chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, FLU4, MMRV, PNC20, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to our facility on 1/13/25 and was refrigerated until admin on 2/5/25.
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, FLU4, MMRV, PNC20, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to our facility on 1/13/25 and was refrigerated until admin on 2/5/25.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to out facility on 11/13/24 and was refrigerated until admin on 1/29/25.
Age: 12.0
Sex: M
Vaccine: COVID19, FLU4, HEP, HEPA, HPV9, IPV, MMRV, TDAP
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to our facility on 11/13/24 and was refrigerated until admin on 1/8/25.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 12/4/24.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 12/4/24.
Age: 9.0
Sex: M
Vaccine: FLUC4, HEP, HEPA, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 12/5/24.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 11/14/24.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 11/14/24.
Age: 6.0
Sex: F
Vaccine: DTAP, FLUC4, HEPA, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024 PH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. It was assumed that ProQuad could be stored in both the freezer and refrigerator and both state and private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. The dose of MMRV administered to this client was received on November 13, 2024 and stored in the refrigerator until administered on January 2, 2025.
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, FLU4, HEPA, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 12/2/24.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, PH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on he FDA website. Unaware that there were two ProQuad products licensed by the FDA, it was assumed that the ProQuad we received could be refrigerated and both state and Private ProQuad were moved to the refrigerators where they remain within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to our facility on 11/13/24 and was refrigerated until admin on 1/6/25.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, PH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on he FDA website. Unaware that there were two ProQuad products licensed by the FDA, it was assumed that the ProQuad we received could be refrigerated and both state and Private ProQuad were moved to the refrigerators where they remain within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client arrived to our facility on 11/13/24 and was refrigerated until admin on 1/6/25.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 10/30/24.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, clinic received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. Unaware that there were two ProQuad products licensed by the FDA, It was assumed that the ProQuad we received could be refrigerated and both State and Private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 10/30/24.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, FLUN4, HEPA, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: On October 1, 2024, PH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. Unaware that there were two ProQuad products licensed by the FDA. It was assumed that the ProQuad we received could be refrigerated and both state and private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 11/20/24.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, FLUN4, HEPA, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: On October 1, 2024, PH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accomodate the shipment. The following document was found on the FDA website. Unaware that there were two ProQuad products licensed by the FDA. It was assumed that the ProQuad we received could be refrigerated and both state and private ProQuad were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of MMRV admin to this client was refrigerated on 10/1/24 until admin on 11/20/24.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching; This non-serious case was reported by a consumer via patient support programs and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: itching). The outcome of the pruritus was not reported.   It was unknown if the reporter considered the pruritus to be related to Shingrix.     It was unknown if the company considered the pruritus to be related to Shingrix.   Linked case(s) involving the same patient:  US2025007560   Additional Information: GSK Receipt Date: 21-JAN-2025 The patient is the reporter. Patient experienced itching after her first dose of Shingrix. For the tolerance of 2nd dose refer US2025007560; Sender's Comments:  US-GSK-US2025007560:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac disorder
Clinical narrative: apprehensive and developed high anxiety because she had an adverse reaction to a Pfizer vaccine; the worst thing that happened to her cardiac-wise; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program IDU8274AA.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ubrelvy, reaction(s): "terrible migraine"; Ubrelvy, reaction(s): "tension headaches". The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "apprehensive and developed high anxiety because she had an adverse reaction to a Pfizer vaccine"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "the worst thing that happened to her cardiac-wise".  Additional information: The caller mentioned that she was given Ubrelvy and is afraid to take anything. She was in pain and has had headaches for a couple of decades, which have gotten much worse. These headaches have imposed on her life for a long time, especially in the last year or so. She was not getting anything accomplished. The caller wants to know what the bad side effects of Nurtec are. She was aware of the possibility of anaphylactic shock but wants to know more about the medication's side effects. She mentioned that if the doctor was only giving her 10 pills a month, she wants to know how toxic the medication is for her. The caller also mentioned some of her experience regarding a Pfizer vaccine. She had a permanent side effect, never wanted to take it, and it's the worst thing that happened to her cardiac-wise. However, agent wasn't able to gather more information because the caller requested to speak to a pharmacist. A callback was offered because no pharmacist was available at the time of the call. The caller accepted.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Impaired work ability, Loss of personal independence in daily activities, Near death experience, Quality of life decreased
Clinical narrative: has cheated death three times now/so near death so many times; can't even work/was incapable of working; so sick; destroyed her life; to the point where she cannot take care of herself; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: NEAR DEATH EXPERIENCE (life threatening), outcome "unknown", described as "has cheated death three times now/so near death so many times"; IMPAIRED WORK ABILITY (disability), outcome "unknown", described as "can't even work/was incapable of working"; ILLNESS (non-serious), outcome "unknown", described as "so sick"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "destroyed her life"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "to the point where she cannot take care of herself". Clinical course: The patient was having severe physical disabilities ever since 2021. The patient informed that she had two Pfizer vaccines, which didn't go well. She has cheated death three times now, so disabled she can't even work. This was extremely difficult on her, begged you to help. The patient informed that she has been so sick and so near death so many times. This destroyed her life; she has lost her home and her business and she was incapable of working and to the point where she cannot take care of herself. She was asking for money. She was homeless and did not have an address. She has a timer going off because all she did was therapy trying to save her life and it was her entire life and she was fighting for her life right now.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400146400 same patient, different dose/event;
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Headache
Clinical narrative: Erythema; fatigue; headache; This non-serious case was reported by a consumer via sales rep and described the occurrence of erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced erythema (Verbatim: Erythema), fatigue (Verbatim: fatigue) and headache (Verbatim: headache). The outcome of the erythema, fatigue and headache were resolved.   The reporter considered the erythema, fatigue and headache to be related to Arexvy.     The company considered the erythema, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-FEB-2025 The patient received Arexvy and had erythema, fatigue, headache.
Age: 1.25
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration
Clinical narrative: administered a dose of FluLaval via subcutaneous route instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 15-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis.   On 22-JAN-2025, the patient received FluLaval 2024-2025 season (subcutaneous). On 22-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of FluLaval via subcutaneous route instead of intramuscular). The outcome of the intramuscular formulation administered by other route was not applicable.   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: 22-JAN-2025 Medical assistant reported a patient was administered a dose of FluLaval via subcutaneous route instead of intramuscular on the day of reporting, which led to an intramuscular formulation administered by other route. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: MENB
Symptoms: Back pain, Decreased appetite, Dizziness, Headache, Pyrexia
Clinical narrative: Fever of 103 fahrenheit; Loss of appetite; Dizziness; Headache; Back pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included cerebral palsy (The patient had a medical history).   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced fever (Verbatim: Fever of 103 fahrenheit), appetite lost (Verbatim: Loss of appetite), dizziness (Verbatim: Dizziness), headache (Verbatim: Headache) and back pain (Verbatim: Back pain). The outcome of the fever, appetite lost, dizziness, headache and back pain were unknown.   It was unknown if the reporter considered the fever, appetite lost, dizziness, headache and back pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, appetite lost, dizziness, headache and back pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2025 and 30-JAN-2025 The patient experienced Fever of 103 fahrenheit, back pain, headache, dizziness, and loss of appetite after receiving the dose of Bexsero. The reporter did not consent to follow-up.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Injection site pain, Syncope
Clinical narrative: pain at injection site; dizzy; had syncope; This serious case was reported by a consumer via call center representative and described the occurrence of syncope in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-FEB-2025, the patient received the 1st dose of Arexvy (left arm). In FEB-2025, 3 hrs after receiving Arexvy, the patient experienced syncope (Verbatim: had syncope) (serious criteria GSK medically significant), injection site pain (Verbatim: pain at injection site) and dizziness (Verbatim: dizzy). In FEB-2025, the outcome of the injection site pain was resolved. The outcome of the syncope was unknown and the outcome of the dizziness was not resolved.   It was unknown if the reporter considered the syncope, injection site pain and dizziness to be related to Arexvy.     The company considered the syncope to be unrelated to Arexvy. It was unknown if the company considered the injection site pain and dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-FEB-2025  The patient self-reported this case himself. The patient stated he received Arexvy in left arm.  3 hours later the patient had pain at injection site and he was dizzy.  The patient reported he read the side effects and warnings and stated he had syncope, but never lost consciousness. The patient's pain in harm had subsided but the dizziness has not.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID after Pfizer COVID shots; COVID after Pfizer COVID shots; needed Paxlovid then, and need Paxlovid now; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An 82-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shots"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "needed Paxlovid then, and need Paxlovid now". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: It was reported that about a year ago, patient was at another institution. She needed Paxlovid then and need Paxlovid now as prescribed by her doctor. This happened last time about a year ago. She got the Paxlovid at no charge. She is now in the same position and she need the Paxlovid, and that's why she was calling. She used Pfizer for all her COVID shots. At her age, she do that every 6 months about it. Once before, she used the Paxlovid, and it gave her helped her just have a really mild case of COVID and now she need it again.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Patient was diagnosed with Covid-19 yesterday 15Feb; Patient was diagnosed with Covid-19 yesterday 15Feb; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in upper arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] (SEQIRUS) taken for immunisation as dose number unknown, sngle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Feb2025, outcome "recovering" and all described as "Patient was diagnosed with Covid-19 yesterday 15Feb". The event "patient was diagnosed with covid-19 yesterday 15feb" required physician office visit. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, Sinusitis
Clinical narrative: the second one I got COVID; the second one I got COVID; sore throat; sinus infection; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "I got a lump in my throa--like on the side of my neck". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the second one I got COVID"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection".  Clinical course: The patient stated that "This is the fourth time I have COVID, and you know I took the first injection, the first vaccination, and I got a lump in my throat--like on the side of my neck, and then the second one I got COVID, and then I had COVID twice with, my sister got it from her husband, and I got it from her, and today we went into the doctor's office because. she said you know, I have a sore throat, and I said, you know I have a little bit of a sore throat, but I think I have a sinus infection.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500019248 same patient and drug, different dose and event;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Leg amputation, Localised infection, Staphylococcal infection
Clinical narrative: I had Complex Regional Pain Syndrome (CRPS) since 2009. The condition was relatively stable, managed through leg braces and a Dorsal Root Ganglion spinal cord stimulator. Four months after the first COVID vaccination, I discovered a serious MRSA infection in the right foot and ankle.  This was an unprecedented event. I did not have any issues with serious infections prior. Over the next two years, I developed further infections, and in October 2023, the leg braces suddenly became ineffective. My physicians decided that a below-the-knee amputation was necessary at that point, which I had done in January 2024. Just recently, I came across scientific data indicating that the COVID vaccinations can make the CRPS worse. Here is an example of one of the articles that I discovered:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Suffered from pain, swelling and redness at injection site for 2 days. In addition, flu like symptoms began within 12 hours of vaccine including headache, body aches, severe runny nose, and stomach ache that lasted for at least 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Suffered from pain, swelling and redness at injection site for 2 days. In addition, flu like symptoms began within 12 hours of vaccine including headache, body aches, severe runny nose, and stomach ache that lasted for at least 24 hours.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles later). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: This case was reported by a patient via interactive digital media Consumer reported that she /he got the vaccine, but still got shingles later.  They mostly had itchy spots on upper right torso.  They were a little painful, but not terrible. The Doctor said patient got a light case because he/she had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: area is swollen and sore and pink; area is swollen and sore and pink; area is swollen and sore and pink; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-FEB-2025, the patient received Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: area is swollen and sore and pink), injection site pain (Verbatim: area is swollen and sore and pink) and injection site discoloration (Verbatim: area is swollen and sore and pink). The outcome of the injection site swelling, injection site pain and injection site discoloration were not reported.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site pain and injection site discoloration to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and the area was swollen, sore and pink. The reporter was this normal.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Heart attack
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Bradykinesia, Decreased activity, Feeling cold, Immediate post-injection reaction, Influenza A virus test negative
Clinical narrative: My son was lethargic immediately following the vaccinations, on the car ride home. He seemed slow moving throughout the rest of the day. All seemed well the following days until Monday February 10, 2025 at 7:00am. He was yawning and laying around on the couch, despite just waking up. He wasn't playing with his toys like he typically does. He kept asking to snuggle and telling me he was cold. I had him lay down at 10:00am to try to take a nap. He slept until 10:45am and woke up cross eyed. He said "Mom, I see two of you." I immediately took him to the ER, since his eyes were staying crossed. When we arrived, his eyes slowly began to go back to normal but he was saying that the things on the wall were "moving".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Influenza B virus test negative, Lethargy, Pyrexia, SARS-CoV-2 test negative, Strabismus
Clinical narrative: My son was lethargic immediately following the vaccinations, on the car ride home. He seemed slow moving throughout the rest of the day. All seemed well the following days until Monday February 10, 2025 at 7:00am. He was yawning and laying around on the couch, despite just waking up. He wasn't playing with his toys like he typically does. He kept asking to snuggle and telling me he was cold. I had him lay down at 10:00am to try to take a nap. He slept until 10:45am and woke up cross eyed. He said "Mom, I see two of you." I immediately took him to the ER, since his eyes were staying crossed. When we arrived, his eyes slowly began to go back to normal but he was saying that the things on the wall were "moving".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Visual impairment, Yawning
Clinical narrative: My son was lethargic immediately following the vaccinations, on the car ride home. He seemed slow moving throughout the rest of the day. All seemed well the following days until Monday February 10, 2025 at 7:00am. He was yawning and laying around on the couch, despite just waking up. He wasn't playing with his toys like he typically does. He kept asking to snuggle and telling me he was cold. I had him lay down at 10:00am to try to take a nap. He slept until 10:45am and woke up cross eyed. He said "Mom, I see two of you." I immediately took him to the ER, since his eyes were staying crossed. When we arrived, his eyes slowly began to go back to normal but he was saying that the things on the wall were "moving".
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had NO adverse events. Patient came into a shingles outreach event located at a senior center. Patient stated he needed a shingles vaccine. Patient answered questions appropriately. Patient filled out consent forms without difficulty. Patient stated he never had a shingles vaccine before. When patient was looked up in grits immunization records it stated no shingles vaccine was given. Shingles vaccine given after consent was signed by patient. Patient alone at this visit. When patient was later notified about an insurance question, wife stated he had already completed his shingles series. Patient had two grits accounts. One stated he had completed the 2 Shingrix vaccines. The other record stated he had none. Patient had received a third dose of Shingrix. When called on 2/19/25 patient had no side effects to report.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received a second RSV vaccine. No adverse reactions to report, unremarkable.
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pharyngeal hypoaesthesia, Rash, Urticaria
Clinical narrative: Patient received Tdap and Hep B vaccine in clinic and reported that her throat started going numb within 5 minutes of receiving immunizations and also reported breaking out in hives to her right arm.  This occured while patient was still in cilnic and diphenhydramine administered after medical director notified.  No visible discoloration to skin noted by nursing staff.   Patient reports she was seen in urgent care the next day and given steroids because she had broken out in "polka dot" rash - rash resolved within 4 days of steroids.
Age: 32.0
Sex: M
Vaccine: PNC20
Symptoms: Blood pressure increased, Chest pain, Hyperhidrosis
Clinical narrative: Rapid Heart Rate over 110, Elevated BP, profuse sweating, chest pain
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: Atrial fibrillation
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Brain fog
Clinical narrative: BRAIN FOG, MEMORY LOSS
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient into Health Dept. on 02/20/2025 stating that she had her vaccination record form her Primcary Care Physican's office and asked if we could enter those vaccines into the database system. The MD office does not use database they use  a different system. Clerk entered them into the database system and it was found that when patient came in asking for first Shingles vaccine on 02/03/2025 it was acutally her 3rd dose. But unaware due to vaccines not being enter into database.  She received her first Shingrix dose on 07/01/20219 and her second on 09/26/2019. Patient did not have any adverse reaction after any doses.
Age: 54.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site reaction
Clinical narrative: 2cm x 2cm know at injection site post vaccine
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal discomfort, Neck pain, Neuralgia
Clinical narrative: Several months after taking the vaccine I woke up in the morning with excruciating pain in my neck and along the right side of my body. I saw a pain doctor who provided pain meds and steroid shot. Since this incident I continue to have nerve pain on my right side and have discomfort in my right neck and shoulder which includes numbness in my right side fingertips Any subsequent doctors have not been able to provide any care that is helpful.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Several months after taking the vaccine I woke up in the morning with excruciating pain in my neck and along the right side of my body. I saw a pain doctor who provided pain meds and steroid shot. Since this incident I continue to have nerve pain on my right side and have discomfort in my right neck and shoulder which includes numbness in my right side fingertips Any subsequent doctors have not been able to provide any care that is helpful.
Age: 12.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Electroencephalogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Seizure
Clinical narrative: Patient had 5 vaccines week before patient started having seizures. Patient has now had three seizures and more episodes of leg numbness. Patient also received HPV Merck lot # x024650, Tdap glaxosmithkline lot #x449y, and MCV4 sanofi Pasteur lot # U837AA on 1/27.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient developed progressive redness, warmth, and swelling on her left upper thigh after the vaccine injection. She was evauated in office 3 days after the injection and diagnosed with cellulitis. She was prescribed cephalexin 7 day course to treat the infection.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Drooling, Dysphonia, Dyspnoea, Erythema, Flushing
Clinical narrative: 1605 MMR vaccine administered 1615 MOC reports redness, hives and shortness of breath. Patient is alert and oriented able to make needs known. Flushing to the face with hives, mouth breathing with drool. High pitched voice with speaking. Audible wheeze present 1617 Pediatric epi (0.15mg) administered IM right thigh. 1620 Spo2 93%, HR 134 - Dr, assessment = diminished breath sounds, requesting Albuterol and oxygen 1621 Inhaled albuterol 2 puffs with aerochamber no mask (supplied by MOC), applied O2 at 3L via face mask and given childrens zyrtec liquid 5mg. 1625 Spo2 94% - Dr. assessment = increasing air flow, request for benadryl. Dose clarification with Dr.  1627 EMT arrive on scene, report given with copy of medications and interventions 1629 Benadryl 21.25 mg administered IM left thigh, Spo2 98% 1630 Transferred to Hospital via ambulance  Breath sounds and macular rash improving by exam at time of transfer and child maintaining sats on RA without difficulty.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Mouth breathing, Rash macular, Urticaria, Wheezing
Clinical narrative: 1605 MMR vaccine administered 1615 MOC reports redness, hives and shortness of breath. Patient is alert and oriented able to make needs known. Flushing to the face with hives, mouth breathing with drool. High pitched voice with speaking. Audible wheeze present 1617 Pediatric epi (0.15mg) administered IM right thigh. 1620 Spo2 93%, HR 134 - Dr, assessment = diminished breath sounds, requesting Albuterol and oxygen 1621 Inhaled albuterol 2 puffs with aerochamber no mask (supplied by MOC), applied O2 at 3L via face mask and given childrens zyrtec liquid 5mg. 1625 Spo2 94% - Dr. assessment = increasing air flow, request for benadryl. Dose clarification with Dr.  1627 EMT arrive on scene, report given with copy of medications and interventions 1629 Benadryl 21.25 mg administered IM left thigh, Spo2 98% 1630 Transferred to Hospital via ambulance  Breath sounds and macular rash improving by exam at time of transfer and child maintaining sats on RA without difficulty.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC20
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 4 vaccines administered on 2/17 by RN.  Documentation noted DTAP/Hib/Prevnar 20 given via right thigh and only influenza given in left thigh however, upon checking patient, 2 vaccines given in each thigh (documentation incorrect).  On 2/18, patient with large areas of redness of left leg.  Parents gave ibuprofen for relief.  No fever or other symptoms.  Patient presented at clinic on 2/19 with continued redness on left thigh.  Unclear which vaccine caused reaction.  Provider instructed to give Benadryl or cetirizine for itching if it continues.  Patient discharged home in stable condition.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Eczema
Clinical narrative: June-July 2021 started to develop Eczema (whole body).
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Pruritus
Clinical narrative: Patient received vaccine 9:40 AM, reported adverse reaction around 12:40 PM. States that he is experiencing itching, red face, and is feeling light-headed. Advised patient to take Tylenol; if no improvement, should be seen at hospital. At this present time, adverse reaction is ongoing; no resolution as of yet.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Doctor put in a n order for incorrect vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, C-reactive protein increased, Dizziness, Feeling drunk, Hemiparesis
Clinical narrative: Chronic dizziness, debilitating brain fog (feeling drunk when sober), light sensitivity, difficulty with every day tasks requiring focus (ex. Driving), numbness/weakness/tingling on one side
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired driving ability, Inflammatory marker increased, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Chronic dizziness, debilitating brain fog (feeling drunk when sober), light sensitivity, difficulty with every day tasks requiring focus (ex. Driving), numbness/weakness/tingling on one side
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Chronic dizziness, debilitating brain fog (feeling drunk when sober), light sensitivity, difficulty with every day tasks requiring focus (ex. Driving), numbness/weakness/tingling on one side
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reaction.   When list was printed there was two patient's with the same date of birth.  This patient was not due for Flu vaccine
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Reaction started 2 days after vaccine. Patient states redness slowing moving down her arm to her elbow. Redness, swelling, itching and warm to the touch. Patient took benadryl at night to help with reaction.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site rash
Clinical narrative: patient has rash about 3 days after shot right above the elbow
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came in with mother for vaccine Update, Provider ordered injection, received order got injection ready confirmed with provider that injection was correct and was given to patient after confirmed. Patient's mother has not called into office regarding any symptoms or signs of side affects.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Fall, Gait disturbance, Musculoskeletal disorder
Clinical narrative: From the day the vaccine was administer our son would randomly fall, almost as though he tripped on something.  He was walking at this point and had been for a couple months.  It looked as though his leg would give out and he would hit the floor.  I, first notices this and thought it was odd but he had no other symptoms.  It was when our oldest daughter made the comment, patient has been falling ever since he got the vaccine that it made me concerned that it may have affected him neurologically.  I was not the only one that noticed the distinct difference in his ability to walk without falling often.  After about a week, the issue subsided.  When we were at the pediatricians office on March 7, 2024, I mentioned the reaction to the CRNP just to have note of it in the medical record.  She had advised us to keep track of that and possibility consider not giving him the next dose that is not due until 4-5 yo.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Irritability, Pyrexia
Clinical narrative: After receiving vaccine later that night they noticed patient developing a minor fever, felt warm to touch. Parents bathed child with warm water then applied warm cloths around the area of the site. No fever, but provided Ibuprofen to help prevent fever. They have noticed increase irritability and fussy. Some mild fatigue.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given MMR#2 at PCP office yesterday, 2/19/25 and sent to Clinic today 2/20/25 for VAR #2. RNs did not notice MMR given 2/19 and administered VAR. After VAR given, realized live-live rule was broken and vaccine will need to be repeated in 28-30 days. Patient noted.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: they reported pain at "all of her body" after second series of Hep b vaccine.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of Hep A given. No reaction