feeling of, swelling arm, skin discoloration, pain in arm, influenza-like symptoms and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient called back, to report adverse reactions to the 1st dose of Shingrix but she got into an accident during the call and had to disconnect the call. The patient received dose of shingrix vaccine into unknown arm and experienced her arm was red and hot and the redness seems to be spreading down. Later in the evening/the next day she experienced swelling in arm, redness at injection site, arm discolouration, trobbing in arm, flu-like symptoms and fever. The patient stated that the symptoms were still ongoing. The patient would like to know if she should still get the 2nd dose. The reporter did not consent to follow-up. Additional supportive Information: Since it was not specified, events were at injected arm or not, coded injection site redness and arm redness separately. Since patient had arm related events, car accident (probably consequence) was not coded as event.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: blisters on his hands as well; rash on both hands; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingrix. On 19th March 2022, 2 days after receiving Shingrix, the patient experienced rash. In April 2022, the patient experienced blister. On an unknown date, the outcome of the rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the rash and blister to be related to Shingrix.     Additional Information: GSK receipt date: 22-Apr-2022 Reporter's comment: The case was reported by patient's wife on behalf of her husband who was also on the call as the consumer.  The patient stated that he received the Shingrix vaccine and two days later he developed a rash on both hands. The patient stated that the rash still persists. Less than 2 months after vaccination, the patient was now developing blisters on his hands as well.  Gave medical disclaimer.  Referred to health care professional.  Spoke as per package insert and content.  Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Rash erythematous, Skin irritation
Clinical narrative: pain/soreness at the injection site; hardness of the left arm at the injection site; red rash on her right breast,  tiny red rash in her right shoulder; irritation in her bra area; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix (intramuscular) and the 4th dose of COVID 19 BOOSTER (intramuscular). In April 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site induration, red rash and skin irritation. The patient was treated with hydrocortisone (Hydrocortisone Cream). In April 2022, the outcome of the injection site pain and injection site induration were recovered/resolved. On an unknown date, the outcome of the red rash and skin irritation were not recovered/not resolved.   The reporter considered the injection site pain and injection site induration to be related to Shingrix. It was unknown if the reporter considered the red rash and skin irritation to be related to Shingrix.     Additional Information: GSK receipt date: 22-Apr-2022 Reporter's comment:The patient self reported this case. On 22nd April 2022, the patient contacted GlaxoSmithKline response center. She had Shingrix shot and a Covid booster shot on the same day in left arm.  She did not remember the day she got the immunizations but she thinks it was late last week.  She did not had the paperwork nearby to check for the date of administration or the lot number/expiration date.  She provided information regarding which pharmacy she had the shots at since they would had that data on file.  She reported that she could felt them being administered (going in) into the muscle.  She experienced pain/soreness and hardness of the left arm at the injection site. These local events had resolved. She started to felt a little irritation in her bra area. She took a shower and noticed a red rash on her right breast. This rash has not yet resolved.  In April 2022, she had been applied hydrocortisone cream and had made an appointment to see her OB/GYN doctor.  She also had a tiny red rash in front of her right shoulder that looks like it could be a (bug) bite. This tiny red rash on her right shoulder had not yet resolved. She was not sure if this rash was due to Shingrix or not but she regrets getting Shingrix and the Covid-19 booster on the same day. Consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain
Clinical narrative: Pain on right side of face that comes and goes; This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 12th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 20th April 2022, 8 days after receiving Shingrix, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was not recovered/not resolved.   It was unknown if the reporter considered the facial pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: This case was self reported by patient. The patient reported that he received first dose of Shingrix dose on left arm and started to experience pain on the right side of his face that comes and goes. The patient reported that this was the location of a previous shingles case that occurred on the right side of his face about one year ago. The patient would like to hear from safety to see if similar cases have been reported and if he should do anything. The patient does not give permission to contact HCP (Health care professional).  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received first dose of Shingrix vaccine in 2018, patient did not return for second dose until today.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Apr-2022 Reporter's comments: The patient did not return for second dose until the date of reporting. The consent to follow up was given.  Additional Supportive Information: The VAERS details were reported for the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered only liquid component; Patient was administered only liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 22-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAX641A, expiry date 30th June 2023) for prophylaxis.   On 22nd April 2022, the patient received Menveo. On 22nd April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022  Reporter's Comments: Physician assistant reported on the day of reporting, that the patient was administered with conjugate vaccine liquid component without the meningococcal A lyophilized conjugate vaccine component. It was accidentally forgot to ask for follow up. Additional Supportive Information: The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 2 years after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th July 2020, batch number:NB9D3, expiry date: 16 April 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The patient was not immunocompromised. The patient had second shingrix dose 2 years after the first dose. The reporter a asked if there was any data on efficacy if he received 2nd dose late.  The reporter consented to follow up. Additional Supportive Information: As the patient received 2nd dose 2 years after 1st dose which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a 2nd dose 30 days after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lymphoma (was in remission of lymphoma). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The reporter reported that, due to a miscommunication, a patient received a second dose of Shingrix 30 days after the first dose instead of 60 days. The reporter consented to follow up. Additional Supportive Information: The patient received a second dose of Shingrix earlier, which led to shortening of vaccination schedule.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a 11 year old patient dtap(infanrix); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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 Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The reporter gave a 11 year old patient dtap (Infanrix) instead of tdap (Boostrix). The reporter mentioned  if the patient needed to wait so long before he could give patient the Boostrix as well as reporter want recommend. The reporter give consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administration error
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 female patient who received Men B NVS (Bexsero) (batch number ABXB06AA, expiry date 31st March 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 25th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th April 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 Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: It was reported that the patient  received expired dose of Bexsero was administered by error to a patient. The reporter consented to follow up by email. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose over 2 years ago didn´t get the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a 2 years ago).   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 Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The pharmacist stated that a patient received the first dose of Shingrix over 2 years ago and would like to know if she needs to restart the series. The health care professional did not have date of birth at this time. The reporter consented to follow up via postal. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inappropriate schedule of product administration
Clinical narrative: her first shingrix vaccine 2 years ago; redness in her arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities and drug dose administration interval too long. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The case reported by patient. Th patient stated that she got her first shingrix vaccine 2 years ago.  She also reported that soon after receiving the vaccine (unknown arm) she had redness in her arm that lasted for about 2 weeks.  The reporter didn't want to provide anymore demographics and didn't have any further details about the vaccine given. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule. From the narrative it was not clear if the patient received 2nd dose late but as per time to onset reported in source document it seems that the patient received 2nd dose 7 months after 1st dose hence lengthening of vaccination schedule coded as event conservatively.
Sex: M
Vaccine: COVID19
Symptoms: Cytogenetic analysis, Hypertrophic cardiomyopathy
Clinical narrative: This spontaneous report received from a consumer concerned a 19 year old male of an unspecified 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 not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 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 hypertrophic cardiomyopathy. On 19-DEC-2021, the patient died from hypertrophic cardiomyopathy. An autopsy was performed on an unspecified date. The consumer reported, the grandson died suddenly on 19-DEC-2021. His autopsy said he died from hypertrophic cardiomyopathy (HCM) and genetic testing should be done on the other kids in the family. The hospital that did the testing called and said, his gene test did not show HCM as the cause. The patient had received the vaccine a month prior to his death and should it be assume as cause? The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0- 20220454599 -COVID-19 VACCINE AD26.COV2.S- Hypertrophic cardiomyopathy. 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: HYPERTROPHIC CARDIOMYOPATHY; Autopsy-determined Cause(s) of Death: HYPERTROPHIC CARDIOMYOPATHY.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Fatigue, Joint swelling, Pain
Clinical narrative: GENERALIZED ACHING/BODY ACHE; SWOLLEN JOINTS; JOINT PAIN; CHILLS; FEVER; TIREDNESS; This spontaneous report received from other manufacturer, and the patient was enrolled in non-Company sponsored solicited program, consumer concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)  (suspension for injection, intramuscular, batch number was not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported On an unspecified date, the patient experienced generalized aching/body ache, swollen joints, joint pain, chills, fever, and tiredness (all events with dose number in series 1) . The patient recovered from generalized aching/body ache, chills, and fever, and was recovering from tiredness, swollen joints, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: GENERALIZED ACHING/BODY ACHE; SWOLLEN JOINTS; JOINT PAIN; CHILLS; FEVER; TIREDNESS; This spontaneous report received from other manufacturer, and the patient was enrolled in non-Company sponsored solicited program, consumer concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)  (suspension for injection, intramuscular, batch number was not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported On an unspecified date, the patient experienced generalized aching/body ache, swollen joints, joint pain, chills, fever, and tiredness (all events with dose number in series 1) . The patient recovered from generalized aching/body ache, chills, and fever, and was recovering from tiredness, swollen joints, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Vasculitis
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a male 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 received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and 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, It was reported that, patient had been battling reoccurring bouts of pericarditis and vasculitis that was started five weeks post receiving the J&J shot. Only thing that keeps it at bay was massive daily doses of prednisone which comes with his own problems. Treatment medications (dates unspecified) included: Prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reoccurring bouts of pericarditis, and reoccurring bouts of vasculitis. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220455313-COVID-19 VACCINE AD26.COV2.S-reoccurring bouts of pericarditis. 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022; Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016j21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received second booster dose. Date of refrigeration was 01-Apr-2022. It was reported that vial had not undergone any temperature excursions. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Non-significant Follow-up appended- I narrative updated. On 25-Apr-2022: Follow-up  No New Information received On 27-Apr-2022: Follow up received contains reporters details and I narrative with information regarding the 6 patient was updated. On 27-Apr-2022: Report type changed from invalid to spontaneous. Added patient demographics and suspect product dose number. Updated I narrative.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered on 06-Apr-2022, stored in refrigerator on 25-Feb-2022 and was expired on 25-Mar-2022; Patient was administered with vaccine which was expired on 25-Mar-2022 and past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine which was expired on 25-Mar-2022 and past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Vaccine was administered on 06-Apr-2022, stored in refrigerator on 25-Feb-2022 and was expired on 25-Mar-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Hydrochlorothiazide allergy), Drug allergy (Lisinopril allergy), Latex allergy and Drug allergy. Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA), CYCLOBENZAPRINE, GABAPENTIN, EPINEPHRINE (EPIPEN), MOMETASONE FUROATE (NASONEX), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), DIAZEPAM (DELICA), ASCORBIC ACID, FERROUS FUMARATE (VITRON C [ASCORBIC ACID;FERROUS FUMARATE]), IBUPROFEN, ALLOPURINOL, LOSARTAN, GLIPIZIDE, LEVOCETIRIZINE, CARVEDILOL, FUROSEMIDE, AMLODIPINE BESYLATE and TRIAMCINOLONE ACETONIDE for an unknown indication.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine which was expired on 25-Mar-2022 and past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered on 06-Apr-2022, stored in refrigerator on 25-Feb-2022 and was expired on 25-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine which was expired on 25-Mar-2022 and past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Vaccine was administered on 06-Apr-2022, stored in refrigerator on 25-Feb-2022 and was expired on 25-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took one touch verio as concomitant medication.  The patient received vaccine which was refrigerated on 25-Feb-2022 and was administered on 06-Apr-2022 after the expiration date of 25-Mar-2022. The vial did not undergo any temperature excursions. Patient did not experience any side effects at the time reporting. Patient have not experienced COVID-19 within last month.   No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     Patient had no allergies. Other vaccine was not given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This Spontaneous case concerns a 53-year-old male patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 which occurred on unspecified day in February 2022 after the second dose of mRNA-1273 vaccine received on unspecified date. SARS-CoV-2 test was positive as of February 2022. Lack of efficacy cannot be concluded as dates of vaccination details were not provided. Ongoing pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority's reporting.   This case was linked to MOD-2022-549198 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 53-year-old male patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 which occurred on unspecified day in February 2022 after the second dose of mRNA-1273 vaccine received on unspecified date. SARS-CoV-2 test was positive as of February 2022. Lack of efficacy cannot be concluded as dates of vaccination details were not provided. Ongoing pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority's reporting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered beyond 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The race of the patient was reported. It was reported that the patient had no known drug and food allergy.  No concomitant information was reported.  It was unknown if the patient had ever tested positive for COVID-19. The patient does not had any acute illness at the time of vaccination and up to 1 month before and not received any vaccine one month prior to moderna COVID-19 vaccine.  No treatment information was reported.   This case was linked to MOD-2022-546730 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (did not feel good at all) and rash (broke-out in rash) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (did not feel good at all) and rash (broke-out in rash). At the time of the report, feeling abnormal (did not feel good at all) and rash (broke-out in rash) outcome: unknown.  No concomitant medication or treatment medication reported. This case linked to MOD-2022-550512 (patient link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Muscle contracture, Pain in extremity
Clinical narrative: Canonot move arm/Cannot move fingers; contracture left hand / contracture right hand; terrible pain on shoulder; terrible pain on arms and hands / feels like RSD; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Canonot move arm/Cannot move fingers), MUSCLE CONTRACTURE (contracture left hand / contracture right hand), ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A, 027620A and 024M30A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy, Allergy to molds, Reflex sympathetic dystrophy (as a chronic illness prior vaccination) and Clot blood. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced HYPOKINESIA (Canonot move arm/Cannot move fingers) and MUSCLE CONTRACTURE (contracture left hand / contracture right hand). 27-Oct-2021, the patient experienced ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (Canonot move arm/Cannot move fingers), MUSCLE CONTRACTURE (contracture left hand / contracture right hand), ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD) had not resolved.            It was reported that the patient received primary series doses on vaccination facility in contact number 2 and booster dose on vaccination facility in contact number 3 of the Moderna Covid-19 vaccine and 1 week after the patient's first booster dose the patient experienced scary things and mentioned all the events.  The patient was never tested positive for COVID-19 and did not receive any other vaccine within one month prior to Moderna Covid-19 vaccine.  It was further mentioned the patient experienced a similar event before 2 times, on 1982 and the other six years after that.  Symptoms were ongoing and the patient was taking Prednisone as treatment, but the patient did not feel much better.