chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "tiredness", "pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; FATIGUE (non-serious), outcome "unknown", described as "tired". Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400257630 same patient, different vaccine doses/events;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation, reaction(s): "tired", "Achy"; Bnt162b2 (Dose 2), for covid-19 immunisation, reaction(s): "tired", "Achy". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400257630 same patient, different vaccine doses/events;
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Rash
Clinical narrative: horrible rash; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-015632, 2024SA161260.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Lot number: 3F297A, Expiration Date: 30Sep2025) at 300 mg (300 mg, qow (every other week)), subcutaneous for illness; allopurinol (ALLOPURINOL). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "recovered", described as "horrible rash". The action taken for dupilumab was unknown; for allopurinol was temporarily withdrawn.  Additional information: It was reported "when she got her first covid shot, she got a horrible rash. She states she got the rest of the shots and was fine. She states they were thinking it could be the allopurinol that she was taking so she was taken off of it and the rash stopped. It is unknown if there were lab data/results available". Drug withdrawn on an unknown date for rash with respect to allopurinol, unknown with respect to other suspects.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Illness
Clinical narrative: she got the first COVID vaccine she was very sick; had reactions to the allergens in it; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "she got the first COVID vaccine she was very sick"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had reactions to the allergens in it".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: My throat closed up; I could not breathe; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "allergy to vaccine" (ongoing), notes: (Had allergic reaction to mRNA vaccines). Concomitant medication(s) included: NOVAVAX COVID-19 VACCINE taken for covid-19 immunisation, on 30Oct2023 as dose number unknown, single. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "My throat closed up"; DYSPNOEA (non-serious), outcome "unknown", described as " I could not breathe".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circulatory collapse, Hypersensitivity
Clinical narrative: extreme allergic reactions; Collapse; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00288 (Novavax).  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "extreme allergic reactions"; CIRCULATORY COLLAPSE (medically significant), outcome "unknown", described as "Collapse".  Additional information: Consumer stated to have had extreme allergic reactions that made her collapse with previous vaccines as Pfizer, Moderna and J&J shingles.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 29-Aug-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 27 years old female pregnant patient who was exposed to Influenza quadrival a-b multidose vaccine preserved [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Vaccine exposure during pregnancy with no reported adverse event occurred at 17 weeks of pregnancy at 17 weeks of pregnancy, during second pregnancy trimester for Influenza quadrival a-b multidose vaccine preserved.  The date of last menstrual period was reported as 11-May-2024. The estimated due date is 04-Mar-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2024, the patient received a dose 1 of suspect Influenza quadrival a-b multidose vaccine preserved Suspension for injection (lot- UT8323JA and expiry- 30-JUN-2025) via intramuscular route in unknown administration site (strength: not provided) for Immunisation and patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy) (latency- same day).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: off-label use as per local labelling due to prescribing and administering fluzone qiv np to a patient at 2 months of age and patient also received a third dose within a year with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 2-month-old female patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] and  reported off-label use as per local labelling due to prescribing and administering Fluzone QIV np and also received a third dose within a year with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 7v (CRM197) (Prevnar; Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel); Hepatitis b vaccine (Hepatitis b vaccine); and Rotavirus vaccine live reassort oral 5v (Rotateq) all for immunization.  On 27-Jan-2021, the patient received 0.5 ml of (dose 1) of suspect standard Influenza Quadrival A-B Vaccine (lot- U7012BA, expiry date: 30-Jun-2021) (expiry date: 30-Jun-2022) and for both 0.5 ml of (dose 2) (lot-UT7336LA) on 07-Sep-2021 and 0.5 ml of (dose 3) (lot-UT7407NA) on 05-Nov-2021 all via intramuscular route in the right thigh for  Influenza and reporter reported, off-label use as per local labelling due to prescribing and administering Fluzone QIV np to a patient at 2 months of age and patient also received a third dose within a year with no reported adverse event (off label use) (latency-same day).  Reportedly, dose was given at 2 months of age inadvertently, then patient received her second dose at 9 months of age. Patient also received a third dose at 11 months of age.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: daptacel was administered to a patient with no reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves Adult and unknown gender patient where diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot- 3CA03C3 and expiry date- 30-SEP-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation and daptacel was administered to a patient with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Reason: Refrigerator issue, Max/low temperature reached: Negative 1.1C, Duration out of labelled range: Less than 5 minutes, Human error? No, Does extended stability data cover the excursion? No, all of the unopened vaccines are not covered by the extended stability data.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm gets a little sore; This spontaneous case initially received on 12-Sep-2024, was reported by a non-health professional and concerns a female patient.  Medical History, and Concomitant Medications were reported as Unknown. There was no Allergy Information.  There is no product complaint associated with this case.  Administration of company suspect drug:  On an unknown date, the patient received Afluria Quadrivalent for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: No batch number available but it would be requested upon further follow-up.  The reporter informed the following words:  The patient thought the doctor gave the patient the single dose. In prior years when the patient had some other brand, the patient had some reactions, but with this one the patient had no reaction, just the arm got a little sore, but what's that, right? The reporter asked if the preservative usually used in making the vaccine. Response received as Ingredients: Thimerosal.   No additional suspect drugs.  Adverse reactions/events and outcomes:  On an unknown date, the patient experienced Arm gets a little sore (outcome: Unknown).  Afluria Quadrivalent action taken: Not Applicable Treatment measures associated with event reported as Unknown.  Reporter assessment:  The reporter considered the event as non-serious and did not provide a causality assessment.; Reporter's Comments: The event is considered as related to Alfuria Quadrivalent.
Sex: M
Vaccine: UNK
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dysstasia, Echocardiogram normal
Clinical narrative: the next day had numbness in fingers; the next day had numbness in legs; Fatigue; inability to stand up/ inability to stand up from the torso up; tired legs; the next day had swelling in fingers; the next day had swelling in legs; Could barely walk; This spontaneous case, initially received on 08-Sep-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Parkinson's Disease.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 03-Sep-2024 04:45, the patient received Fluad (TIV) for Flu immunization, Dose regimen: .5 ml, Route of administration: Intramuscular, Lot number reported as 388492 but this unable to match with company batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 04-Sep-2024, the patient experienced the next day had swelling in fingers (outcome: Recovering / Resolving), the next day had swelling in legs (outcome: Recovering / Resolving), Could barely walk (outcome: Not recovered / Not resolved). On 04-Sep-2024 06:45, the patient experienced the next day had numbness in fingers (Hospitalized, outcome: Not recovered / Not resolved), the next day had numbness in legs (Hospitalized, outcome: Not recovered / Not resolved), Fatigue (Hospitalized, outcome: Not recovered / Not resolved), inability to stand up/ inability to stand up from the torso up (Hospitalized, outcome: Not recovered / Not resolved), tired legs (Hospitalized, outcome: Not recovered / Not resolved).  Event description: The patient ended up going to the hospital. Numbness, inability to stand up, fatigue, tired legs, inability to stand up from the torso up. Numbness, which he still have in my fingers and left hand. Treatment measures associated with event doctor had patient go to hospital for computed axial tomography (CAT) scan, Echo, EKG, blood, urine, blood pressure and chest x-ray all tests were negative. I was discharged. Patient think they gave me pills for blood thinner, but it was not a stroke. Patient attributed it to the vaccine.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the all events serious except the events next day had swelling in fingers, the next day had swelling in legs, could barely walk and consider all the events related to Fluad (TIV).; Reporter's Comments: Causality: Related for all the events considering close temporal plausibility (1 day after vaccination). Of note, contributory factors for events of gait disturbance, fatigue and dysstasia include underlying Parkinsons disease and patient's elderly age (90 years old).
Sex: M
Vaccine: UNK
Symptoms: Electrocardiogram normal, Fatigue, Gait disturbance, Hypoaesthesia, Peripheral swelling
Clinical narrative: the next day had numbness in fingers; the next day had numbness in legs; Fatigue; inability to stand up/ inability to stand up from the torso up; tired legs; the next day had swelling in fingers; the next day had swelling in legs; Could barely walk; This spontaneous case, initially received on 08-Sep-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Parkinson's Disease.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 03-Sep-2024 04:45, the patient received Fluad (TIV) for Flu immunization, Dose regimen: .5 ml, Route of administration: Intramuscular, Lot number reported as 388492 but this unable to match with company batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 04-Sep-2024, the patient experienced the next day had swelling in fingers (outcome: Recovering / Resolving), the next day had swelling in legs (outcome: Recovering / Resolving), Could barely walk (outcome: Not recovered / Not resolved). On 04-Sep-2024 06:45, the patient experienced the next day had numbness in fingers (Hospitalized, outcome: Not recovered / Not resolved), the next day had numbness in legs (Hospitalized, outcome: Not recovered / Not resolved), Fatigue (Hospitalized, outcome: Not recovered / Not resolved), inability to stand up/ inability to stand up from the torso up (Hospitalized, outcome: Not recovered / Not resolved), tired legs (Hospitalized, outcome: Not recovered / Not resolved).  Event description: The patient ended up going to the hospital. Numbness, inability to stand up, fatigue, tired legs, inability to stand up from the torso up. Numbness, which he still have in my fingers and left hand. Treatment measures associated with event doctor had patient go to hospital for computed axial tomography (CAT) scan, Echo, EKG, blood, urine, blood pressure and chest x-ray all tests were negative. I was discharged. Patient think they gave me pills for blood thinner, but it was not a stroke. Patient attributed it to the vaccine.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the all events serious except the events next day had swelling in fingers, the next day had swelling in legs, could barely walk and consider all the events related to Fluad (TIV).; Reporter's Comments: Causality: Related for all the events considering close temporal plausibility (1 day after vaccination). Of note, contributory factors for events of gait disturbance, fatigue and dysstasia include underlying Parkinsons disease and patient's elderly age (90 years old).
Sex: M
Vaccine: UNK
Symptoms: Urine analysis normal
Clinical narrative: the next day had numbness in fingers; the next day had numbness in legs; Fatigue; inability to stand up/ inability to stand up from the torso up; tired legs; the next day had swelling in fingers; the next day had swelling in legs; Could barely walk; This spontaneous case, initially received on 08-Sep-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Parkinson's Disease.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 03-Sep-2024 04:45, the patient received Fluad (TIV) for Flu immunization, Dose regimen: .5 ml, Route of administration: Intramuscular, Lot number reported as 388492 but this unable to match with company batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 04-Sep-2024, the patient experienced the next day had swelling in fingers (outcome: Recovering / Resolving), the next day had swelling in legs (outcome: Recovering / Resolving), Could barely walk (outcome: Not recovered / Not resolved). On 04-Sep-2024 06:45, the patient experienced the next day had numbness in fingers (Hospitalized, outcome: Not recovered / Not resolved), the next day had numbness in legs (Hospitalized, outcome: Not recovered / Not resolved), Fatigue (Hospitalized, outcome: Not recovered / Not resolved), inability to stand up/ inability to stand up from the torso up (Hospitalized, outcome: Not recovered / Not resolved), tired legs (Hospitalized, outcome: Not recovered / Not resolved).  Event description: The patient ended up going to the hospital. Numbness, inability to stand up, fatigue, tired legs, inability to stand up from the torso up. Numbness, which he still have in my fingers and left hand. Treatment measures associated with event doctor had patient go to hospital for computed axial tomography (CAT) scan, Echo, EKG, blood, urine, blood pressure and chest x-ray all tests were negative. I was discharged. Patient think they gave me pills for blood thinner, but it was not a stroke. Patient attributed it to the vaccine.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the all events serious except the events next day had swelling in fingers, the next day had swelling in legs, could barely walk and consider all the events related to Fluad (TIV).; Reporter's Comments: Causality: Related for all the events considering close temporal plausibility (1 day after vaccination). Of note, contributory factors for events of gait disturbance, fatigue and dysstasia include underlying Parkinsons disease and patient's elderly age (90 years old).
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None reported per client; vaccine was given 12 days early in relation to an MMR given n7/24/24.
Age: 18.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 influenza vaccines in the same season.  Both were Flucelvax TRIvalent (only quadrivalent populated in the list, so it was selected; choosing "other vaccine" would result in error message). First done administered on 8/5/24, second dose on 9/17/24. Patient states she has had no adverse effects and feels fine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Technician administered  first dose of shingrix to the patient and then administered a second dose of shingrix that was intended for her spouse. The patient did not report any signs of symptoms of an ill effect at the time of and for approximately 15 minutes after administration. No ill effects were observed by the pharmacy staff during the same time frame.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Pfizer Comirnaty 2024-25 (12y  UP) vaccine was given to a 2 year old.  Patient had high fever and was lethargic per mother. The mother called the child's provider and informed her what happened.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Meniere's disease, Sleep disorder, Tinnitus
Clinical narrative: Loud, whooshing tinnitus in right ear (quieter in left).   Loud enough to keep me awake until ~ 4 in the morning.  This happened with earlier Moderna vaccinations as well.   It's still whooshing now, 16 hours later.  (I have been diagnosed with Meneire's Disease in the right ear - it has moderate to severe hearing loss.  Left ear hearing is normal.)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: reported that around 6am she was going to the kitchen for a drink she was sweaty feeling dizzy and then she fainted waking up shortly after feeling fine, no issues reoccurred as of this evening.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Vision blurred
Clinical narrative: Blurred vision starting 3 hours after dose and lasting more than 3 hours.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Heart rate increased, Wheezing
Clinical narrative: Noticed after a day or so, my heartrate increased, as observed on my tracker. Over the following almost 2 weeks now, my resting heartrate has increased from 61-62 bpm to 70 bpm. Considering my heartrate has been consistent for years, it gives me cause for concern.  Also, though I have COPD, wheezing started about the same time and I now use an inhaler morning and evening. This too has become abnormal for me.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Limb mass, Skin warm
Clinical narrative: Pt stated approx. 1 mo. after receiving injection she noted a non tender lump to her arm that she states has grown in size. Area was approx. the size of a large marble , non tender and warm to the touch , no redness noted.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Pain, Paraesthesia
Clinical narrative: SHOULDER PAIN, RADIATING PAIN TO NECK, TINGLING AND NUMBNESS IN ARM.  NO RESOLVE  AFTER 3.5 WEEKS. HAS TRIED IBUPROFEN, ACETAMINOPHEN, ICE/HEAT, LIDOCAINE PATCHES
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypertension
Clinical narrative: High blood pressure and headache, no fever
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: (Duplicate vaccine) Patient received 2 vaccines on 8/13/24 (TDAP and FLUCELVAX). Patient forgot she had already completed the flushot and received a second dose on 9/16/24. Pt has no adverse effects.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Extra dose administered, Product administration error
Clinical narrative: During administering Vaccine for COVID, Pharmacist administered 2x  (0.3ml)  PFIZER COVID vaccines to the same person. (One in each arm). Immediately after the 2nd shot was given, pharmacist noticed, which vaccine it was while it was being dropped into sharps container. Pharmacist immediately disclosed the error and apologized. Patient was instructed to wait for 20 minutes and to report any ADRs. If any significant ADRs noted, then go to the ER, if any ADRs minor in nature, give me a call and seek medical attention. Immediately after this, the spouse received her vaccines. Then error was divulged to the other pharmacists on duty.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tinnitus
Clinical narrative: Tinnitus: constant high pitched noise both ears
Age: 28.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Vision blurred
Clinical narrative: Immedialty after patient recieved vaccines and PPD testing he reported he felt dizzy and his vision was blurry. Patient was pale and had no color in his lips, BP checked at 60/43, HR 50, SpO2 91% seated. Patient placed in Trendelenburg position and given water, apple juice and peanut butter. Patient reported he started to feel better, color started returning to his face. BP rechecked 5 minutes later at 107/64 HR 60, SpO2 95% RA. Patient reported his vision was no longer blurry at 10 minutes BP rechecked at 112/77 HR 68 SpO2 97% RA. Patient reported he felt complelty fine 20 minutes later, BP rechecked at 114/79, HR 78, SpO2 98% RA. BP rechecked standing at 112/76, HR 80 SpO2 98%RA.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: erythema, swelling itching on vaccine site. warmth and tenderness 1 day after vaccination
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states that the next day after immunization she experienced redness and itching and swelling at the reaction site
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Extreme pain in arm at injection site. Headache, fatigue times 2 days
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Presyncope, Syncope
Clinical narrative: patient experienced lightheadedness then briefly fainted due to a vasovagal response approx. 3 min following vaccination. I gave patient a bottle of water and an apple juice to help her return to homeostasis. I advised patient to stay in vaccination area for 30 minutes and I checked on her every 10 minutes until she felt comfortable being released and having her mom drive her home.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT GOT HER FIRST FLU SHOT HIGH DOSE ON 09/04/2024 AND RECIVED ANOTHER SHOT ON 09/13/2024
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac dysfunction, Cardiomegaly, Cardiomyopathy, Cerebrovascular accident
Clinical narrative: After receiving the COVID-19 Booster shot on 2/14/2023 I started having what felt like a racing heart and just feeling uncomfortable. I made an appointment to the Hospital for a check-up. When they ran their tests, they reported that I had an enlarged heart - what they term as non-ischemic cardiomyopathy - this was noted in about April/MAY 2023. They also noted that my heart was not pumping at the rate that it normally should, mine was pumping at about 20% they said. This year on August 3, 2024, I had an episode and went to the ER they reported that I had a mild stroke which is most likely caused by the slow pumping of my heart condition which was recorded the previous year in 2023.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Electrocardiogram, Hyperbaric oxygen therapy, Laboratory test, Magnetic resonance imaging
Clinical narrative: After receiving the COVID-19 Booster shot on 2/14/2023 I started having what felt like a racing heart and just feeling uncomfortable. I made an appointment to the Hospital for a check-up. When they ran their tests, they reported that I had an enlarged heart - what they term as non-ischemic cardiomyopathy - this was noted in about April/MAY 2023. They also noted that my heart was not pumping at the rate that it normally should, mine was pumping at about 20% they said. This year on August 3, 2024, I had an episode and went to the ER they reported that I had a mild stroke which is most likely caused by the slow pumping of my heart condition which was recorded the previous year in 2023.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: After receiving the COVID-19 Booster shot on 2/14/2023 I started having what felt like a racing heart and just feeling uncomfortable. I made an appointment to the Hospital for a check-up. When they ran their tests, they reported that I had an enlarged heart - what they term as non-ischemic cardiomyopathy - this was noted in about April/MAY 2023. They also noted that my heart was not pumping at the rate that it normally should, mine was pumping at about 20% they said. This year on August 3, 2024, I had an episode and went to the ER they reported that I had a mild stroke which is most likely caused by the slow pumping of my heart condition which was recorded the previous year in 2023.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Respiratory arrest
Clinical narrative: Adverse events: Patient was pale and lost breathing for a couple of seconds. Treatment:  Taken vital signs, provided juice and food. Recommended to contact PCM. Outcome: Patient left after her daughter was safe.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Fluad on 8/28/24 @ facility during a flu shot clinic provided by Pharmacy. Today patient received another dose of Fluad (2nd dose, only needed one for the 2024-2025 year) on 9/18/24 during another clinic @ facility provided by Pharmacy.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I previously had 3 Moderna vaccines that I had a similar reaction to, and with each of the three, the reaction was progressively worse. So for this booster I decided to go with Pfizer, hoping to not have a reaction.  I have noticed this evening about 9:30pm that my left deltoid area that the area around the injection site is now red, hot, raised, and itchy. The red/raised are is in a circular pattern about 2 inches in diameter.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt. was given Tuberculin Derivative Protein instead of Tetnus, Diptheria, Purtussis vaccine.. Pt. had no adverse affects, no swelling, arm pain or any stomach pain. No dizziness or bleeding
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke/the vaccine nearly killed me and it gave me a stroke.; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (ischemic stroke/the vaccine nearly killed me and it gave me a stroke.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 009C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ISCHAEMIC STROKE (ischemic stroke/the vaccine nearly killed me and it gave me a stroke.) (seriousness criteria hospitalization and medically significant). At the time of the report, ISCHAEMIC STROKE (ischemic stroke/the vaccine nearly killed me and it gave me a stroke.) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient  was Perfectly healthy prior to ischemic stroke. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was hospitalized for ischemic stroke for couple of days. No treatment medications provided by the reporter.  Company comment- This is a spontaneous case, concerning a 53-year-old male patient with no medical history reported, who experienced the serious (due to medically significant and hospitalization) unexpected AESI of ischaemic stroke. The event  ischaemic stroke occurred fifty-nine days after a dose of mRNA-1273 vaccine, given as the second dose of covid vaccination schedule. Both doses were administered in an appropriate schedule. It was reported that the patient was perfectly healthy prior to ischemic stroke; and was hospitalized for ischemic stroke for couple of days. The outcome of the event ischaemic stroke was reported as resolving. In view of the long non-suggestive onset latency the causality of the event  ischaemic stroke was assessed as not related to the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2024: Live significant follow received in which new event Cerebrovascular accident was added and new reference number was added.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Hives on my chest; broke out in rash on my chest; Allergic to their preservative in that non frozen vaccine (Comirnaty); allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; RABEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for covid-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN), for covid-19 immunisation. The following information was reported: REACTION TO PRESERVATIVES (non-serious) with onset 12Sep2024, outcome "recovering", described as "Allergic to their preservative in that non frozen vaccine (Comirnaty)"; URTICARIA (non-serious) with onset 12Sep2024, outcome "recovered", described as "Hives on my chest"; PRURITUS (non-serious) with onset 12Sep2024, outcome "recovering", described as "Itching"; HYPERSENSITIVITY (non-serious) with onset 12Sep2024, outcome "recovering", described as "allergic reaction"; RASH (non-serious) with onset 12Sep2024, outcome "recovering", described as "broke out in rash on my chest". Therapeutic measures were taken as a result of pruritus, urticaria, rash, reaction to preservatives, hypersensitivity. Additional information: the patient took allergy medication (Chlorpheniramine Maleate) as treatment.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Reaction to preservatives, Urticaria
Clinical narrative: Itching; Hives on my chest; broke out in rash on my chest; Allergic to their preservative in that non frozen vaccine (Comirnaty); allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; RABEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for covid-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN), for covid-19 immunisation. The following information was reported: REACTION TO PRESERVATIVES (non-serious) with onset 12Sep2024, outcome "recovering", described as "Allergic to their preservative in that non frozen vaccine (Comirnaty)"; URTICARIA (non-serious) with onset 12Sep2024, outcome "recovered", described as "Hives on my chest"; PRURITUS (non-serious) with onset 12Sep2024, outcome "recovering", described as "Itching"; HYPERSENSITIVITY (non-serious) with onset 12Sep2024, outcome "recovering", described as "allergic reaction"; RASH (non-serious) with onset 12Sep2024, outcome "recovering", described as "broke out in rash on my chest". Therapeutic measures were taken as a result of pruritus, urticaria, rash, reaction to preservatives, hypersensitivity. Additional information: the patient took allergy medication (Chlorpheniramine Maleate) as treatment.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Total loss of taste and smell
Age: 80.0
Sex: M
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative
Clinical narrative: Total loss of taste and smell
Age: 1.0
Sex: F
Vaccine: MMRV, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Noticed temperature excursion. Vaccine administered before vaccine was cleared by manufacturer; This spontaneous report was received from a registered nurse, concerning a 12-month-old female.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 06-AUG-2024, the patient was vaccinated with an improperly dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1st dose, lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously in the right thigh (RT) (albumin status: recombinant human albumin (rHa)) for prophylaxis (strength was not provided); and with the fourth dose of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), lot number HL3889, expiration date: 31-MAY-2025, administered intramuscularly in the left thigh (LT) for prophylaxis (strength, formulation, were not provided). The patient was vaccinated at private doctors office/hospital and purchased with public funds. The temperature excursion did occur as a result of reading from a Digital Data Logger.   It was reported that temperature excursion was -12 degrees Celsius, time frame 37 minutes, with previous temperature excursion. Additionally, the form was completed by vaccine provider. The medication error occurred storage in clinical practice (temperature excursion). No product quality complaint. The adverse event was previously reported to manufacturer. Un-noticed temperature excursion occurred. Vaccine administered before was cleared by manufacturer. Vaccine has been cleared for use. No adverse events reported.   This is one of the 16 cases created from the same source.
Age: 62.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Consumer reporting he contracted HPV and received two doses of GARDASIL 9 at the age of 62.; Consumer reporting he contracted HPV and received two doses of GARDASIL 9 at the age of 62.; This spontaneous report was received from a consumer and refers to himself, a 62-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two doses of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). On an unknown date, the patient contracted human papillomavirus (HPV). No side effects were reported.  The causal relationship between human papillomavirus and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA930A, expiry date 30-JUN-2024) for prophylaxis.   On 09-SEP-2024, the patient received Menveo. On 09-SEP-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2024. The healthcare professional reported that he given an injection to a patient and it was expired by a couple of months, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Neck pain, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: severe arm and neck pain; severe arm and neck pain; shoulder injury related to vaccine administration (SIRVA); This is a spontaneous report received from a Physician.  A 45-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Sep2024 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: PAIN IN EXTREMITY (medically significant), NECK PAIN (medically significant) all with onset 03Sep2024, outcome "unknown" and all described as "severe arm and neck pain"; SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (medically significant) with onset 03Sep2024, outcome "unknown", described as "shoulder injury related to vaccine administration (SIRVA)". The events "severe arm and neck pain" and "shoulder injury related to vaccine administration (sirva)" required emergency room visit. The clinical course was reported as follows: The physician reported for a colleague who had a Pfizer COVID-19 vaccine and on 03Sep2024 (48 hours later as reported), the patient had severe arm and neck pain and, when it persisted, patient went to the emergency department (ED) due to pain on day 7 (as reported). They did a computerised tomogram (CT) but did not find anything. The reporter indicated that the patient was quite tough, therefore, if patient said she had to go to the ED for pain, it must have been significant. The reporter said the patient ended up diagnosing herself with shoulder injury related to vaccine administration (SIRVA). The patient underwent the following laboratory tests and procedures as aforementioned.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMICRON (KP.2) administration cannot be completely excluded. This case will be reassessed should additional information become 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: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Discomfort, Exposure during pregnancy, Fatigue, Headache, Injection site pain
Clinical narrative: In addition to the normal side effects like sore muscle at injection site, nausea started at 9pm on the day of injection. The next morning I had whole body aches, a severe headache, sore neck and swollen lymph nodes on left neck and along left clavicle. Temperature was 99.9 at 9am, then up to 100.2 at 11am. Due to being 6 mos pregnant and knowing fevers can be very serious for pregnant people I called my OB to see if I could take Tylenol to keep the fever down. I was instructed to take 1000mg of Tylenol and if my fever got above 100.4 to call them back ASAP. The Tylenol kept my fever around 100 for the rest of the day. I could not do anything but lay in bed all day aside from getting up to use the restroom/grab food from the fridge/pantry. I was extremely uncomfortable. I slept hard that night and woke up today 9/18 with no fever, body aches, or headache. The only symptoms I have had all day today have been tiredness and swollen lymph nodes still. This was my 2nd booster shot and I have had this type of reaction to each COVID shot I have received. The first two vaccinations and 1st booster I had fevers of 102.5, swollen neck/clavicle lymph nodes has only happened with the boosters.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymphadenopathy, Nausea, Neck pain, Pain
Clinical narrative: In addition to the normal side effects like sore muscle at injection site, nausea started at 9pm on the day of injection. The next morning I had whole body aches, a severe headache, sore neck and swollen lymph nodes on left neck and along left clavicle. Temperature was 99.9 at 9am, then up to 100.2 at 11am. Due to being 6 mos pregnant and knowing fevers can be very serious for pregnant people I called my OB to see if I could take Tylenol to keep the fever down. I was instructed to take 1000mg of Tylenol and if my fever got above 100.4 to call them back ASAP. The Tylenol kept my fever around 100 for the rest of the day. I could not do anything but lay in bed all day aside from getting up to use the restroom/grab food from the fridge/pantry. I was extremely uncomfortable. I slept hard that night and woke up today 9/18 with no fever, body aches, or headache. The only symptoms I have had all day today have been tiredness and swollen lymph nodes still. This was my 2nd booster shot and I have had this type of reaction to each COVID shot I have received. The first two vaccinations and 1st booster I had fevers of 102.5, swollen neck/clavicle lymph nodes has only happened with the boosters.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Hypoaesthesia, Pain
Clinical narrative: Headaches 2 months, when my head moves as well as  my neck , body numbness 2 months,
Age: 31.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: I received the flu and rsv vaccines on 9/4. I went into early labor on 9/8 at 37 weeks and 2 days.  This was my first pregnancy. Birth weight was 5 pounds 6 ounces.