chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Immediate post-injection reaction, Incomplete course of vaccination, Influenza like illness
Clinical narrative: I have not taken the second injection; After 1st dose, sick with flu like symptoms; sick; This case was reported by a other health professional and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2022, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The reporter stated that patient took first injection of Shingrix in February 2022. The patient immediately got sick with flu like symptoms that lasted for 3 weeks. The patient had not taken the second dose of Shingrix also considering for getting second dose. Patient asked that whether he/she waited to long or would get it. Additional supportive information: Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 FLulaval 12 days apart.; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 3-year-old patient who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Previously administered products included Flulaval. Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent and an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The case was reported by nurse. The nurse reported that had a recent vaccine error in clinic where patient received 2 doses of the Flulaval vaccine 12 days apart. The child had received a dose previously in clinic but was brought by the grandparent, and the mother did not know he had already received this and signed the permission form. The vaccine was administered without checking the vaccine record. The reporter did not share any information about patient reactogenicities to doses. Additional supportive information: As patient received 2 doses of Flulaval vaccine which led to extra dose administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Tinnitus
Clinical narrative: Pain at injection site; Permanent ringingin ears, predominantly in right ear, sometimes dissipates; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and ringing in ears. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and ringing in ears to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm about 6 months ago at her doctor's office. The patient reported that she had a permanent ringing in both ears, but it was predominantly in the right ear, sometimes it dissipates, but it came back.  The reporter reported that it started immediately but patient reported that she did not realize it was related to the vaccine, so it started in a weeks' time.  The patient reported that she was provided a sheet with vaccine information that stated if you have any of these adverse reactions do not take the second dose. The patient reported she had not taken the second dose. The patient had pain at the injection site. The patient took a pain medication to sleep. Not all information was available. Lot and expiry date were unknown. The patient reported that her health care professional going to report her reaction and reported that she was not sure if this was done or not. The patient reported that she had not received any communication about the event. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 MO recieved Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 3rd June 2023) 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 2nd December 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-Dec-2022 Reporter's Comment: The reporter reported that a 4 month old patient received Flulaval QIV . The reporter information was sent by email to team. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that a 4 month old patient received Flulaval QIV, which led to inappropriate age at vaccine administration.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 MO received Engerix-B (1ml); 2 MO received Engerix-B (1ml); This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 2-month-old female patient who received HBV (Engerix B) (batch number 9255P, expiry date 15th February 2024) for prophylaxis.   On 1st December 2022, the patient received Engerix B 1 ml. On 1st December 2022, unknown after receiving Engerix B, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.      Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The physician reported that the patient administered 1 dose of Engerix B 1 ml instead of 0.5 ml to the patient. The reporter asked for safety information. The reporter consented to follow up. Additional supportive information: 1 ml of dose was intended for use in patients 16 years of age and above however patient was 2 months old and was administered 1 ml of dose of Engerix B which led to overdose and adult product administered by child.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient already had 3 Menveo dose series.; Menveo instead of Meningococcal B vaccine (Bexsero); This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA6598A, expiry date 20th January 2023) for prophylaxis.   Previously administered products included Menveo (On unknown date had a 3 dose series).   On 29th November 2022, the patient received the 4th dose of Menveo. On 29th November 2022, unknown after receiving Menveo, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient inadvertently received Menveo vaccine instead of Meningococcal B vaccine Bexsero. The reporter stated that the patient already received 3 dose series of Menveo vaccine. The reporter did consent to follow up. Additional supportive information: The patient received extra dose of Menveo inadvertently, which led to extra dose administered. The reporter reported that, they were intending to administered Bexsero and inadvertently administered Menveo instead of Bexsero, which led to wrong vaccine administered.
Age: 83.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: 1st dose 28May2022, 2nd June2022; received the second Havrix vaccine in June 2022, in the left arm at the recommendation of the pharmacy; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In June 2022, the patient received the 2nd dose of Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. In June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short and off label use. On an unknown date, the outcome of the drug dose administration interval too short and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter was a pharmacist. The patient reported that she received 1st dose of Havrix vaccine on 28th May 2022 and in June 2022 she received 2nd dose of Havrix vaccine at the recommendation of the pharmacy. The patient wanted to know if she covered for Hepatitis A and if not to please call her. Caller would also contact her HCP. The reporter did not consent to follow up. Caller did not give permission for GlaxoSmithKline to contact HCP. Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule. The patient received the second dose of Havrix vaccine in June 2022, in the left arm at the recommendation of the pharmacy, which led to off label use. This case had been linked with US2022181002 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022181002:Same reporter
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose june 2022, 2nd jul 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 38-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In July 2022, the patient received the 2nd dose of Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. In July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   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: 02-DEC-2022 Reporter's Comment: The reporter was the mother of the patient. The reporter reported that the patient received both doses of Havrix vaccine in 1 month apart. The reporter stated that the patient received 1st dose of Havrix vaccine on June 2022 and 2nd dose on July 2022 in an unknown arm. The reporter did not give permission to contact healthcare professional. Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule. This case had been linked with US2022181000 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022181000:Same reporter
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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: 02-Dec-2022 Reporters comment: A pharmacist reported that the patient received an expired dose of Engerix B. The reporter consented to follow up. Additional supportive information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose years ago, wants 2nd dose today; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml 1st dose in October 2020 into unknown arm intramuscularly).   On 2nd December 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 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: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient got the first dose of Shingrix vaccine two years ago and was getting the second dose of Shingrix today (on the day of reporting). The patient did not have any further information about the first or second vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 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 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient did not receive second dose of Shingrix within the recommended window post the first dose. The reporter did not have lot or expiry date of the first dose of Shingrix. The reporter consented 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. This case had been linked to the case US2022181026, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181026:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 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 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient did not receive second dose of Shingrix within the recommended window post the first dose. The reporter did not have lot or expiry date of the first dose of Shingrix. The reporter consented 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. This case had been linked to the case US2022181027, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181027:Same reporter
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 7 year-old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported administration of Kinrix to a 7 year old patient. Additional adverse event details were unavailable per health care professional.  The reporter consented to follow up. Additional Supportive Information: The seven-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 67.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 18May2022, 3rd on 29Oct2022; 1st dose on 18May2022, 2nd on 27Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 29th October 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th June 2022, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 29th October 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The patient received 1st dose of Twinrix on 18th May 2022. The pharmacist reported that the patient received third dose of Twinrix on 29th October 2022 and second dose on 27th June 2022. The reporter consented to follow up by email. Additional supportive information: The patient received the third dose of Twinrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 2nd September 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 1st December 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Pediarix and Pediarix 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: 02 DEC 2022 Reporter's comment:  This case was reported by physician. The physician reported that the patient administered a dose of Pediarix on 1st December 2022 and it was then discovered the dose had an expiration date of 2nd September 2022. This was the patient's third dose in the series. At the time of reporting, the Physician did not have the lot number available. Additional supportive information: As patient received the expired vaccine which led to expired vaccine used. Reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date 30th November 2023) for prophylaxis.   On 2nd December 2022, the patient received Menveo. On 2nd December 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.       Additional Information: GSK receipt date: 02-DEC-2022 Reporter's comment: The reporter stated that patient received diluent of a dose of Menveo vaccine by the patient. Additional supportive information: As patient only received only the diluent part of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of product administration
Clinical narrative: Administered via subcutaneous route; This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 57-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   In November 2022, the patient received Influenza vaccine (subcutaneous). In November 2022, unknown after receiving Influenza vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The case was reported by physician. The physician reported that the patient was administered Fluarix or Flulaval subcutaneously. The brand name was not known but health care professional stated it was from GlaxoSmithKline. The event occurred three days ago.The reporter consented to follow up. Additional supportive information: As patient administered Fluarix or Flulaval subcutaneously which led to intramuscular formulation administered by other route.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 26th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Infanrix and Infanrix 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: 05-DEC-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that on 01st December 2022  the patient received Infanrix vaccine which was already expired on 26th November 2022. The reporter did consent to follow up via email. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Echocardiogram normal, Fatigue, Magnetic resonance imaging normal
Clinical narrative: Right after my vaccination I got a dry cough, fatigue, and felt feverish. When it got to Friday, I tested myself for COVID-19 and it was negative. I went in to get tested at 4pm and it was positive for COVID-19. They prescribed me an antiviral. I developed TGA on 11/20/2022 for 2 hours. They took me to the doctor, and they did an MRI and echocardiogram. Everything was normal
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Right after my vaccination I got a dry cough, fatigue, and felt feverish. When it got to Friday, I tested myself for COVID-19 and it was negative. I went in to get tested at 4pm and it was positive for COVID-19. They prescribed me an antiviral. I developed TGA on 11/20/2022 for 2 hours. They took me to the doctor, and they did an MRI and echocardiogram. Everything was normal
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient started to experience shortness of breath, swelling of the throat/tongue and gasping for air. Team members began to take vitals and once provider was called out, 0.3mg Epi pen was administered to patient with approval from patient and oxygen was started at 4 LPM.  Once oxygen was administered, patients O2 sats increased as well as her breathing. EMS was called after administration of Epi pen, once they arrived they began their own evaluation of patient and monitored for the next 20-30 minutes. Pt. denied transport to hospital and family stated that she would be fine with time as they have experienced this situation before.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Balance disorder, Blood test normal, Discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: Friday evening around that evening I was laying on the couch and felt dizzy. I got up to go to sleep and it was hard to keep my balance. It felt like a downward pressure was over me while walking and I fell to the floor. I got up the next morning, I also felt nauseous and the ringing in my ears intensified. It has gotten worse today. I made a appointment to my PCP and urgent care and the sent me to ER for about four hours. I did test that came back as normal.  They gave a dose of meclizine 25mg that was to help with the symptoms.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall, Gait disturbance, Nausea, Tinnitus
Clinical narrative: Friday evening around that evening I was laying on the couch and felt dizzy. I got up to go to sleep and it was hard to keep my balance. It felt like a downward pressure was over me while walking and I fell to the floor. I got up the next morning, I also felt nauseous and the ringing in my ears intensified. It has gotten worse today. I made a appointment to my PCP and urgent care and the sent me to ER for about four hours. I did test that came back as normal.  They gave a dose of meclizine 25mg that was to help with the symptoms.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device, Skin laceration
Clinical narrative: Child moved when attempted to give shot in Left Arm. Child received 2 to 3 inch cut from needle.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: I contracted COVID-19 with symptoms of sore throat, congestion, severe headache, cough, loss of smell, loss of taste, fatigue, and laryngitis. I was prescribed PAXLOVID but instructed not to take it if I felt better by day 5. I was ill for 5 days before my symptoms began to resolve so I did not take PAXLOVID. I am still experiencing fatigue, and lingering cough. I am still not fully recovered.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Laryngitis, Malaise, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I contracted COVID-19 with symptoms of sore throat, congestion, severe headache, cough, loss of smell, loss of taste, fatigue, and laryngitis. I was prescribed PAXLOVID but instructed not to take it if I felt better by day 5. I was ill for 5 days before my symptoms began to resolve so I did not take PAXLOVID. I am still experiencing fatigue, and lingering cough. I am still not fully recovered.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19 with symptoms of sore throat, congestion, severe headache, cough, loss of smell, loss of taste, fatigue, and laryngitis. I was prescribed PAXLOVID but instructed not to take it if I felt better by day 5. I was ill for 5 days before my symptoms began to resolve so I did not take PAXLOVID. I am still experiencing fatigue, and lingering cough. I am still not fully recovered.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Patient family member called later that day and stated that she was feeling very ill (did not specify symptoms) and that she was being brought to her physician for evaluation
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, not gotten 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose into left arm intramuscularly on 25th September 2021 from batch number 3s3x7 with expiry date 20th March 2023).   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: 05-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient did not receive second dose of Shingrix yet. The reporter reported that they do plan to get the second vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Influenza, Influenza virus test negative, SARS-CoV-2 test negative, X-ray
Clinical narrative: My joints were aching (shoulders and knees) and I felt flu like symptoms went to urgent care all tests for flu and Covid came back negative. Primary care referred me to orthopedic doctor.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site nodule, Injection site pain, Muscular weakness
Clinical narrative: At the time of the vaccination, I felt the burn of the injection. I have been fully vaccinated for COVID with boosters and I have had annual flu shots. This has NEVER burned before. I mentioned to the lady that administered the vaccine that it burned. She seemed puzzled, like this has never happened before. My husband was in the room and he asked if that was normal and she said that she did not know. The burn moved down my arm and over the following weeks I developed a dull pain, muscle weakness and limited mobility in my right arm and hand.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: At the time of the vaccination, I felt the burn of the injection. I have been fully vaccinated for COVID with boosters and I have had annual flu shots. This has NEVER burned before. I mentioned to the lady that administered the vaccine that it burned. She seemed puzzled, like this has never happened before. My husband was in the room and he asked if that was normal and she said that she did not know. The burn moved down my arm and over the following weeks I developed a dull pain, muscle weakness and limited mobility in my right arm and hand.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient indicated in the vaccination room that he would like his flu shot in addition to his Covid vaccine that he was scheduled for.  I verified his age and that he had not received his flu shot yet this season with him and administered the 65+ flu vaccine.  After administration we entered the vaccine into our pharmacy system and a data utilization review indicated that he had already receive one flu vaccine for 2022.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: No known adverse event
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, Malaise, Pain
Clinical narrative: My son received the second dose of the Pfizer COVID-19 vaccine on 10/22/2021. In May or June 2022, he was exposed to COVID-19 through family and got sick. He took a home antigen test and got a positive result. He had a fever of about 100 or 101 for one day. He had fatigue, body aches, and a runny nose. He was down for maybe about a day or two, but around day 5, he showed few or no symptoms. It was basically like a bad cold he quickly got over.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My son received the second dose of the Pfizer COVID-19 vaccine on 10/22/2021. In May or June 2022, he was exposed to COVID-19 through family and got sick. He took a home antigen test and got a positive result. He had a fever of about 100 or 101 for one day. He had fatigue, body aches, and a runny nose. He was down for maybe about a day or two, but around day 5, he showed few or no symptoms. It was basically like a bad cold he quickly got over.
Age: 40.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: Patient was to be given moderna bivalent and was given pfizer bivalent . And because we thought we were giving moderna bivalent patient was given .5 ml pfizer bivalent instead of .3 pfizer bivalent
Age: 40.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Patient was to be given moderna bivalent and was given pfizer bivalent . And because we thought we were giving moderna bivalent patient was given .5 ml pfizer bivalent instead of .3 pfizer bivalent
Age: 40.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: Today our patient came into the clinic to receive a Moderna Vaccine and my co worker and I were pulling the vaccine to give to the patient and we pulled a Pifzer Vaccine instead of a Moderna Bivalent vaccine.  I pulled 0.3ml of Pifzer and not 0.5ml of Moderna. As the patient requested a Moderna Bivalent I gave him the wrong Covid vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Today our patient came into the clinic to receive a Moderna Vaccine and my co worker and I were pulling the vaccine to give to the patient and we pulled a Pifzer Vaccine instead of a Moderna Bivalent vaccine.  I pulled 0.3ml of Pifzer and not 0.5ml of Moderna. As the patient requested a Moderna Bivalent I gave him the wrong Covid vaccine.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: no known adverse events
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave undiluted COVID-19 Vaccine.  Parent notified, no s/s reported.  Dr notified
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient received what we thought was covid bivalent vaccine, but it was determined that it was the standard dose that patient received.  patient has been notified after risk management, clinic manager and rn's determined there was no hard in patient receiving another standard dose.
Age: 0.58
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC15, RV5
Symptoms: Vaccination error
Clinical narrative: Pt was out of clinic once vaccine error was noted. As of now no call from mother with symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Heart rate increased, Oropharyngeal pain, Pain
Clinical narrative: I woke up with a sore throat, body aches and it felt like a sinus congestion. On 09/19/2022 I took my temperature, and it was 101.7, my oxygen was in the 90s, and my pulse was at 103 resting. The next day my temperature was 101.3. I tested positive for COVID-19 on 09/20/2022. On 09/21/2022 my temperature was between 100-101. My resting pulse was in the high 90s and normally it is in the 60s. On 09/22/2022 I called my doctor but because I was out of town, they couldn't prescribe me anything. On 09/24/2022 my temperature was down to 96 and pulse in the 70s. On 10/01/2022 I tested negative.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I woke up with a sore throat, body aches and it felt like a sinus congestion. On 09/19/2022 I took my temperature, and it was 101.7, my oxygen was in the 90s, and my pulse was at 103 resting. The next day my temperature was 101.3. I tested positive for COVID-19 on 09/20/2022. On 09/21/2022 my temperature was between 100-101. My resting pulse was in the high 90s and normally it is in the 60s. On 09/22/2022 I called my doctor but because I was out of town, they couldn't prescribe me anything. On 09/24/2022 my temperature was down to 96 and pulse in the 70s. On 10/01/2022 I tested negative.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: No known adverse events
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Angiogram, Angiogram abnormal, Carotid aneurysm rupture, Gene mutation identification test, Internal carotid artery deformity
Clinical narrative: Suffered an  SAH from a ruptured carotid terminus aneurysm 2 weeks after vaccine.  Underwent coiling. Pt. started to not feel well a week after receiving the vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Magnetic resonance imaging abnormal, Malaise, Subarachnoid haemorrhage
Clinical narrative: Suffered an  SAH from a ruptured carotid terminus aneurysm 2 weeks after vaccine.  Underwent coiling. Pt. started to not feel well a week after receiving the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear. Constant.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bed sharing, Cough, Dysphonia, Fatigue, Flushing
Clinical narrative: On December 1, 2022 I had a scratchy throat and I felt flushed.  I tested positive for COVID-19 on December 3 2022.  I felt a little congested and it started to increase.  I had a low-grade fever and my heart rate would accelerate as resting at 80 and normally is in the fifties.  My congestion got worse.  I saw the doctor on 12//2022 and was prescribed Paxlovid.  As of today, 12/12/2022, I still have fatigue, cough and congestion and my voice is hoarse.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On December 1, 2022 I had a scratchy throat and I felt flushed.  I tested positive for COVID-19 on December 3 2022.  I felt a little congested and it started to increase.  I had a low-grade fever and my heart rate would accelerate as resting at 80 and normally is in the fifties.  My congestion got worse.  I saw the doctor on 12//2022 and was prescribed Paxlovid.  As of today, 12/12/2022, I still have fatigue, cough and congestion and my voice is hoarse.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Multiuse vial was in the refrigerator, dated 12/09 as being opened. Vial was used for administration 12/12 but the vial should have been discarded. There was no adverse reaction noted to the patient.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: Patient developed firm lump at injection site, still present 2 months after injection.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: No known adverse event
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic thrombosis, Pelvic venous thrombosis, Renal vascular thrombosis, Surgery, Vascular graft
Clinical narrative: S/P SURGERGY FOR PELVIC CLOTS AND RENAL CLOTS        AND AORTA -         AND BYPASS DONE ON THE LOWER EXT..        LEG / FOOT HEALING BETTER WITH IMPROVED VASCULAR FLOW..        PT SUSPECTS THAT THE VACCINE TRIGGERED THE MANY CLOTS..        SUGGESTED TO REPORT TO VAERS.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eczema, Herpes zoster, Psoriasis, Vaccination failure
Clinical narrative: 2 SHINGRIX in 2018, year later shingles/suspected vaccination failure; shingles under breast, arm , around the back; Eczema; Psoriasis; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2018, the patient received the 2nd dose of Shingrix. On 29th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, eczema and psoriasis. On an unknown date, the outcome of the vaccination failure, eczema and psoriasis were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, eczema and psoriasis to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 05-DEC-2022 and 07-DEC-2022 Reporter's Comment: The case was reported by the patient. She received 2 doses of Shingrix in 2018 at clinic.  Despite receiving a full dose of Shingrix, patient had shingles 3 times.  The patient's first event of shingles occurred a year after the vaccination in 2019 and the shingles were under breast and under arm and around the back.  Second event of shingles occurred around 2020 or 2021, on right leg.  Third event of shingles occurred in October 2022 on right side of inner thigh and extended on the back of the right side.  All 3 events were resolved after a week post occurrence.  The reporter did not specify whether reporter diagnosed her with the eczema/psoriasis after each visited to clinic post shingles occurrence. However, she stated that, could not believe that shingles could happen that often.  They diagnosed this to be eczema or psoriasis and that was a wrong diagnosis totally. Because The patient never had eczema or psoriasis. The patient did not have lot/expiry date of both of the doses. The patient gave consent to follow up with HCP (healthcare professional).  The contact information to HCP had been collected.  The patient gave email address for an acknowledgement letter. The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2022AMR183527 and US2022AMR183527, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR183520:same reporter