chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Neck pain all over her neck; This non-serious case was reported by a nurse via call center representative and described the occurrence of neck pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clavicle fracture (broken clavicle on left side in 2016) and rotator cuff tear (left Rotator Cuff tear and surgical repair in 2006). Concurrent medical conditions included arthritis of neck.   On 02-NOV-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced neck pain (Verbatim: Neck pain all over her neck). The patient was treated with prednisone. The outcome of the neck pain was not reported.   It was unknown if the reporter considered the neck pain to be related to Shingrix.     It was unknown if the company considered the neck pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR015766   Additional Information: GSK Receipt Date: 30-Jan-2024 The patient was self-reported this case. The patient received the first dose of Shingrix vaccine experienced neck pain all over her neck.  The patient took Meloxicam and Prednisone but did not relieve the pain.   The pain in her neck became worse and she was prescribed physical therapy and muscle relaxants. The reporter consented to follow up. This US2024AMR015766 case has been linked to the case reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2024AMR015766:same patient different dose
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a dose of Menveo, patient is 57 years old; 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 57-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Menveo, patient is 57 years old). Rechallenge with Menveo was negative. The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 The nurse practitioner reported an HIV+ patient may have been administered a dose of Menveo, patient was 57 years old, which led inappropriate age vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis, ER visit; This serious case was reported by a consumer via call center representative and described the occurrence of diverticulitis in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (As a child, had a mild case of chicken pox), herpes simplex, shingles (already had shingles in 2019), multiple myeloma (Since 2018 the patient had been under care and being treated for Multiple Myeloma) and lung cancer (Since 2022 the patient had been treated for a small lung cancer nodule). Previously administered products included Valtrex and Zoster vaccine (In 2007, the patient had the zoster vaccine). Concomitant products included metronidazole, nystatin (Flagyl) and ciprofloxacin hydrochloride monohydrate (Cipro).   On 01-SEP-2022, the patient received the 1st dose of Shingrix (intramuscular). On 30-DEC-2022, 120 days after receiving Shingrix, the patient experienced diverticulitis (Verbatim: Diverticulitis, ER visit) (serious criteria GSK medically significant). The patient was treated with neomycin sulfate, polymyxin b sulfate (Antibiotic). On 30-JAN-2023, the outcome of the diverticulitis was resolved (duration 1 month).   It was unknown if the reporter considered the diverticulitis to be related to Shingrix.     It was unknown if the company considered the diverticulitis to be related to Shingrix.   Linked case(s) involving the same patient: US2022AMR082721   Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media. Most of his life, the patient had been prone to cases of lip fever blisters (herpes simplex) and was often treated with Valtrex. The zoster vaccine did not help because the patient had shingles on his neck, ear and the side of his head and face. The patient's oncologist said that he should get the Shingrix vaccines since the patient had shingles once, the patient could get it again. The patient's internist said he need not get it since he already had shingles and it was almost certain the patient would never get it again. The reporter wanted to know what advice could you give him regarding his need and/or effectiveness of the Shingrix vaccines in a case such as mine. The patient called to ask about timing of 2nd dose of Shingrix, having recently finished a round of antibiotics for diverticulitis.  The reporter offered medical disclaimer, referred to healthcare professional, offered after-call survey.  ER (emergency room) visit required. The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022AMR082721 , reported by the same reporter, for a different product.  Upon internal review the case was updated on 05-Feb-2024. The invalid case became valid and tracking memo of invalid to valid was added. Summary of changes: General tab and narrative details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR082721:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral disorder, Death, Thrombosis
Clinical narrative: Lost my mom, blood clots shut down brain, died 4 days later; Lost my mom, blood clots shut down brain, died 4 days later; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Lost my mom, blood clots shut down brain, died 4 days later) (serious criteria death and GSK medically significant) and clot blood (Verbatim: Lost my mom, blood clots shut down brain, died 4 days later) (serious criteria GSK medically significant). The outcome of the clot blood was unknown. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death and clot blood to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death and clot blood to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that it was so sad that everyone trust doctors that would lose their license if they did not push the poisons.  The reporter lost his/her mom (patient) to the boosters of shingles vaccine.  She had 6 blood clots that shut down her brain dying 4 days later.  The reporter had not been to a doctor in 10 years.  The reporter healed his/her brain from MS since 2007.  The reporter kept most of his/her natural healing Information .  The reporter further stated that all the information on the poisonous V were in the comments of the top photo. Additional Supportive Information: The follow up would not possible, as no contact details were available.  Upon internal review the case was updated on 05-Feb-2024. The invalid case became valid and tracking memo of invalid to valid was added. Summary of changes: General tab and narrative details were updated.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Laboratory test, Vaccination failure
Clinical narrative: TIRED; COVID-19 INFECTION; HAD COVID ONCE IN SUMMER; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed with additional information received on 29-JAN-2024. The patient's weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in 2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced had covid once in summer and covid-19 infection. On an unspecified date, the patient experienced tired. Got two doses of the J and J vaccine before it was recommended that the second one be another brand and received both shots in 2021 and had Covid once in summer of 2022, really had no trouble with the illness and it's like the pressure to get boosters was very high and not sure if it was safe. consumer states that patient caught COVID about a year after getting her COVID-19 vaccine. Other than catching covid said that did not have any reactions to the vaccine besides being tired. Patient was grateful that when did catch covid did not feel terrible and did not have any long term side effects like thought she would. On 2022,  Laboratory data included: Lab test had covid once in the summer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had covid once in summer,covid-19 infection and tired was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Considering the biological variation in vaccine response in different individuals, and lack of pertinent information regarding product quality issues, causality for the event vaccination failure is assessed as not related
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Insomnia, Nightmare
Clinical narrative: Insomnia; nightmares; vivid dreams; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier: US-MODERNATX-MOC20231113000098 (MODERNATX).  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS, Strength: 0.3 mL), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Meniere's Disease" (unspecified if ongoing); "Fuchs" (unspecified if ongoing); "Cornea Dystrophy" (unspecified if ongoing); "diagnosed with Covid 19", start date: 13Jan2022 (unknown if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 25Oct2023, outcome "not recovered"; NIGHTMARE (non-serious) with onset 25Oct2023, outcome "not recovered", described as "nightmares"; ABNORMAL DREAMS (non-serious) with onset 25Oct2023, outcome "not recovered", described as "vivid dreams".  Additional information: It was unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease, or risk factor. There were no lab data/results available.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Patient stated not being able to walk or cross the street and not being able to do the sports or activities she did prior receiving the Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (Patient stated not being able to walk or cross the street and not being able to do the sports or activities she did prior receiving the Covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GAIT INABILITY (Patient stated not being able to walk or cross the street and not being able to do the sports or activities she did prior receiving the Covid-19 vaccine). At the time of the report, GAIT INABILITY (Patient stated not being able to walk or cross the street and not being able to do the sports or activities she did prior receiving the Covid-19 vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was very healthy prior to the Moderna Covid-19 vaccine. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The patient visited the emergency department on April 2021 to rule out a heart attack or stroke. The patient reported getting three chest x-rays, an MRI to rule out blood clots, and blood tests. The patient reported a worsening of these symptoms. The patient also indicated that she was seeing a homeopathic doctor. No treatment medication was reported.   Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.; Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.) and CHILLS (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.) in a 25-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.) and CHILLS (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.). At the time of the report, PYREXIA (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.) and CHILLS (Caller mentioned that she remembered experiencing fever and chills after getting the Moderna vaccine.) had resolved.            No concomitant medication was reported. It was reported that she got one standard shot plus 2 boosters (so the one that caused her fever and chills would have been the third dose). No treatment medication was reported.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Adult Moderna Spikevax Age 12+ 0.5mL dose instead of Moderna 2023-2024 Age 5-11yo.  Mother of child was contacted and made aware. She will monitor for and report any adverse events. Patient is having no adverse advents at this time.
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Blister, Pain, Rash, Rash erythematous
Clinical narrative: 18  y/o male client needing Hep B #3.   Client previously came to the clinic in the past for primary school vaccinations on 10/04/2023, then came back on 12/13/2023. Patient at that time, did not report of any adverse reactions to vaccines received prior to immunizing. However, upon assessment today 02/06/2024, patient reported having a red, stinging rash around the neck collar area with blisters that lasted for a month after receiving vaccines in 12/13/2023. Patient did not call back clinic at the time of adverse reaction but reported symptoms felt during last appointment today, 02/06/2024. Vaccines received on last visit 12/13/2023 includes Hep B#2, MMR #2, Varicella #2, Polio #2, and Td. Patient reported not seeking a doctor nor treatment during that month of symptoms.   Today 02/06/2024, patient wanted to receive Hep B#3 for school. However, I did not immunize, patient was not seen, and instead, referred out to a federal funded clinic for further evaluation/consultation. Patient was compliant.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Headache, Swelling, Urticaria
Clinical narrative: redness on arm about 4.5 inches, sweling, heafdache, hives
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Angiopathy, Blood test, Brain fog, Cardiac disorder
Clinical narrative: Severe covid arm. Severe swelling and pain for three weeks. Pharmacist still administered second. Severe hairloss, veins athrophied,  heart problems, brain.. mcas
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fibrin D dimer, Immunisation reaction, Laboratory test
Clinical narrative: Severe covid arm. Severe swelling and pain for three weeks. Pharmacist still administered second. Severe hairloss, veins athrophied,  heart problems, brain.. mcas
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mast cell activation syndrome, Muscle atrophy, Myalgia, Pain in extremity
Clinical narrative: Severe covid arm. Severe swelling and pain for three weeks. Pharmacist still administered second. Severe hairloss, veins athrophied,  heart problems, brain.. mcas
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Urticaria, Vascular dementia, Vein disorder
Clinical narrative: Severe covid arm. Severe swelling and pain for three weeks. Pharmacist still administered second. Severe hairloss, veins athrophied,  heart problems, brain.. mcas
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Attempting to give MMR and Varicella vaccines separately, but accidently drew up Proquad and Varicella instead. Only one of the vaccines given, but unsure if it was the Proquad or Varicella. Other drawn up vaccine discarded. Furthermore, the Proquad had expired 1/31/2024.
Sex: U
Vaccine: RSV
Symptoms: CSF protein increased, Dysarthria, Facial paralysis, Facial paresis, Gait disturbance
Clinical narrative: Severe leg nerve pain fat night, right side facial droop w slurred speech,  instability in walking   Diagnosed  w Gillian Barre Syndrome. Treatment: five (5) IVIG infusion in ICU.   Outcome. No more nerve pain. Still have Right side Facial muscle weakness  w improved droop. Slurred speech
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Neuralgia, Pain in extremity
Clinical narrative: Severe leg nerve pain fat night, right side facial droop w slurred speech,  instability in walking   Diagnosed  w Gillian Barre Syndrome. Treatment: five (5) IVIG infusion in ICU.   Outcome. No more nerve pain. Still have Right side Facial muscle weakness  w improved droop. Slurred speech
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Red rashes (2+) noticed Wednesday in morning, vaccine given Monday (2 days previous) ~2pm; very sore arm per patient
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse effects reported (no adverse event); the patient that received MMR II during supported temperature excursion (TE) (product storage error); This spontaneous report was received from a nurse and refers to a 13-month-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 20-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) injection, at a dose of 0.5 milligram, lot #W029539, (expiration date: 15-SEP-2024), administered for prophylaxis (strength, and route of administration were not provided). On the he same date, it was informed that the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) during supported temperature excursion (TE) (product storage error) the following time 52.0 Degree farenhaiht for 0 hours 47 minutes, 46.6 Degree farenhaiht  for 0 hours 3 minutes and 49.5 Degree farenhaiht for 0 hours 12 minutes. Additionally, no adverse event or previous temperature escursions were reported. By the time of reporting, the outcome of the event was not provided.
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Gait disturbance
Clinical narrative: the patient was diagnosed with Ataxia after receiving a dose of VAQTA, MMR II, VARIVAX and PREVNAR 13.  The patient received all 4 vaccines on 01/19/2023 and 4 days later ( 01/23/2023) the patient was diagnosed with Ataxia; This spontaneous report was received from a physician regarding a female patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, 0.5 milliliter/series, lot #W017344, expiration date: 13-DEC-2023, administered as prophylaxis (anatomical location and route of administration were not provided); in combination with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), 0.5 milliliter/series, batch/lot #fy2475, expiration date: 31-DEC-2024 (formulation, anatomical location, route of administration, and indication were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milligram/ series, lot #W017552, expiration date: 01-JUN-2024, administered as prophylaxis (anatomical location and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection, 0.5 milliliter, lot #U039907, expiration date: 16-DEC-2023, administered as prophylaxis (anatomical location and route of administration were not provided).  On 23-JAN-2023 (also reported as "4 days later"), the patient was diagnosed with ataxia in the form of an unsteady gait, after receiving a dose of hepatitis a vaccine, inactivated (VAQTA), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX), and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). No treatment was given for ataxia. At the time of reporting, the outcome of the event ataxia was not provided, however, the reporter stated that according to the notes, the patient was still recovering about 4 months later. The patient's next appointment was scheduled on 23-JAN-2024. The patient sought medical attention.  The causal relationship between ataxia, hepatitis a vaccine, inactivated (VAQTA), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX), and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was unknown.
Age: 0.5
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: did not report any adverse issues or side effects; temperature excursion for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 19-DEC-2023.; This spontaneous report was received from a medical assistant concerning a 6-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 19-DEC-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # X003664, at 0.5 milliliter once, expiration date on 10-NOV-2025, for prophylaxis (route not reported); and oral rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dose, lot# 1965644, expiration date on 02-OCT-2024, for prophylaxis; both after temperature excusions (on 04-DEC-2023 at 54.3F for 9 hours 32 minutes 0 seconds; on 05-DEC-2023 at 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023 at 50.2F for 5 hours 43 minutes 0 seconds; on 07DEC-2023 at 30.6F for 1 hour 55 minutes 0 seconds; on 07-DEC-2023 at 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023 at 48.4F for 1 hour 47 minutes 0 seconds). No other reported current or previous temperature excursions were reported. No other adverse event information was able to be provided during the call.   This is one of several reports from the same reporter.
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Both shoulders affected; reduce range of motion; This non-serious case was reported by a consumer and described the occurrence of shoulder pain in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F3Z39, expiry date 02-FEB-2025) and (batch number F7SE4) for prophylaxis.   Concurrent medical conditions included gout and blood cholesterol increased. Concomitant products included allopurinol and rosuvastatin.   On 05-DEC-2023, the patient received Arexvy. On 22-DEC-2023, 17 days after receiving Arexvy, the patient experienced shoulder pain (Verbatim: Both shoulders affected) and mobility decreased (Verbatim: reduce range of motion). The outcome of the shoulder pain and mobility decreased were not resolved.   It was unknown if the reporter considered the shoulder pain and mobility decreased to be related to Arexvy.     It was unknown if the company considered the shoulder pain and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-JAN-2024 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient received Arexvy and experienced shoulder pain and reduce range of motion. The reporter stated that both shoulders affected and left more severe. The symptoms were not treated. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Abrysvo vaccine and it comes with a separate syringe, where you can draw up after mixing or reconstituting the vaccine, that one broke apart as I was injecting it; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow-up information on 26Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HA3218, Expiration Date: Mar2025) for immunisation, Device Lot Number: H790, Device Expiration Date: 01Aug2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown" and described as "Abrysvo vaccine and it comes with a separate syringe, where you can draw up after mixing or reconstituting the vaccine, that one broke apart as I was injecting it". Additional information: the reporter stated they were preparing the vaccine and it came with a separate syringe, where you can draw up after mixing or reconstituting the vaccine. That one broke apart as the reporter was injecting it (as reported). When asked if the vaccine was administered to any patient, the reporter stated, "No, it broke during reconstitution. So, I used a completely new one." The reporter considered the event associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for the event was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Follow-up (26Jan2024): This is a spontaneous follow-up report received from the product quality group. Updated information includes: event details (new events added), causality and clinical details.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Incorrect route of product administration, Swelling
Clinical narrative: having bump for many days such as a welt; have been administered Abrysvo subcutaneously; This is a spontaneous report received from a Pharmacist from medical information team.  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Jan2024 as dose number unknown, single (Lot number: HM9849, Expiration Date: Mar2025) at the age of 33 years subcutaneous, in right arm for immunisation, Device Lot Number: HG1756, Device Expiration Date: May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Jan2024, outcome "unknown", described as "have been administered Abrysvo subcutaneously"; URTICARIA (non-serious) with onset 25Jan2024, outcome "recovered" (30Jan2024), described as "having bump for many days such as a welt".  Causality for "have been administered abrysvo subcutaneously" and "having bump for many days such as a welt" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Additional information: Pharmacist reported a patient thought she might have been administered Abrysvo subcutaneously rather than in the muscle as it was described to be administered in the back of her right arm more than in her muscle. The patient having a bump for many days, as a welt. The reporting pharmacist did not administered the vaccine, a staff pharmacist did, so she was not sure how the vaccine was actually administered. The reporting pharmacist did not know for sure but the patient believed it was Sub-Q but it was 1 inch needle so the pharmacist did not know. The patient did not administered any vaccine on the same day of vaccination. Vaccination time: It sometime between 2 and 5.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Raised, puffy, itchy rash on thighs, buttocks, upper and lower arms (not injection sight), elbow crux, and scalp that has lasted for over 2 weeks; Raised, puffy, itchy rash on thighs, buttocks, upper and lower arms (not injection sight), elbow crux, and scalp that has lasted for over 2 weeks; Raised, puffy, itchy rash on thighs, buttocks, upper and lower arms (not injection sight), elbow crux, and scalp that has lasted for over 2 weeks; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Jan2024 at 13:00 as dose 1, single (Lot number: HGE 967) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 16Jan2024; RSV VACCINE, on 17Jan2024; PNEUMOCOCCAL VACCINE, on 16Jan2024; XIGDUO XR; TRULICITY; LOSARTAN HCTZ; ROSUVASTATIN. The following information was reported: RASH PRURITIC (non-serious), RASH PAPULAR (non-serious), RASH (non-serious) all with onset 17Jan2024, outcome "not recovered" and all described as "Raised, puffy, itchy rash on thighs, buttocks, upper and lower arms (not injection sight), elbow crux, and scalp that has lasted for over 2 weeks". Therapeutic measures were taken as a result of rash pruritic, rash papular, rash and included hydrocortizone cream and tylonol.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. There was no drug allergies.
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-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: Moderna (Dose 1), for covid-19 immunisation; Pfizer covid vaccine (Dose 2), for covid-19 immunisation; Pfizer covid vaccine (Dose 3), for covid-19 immunisation. The following information was reported: VITILIGO (non-serious) with onset 27Sep2023, outcome "unknown". The event "vitiligo" required physician office visit. Additional information: Patient received the Pfizer COVID-19 vaccine, and she had been diagnosed with vitiligo. She saw six cases online of people who also developed vitiligo after receiving the Pfizer vaccine, and she was now the seventh case. Her daughter told her about a gentleman who was familiar or a friend of hers, who was 45 years old and also had vitiligo. His dermatologist told him it's due to the Pfizer vaccine, as it can trigger autoimmune disorders. She didn't know why this didn't come up before; she heard vitiligo is genetic, but no one in her family has it, and she was 72 years old. Since she got the Pfizer COVID shots, she was diagnosed with Vitiligo. She was not sure why people aren't reporting and discussing this. She spoke to her rheumatologist, but she had no clue why she had developed vitiligo. Someone needs to look into this and understand that vitiligo can be triggered by the vaccine. She read online that vitiligo attacks skin cells and can affect younger people but not older adults like her. She was concerned because she just saw that 17 patients have now been identified with this issue. She didn't understand why this was happening, and it's a serious situation caused by the Pfizer vaccine. She was calling about covid shot. Originally started off with Moderna covid vaccine. And her last three covid vaccines have been Pfizer covid vaccines. She is 72 years old and has no history of any skin issues. She was just diagnosed with vitiligo. She saw a dermatologist and the dermatologists' hands are up in the air since the caller has no history. She did research and googled and saw there were 6 cases so far of vitiligo and online it said it was the Pfizer covid vaccine. Stated her dermatologist Dr. PRIVACY diagnosed her with vitiligo around 27Sep2023. She thought it was 27Sep2023. Declines any treatment. Indication reported as senior citizen and did not want to get covid.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400032888 Different patient, same drug/event.;
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Dyspnoea, Fatigue, Loss of personal independence in daily activities, Nausea
Clinical narrative: Shortness of breath; Dizziness; Fatigue; Nausea; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2024 as dose number unknown, single (Lot number: HE6175, Expiration Date: 31Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Jan2024, outcome "unknown"; FATIGUE (non-serious) with onset Jan2024, outcome "unknown"; NAUSEA (non-serious) with onset Jan2024, outcome "unknown"; DYSPNOEA (non-serious) with onset Jan2024, outcome "not recovered", described as "Shortness of breath". The events "shortness of breath", "dizziness", "fatigue" and "nausea" required physician office visit and emergency room visit.  Additional information: the patient commented that she has visited emergency room twice and has also seen two separate doctors. She considered that particular batch of Prevnar 20 may be responsible for AE. Her primary adverse reaction was shortness of breath, which comes and goes, and that secondary adverse reactions were dizziness, fatigue and nausea. She had trip planned and had to cancel due to condition.
Sex: F
Vaccine: RSV
Symptoms: Device connection issue, Needle issue
Clinical narrative: It just broke when I was trying that; Was administered to patient; Threaded part of the needle would not stay on to the port or would not connected to the port and then it came off; tip of the pen needle came off, it broke off; This is a spontaneous report received from a Pharmacist.  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose numer unknown, single (Lot number: HR4390, Expiration Date: May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), described as "It just broke when I was trying that; Was administered to patient"; DEVICE ISSUE (non-serious), described as "Threaded part of the needle would not stay on to the port or would not connected to the port and then it came off"; NEEDLE ISSUE (non-serious), described as "tip of the pen needle came off, it broke off".  Causality for "it just broke when i was trying that; was administered to patient", "threaded part of the needle would not stay on to the port or would not connected to the port and then it came off" and "tip of the pen needle came off, it broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist was administering an Abrysvo vaccine and the tip of the pen needle came off, it broke off. The threaded part just broke when pharmacist was trying that. Pharmacist stated the threaded part of the needle would not thread on to the port, it would not stay onto the port and then it fall off. Pharmacist put it back on and did give the shot but, it was not idea at all, like it was definitely a faulty. Adaptor: LOT#: HR4390, Expiration date: Feb2025, NDC#: 0069034401, UPC#: 300690344010. Vial: LOT#: HR4390, Expiration date: Feb2025, NDC#: 0069020701, UPC#: may be it is PAA209777 (Reporter was not sure). Diluent: NDC#: 0069025001, UPC#: PAA209778, Expiration date: Mar2025, LOT#: HA3218.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "significant hearing loss" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FH8030, Location of injection: Arm Left), administration date: 15Nov2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FP4554, Location of injection: Arm Left), administration date: 04May2022, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GJ6796, Location of injection: Arm Right), administration date: 10Nov2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (30Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Jan2024 to 28Jan2024. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy; This is a spontaneous report received from a Pharmacist from medical information team, Program ID.  A patient (age and gender not provided) 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy". Clinical course: The reporter mentioned that she has a friend that experienced neuropathy after taking the vaccine.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 14.0
Sex: U
Vaccine: MENB
Symptoms: Splenectomy
Clinical narrative: The patient had their spleen removed; This is a spontaneous report received from an Other HCP from medical information team.  A 14-year-old patient received meningococcal group b Rlp2086 (TRUMENBA), on 02Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 14 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bexsero, administration date: Jul2023, when the patient was 14 years old, for Immunization. The following information was reported: SPLEEN OPERATION (medically significant), outcome "unknown", described as "The patient had their spleen removed".  Additional information: A patient has received Bexsero at the age of 14 on Jul2023 and then Trumenba on 02Jan2024. Knowing that the vaccines are not interchangeable and the patient had their spleen removed, would they need a 3rd dose or would they need to restart the series? Office is seeking guidance.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event spleen operation and the suspect drug MENINGOCOCCAL GROUP B RLP2086 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm and on 23Aug2023 as dose 6 (booster), single (Lot number: GM1767) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 07Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 25Oct2023 as dose 7 (booster), single (Lot number: 3031419), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no Known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". The patient received Paxlovid from 21Jan2024 to 25Jan2024 as treatment.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus; it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus". Clinical courses: the reporter was 50 the first time, the patient was diagnosed with acute pancreatitis and it happened to come a few days after first vaccination. Since then the patient has had several instances of this and it has correlated with either boosters received (all were Pfizer) or getting the actual COVID virus.  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-202400027564 same vaccine/patient, different doses/events;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Lot number: HM7010) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 02Feb2015. 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 (BOOSTER) , MANUFACTURER UNKNOWN, ), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Faint, notes: after a week of only a faint result. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 23Jan2024 to 28Jan2024. Clinical course: Patient had no known allergies.