chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin lesion, Vaccination failure
Clinical narrative: fully vaccinated. He got them/ suspected vaccination failure; got them; lesions; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 skin lesion. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin lesion were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and skin lesion to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient was fully vaccinated for shingles and he got them anyway but had no pain. The patient had very few lesions. The patient took an antiviral prescription pill and shingles were gone in 5 days. The reporter stated that the vaccines work. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Mobility decreased, Walking aid user, Wheelchair user
Clinical narrative: guillain barre; has to use a wheelchair and walker; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a male 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 guillain barre syndrome (serious criteria GSK medically significant) and mobility decreased. On an unknown date, the outcome of the guillain barre syndrome and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome and mobility decreased to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingles vaccine and now has Guillain barre. The patient had to use a wheelchair and walker to get around. The reporter stated that they have a class action lawsuit against the makers of the shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Pain
Clinical narrative: abdominal pain; enema relieved pain; This case was reported by a other health professional via sales rep and described the occurrence of abdominal pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal pain and pain. On an unknown date, the outcome of the abdominal pain and pain were unknown.   It was unknown if the reporter considered the abdominal pain and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. The patient had symptoms of left lower quadrant abdominal pain and pain after Shingrix. The reporter agreed to follow up. This case was linked with case US2021AMR206096, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206096:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was the reporter's little brother. The age at vaccination was not reported. The patient died from complications after receiving a Flu shot.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: FLUX
Symptoms: Angioedema
Clinical narrative: Lip angioedema; This case was reported by a other health professional and described the occurrence of lip angioedema in a 29-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included dermal filler injection (had in the lips (unknown how long prior to the vaccination)).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced lip angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the lip angioedema was unknown.   It was unknown if the reporter considered the lip angioedema to be related to Influenza vaccine.  Additional details were reported as follows: This case was identified in FDA Briefing Document with respect to the Moderna COVID-19 vaccine. The age at vaccination was not reported. The patient experienced lip angioedema after receiving an Influenza vaccine. The patient also had lip angioedema 2 days after vaccination with Moderna COVID-19 vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: dispensed a dose from recall batch; dispensed a dose from recall batch; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On 30th June 2021, unknown after receiving Shingrix, the patient experienced drug dispensing error. On an unknown date, the patient experienced recalled drug administered. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The pharmacist reported that, their pharmacy dispensed a dose of Shingrix on 30th June 2021 from the recall batch, which led to recalled drug administered and drug dispensing error. The vaccine was meant to be administrated to a male patient but the facility was unaware of the date of the administration. The adverse event report came from a pharmacy who dispensed doses of the vaccine to other health institutions. The Shingrix doses were administrated in another facility and the reporter did not know when (exact date) or if the vaccines were in fact administrated, they only had the date in which the vaccines were dispensed from the pharmacy which were after the date of the Shingrix recall. The reporter of the adverse event did not know if the patients had adverse events after the administration of the vaccine. No further events were reported. The reporter consented to follow up. This case was linked with US2021202999 and US2021202998, reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202998:same reporter US-GLAXOSMITHKLINE-US2021202999:same reporter
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cough, Injection site swelling, Nasal congestion, Pyrexia
Clinical narrative: stuffy nose; dry cough; small bump at the injection site; high fever; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th September 2021, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 25th September 2021, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced injection site swelling and fever. On 28th September 2021, the patient experienced nasal stuffiness and dry cough. The patient was treated with paracetamol (Tylenol). On 26th September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the nasal stuffiness and dry cough were not recovered/not resolved.   The reporter considered the injection site swelling to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the reporter considered the fever, nasal stuffiness and dry cough to be related to Pediarix and Pediarix 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 details were reported as follows: This case was reported by the health care professional. The physician reported that the patient received his 2nd dose of Pediarix vaccine in the right thigh. The physician reported that the patient experienced a high fever approximately 8 hours after receiving the injection. The physician reported that patient was brought to the Emergency room and given Tylenol to reduce the fever. The patient had small bump on the right thigh at the injection site. On the same day, the patient was released from the Emergency room  with a fever of 100.8 Fahrenheit and on the day of reporting, the fever has resolved at 99.6 Fahrenheit. The physician reported that the mother of the patient texted him that as on the reporting day morning, the patient had a stuffy nose and a dry cough, but otherwise doing well. The reporter consented to follow- up. This case has been linked with US2021203779, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203779:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza virus test negative, Pain
Clinical narrative: feeling a little "yucky"; headache; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary tract infection (had a pre-existing urinary tract infection at the time of the immunization).   On 20th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a week after receiving Shingrix, the patient experienced fever. On 21st September 2021, the patient experienced feeling abnormal, headache, general body pain and chills. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, headache, fever, general body pain and chills were not recovered/not resolved.   The reporter considered the feeling abnormal, headache, fever, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient had Shingrix shot intramuscularly in her left deltoid. The patient had a pre-existing urinary tract infection and was on unspecified medication for that. The patient did not had the lot or expiry of the Shingrix but she did provide the contact information for the Medical doctor office where she got the immunization and they should had that on record.  Next day of the vaccination, patient felt a little "yucky". The patient reported that she experienced headache, maybe chills, and body aches. One day before reporting, patient went to doctor because she was thinking she might had a virus.  She was tested for flu (influenza) and flu test was negative.  She also indicated that she had also recently tested for Covid and it was negative also. She said her doctor thought her symptoms were side effects from Shingrix.  She said her symptoms had progressively gotten worse.  She experienced fever and she could only keep the fever down if she was taking Ibuprofen and Tylenol.    On the day of reporting, patient indicated that she was still not recovered, she thought her body was responding negatively to the Shingrix vaccine.  The patient wondered if side effects could last this many days after the shot. The reporter consented to follow up. This case had been linked with US2021203777 and US2021203778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203777:same reporter US-GLAXOSMITHKLINE-US2021203778:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: feeling a little "yucky"; headache; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary tract infection (had a pre-existing urinary tract infection at the time of the immunization).   On 20th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a week after receiving Shingrix, the patient experienced fever. On 21st September 2021, the patient experienced feeling abnormal, headache, general body pain and chills. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, headache, fever, general body pain and chills were not recovered/not resolved.   The reporter considered the feeling abnormal, headache, fever, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient had Shingrix shot intramuscularly in her left deltoid. The patient had a pre-existing urinary tract infection and was on unspecified medication for that. The patient did not had the lot or expiry of the Shingrix but she did provide the contact information for the Medical doctor office where she got the immunization and they should had that on record.  Next day of the vaccination, patient felt a little "yucky". The patient reported that she experienced headache, maybe chills, and body aches. One day before reporting, patient went to doctor because she was thinking she might had a virus.  She was tested for flu (influenza) and flu test was negative.  She also indicated that she had also recently tested for Covid and it was negative also. She said her doctor thought her symptoms were side effects from Shingrix.  She said her symptoms had progressively gotten worse.  She experienced fever and she could only keep the fever down if she was taking Ibuprofen and Tylenol.    On the day of reporting, patient indicated that she was still not recovered, she thought her body was responding negatively to the Shingrix vaccine.  The patient wondered if side effects could last this many days after the shot. The reporter consented to follow up. This case had been linked with US2021203777 and US2021203778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203777:same reporter US-GLAXOSMITHKLINE-US2021203778:same reporter
Age: 52.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo administered instead of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA571A, expiry date 30th June 2022) and (batch number AMVA571A, expiry date 30th June 2022) for prophylaxis.   On 28th September 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 28th September 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details provided were as follows: The reporter provided 2 different batch numbers for the same suspect Menveo as AMXA571A and AMVA571A. Licensed practical nurse called in to report that they inadvertently administered Menveo to a patient instead of Shignrix which led to wrong vaccine administered. The reporter consented to follow-up.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Diarrhoea, Dysphonia, Eyelid function disorder, Fatigue
Clinical narrative: redness at injection site; itchiness at injection site; Loss of appetite; Hoarseness; Hives right arm above injection site; low grade fever; Tiredness; Queasy/ Nausea; Diarrhea; Muscle weakness; Headache; could not keep eyes open; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Flu Seasonal QIV(Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included transient ischemic attack (in 2009), tachycardia, bradycardia and hypertension (bedrest due to HTN,). Previously administered products included Steroid shot (steroid shot in right knee August 2021). Concurrent medical conditions included intervertebral disc protrusion (bulging disks) and overweight.   On 24th September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, several hours after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On 25th September 2021, the patient experienced appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder. In September 2021, the outcome of the injection site erythema, injection site itching, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder were recovered/resolved. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received Flu shot (did not know which one) and had the following reactions like redness, swelling and itchiness at injection site hours after vaccine given in right arm. The patient also stated that, the next day itching got worse and she had a low grade fever, tiredness, queasy/nausea, diarrhea, muscle weakness, headache, could not keep her eyes open, hoarseness and loss of appetite. The patient also had hives at right arm above the injection site. The patient stated she had recovered since then. The reporter consented to follow-up. Note: There is discrepancy reported for the time to onset of event hoarsness and loss of appetite. In the structured field it is reported as 2 days however, in the narrative it is reported as occurred on the next day of vaccination. The TTO for these events captured as per narrative.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Muscular weakness
Clinical narrative: redness at injection site; itchiness at injection site; Loss of appetite; Hoarseness; Hives right arm above injection site; low grade fever; Tiredness; Queasy/ Nausea; Diarrhea; Muscle weakness; Headache; could not keep eyes open; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Flu Seasonal QIV(Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included transient ischemic attack (in 2009), tachycardia, bradycardia and hypertension (bedrest due to HTN,). Previously administered products included Steroid shot (steroid shot in right knee August 2021). Concurrent medical conditions included intervertebral disc protrusion (bulging disks) and overweight.   On 24th September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, several hours after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On 25th September 2021, the patient experienced appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder. In September 2021, the outcome of the injection site erythema, injection site itching, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder were recovered/resolved. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received Flu shot (did not know which one) and had the following reactions like redness, swelling and itchiness at injection site hours after vaccine given in right arm. The patient also stated that, the next day itching got worse and she had a low grade fever, tiredness, queasy/nausea, diarrhea, muscle weakness, headache, could not keep her eyes open, hoarseness and loss of appetite. The patient also had hives at right arm above the injection site. The patient stated she had recovered since then. The reporter consented to follow-up. Note: There is discrepancy reported for the time to onset of event hoarsness and loss of appetite. In the structured field it is reported as 2 days however, in the narrative it is reported as occurred on the next day of vaccination. The TTO for these events captured as per narrative.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: redness at injection site; itchiness at injection site; Loss of appetite; Hoarseness; Hives right arm above injection site; low grade fever; Tiredness; Queasy/ Nausea; Diarrhea; Muscle weakness; Headache; could not keep eyes open; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Flu Seasonal QIV(Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included transient ischemic attack (in 2009), tachycardia, bradycardia and hypertension (bedrest due to HTN,). Previously administered products included Steroid shot (steroid shot in right knee August 2021). Concurrent medical conditions included intervertebral disc protrusion (bulging disks) and overweight.   On 24th September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, several hours after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On 25th September 2021, the patient experienced appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder. In September 2021, the outcome of the injection site erythema, injection site itching, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder were recovered/resolved. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received Flu shot (did not know which one) and had the following reactions like redness, swelling and itchiness at injection site hours after vaccine given in right arm. The patient also stated that, the next day itching got worse and she had a low grade fever, tiredness, queasy/nausea, diarrhea, muscle weakness, headache, could not keep her eyes open, hoarseness and loss of appetite. The patient also had hives at right arm above the injection site. The patient stated she had recovered since then. The reporter consented to follow-up. Note: There is discrepancy reported for the time to onset of event hoarsness and loss of appetite. In the structured field it is reported as 2 days however, in the narrative it is reported as occurred on the next day of vaccination. The TTO for these events captured as per narrative.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 06Jan2020, second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th January 2020, batch number 3C3YW, expiry date 5th March 2022).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not believe the reason for delay was due to any supply issue. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago from the date of reporting).   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 details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient inquired if he should restart series or when should he receive the second dose to which the call center representative provided medical advice disclaimer. No additional details were provided by reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: gave dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 14th September 2021) for prophylaxis.   On 28th September 2021, the patient received Engerix B. On 28th September 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist gave a dose of Engerix-B that had expired which led to expired vaccine used. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: 11 weeks pregnant received fluarix vaccine; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at week 11 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient herself. A 11 weeks pregnant patient reported that she had received her fluarix vaccine through her employer, which led to vaccine exposure during pregnancy. She was not experiencing any symptoms and was advised by her employer to report pregnant, when getting the vaccine.  Obstetrician gynecologist (OB/GYN), the patient's health care professional information obtained for any necessary follow-up. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 4 years ago, would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago, from the date of reporting).   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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter inquired if the patient restart the series or get a second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter unable to provide details on first dose. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: pressurized spray from the adjuvant vial hit him in the eye; pressurized spray from the adjuvant vial hit him in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a 25-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown.  Additional details were provided as follows: The patient was pharmacist and self-reported this case. The age at vaccination was not reported. The pharmacist reported that they were drawing up the Shingrix adjuvant for reconstitution, when a pressurized spray from the adjuvant vial hit him in the eye, as the needle was being removed from the adjuvant vial, which led to inadvertent exposure to vaccine, exposure via eye contact. The patient immediately rinse the eye and not experienced any side effects, at the time of reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix 720 Junior) (batch number 94J24, expiry date 26th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Havrix 720 Junior (intramuscular) and Havrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Havrix 720 Junior and Havrix 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 details were provided as follows: The age at vaccination was unknown. The SNP stated that, the patient was administered with Havrix vaccine in the right thigh and the nurse then noticed the vaccine had already expired. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix exposed to freezing temperatures; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th September 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Boostrix that had been exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in left thigh; This case was reported by a consumer via call center representative and described the occurrence of pain in thigh in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2021, 7 days after receiving Shingrix, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was not recovered/not resolved.   It was unknown if the reporter considered the pain in thigh to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The batch number and expiry date was unknown. The patient reported that he received Shingrix vaccine, at the time of reporting the patient was experiencing pain in his left thigh. The reporter consented to follow up with health care professional.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administered a half dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received HBV (Engerix B adult) for prophylaxis.   On 29th September 2021, the patient received Engerix B adult .5 ml. On an unknown date, unknown after receiving Engerix B adult, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The pharmacist reported that a nurse only administered a half dose of adult formulation of Engerix-B (0.5 ml) to adult patient, which led to underdose. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site warmth
Clinical narrative: experienced pain when the medicine goes in; experienced burning feeling when the medicine goes in; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site warmth. On an unknown date, the outcome of the injection site pain and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain and injection site warmth to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra 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 was provided as follows: The pharmacist wanted to report that in 3 different facilities 70-100 patients who received Flulaval experienced pain and burning feeling when the medicine goes in. All of these patients had the same reactions regarding the injection site. It hurt worse than last year. She also confirmed that these patients received the vaccine in other facilities thats why she didn't have demographic details to provide regarding those patients The reporter did not consent to follow-up. The case has been linked with US2021AMR206679, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206679:same reporter
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Inappropriate formulation of vaccine administered; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Aug-2021, INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patients were given Moderna vaccine as though it had preservative and dose administered after 7 days from  punctured vial. No Concomitant medications were reported.  No Treatment medication was reported.   This case was linked to MOD-2021-332833, MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received on 29 Sep 2021 contains non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: slept the entire day; wiped out; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the entire day) and FATIGUE (wiped out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised since an unknown date.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SOMNOLENCE (slept the entire day) and FATIGUE (wiped out). At the time of the report, SOMNOLENCE (slept the entire day) and FATIGUE (wiped out) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: PARALYZED ON ONE SIDE; This spontaneous report received from a consumer via a company representative from social media concerned a patient of unspecified age, race, sex and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, with frequency 1 total used 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.  The reporter stated that on an unspecified date, the patient (very sporty person) experienced paralyzed on one side since the vaccination (real case) 100 percent convinced it was the vaccination. The doctor thought that this was not the case as (no side effect). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed on one side was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211001451-COVID-19 VACCINE AD26.COV2.S.- Paralyzed on one side. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report was received from literature. This report concerned multiple female patients (6) 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced cerebral venous sinus thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cerebral venous sinus thrombosis was not reported. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210957986.; Sender's Comments: V0: 20211002675-covid-19 vaccine ad26.cov2.s-cerebral venous sinus thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Feeling cold, Malaise, Pyrexia
Clinical narrative: SOMETHING BAD IN HEART, LIKE FEELING A BOOM BOOM; CHILLS; FEEL COOL; DONT FEEL GOOD; A LITTLE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-OCT-2021 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 01-OCT-2021, the patient experienced something bad in heart, like feeling a boom boom. On 01-OCT-2021, the patient experienced chills. On 01-OCT-2021, the patient experienced feel cool. On 01-OCT-2021, the patient experienced dont feel good. On 01-OCT-2021, the patient experienced a little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feel cool, a little fever, something bad in heart, like feeling a boom boom, and dont feel good. This report was non-serious.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: ARM BARELY SORE; BIT TIRED; This spontaneous report received from a patient concerned an 89 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced vaccination adverse reaction when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced arm barely sore, and bit tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm barely sore and bit tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: BAD FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad fever, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever, nausea and headache was not reported. This report was non-serious.