chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache after getting second Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK receipt date: 13-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had headache after getting the second Shingrix shot. The patient asked that he/she could take something for headache. Additional Supportive Information: Follow-up could be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated, about a year, with only one dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago from the date of reporting).   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: 17-MAY-2022 Reporter's Comment: The patient's wife reported this case via. The patient already vaccinated (about a year) with Shingrix but only one dose by skipping the 2nd dose. The reporter asked that the patient would need to start with the 2 doses again. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the sterile diluent was administered to a patient; Only the sterile diluent was administered to a patient; This case was reported by a consumer via other manufacturer and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter stated that only the sterile diluent was administered to a patient and not the Shingrix with the diluent. The reporter disconnected quickly after realizing she needed to call other company and all questions were not answered. The reporter did not consent to follow-up. Additional supportive information: The patient received only the sterile diluent and not the Shingrix with the diluent, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.   No additional details were available. No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: dime size blister, full of liquid; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and shortly after the vaccination experienced dime size blister, full of liquid. The patient asked if it could have caused by vaccine or something else. The patient stated that it went away in one week, but was still healing after two weeks. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: arm blister; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced arm blister after Shingrix vaccine. The reporter wanted to know what caused it. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR081015   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the 2 dose shingles vaccine. The patient only had a sore arm with the first one. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081015.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081015:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: 3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080983:Same Reporter US-GLAXOSMITHKLINE-US2022AMR081065:Same Reporter
Sex: M
Vaccine: FLUX
Symptoms: Pemphigoid
Clinical narrative: Bullous pemphigoid; This case was reported in a literature article and described the occurrence of bullous pemphigoid in a 74-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The subject's past medical history included psoriasis.   On an unknown date, the patient received Flu vaccine. On an unknown date, 10 days after receiving Flu vaccine, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). The subject was treated with corticosteroid nos (Corticosteroid (Trade Name Unknown)). On an unknown date, the outcome of the bullous pemphigoid was recovered/resolved.   The reporter considered the bullous pemphigoid to be possibly related to Flu vaccine.   Additional Information: GSK receipt date: 17 May 2022 Authors comment:  This case corresponds to reported in this literature article. To better understand the potential link between vaccinations and the development of autoimmune bullous diseases (AIBDs), a systematic review was performed, which included 26 papers published between 1995 and 2021.  The patient had past medical history of Psoriasis. The patient received Influenza vaccine and had bullous pemphigoid. Course of the diseases was reported as remission after topical/oral corticosetroids. "Overall, there was currently insufficient data to suggest that vaccinations were truly or commonly related to an increased risk of AIBDs, taking into account that the available information was generally based on anecdotal, single case reports with a low level of evidence and not being confirmed in largescale, population-based studies. Consequently, there was no need to modify the present vaccination recommendations for patients with AIBD, because the benefits of vaccines outweigh the likelihood of instigating autoimmune manifestations, even though real-world data on COVID-19 vaccines in AIBD patients are currently lacking". Additional supportive information: This case is 1 of the 7 cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK081504:same reporter US-GLAXOSMITHKLINE-US2022GSK081553:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Pemphigus
Clinical narrative: pemphigus vulgaris; This case was reported in a literature article and described the occurrence of pemphigus vulgaris in a 72-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, 4 weeks after receiving Flu vaccine, the patient experienced pemphigus vulgaris (serious criteria GSK medically significant). On an unknown date, the outcome of the pemphigus vulgaris was recovered/resolved.   The reporter considered the pemphigus vulgaris to be possibly related to Flu vaccine.   Additional Information: GSK receipt date: 17 May 2022 Authors comment: This case corresponds to Table-1 reported in this literature article. To better understand the potential link between vaccinations and the development of autoimmune bullous diseases (AIBDs), a systematic review was performed, which included 26 papers published between 1995 and 2021.  The patient received Influenza vaccine and had pemphigus vulgaris.  "Overall, there was currently insufficient data to suggest that vaccinations were truly or commonly related to an increased risk of AIBDs, taking into account that the available information was generally based on anecdotal, single case reports with a low level of evidence and not being confirmed in largescale, population-based studies. Consequently, there was no need to modify the present vaccination recommendations for patients with AIBD, because the benefits of vaccines outweigh the likelihood of instigating autoimmune manifestations, even though real-world data on COVID-19 vaccines in AIBD patients are currently lacking". Additional supportive information: This case is 1 of the 7 cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK081450:Same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Paraesthesia, Pruritus, Urticaria
Clinical narrative: itching, itched; Break out in hives/hives were red and itched/ hives are itched; and burned and were hard and raised patches.; that felt like a pin was pricking him; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2002).   On 6th May 2022, the patient received the 1st dose of Shingrix. In May 2022, 76 hrs after receiving Shingrix, the patient experienced pruritus, hives, burning sensation and pins and needles. The patient was treated with prednisone and antihistamine (Antihistamines). On an unknown date, the outcome of the pruritus, hives, burning sensation and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives, burning sensation and pins and needles to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received Shingirx in the left arm. About 76 hours later, he started itching and began to break out in hives. The hives were red and itched and burned and were hard and raised patches that felt like a pin was pricking him. They were located on the injected arm (left arm) and on the left calf. The patient was treated with antihistamines and got a prescription of a 6 days taper of prednisone. This event was not yet fully resolved. He stated that if he did not take the antihistamines then he continued to have itching. The reporter did not have the lot number of the injection that he received. The reporter said that he called control regarding this and they advised him to go online to fill out a VAERS form, but because he did not like putting his personal information on websites he did not. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Animal bite, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite.; Adult patient was administered a dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult 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 15th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Reporter's Comment: The reporter reported that, a patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite. The lot number was not available. The reporter declined to have contact information stored.  The reporter declined follow-up from safety in escalated call to 2nd line agent. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was administered a dose of Infanrix instead of a Td vaccine for a dog bite, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 10.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Men B instead of MCV4; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old patient who received Men B NVS (Bexsero) 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 13th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 13th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 10-May-2022 Reporter's comment: An anonymous provider gave Meningococcal B vaccine instead of MCV4 to a 10-year-old patient. No adverse event details were available. Additional Supportive Information: The patient received Meningococcal B vaccine instead of MCV4, which led to wrong vaccine administered. Follow-up could not be possible as no contact details were available. Note: As event onset was reported and for medication error vaccination date and event onset date will same so in worst approach vaccination date was captured same as onset date. Suspect was coded as Bexsero, clarification was raised for the same.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: administered in 17May2022, expiration date of 01May2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 5994B, expiry date 1st May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 17th May 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 17th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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:17-May-2022 Reporter's comments: Clinical Supervisor reported that the patient received expired Rotarix. At the time of reporting, the dose has not been repeated. The reporter gave permission for follow-up. Additional Supportive Information: The patient received expired dose of Rotarix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered the ASO1B diluent without reconstitution; Patient was administered the ASO1B diluent without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The nurse reported that a patient received ASO1B diluent without reconstitution with the powder antigen component of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: The patient received diluent without reconstitution with the powder antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine(31-January-2022) was administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male 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 18th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th May 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:18-May-2022 Reporter's comments: The practice administrator reported that an expired Bexsero vaccine was administered to the patient. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 54 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 212A21A expiry: 20-MAY-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 18-NOV-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537532, 2005084289, 20220537548, 20220538238, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220538666, 20220537688, 20220538693, 20220540524, 20220540474, 20220538890, 20220540853, 20220540611, 20220538292, 20220538316, 20220540688, 20220540420 and 20220540570.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 36 year old female. 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: 212A21A and expiry: 20-MAY-2022) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. Age at time of vaccination 36 years old. No concomitant medications were reported. On 24-NOV-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537532, 20220538238, 20220538292, 20220537356, 20220537507, 20220537548, 20220537688, 20220538146, 20220538210, 20220538297, 20220539045, 20220538425, 20220538428, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220538666, 20220540611, 20220538693, 20220540524, 20220540474, 20220538890, 20220540853, 20220540570, 20220538316, 20220540688, 20220540420, 20220540816, 20220540642, 20220540814 and 20220540765.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 43 year old female. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. Age at time of vaccination 43 years old. No concomitant medications were reported. On 01-NOV-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and the janssen covid 19 vaccine was refrozen and administered to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538292, 20220538693, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538146, 20220538149, 20220538210, 20220538238, 20220538297, 20220538316, 20220538347, 20220538411, 20220538428, 20220538666, 20220538890, 20220539045, 20220540420, 20220540435, 20220540474, 20220540536, 20220540570, 20220540611, 20220540642, 20220538480, 20220540853, 20220540816, 20220540814, 20220540765, 20220540688, 20220541085, 20220537341, 20220537507, 20220538425, 20220538437, 20220538573, 20220538627, 20220540324, 20220541180, 20220541401, 20220541506, 20220540524 and 20220538758.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 52 year old female. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On 08-SEP-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220538379. This case, from the same reporter is linked to 20220537356, 20220537532, 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538437, 20220538666, 20220537341, 20220538292, 20220538411, 20220538316, 20220538210, 20220538693, 20220540435, 20220538146, 20220538758, 20220540474, 20220537507, 20220540853, 20220541180, 20220540570, 20220540688, 20220538347, 20220540642, 20220540814, 20220540765, 20220540420 and 20220540816.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO  PATIENTS; This spontaneous report received from a health care professional concerned a 30 year old male. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported. On 01-NOV-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patients and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538379, 20220537507, 20220538627, 20220537683, 20220537341, 20220538437, 20220538573, 20220537444, 20220538292, 20220537548, 20220538347, 20220538411, 20220539045, 20220538428, 20220538146, 20220538297, 20220538316, 20220538210, 20220538238, 20220538758, 20220537688, 20220538480, 20220537356, 20220538693, 20220540611, 20220540474, 20220538890, 20220540853, 20220541180, 20220540524 and 20220540570.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS  REFROZEN AND ADMINISTERED TO  PATIENTS; This spontaneous report received from a health care professional concerned a 59 year old male. 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: 212A21A, expiry: 20-MAY-2022) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and the janssen covid 19 vaccine was refrozen and administered to patients was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220538666, 20220537688, 20220538693, 20220540524, 20220540474, 20220538890, 20220540611, 20220541180, 20220537507, 20220538627, 20220537341, 20220540570, 20220538316, 20220540688, 20220540420 and 20220538347.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Age at time of vaccination 41 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537532, 20220537683, 20220537548, 20220538238, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538666, 20220537688, 20220540611, 20220538693, 20220540435, 20220540524, 20220540474, 20220538890, 20220540853, 20220541180, 20220540570, 20220537507, 20220538627, 20220537341, 20220537444, 20220538292, 20220538347, 20220538411, 20220537356, 20220538146, 20220538210, 20220540688, 20220540420, 20220540642, 20220540814 and 20220540765.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE (VACCINE WAS REFROZEN); OUT OF SPECIFICATION PRODUCT USE (ADMINISTRATION OF REFROZEN VACCINE); This spontaneous report received from a health care professional concerned a 34 year old male. 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: 212A21A, and expiry: 20-MAY-2022) dose was not reported, administered on 04-APR-2022 for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported.  On 04-APR-2022, the patient experienced out of specification product use (administration of refrozen vaccine). On an unspecified date, the patient experienced incorrect storage of vaccine (vaccine was refrozen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (vaccine was refrozen) and out of specification product use (administration of refrozen vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220539045, 20220538425, 20220537688, 20220538379, 20220537507, 20220538627, 20220537341, 20220538437, 20220538573, 20220537444, 20220538292, 20220538347, 20220538411, 20220538693, 20220539045, 20220537532, 20220538146, 20220538316, 20220538210, 20220538758, 20220538238, 20220538297, 20220538480, 20220538149, 20220538666, 20220540435, 20220540524, 20220540474, 20220538890, 20220540853 and 20220540611.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 53 year old female. 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: 212A31A expiry: UNKNOWN) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. No concomitant medications were reported. On 24-NOV-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220538428, 20220538297, 20220539045, 20220538425, 20220537688, 20220538379, 20220537507, 20220538627, 20220537341, 20220538437, 20220537444, 20220538292, 20220538347, 20220538411, 20220538693, 20220539045, 20220538146, 20220538316, 20220538210, 20220538758, 20220538238, 20220538480, 20220538149, 20220538666, 20220540435 and 20220540524.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: REBOUND COVID; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 43 year old male. 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, intramuscular, batch number: 1805081 and expiry: unknown) dose was not reported, 1 total administered on 13-MAR-2021 at 12:45 on left arm for prophylactic vaccination. Age at time of vaccination 42 years old. 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). No concomitant medications were reported. The patient received second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: unknown expiry: unknown) dose was not reported, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2). The patient received third dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Spikevax) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: 032F21A expiry: unknown) dose was not reported, administered on 30-OCT-2021 at 13:00 in left arm for prophylactic vaccination.  Treatment medications included: Paxlovid (ritonavir/nirmatrelvir) from 25-APR-2022 to 01-MAY-2022 for covid-19. On 07-MAY-2022 at 18:00 the patient experienced rebound covid (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, covid-19 vaccine (unspecified manufacturer) and Spikevax was not applicable. The patient had not recovered from rebound covid. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE REFROZEN; REFROZEN VACCINE ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 42 year old female. 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: 212A21A, expiry: 20-MAY-2022) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination.  Age at time of vaccination 42 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced refrozen vaccine administered to patient. On an unspecified date, the patient experienced vaccine refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the refrozen vaccine administered to patient and vaccine refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220538437, 20220538379, 20220537688, 20220537507, 20220538480, 20220537341, 20220537444, 20220538292, 20220537548, 20220538411, 20220539045, 20220538425, 20220538316, 20220538210, 20220538149, 20220538573, 20220537356, 20220537532, 20220538428, 20220538238, 20220538428, 20220538573, 20220538437, 20220538758, 20220537532 and 20220537356.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced the janssen covid 19 vaccine was refrozen and administered, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220537683, 20220538379, 20220538437, 20220539045, 20220538666, 20220538693, 20220540435, 20220540524, 20220537548, 20220537688, 20220540474, 20220538890, 20220540853, 20220540611 and 20220541180.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS  REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 41 year old female. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Age at time of vaccination 41 years old. No concomitant medications were reported. On 30-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538292, 20220538693, 20220537341, 20220537356, 20220537444, 20220537548, 20220538210, 20220538297, 20220538316, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538758, 20220538890, 20220539045, 20220540324, 20220540420, 20220540474, 20220540536, 20220540570, 20220540611, 20220540642, 20220537507, 20220537683, 20220537532, 20220538146, 20220538149, 20220538238, 20220538347, 20220538411, 20220540435, 20220540816, 20220540814, 20220540765, 20220540688, 20220541085, 20220541180, 20220541401, 20220538379, 20220540853 and 20220541506.