chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 01:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes 2", start date: 28Nov2021 (unspecified if ongoing); "Heart attack", start date: 28Nov2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with nirmatrelvir, ritonavir (PAXLOVID) from 04Jan2024 to 09Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), on 01Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2007; SIMVASTATIN, start date: 01Jan2009; COZAAR, start date: 01Jan2019; WELLBUTRIN, start date: 01Jan2020. Past drug history included: Lexapro, start date: 01Jan2020, stop date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Jan2024 to 05Jan2024. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Dec2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 with Paxlovid from 26Dec2023 to 30Dec2023. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male 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: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer 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-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer (Patient). A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. Patient received Paxlovid as COVID-19 treatment from 04Jan2024 to 09Jan2024. COVID rebound and tested positive at the fourth day after testing negative for 4 days. Patient has no known allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2024) Positive, notes: 08:00 AM, COVID rebound; (Jan2024) Negative; (Jan2024) Negative; (Jan2024) Negative; (Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Mar2023 as dose 1, single (Lot number: GJ3268), in right arm and on 16Sep2023 as dose 2, single (Lot number: GJ2524) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer with mastectomy" (unspecified if ongoing); "Breast cancer with mastectomy", start date: 11Jan2021 (not ongoing); "HSV (G)", start date: 1987 (unspecified if ongoing); "HPA axis dysfunction", start date: 1984 (unspecified if ongoing); "known allergies: Neosporin topical" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mavyret, start date: 07Oct2019, for HCV, notes: HCV cured with Mavyret. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jan2024, outcome "recovered" (13Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2024) Positive; (13Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 07Jan2024 to 10Jan2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015337 same patient/Drug, different doses/event;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 31May1993. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid from 03Jan2024 to 08Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Immunisation reaction, Laboratory test, Magnetic resonance imaging
Clinical narrative: Head tension not head ache that I've have never had before combined with very sensitive chest bone (not painful) .  This has continued daily since 4/2/2022, never going to zero on 10 point scale and rising to level 7 and that makes sleepy.  Unaffected by Ibuprofen or acetominophen, benadryl.   Severe enough to go to ER had CAT, MRI workups and full chemistries.  Have seen two neurologists who thought it was due to the vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tension headache
Clinical narrative: Head tension not head ache that I've have never had before combined with very sensitive chest bone (not painful) .  This has continued daily since 4/2/2022, never going to zero on 10 point scale and rising to level 7 and that makes sleepy.  Unaffected by Ibuprofen or acetominophen, benadryl.   Severe enough to go to ER had CAT, MRI workups and full chemistries.  Have seen two neurologists who thought it was due to the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Ischemic Stroke
Age: 82.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Transient ischaemic attack
Clinical narrative: THE EVENING AFTER RECEIVING THE VACCINE, PATIENT WAS ADMITTED TO THE HOSPITAL WITH A TIA. HE WAS IN THE HOSPITAL FOR 6 DAYS AND HAD A 2 WEEK RECOVERY AT A REHABILITATION HOSPITAL.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Injection site discolouration, Skin discolouration
Clinical narrative: Upon administration there was a small black circle that formed around the injection site. i asked the patient if this had ever occurred and he notified me it hasn't. I told him it was best to monitor his arm and I would follow up a week later. The patient did not answer the call at the time. Since he never called back, I thought his arm had healed up fine. I was incorrect as the patient had come in today (1-18-24) for an unrelated consult on something else over the counter. His face and name were familiar, so I asked how his arm had healed up. The patient showed me his arm which had gotten substantially worse. The black pigmentation had spread throughout the back of his right arm from shoulder to wrist. I called his primary doctor to inform them what was going on and they requested to follow up with the patient before reaching back out to pharmacy in case there is anything else we need to do. According to the patient he had some shoulder pain right after, but it subsided not too long after receiving the vaccine. As of now it is just the large area of pigmentation that is a cause of concern. In reference to Item 21 the patient did not mention hospitalization or visiting his PCP since the receiving the vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Discomfort, Lethargy
Clinical narrative: AS WAS COUNSELED, PATIENT EXPERIENCED LETHARGY/DISCOMFORT 24 HOURS AFTER VACCINATION THAT LASTED AN ADDITIONAL 24 HOURS. NO OTHER ADVERSE REACTIONS.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient developed significant thrombocytopenia - platelet count nadir was 4,000. Patient was admitted to Medical Center from 1/15/24 to 1/17/24. She received IVIG. Platelet count rebounded to 40,000 prior to discharge.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Dyspnoea exertional, Pruritus, Respiratory disorder
Clinical narrative: Upper airway inflammation, Abdominal crambing, increasing walking breathing, patchy itching, constitutional poor
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Extra dose administered, Fatigue, Malaise, Pain
Clinical narrative: PATIENT CAME INTO THE PHARMACY ON 1/17/2024 AND ASKED FOR A RSV VACCINE SINCE SHE MISSED THE CLINIC AT THE MOTHER HOUSE.  THE PHARMACIST ON DUTY, PROCEEDED TO REVIEW HER VACCINATION FORM AND GIVE HER THE VACCINATION. HER INSURANCE CHANGED IN THE NEW YEAR AND DID NOT FLAG A DUPLICATE VACCINATION. ON 01/18/2024 I CAME INTO THE PHARMACY AND WENT TO GET READY TO PUT HER VACCINE IN THE NEW SYSTEM. BEFORE I WENT INTO SYSTEM I WENT INTO TO VERIFY HOW WE ENTERED HER IN THE PAST WHEN I WENT INTO I NOTICED SHE HAD GOTTEN THE VACCINE ON 12/01/23 FROM OUR PHARMACY, I THEN WENT AN GRABBED THE FOLDER FROM 12/01 AND REVIEWED THE PATIENTS WHO RECEIVED RSV AND SURE ENOUGH SHE HAD GOTTEN ONE THAT DAY.  I THEN CONTACTED HER PHYSICIAN AND HAD TO LEAVE A MESSAGE.  I CALLED GSK TO GET INFORMATION ON DUPICATE VACCINATIONS OF AREXY. THEY HAD A CASE STUDY OF PEOPLE WHO HAD GOTTEN THEM IN TWO DIFFERNT SEASONS (NOT THE SAME TIME FRAME AS OURS) THEY REVIEWED THE PERCENTAGES AND WHAT SIDE EFFECTS AFTER THE 2ND DOSE. I WROTE THEM ALL DOWN AND PROVIDED OUR INFORMATION TO GSK. THEY HAVE A CASE NUMBER 01910702 FOR THIS ENCOUNTER AND FOR ANY SUBSEQUENT INFORMATION. I TRIED TO CONTACT THE DOCTOR AGAIN AND LEFT ANOTHER URGENT MESSAGE. I THEN CALLED PATIENT. I ASKED HER HOW SHE WAS FEELING SHE TOLD ME THAT SHE WAS NOT FEELING THE GREATEST, THAT SHE WAS WIPED OUT, TIRED AND ACHY. I EXPLAINED THAT SHE HAD TWO AREXVY VACCINES ONE IN DEC AND ONE IN JAN.  SHE THEN STARTED TO APOLOGIZE AND SAID SHE WAS CONFUSED AND THOUGHT SHE GOT A COVID VAX IN DEC. I TOLD HER NOT TO APOLOGIZE AND THAT WE WERE JUST CONCERNED. I EXPLAINED I SPOKE TO GSK AND THAT I WAS WAITING FOR HER PHYSICIAN TO CONTACT US. I TOLD HER I WOULD BE IN CONTACT LATER ONCE THE PHYSICIAN OFFICE CALLED ME BACK. IN THE AFTERNOON STAFF FROM DR OFFICE CONTACTED ME AND I TOLD HER EVERYTHING I KNEW AT THAT POINT. SHE SAID THAT SHE WOULD FOLLOW UP WITH PATIENT AND THAT SHE WOULD TELL THE DOCTOR. I SHARED THE INFORMATION I OBTAINED FROM GSK AND THE CASE NUMBER. I ALSO INFORMED THEM I WAS DOING A VAERS ALSO. I CONTACTED PATIENT AFTER ABOUT TEN MINUTES AND SHE TOLD ME SHE SPOKE WITH THE DOCTORS OFFICE AND THAT SHE STILL WAS VERY TIRED.  I ANSWERED SOME QUESTIONS AND TOLD HER I WOULD BRING HER SOME LITERATURE TO REVIEW ON AREXVY WITH CASE STUDIES. SHE WAS VERY GRATEFUL AND SAID SHE WOULD REST.  WE DELIVERED TO THE MOTHER HOUSE SOME LITERATURE FOR HER. THE LOT ON 12/01/23 3F729 EXP 08/26 LEFT IM   THE LOT ON 01/17/24 91872 EXP 07/25 LEFT IM
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Mobility decreased, Pain, Pyrexia
Clinical narrative: Bodyache could not lift limbs and could not move arm  , headache and fever
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT received two doses of RSV Abrysvo. One dose in 1/8/24, and one dose on 1/17/24. It did not present adverse events.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Abdominal distension, Aldolase normal, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthritis
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Blood creatine phosphokinase normal, Blood urea nitrogen/creatinine ratio increased, Differential white blood cell count normal, Double stranded DNA antibody, Endometriosis
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Full blood count normal, Gamma-glutamyltransferase normal, Hernia, Joint swelling, Lipids normal
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Mobility decreased, Muscle contracture, Pain, Pain in extremity, Parvovirus B19 test
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Peripheral swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Ultrasound Doppler abnormal, Ultrasound scan vagina abnormal
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Urine analysis normal, Urticaria, Vaginal cyst, X-ray limb
Clinical narrative: 4. September 27, 2023  Phizer booster received at 10:30am a. 10 hours later my left middle finger swelled & has not gone down as of 12/2023 despite many different treatments attempted. It is painful. b. September 28th Dr ordered an x-ray of my finger & prescribed Naproxen 500mg & told me to ice & elevate my finger.  This resulted in no improvement in swelling & pain. c. September 29th  my top knuckles on 5 fingers swelled and have not gone down despite many medical attempts. d. October 6th  had bloodwork ordered by Dr to try determine why this was happening to me. e. October 13th  my entire body became painful & achy.  I could barely move; I felt like a 90 year old woman that just ran a marathon Dr (Family dr) prescribed 20mg Prednisone 2x/day for 1 week f. October 14th-18th  in extreme pain; My hernia killed, I was very bloated & I felt like all of the female issues I had over the past 25 years were happening which did not make sense since I had a partial hysterectomy 9 years ago & had been fine ever since.  g. Afternoon of October 18th my entire lower right rear side of my body seized up & I was in extreme pain. h. October 18th I had a vaginal ultrasound & Dr (OB) confirmed I had 1 cyst, most likely another cyst had exploded given my symptoms & endometriosis on my vagina which made no sense to him given my partial hysterectomy. He said I was a textbook case' (he'd maybe seen this happen 2x before).  He put me back on Norethindrone 5mg (I had been off of it successfully since June since I was 99% into Menopause & shouldn't need it).  I saw him a monthh later & he's keepong me on Norethindrone  i. October 19th  saw RA Dr who was baffled about my symptoms since I tested negative for RA. She thought my hands looked like Osteoarthritis possibly.  She sent me for x-rays and ultrasounds of my hands & wrists & ordered more bloodwork.  She told me to take 3 Tylenol Muscle (650mg) per day & a muscle relaxant 3X/day (Cyclobenzaprine 10mg) but my fingers are still swollen & painful & I am in a ton of pain (I feel like an old lady). j. October 24th Hives appeared on my arms & legs  improved w/oral Benadryl & Benadryl cream. k. Prior to the booster I worked out vigorously 6x/week for 45 minutes & walked my dog at least 2 miles per day & was always on the go.  Now I am in constant pain w/no explanation beyond possibly the Covid booster caused a super immune response in my body OR I have some sort of immune issue that triggered everything that has bothered me over the past 25 years to come back 10x as bad!!!
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Pt had preterm delivery at 36w0d, this was days after vaccine.
Age: 0.58
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old patient was inadvertently administered Arexvy; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Y2J2B) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 month old patient was inadvertently administered Arexvy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-Jan-2024 The reporter reported that the patient inadvertently administered Arexvy vaccine. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The expiration date was not available. The reporter consented to follow up.
Sex: U
Vaccine: PPV
Symptoms: Accident at work, Haemorrhage, Syringe issue
Clinical narrative: Which resulted in being cut and bleeding/the nurse's wound; Which resulted in being cut and bleeding/the nurse's wound; The nurse's wound and the nurse is recovered from the injury sustained from the defective product; syringe broken/ the breakage occurred at the syringe hub; This spontaneous report was received from a physician and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2024, the nurse discovered a breakage while removing the original syringe 10x10 carton of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, (lot number X022827 has been verified to be a valid lot number, expiration date reported and validated as 14-AUG-2025) at a dose of 0.5 milliliter; however, the product was not administered; therefore, there was no administration details such as vaccination scheme, anatomical location and route of administration provided). The syringe was broken, and the breakage occurred at the syringe hub (syringe issue). It was presumed that the breakage had a jagged edge, and the product was discarded. Later that day, the nurse resulted in being cut and bleeding and required treatment with stitches in the wound (the location was unknown) (skin laceration, wound haemorrhage, and accident at work). Later on the same day, the patient recovered from skin laceration, wound haemorrhage and accident at work.  The causality between skin laceration, wound hemorrhage and accident at work was reported as related.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Autoimmune disorder, Autoimmune thyroiditis, Autonomic nervous system imbalance, Brain fog
Clinical narrative: autoimmune/ heterogenous autoimmune disease; neurological disease; autonomic, and neurological injuries/ dysautonomia; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; Hashimoto's Thyroiditis/enlargement thyroid beyond chin to the point; POTS/difficulty sleeping, joint pains, brain fog, stomach issues, migraines/depression; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a current adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was health and had no autoimmune disease or autonomic issues. On 14-MAY-2019 (at age of 17-year-old), the patient was vaccine with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose,lot #, expiry date, route of administration were not provided). On unknown dates in November 2019 (around six months after vaccination), the patient developed symptoms that included difficulty sleeping, joint pains, brain fog, stomach issues, migraines, and depression, which were consistent with POTS. These symptoms ultimately included enlargement of the patient's thyroid beyond her chin to the point that the patient could not breath or swallow and was taken to the emergency room for treatment. The patient had been diagnosed with Hashimoto's Thyroiditis. The patient also experienced neurological disease, heterogenous autoimmune disease, POTS, autonomic and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries (Ill-defined disorder), and other adverse events. The outcome of all events were not recovered. The patient contended all above events were caused by quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) otherwise linked to her Gardasil-induced autoimmune disorder. The patient was unable to engage in normal activities as a result of post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms. The All events were determined to be disability. Upon internal review, the events autoimmune disorder and Hashimoto's thyroiditis were determined to be medically significant.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Dysphagia, Dyspnoea, Gastrointestinal disorder, Goitre
Clinical narrative: autoimmune/ heterogenous autoimmune disease; neurological disease; autonomic, and neurological injuries/ dysautonomia; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; Hashimoto's Thyroiditis/enlargement thyroid beyond chin to the point; POTS/difficulty sleeping, joint pains, brain fog, stomach issues, migraines/depression; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a current adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was health and had no autoimmune disease or autonomic issues. On 14-MAY-2019 (at age of 17-year-old), the patient was vaccine with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose,lot #, expiry date, route of administration were not provided). On unknown dates in November 2019 (around six months after vaccination), the patient developed symptoms that included difficulty sleeping, joint pains, brain fog, stomach issues, migraines, and depression, which were consistent with POTS. These symptoms ultimately included enlargement of the patient's thyroid beyond her chin to the point that the patient could not breath or swallow and was taken to the emergency room for treatment. The patient had been diagnosed with Hashimoto's Thyroiditis. The patient also experienced neurological disease, heterogenous autoimmune disease, POTS, autonomic and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries (Ill-defined disorder), and other adverse events. The outcome of all events were not recovered. The patient contended all above events were caused by quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) otherwise linked to her Gardasil-induced autoimmune disorder. The patient was unable to engage in normal activities as a result of post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms. The All events were determined to be disability. Upon internal review, the events autoimmune disorder and Hashimoto's thyroiditis were determined to be medically significant.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ill-defined disorder, Insomnia, Loss of personal independence in daily activities, Migraine, Nervous system disorder
Clinical narrative: autoimmune/ heterogenous autoimmune disease; neurological disease; autonomic, and neurological injuries/ dysautonomia; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; Hashimoto's Thyroiditis/enlargement thyroid beyond chin to the point; POTS/difficulty sleeping, joint pains, brain fog, stomach issues, migraines/depression; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a current adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was health and had no autoimmune disease or autonomic issues. On 14-MAY-2019 (at age of 17-year-old), the patient was vaccine with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose,lot #, expiry date, route of administration were not provided). On unknown dates in November 2019 (around six months after vaccination), the patient developed symptoms that included difficulty sleeping, joint pains, brain fog, stomach issues, migraines, and depression, which were consistent with POTS. These symptoms ultimately included enlargement of the patient's thyroid beyond her chin to the point that the patient could not breath or swallow and was taken to the emergency room for treatment. The patient had been diagnosed with Hashimoto's Thyroiditis. The patient also experienced neurological disease, heterogenous autoimmune disease, POTS, autonomic and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries (Ill-defined disorder), and other adverse events. The outcome of all events were not recovered. The patient contended all above events were caused by quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) otherwise linked to her Gardasil-induced autoimmune disorder. The patient was unable to engage in normal activities as a result of post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms. The All events were determined to be disability. Upon internal review, the events autoimmune disorder and Hashimoto's thyroiditis were determined to be medically significant.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: autoimmune/ heterogenous autoimmune disease; neurological disease; autonomic, and neurological injuries/ dysautonomia; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; Hashimoto's Thyroiditis/enlargement thyroid beyond chin to the point; POTS/difficulty sleeping, joint pains, brain fog, stomach issues, migraines/depression; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a current adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was health and had no autoimmune disease or autonomic issues. On 14-MAY-2019 (at age of 17-year-old), the patient was vaccine with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose,lot #, expiry date, route of administration were not provided). On unknown dates in November 2019 (around six months after vaccination), the patient developed symptoms that included difficulty sleeping, joint pains, brain fog, stomach issues, migraines, and depression, which were consistent with POTS. These symptoms ultimately included enlargement of the patient's thyroid beyond her chin to the point that the patient could not breath or swallow and was taken to the emergency room for treatment. The patient had been diagnosed with Hashimoto's Thyroiditis. The patient also experienced neurological disease, heterogenous autoimmune disease, POTS, autonomic and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries (Ill-defined disorder), and other adverse events. The outcome of all events were not recovered. The patient contended all above events were caused by quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) otherwise linked to her Gardasil-induced autoimmune disorder. The patient was unable to engage in normal activities as a result of post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms. The All events were determined to be disability. Upon internal review, the events autoimmune disorder and Hashimoto's thyroiditis were determined to be medically significant.
Age: 0.5
Sex: U
Vaccine: DTAPIPV, PNC15, UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Reporter calling to report an adverse event for VAXELIS. She states that a dose of QUADRACEL was given instead of VAXNEUVANCE.. Reporter states that the physician would like to know next best steps for administration of VAXNEUVANCE and any complications from d; overdose; No additional AE; This spontaneous report was received from a physician and refers to a 6-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (wrong product administered) instead of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (wrong product administered). On unknown date the patient was vaccinated with both diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (overdose and no adverse event). ; Sender Comments: Keywords : BP
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Just got shingles; 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: Just got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JAN-2024 The patient just got shingles and had been vaccinated. The shingles were not pleasant. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.