chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported; The nurse stated that improperly stored vaccines were administered to patients.     ?; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 11-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported) (product storage error).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 08-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported) (Product storage error).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 06-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 11-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported) (product storage error).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted.; Varivax had a temperature excursion nad had been administered; This spontaneous report was received from an office manager, referring to a patient of 4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 14-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported) (product storage error). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a patient of4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 11-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a patient of 4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 08-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Woke up with a nickel size red spot where the vaccine was administered; Was a rash up my arm/6 days after shingles; Rash warm to the touch/ 6 days after shingles; I had a sore arm for a couple days; 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 4th April 2022, the patient received Shingles vaccine. On 10th April 2022, 6 days after receiving Shingles vaccine, the patient experienced injection site erythema, injection site rash and injection site warmth. In April 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site erythema, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site rash and injection site warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced a sore arm for a couple days and then on Sunday (10th April 2022) woke up with a nickel size red spot where the vaccine was administered. Later that night it was a rash up his/her arm which was warm to the touch. The patient asked what could he/she do. Additional supportive information: The follow-up would not possible, as no contact details were available. Note: The event injection site rash and injection site warmth coded as it seems as per description that, the rash and warmth is on the same place where there was red spot.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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, less than a month after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine and felt it's kicked his/her buttock but worth it. The patient stated that seen patients with it and hoping to not get it. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: No arm just a little sore for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced no arm just a little soreness for 2 days. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, COVID-19, Taste disorder
Clinical narrative: Anaphylaxis; This case was reported by a consumer via other manufacturer and described the occurrence of anaphylaxis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included urticaria (patient was allergic to Amox and had hives). Concurrent medical conditions included hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea syndrome, gene mutation (heterozygous PRF1 mutation) and penicillin allergy. Concomitant products included levonorgestrel (Mirena Intrauterine Device), sertraline, cetirizine, metoprolol, sennosides (Senna Tabs), magnesium (Magnesium Supplement), colecalciferol (Vitamin D3), paroxetine hydrochloride (Paxil) and spironolactone.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to Shingrix.     Additional Information: GSK receipt date: 14-Apr-2022 Reporter's comment: The patient was taking Provigil 250 mg daily for 4 weeks for unknown indication as concomitant medication. Recently, the patient was diagnosed with Covid on 29th March 2022, treated with Pf-07321332, Ritonavir (Paxlovid), 3 tablets twice a day for 5 day and experienced horrid taste in mouth. The reporter consented to follow-up. Additional Supportive Information: It was unknown if the reporter considered the anaphylaxis and hives to be related to Amox.    Note: As this case was received for Pfizer product for Covid which patient had received recently and there is no information regarding the vaccination details of Shingrix, therefore conservatively Shingrix was captured as suspect with event anaphylaxis.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Faint several minutes after vx; This case was reported by a nurse via sales rep and described the occurrence of fainting in a 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several minutes after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was recovered/resolved.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comment: The reporter had no further information about the vaccine, demographics of the patients, or the event itself.  The reporter reported that, the patient faint several minutes after receiving Bexsero.  The patient was fine and recovered quickly from the fainting spell.  The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022065232, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065232:Same reporter. Pt 1.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: got shingles, had received 2 doses previously/Suspected vaccination failure; got shingles after getting COVID; got shingles after getting COVID; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 15-APR-2022  Reporter's Comments: The patient had 2 doses of Shingrix previously and got shingles after getting COVID.  The reporter thought COVID played a part in patient's acquiring shingles. The reporter agreed to follow up from GlaxoSmithKline (GSK). Additional Supportive Information:  This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Note- As it is unknown if the patient experienced Covid after 1st dose or after 2nd dose of Shingrix, it is linked with both the doses.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Shingles shot gave discomfort for a few days after; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (dad had shingles, he was in so much pain) and pain (Family History) (dad had shingles, he was in so much pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   The reporter considered the discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-APR-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced discomfort for a few days after.  The patient felt happy to be protected, though. Additional Supportive Information: The follow-up could not be possible as no contact details were available. This case has been linked with case US2022AMR064705, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064705:Same Reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: had them four times, gotten both my shots/suspected vaccination failure; had them four times- they're miserable; ha an immune response, I felt awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling bad. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling bad to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 17th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had shingles four times, they were miserable. The patient had gotten both shingles shots. The second one, the patient had an immune response to which was normal. The patient felt awful for about one and half days but it was over. It was reported that the beats getting the shingles any ole day. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles but I had been vaccinated/suspected vaccination failure; shingles on right hand; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got shingles but she had been vaccinated so the patient did not know if the case had anything to do with that but only had it on right hand. It was not that bad. But the patient know how bad it was. That was the reason the patient got the vaccine in the first place. The patient's  hubby got it on his face and head. It was bad. The patient had go pick him up a prescription that when got her shot. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided. Note:Since narrative did not specify if the reporter's husband was vaccinated or not, only a single case was considered for the reporter themselves.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles on my back, had the Shingles shot's/Suspected vaccination failure; Shingles on my back, had the Shingles shot's; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-APR-2022 Reporter's comment: This case was received from consumer via interactive digital media. The patient self-reported this case. After receiving Shingles shot, the patient just getting over shingles on his/her back and this was second time for him/her.  The patient asked that what was up with that. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: MD requiring 2nd series of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stem cell transplant. Previously administered products included Shingrix (received a series of Shingrix vaccination on an unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK receipt date: 12-Apr-2022 Reporter's comments: Pharmacist reported that the patient had stem cell transplant and doctor of medicine (MD) requiring 2nd series of Shingrix vaccinations. The original dates of 1st Shingrix vaccination series unknown. The reporter refused to provide any patient demographics. The reporter consented to follow-up. Additional Supportive Information: The reporter reported that doctor of medicine (MD) requiring 2nd series of Shingrix vaccinations, which led to off label use.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Faint several minutes after vx; This case was reported by a nurse via sales rep and described the occurrence of fainting in a 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several minutes after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was recovered/resolved.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comment: The reporter had no further information about the vaccine, demographics of the patients, or the event itself.  The reporter reported that, the patient faint several minutes after receiving Bexsero.  The patient was fine and recovered quickly from the fainting spell.  The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022AMR065588, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR065588:Same reporter. Pt 2.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: received a second dose in error; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received 1st dose of Kinrix on 12th October 2021 from batch number 29MZ2 with expiry date unknown).   On 14th April 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 15-APR-2022 Reporter's comment: The practice director reported that a patient received second dose of Kinrix in error. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose on 14th April 2022, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, never received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose of Shingrix three years ago).   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: 15-APR-2022 Reporter's Comments: The reporter stated that patient who got his 1st dose of Shingrix three years ago and never received the 2nd dose. The reporter did not had any additional information and demographics.  The reporter did not have a record of vaccine because it was given at a different location. The reporter did not provided 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.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 1st dose on  May 2021 got 2nd dose on February 2022; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   In February 2022, the patient received the 2nd dose of Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: The registered pharmacist reported that a patient who received 1st dose of Shingrix in May 2021 got 2nd dose in February 2022. It had been longer than 6 months since patient got first dose. Lot number and expiration date of second dose, patient's demographics asked but wasn't provided by health care professional.  Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2018, did not receive 2nd dose; This case was reported by a pharmacist 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 Shingrix (received 1st dose on 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: 18th Apr 2022 Reporter's Comments: The pharmacist stated that the patient received first dose of the Shingrix series in 2018, but they did not receive second dose. The patient had now came in to pharmacy requesting second dose. The first dose was administered at a different location so the reporter did not have the exact date, lot number, or expiration date information. At the time of reporting, the second dose had not administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066312:Same Reporter
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB0588, 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 19th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 19th 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: 19-Apr-2022 Reporter's comments: The nurse reported that the patient received an expired dose of Bexsero. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Asthma, Drug ineffective, Fatigue, Malaise, Pain
Clinical narrative: PAIN; FEELING UNWELL; FATIGUE EXTREME; LACK OF DRUG EFFECT; ASTHAMA AGGRAVATED; This spontaneous report received from a patient via other manufacturer concerned a 31 year old male of unspecified race and ethnicity. The patient was enrolled in a non-Company sponsored solicited program Facilitated Collection. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (benadryl, dye free benadryl, glycopyrrolate), and ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 (Dose 1 of dose number in series 1) (Age at time of vaccination 30 years old) and 16-OCT-2021 (Dose 2 of dose number in series 1) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown expiry: unknown) 40 mg, 1 time every 2 weeks from 17-DEC-2021 to 25-MAR-2022 for ankylosing spondylitis. On 17-DEC-2021, the patient felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up (asthma aggravated) and lack of effect (dose number in series 1). On an unspecified date, the patient experienced fatigue/tired/extremely drained more than usual/fatigue was extreme, felt poorly and pain (all events with dose number in series 1). The patient received booster non-company pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin not reported, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, administered on 15-MAR-2022 for covid-19 vaccination. It was unknown if the patient experienced any adverse event after vaccination with pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on 25-MAR-2022. The patient recovered from lack of drug effect, and asthama aggravated on 25-MAR-2022, had not recovered from fatigue extreme, and the outcome of feeling unwell and pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220427755- covid-19 vaccine ad26.cov2.s- lack of drug effect. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 28-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 30-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2022, the patient had covid-19 (Dose number in series 2). On 18-APR-2022, patient was calling to report that patient was feeling better and returning to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19. This report was non-serious. This report was associated with product quality complaint.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: 3 BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported batch: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 3 blood clots in lungs. On an unspecified date patient was hospitalized for unspecified days. Patient was going to intensive care for two weeks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 blood clots in lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220434245-covid-19 vaccine ad26.cov2.s-3 blood clots in lungs . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient found a blood clot in leg after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220438559-Covid-19 vaccine ad26.cov2.s-Blood clot in leg.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Reporter reported that the patient experienced stroke following vaccination.  Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unknown age and no medical history reported, who experienced the unexpected serious AESI of  Cerebrovascular accident, on an unspecified date after receiving a dose of mRNA-1273 vaccine (dose number not specified). The patient had experienced stroke and outcome was unknown. No further details on clinical presentation, diagnostic and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age and no medical history reported, who experienced the unexpected serious AESI of  Cerebrovascular accident, on an unspecified date after receiving a dose of mRNA-1273 vaccine (dose number not specified). The patient had experienced stroke and outcome was unknown. No further details on clinical presentation, diagnostic and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Malaise, Pulmonary congestion
Clinical narrative: Their lungs are congested, they are all stuffed up; Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed; Real bad cough; Fever; Have the chills; Achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever) and CHILLS (Have the chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, B58F21A, 011A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever), CHILLS (Have the chills) and ARTHRALGIA (Achy joints). At the time of the report, PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever), CHILLS (Have the chills) and ARTHRALGIA (Achy joints) was resolving.            Patient had not seek any medical care (office visit, Urgent care, ER, hospitalized) for AEs and haven't experienced these events in the past. Patient had not experienced any side effects with first three doses. Patient felt a little better after 8 days. No concomitant medications were reported by reporter. Patient had OTC medications and took lots of rest as a treatment.   This case was linked to MOD-2022-542336 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Their lungs are congested, they are all stuffed up; Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed; Real bad cough; Fever; Have the chills; Achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever) and CHILLS (Have the chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, B58F21A, 011A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever), CHILLS (Have the chills) and ARTHRALGIA (Achy joints). At the time of the report, PULMONARY CONGESTION (Their lungs are congested, they are all stuffed up), MALAISE (Feeling sick, they ve been in bed for six or seven days now. They can hardly get out of bed), COUGH (Real bad cough), PYREXIA (Fever), CHILLS (Have the chills) and ARTHRALGIA (Achy joints) was resolving.            Patient had not seek any medical care (office visit, Urgent care, ER, hospitalized) for AEs and haven't experienced these events in the past. Patient had not experienced any side effects with first three doses. Patient felt a little better after 8 days. No concomitant medications were reported by reporter. Patient had OTC medications and took lots of rest as a treatment.   This case was linked to MOD-2022-542336 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: focal seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of PARTIAL SEIZURES (focal seizure) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARTIAL SEIZURES (focal seizure) (seriousness criterion medically significant). At the time of the report, PARTIAL SEIZURES (focal seizure) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient recovered from the event of focal seizure after one week of receiving the first dose.  Company Comment: This is a spontaneous case concerning an elderly patient (unknown age and gender) with no reported medical history, who experienced the unexpected, serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on unknown date after receiving the first dose of mRNA-1273 vaccine and had resolved after a week. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542549, MOD-2022-542594 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly patient (unknown age and gender) with no reported medical history, who experienced the unexpected, serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on unknown date after receiving the first dose of mRNA-1273 vaccine and had resolved after a week. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.