chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash pruritic, Skin weeping
Clinical narrative: She has not gotten dose 2 yet; itchy, oozing rash on right arm from right shoulder to hand; itchy, oozing rash on right arm from right shoulder to hand; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix and the patient received the Flu vaccine. On 29th October 2021, 45 days after receiving Shingrix, not applicable after receiving Shingrix and unknown after receiving Flu vaccine, the patient experienced itchy rash and skin oozing. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the itchy rash and skin oozing were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the itchy rash and skin oozing to be related to Shingrix and Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR064096   Additional Information: GSK receipt date: 11-Apr-2022 Reporter's comment: The case was reported by patient for herself. The patient reported that she received dose 1 of Shingrix in left arm and Flu vaccine in right arm. The patient had an itchy, oozing rash on right arm from right shoulder to hand.  She went to health care professional who put her on Valtrex.  When she finished the medicine, she reported the same rash coming back from top of right arm to hand.  She stated that she was put on medicine again.  She stated the second time was less severe. She had had not gotten dose 2 yet, she stated her health care professional told her to wait a year before getting dose 2, but registered pharmacist said get it sooner. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. For tolerance of 2nd episode, refer case US2022AMR064096, reported by same reporter. The case was linked with case US2022AMR063764, reported by same reporter for husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR063764:same reporter US-GLAXOSMITHKLINE-US2022AMR064096:same PT, Shingrix case
Age: 47.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 47-year-old patient (not immunocompromised) received Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: The pharmacist reported that a 47 year old patient (not immunocompromised) received one dose of Shingrix, which led to inappropriate age at vaccine administration. The pharmacist did not want to stay to answer safety related questions but agreed to follow-up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 19Dec2018, has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th December 2018).   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: 12-APR-2022 Reporter's comment: Pharmacist reported a patient received the first dose of Shingrix and had not receive dose two. The reporter only agreed to follow-up telephonically. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2019, asks how to proceed; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th October 2019).   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: 12-Apr-2022 Reporter's comments: Pharmacy intern wanted guidance on how to proceed for 2nd dose. The consent to follow up was given. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received a boostrix dose and then realized about a tag alert; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Boostrix 1 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 12-Apr-2022 Reporter's comment: The medical assistant stated that a patient at their medical office was administered a dose of Boostrix vaccine on the date of reporting (today) into his right deltoid that had been stored outside of the recommended temperature range. After administration then realized about a tag alert. The health care professional reported that did not get consent from patient to contact. Did not consent to follow-up. Additional Supportive Information: The patient received a dose of Boostrix that had been stored outside of the recommended temperature range, which led to incorrect storage of drug. This case was found as duplicate of case US2022064048. All the information from the case US2022064048 was merged into this case. The case US2022064048 was deleted and this case stand as case of record for this patient.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Received Rotarix diluted with sterile water; Received Rotarix diluted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7h9ch, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 11th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   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: 13-Apr-2022 Reporter's Comments: Medical assistant reported on April 13th 2022 that two patients received Rotarix diluted with sterile water instead of the correspondent diluent on April 11th 2022. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received Rotarix diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  This case is linked with case US2022064750, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064750:Same reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose in July 2021, received on April 13th 2022 second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in July 2021).   On 13th April 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th April 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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: 13-Apr-2022 Reporter's Comments: Registered pharmacist reported that a patient received 1st dose of Twinrix in July 2021 and received on April 13th 2022 second dose. The Healthcare professional wanted to know if the patient had to start over the schedule or how to proceed in this situations. Call Notes:Patient's demographic details were asked but Healthcare professional wasn't sure if she could share that information so she didn't provide that information. Lot number and expiration date asked but Healthcare professional didn't have that information. 1st dose date of vaccination : July 2021 2nd dose date of vaccination : April 13th 2022. The reporter consented to follow up. Additional Supportive Information:  The patient received the 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administrated with  only the liquid component of Menveo; administrated with  only the liquid component of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva639a, expiry date 8th October 2022) for prophylaxis.   On 13th April 2022, the patient received Menveo. On 13th 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: 13-Apr-2022 Reporter's Comments: Nurse reported on 13th April 2022 that a male patient was administrated with  only the liquid component of Menveo without the powder.  No adverse event was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with only the liquid component of Menveo without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 72.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: EngerixB 1st dose 20Aug2014, no further doses given; Havirx 1st dose 20Aug2014, 2nd dose 12Apr2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 20th August 2014, batch number 793JR) and Engerix B (received 1st dose on 20th August 2014, batch number B3744L).   On 12th April 2022, the patient received the 2nd dose of Havrix. On an unknown date, the patient did not receive the 2nd dose of Engerix B. On 12th April 2022, unknown after receiving Havrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comments:  On 12th April 2022 the patient received a second dose of Havrix but the patient had not received any further doses of Engerix B. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Havrix later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received Shingrix adjuvant portion alone; received Shingrix adjuvant portion alone; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult male patient who received Herpes zoster (Shingrix) (batch number 45G33, expiry date 24th August 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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: 13th Apr 2022 Reporter's Comments: The patient received Shingrix adjuvant portion alone by error. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Shingrix adjuvant portion alone which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 11th April 2022, unknown after receiving Boostrix and Boostrix 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient on the same day. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient. The patient had not experienced any adverse events.  The reporter was with provided telephone number for medical information for future reference. The reporter disconnected call whilst transferring to medical information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was one of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 13th April 2022, unknown after receiving Boostrix and Boostrix 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient on the same day. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot #1 on 2018, yet to receive #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included vaccination with live shingles vaccine (Zostavax) in 2014 (received zostavax in 2014) and Shingrix (received 1st dose of shingrix on 18th November 2018).   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: 14th Apr 2022 Reporter's Comments: The reporter was the patient. The patient received Shingrix shot 1 but had yet to receive Shingrix shot 2. The reporter did not have the lot number of the shot which was administered. The reporter provided limited information. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The case has been linked with the case US2022065243 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065243:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot #1 on 2018, yet to receive #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included vaccination with live shingles vaccine (Zostavax) in 2014 (received zostavax in 2014) and Shingrix (received 1st dose on 18th November 2018).   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: 14th Apr 2022 Reporter's Comments: The case was reported by patient's husband. The patient received Shingrix shot 1 but had yet to receive Shingrix shot 2. The reporter did not have the lot number of the shot which was administered. The reporter provided limited information. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This case has been linked with case US2022065242 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065242:Same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: give 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 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB08AZ, 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 14th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 14th 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: 14th Apr 2022 Reporter's Comments:  The health care professional reported that one of her colleagues give by error a Bexsero expired dose to a patient. The reporter consented to follow up by email. Additional Supportive Information: The patient received a dose of Bexsero which was already expired which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB06BA, 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 13th April 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 13th 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: 14th Apr 2022 Reporter's Comments: The nurse reports male patient was administered an expired dose of Bexsero. At the time of reporting, a repeat dose had not been administered. The reported consented to follow up. Additional Supportive Information: The patient received Bexsero which was already expired which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: About a third of the dose spilled out; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number P39GK, expiry date 9th June 2023) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix. On 15th April 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.       Additional Information: GSK Receipt Date: 15th Apr 2022 Reporter's Comments: The pharmacist reported she was administering a dose of Shingrix vaccine to a patient, but about a third of the dose spilled out. This was the patient's second dose in the series. At the time of reporting, repeat dose had not been performed. The reporter consented to follow up. Additional Supportive Information: It was stated that a third of the dose spilled out, which led to incomplete dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: WEIRD COUGH WITH A LITTLE BIT OF MUCUS, AND MUCUS SETTLED DEEP IN LUNGS WHICH CAN EXPEL IF COUGH A LOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced weird cough with a little bit of mucus, and mucus settled deep in lungs which can expel if cough a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird cough with a little bit of mucus, and mucus settled deep in lungs which can expel if cough a lot. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, SARS-CoV-2 antibody test
Clinical narrative: BILATERAL SWOLLEN LEGS; NUMBNESS ON LEFT ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: left hip replacement, right knee replacement, cardiac stent, and covid-19, and concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included furosemide. On NOV-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) not reported. On 12-MAR-2022, the patient experienced bilateral swollen legs, and numbness on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs, and numbness on left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: CHEST PAIN; INJECTION SITE PAIN; INCORRECT ADMINISTRATION (VACCINE ADMINISTERED TOO LOW IN HER ARM); This spontaneous report received from a patient concerned an 18 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 DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced incorrect administration (vaccine administered too low in her arm). On an unspecified date, the patient experienced chest pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and injection site pain, and the outcome of incorrect administration (vaccine administered too low in her arm) was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation reaction, Pyrexia
Clinical narrative: difficulty with all of the shots; fever of 102 degrees; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (difficulty with all of the shots) and PYREXIA (fever of 102 degrees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031LR0A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (difficulty with all of the shots) and PYREXIA (fever of 102 degrees). At the time of the report, VACCINATION COMPLICATION (difficulty with all of the shots) outcome was unknown and PYREXIA (fever of 102 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees 102 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-538659, MOD-2022-538669, MOD-2022-538668 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation reaction, Pyrexia
Clinical narrative: Had difficulty with all of the shots; Had fever after 1st booster dose/ After 1st booster dose - fever of 102 degrees for 48 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had difficulty with all of the shots) and PYREXIA (Had fever after 1st booster dose/ After 1st booster dose - fever of 102 degrees for 48 hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 031LR0A and 042L20A) for COVID-19 vaccination.     The patient did not had any past medical history or allergies.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had difficulty with all of the shots) and PYREXIA (Had fever after 1st booster dose/ After 1st booster dose - fever of 102 degrees for 48 hours). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Had difficulty with all of the shots) outcome was unknown and PYREXIA (Had fever after 1st booster dose/ After 1st booster dose - fever of 102 degrees for 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 degrees for 48 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient alternated between Tylenol and Motrin for treatment.   This case was linked to MOD-2022-538659, MOD-2022-538669, MOD-2022-538666 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: she started experiencing redness at the injection site; she started experiencing swelling at the injection site; bruising at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (she started experiencing redness at the injection site), VACCINATION SITE SWELLING (she started experiencing swelling at the injection site) and VACCINATION SITE BRUISING (bruising at the injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2022. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Birth control.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (she started experiencing redness at the injection site), VACCINATION SITE SWELLING (she started experiencing swelling at the injection site) and VACCINATION SITE BRUISING (bruising at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (she started experiencing redness at the injection site) and VACCINATION SITE SWELLING (she started experiencing swelling at the injection site) had resolved and VACCINATION SITE BRUISING (bruising at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient information height 5.6 It was reported as patient received her first dose and now there's bruising around the indentation. It hurts in that area and was getting worse. patient said that there was no muscle in that area anymore as there is a big indentation there,  finally saw a doctor today for this issue. patient had notexperienced a similar event in the past. No treatment information was provided by the reporter.   This case was linked to MOD-2022-538690 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Glomerulonephropathy
Clinical narrative: Collapsing glomerulopathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHROPATHY (Collapsing glomerulopathy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHROPATHY (Collapsing glomerulopathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHROPATHY (Collapsing glomerulopathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: glomerular disease Biopsy-proven glomerular disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHROPATHY (Collapsing glomerulopathy) to be related.    No concomitant and treatment medication were reported.  The patients with collapsing glomerulopathy were of this descent and had two APOL1 genomic risk alleles.  Company Comment: This literature-non-study case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of collapsing glomerulopathy (biopsy-proven glomerular disease) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903.; Sender's Comments: This literature-non-study case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of collapsing glomerulopathy (biopsy-proven glomerular disease) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Glomerulonephritis membranous, Glomerulonephropathy
Clinical narrative: Collapsing glomerulopathy; membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHROPATHY (Collapsing glomerulopathy) (seriousness criterion medically significant) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: glomerular disease biopsy-proven glomerular disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) to be related.    Concomitant and treatment medications were not reported.  It was reported that the patients with collapsing glomerulopathy were of descent and had two APOL1 genomic risk alleles.  Company Comment: This literature-non-study case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of collapsing glomerulopathy and membranous nephropathy (biopsy-proven glomerular diseases) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-539885, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This literature-non-study case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of collapsing glomerulopathy and membranous nephropathy (biopsy-proven glomerular diseases) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Glomerulonephritis minimal lesion
Clinical narrative: Minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: glomerular disease Proven glomerular disease in patients recently vaccinated against SARS-CoV-2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) to be related.    No Concomitant medications were reported. No Treatment information was reported. 28 patients were found with disease of de novo GN within native kidney biopsies and one patient with disease flare in an allograft  This is a literature non-study case concerning a 72-year-old male patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant occurred on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients lab test showed Biopsy: glomerular disease. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539885, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903.; Sender's Comments: This is a literature non-study case concerning a 72-year-old male patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant occurred on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients lab test showed Biopsy: glomerular disease. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.