chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Thrombosis, X-ray
Clinical narrative: Blood clot left arm. Swelling on left arm and upper and lower leg swelling. 3 Er visits,  2 Pcp visits in reference to o going swelling after shot and pain.
Age: 84.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Chills, Erythema, Hypopnoea, Pruritus, Pyrexia
Clinical narrative: fever, chills, shallow breathing, red cheeks, shallow breathing, tightness on same day of vaccination, 10/4 bp107/55, 108/58 also has red itchy on inside of both thighs
Age: 84.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Skin tightness
Clinical narrative: fever, chills, shallow breathing, red cheeks, shallow breathing, tightness on same day of vaccination, 10/4 bp107/55, 108/58 also has red itchy on inside of both thighs
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Flozone HD was administered to this 5 year old patient instead of Flozone PF
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse effects noted
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Fall, Loss of consciousness, Pallor
Clinical narrative: About 1 minute after receiving the vaccine, client lost color.  Her eyes rolled back into her head and she fell back onto the exam table. After less than 1 minute, she regained consciousness and said she had felt dizzy before she passed out. She drank some water and stood up after a couple of minutes. She said she felt better. She wanted to sit in the lobby with her mother and sister, so she did that for about 10 more minutes before leaving the clinic.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Pain, Treatment failure
Clinical narrative: Patient contacted pharmacy on Friday, 10/4/2024 at 4:30 pm.  Received both 2024-25 COVID-19 vaccine and 2024-25 Flu vaccine on Wednesday, 10/2/2024.  Reports having adverse reaction that started later Wednesday, 10/2/2024 around 8 pm.  Described feeling 'awful', was bed ridden with body aches for 24 hours.  Tried taking acetaminophen and did not help.  Patient said she feels better today (Friday, 10/4/2024) however has significant swelling and redness at injection site.  I recommended her to apply ice pack, continue to monitor her symptoms, and referred her to follow up with her physician if swelling/redness did not improve.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient experienced swelling in her left arm from her shoulder to her elbow which she described as very painful.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient given wrong dose. Patient received dose for ages 5-11 years, instead of age 12 and up vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: PER PATIENT AFTER VACCINE, HAD LEFT ARM PAIN RADIATING AFTER.  AFTER 1 DAY OF REST PAIN SUBSIDED.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received high dose flu vaccine on 09/26/2024 and 10/02/2024. Patient denies any symptoms following vaccination on 10/02/2024.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Maternal exposure during pregnancy
Clinical narrative: she received a booster and died at 39; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of DEATH (she received a booster and died at 39) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced DEATH (she received a booster and died at 39) (seriousness criteria death and medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown. It was reported that pregnant woman with side effects. One of her acquaintance told her that he knows somebody, 39 year old, a friend of his, a mother, married with two Children that died, she received a booster and died at 39. Reporter causality was not reported. No treatment medication was reported.  Company comment-This spontaneous maternal exposure during pregnancy case concerns a 39-year-old, female patient with no reported medical history, who experienced the unexpected, serious (death and medically significant) event death after a dose of SPIKEVAX COVID-19 VACCINE NOS was administered as a booster dose of COVID vaccination schedule. Onset date of the event was not reported hence latency cannot be assessed. It was reported that a pregnant woman had side effects; she received a booster and died. The cause of death was not provided, and it is unknown if an autopsy was performed. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774192:Reporter's case(Master case); Reported Cause(s) of Death: she received a booster and died at 39
Age: 35.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Swollen axillary lymph nodes,with the one in the arm /Lymph node is palpable in arm pit; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen axillary lymph nodes,with the one in the arm /Lymph node is palpable in arm pit) in a 35-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concomitant products included ESCITALOPRAM and CETIRIZINE for an unknown indication.   On 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen axillary lymph nodes,with the one in the arm /Lymph node is palpable in arm pit). At the time of the report, LYMPHADENOPATHY (Swollen axillary lymph nodes,with the one in the arm /Lymph node is palpable in arm pit) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter considered LYMPHADENOPATHY (Swollen axillary lymph nodes,with the one in the arm /Lymph node is palpable in arm pit) to be related.    Patient reported that she did not connect swollen axillary lymph nodes with vaccine, but had it checked at a doctor appointment on the day of reporting, and they made this connection based on recent guidance. On an unknown date patient had Ibuprofen the week after for menstrual cramps 400-600 mg every 5 hours and Apri (birth control). The patient had no medical history, concomitant disease or risk factor. No treatment medication reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: full body rash/itching from the rash; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (full body rash/itching from the rash) in an 80-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080750) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Booster Dose) on 28-Oct-2022; for COVID-19 prophylaxis: Spikevax on 18-Oct-2023. Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 Vaccine and Spikevax. Concurrent medical conditions included Cholesterol and Diabetes.    On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 27-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced RASH PRURITIC (full body rash/itching from the rash). At the time of the report, RASH PRURITIC (full body rash/itching from the rash) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any vaccines 4 weeks prior to this vaccine at the pharmacy. No known allergies were reported for the patient. Patient received the Spikevax 2023-2024 formula on 18-OCT-2023 and patient does not recall a reaction to that vaccine.  The patient was taking cholesterol medicine, blood pressure medicine and diabetes medicine. It was reported that patient started a rash 3 days after receiving it. It turned into a full body rash. He still had some rash on the day of reporting. Patient did not change any laundry detergents or anything that sometimes they saw a full body rash. The patient said the only thing different medicinally wise was some cough medicine which had dextromethorphan. It was reported that patient did not had shortness of breath, just an intense amount of itching from the rash. Rash started 3 days after the vaccine so approximately 27-SEP-2024. The rash has improved since then, the itching and stuff has gotten better. The patient lifted his shirt, and it was still all over his belly. The patient mentioned his chest, his arms, his groin area. HCP confirmed it was not resolved, but it was improving. The treatment medication was not reported by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; soreness at injection site; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (soreness at injection site) in a 51-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.  On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Oct-2024, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (soreness at injection site) had not resolved.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient did not experience any additional symptoms/events.  The patient had concomitant disease or risk factor. There were no lab data/results available.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.
Sex: F
Vaccine: FLUX, PNC20
Symptoms: Dizziness, Extra dose administered, Injection site pruritus, Myalgia
Clinical narrative: Muscle fatigue; Dizziness/lightheadedness; Experienced itching in left arm, where it was admisntered; Muscle pain; 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), on 19Sep2024 as dose 2, single (Batch/Lot number: unknown), in left arm for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 19Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: prevnar 20 (DOSE 1, SINGLE, at doctor office), administration date: 28Dec2022, for Immunization; Prevnar 13 (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Pneumovax (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2018, for Immunization; Rsv (DOSE NUMBER UNKNOWN, SINGLE), for Immunization. The following information was reported: DIZZINESS (non-serious) with onset Sep2024, outcome "unknown", described as "Dizziness/lightheadedness"; VACCINATION SITE PRURITUS (non-serious) with onset Sep2024, outcome "unknown", described as "Experienced itching in left arm, where it was admisntered"; MUSCLE FATIGUE (non-serious) with onset Sep2024, outcome "unknown"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "Muscle pain".  Additional information: Connected with the patient who stated that she had received a second dose of the Prevnar 20 vaccine, and she wanted to know if there were any long-term consequences to that or if she could just forget about it? Her HCP had told her that she does not need any more pneumonia vaccines. On 19Sep2024, she stated she went to the pharmacy for her flu shot and then didn't even know she received the Prevnar 20 in addition to the flu shot until after it had already been administered. She relayed that she was caught up on the RSV vaccine, received Prevnar 13, Pneumovax in 2018, and Prevnar 20 in 2022. The patient asked if she could get the covid 19 shot now. The patient stated physician said not to get anymore vaccines. However, pharmacist advised her that, it was time for her to be administered another Prevnar 20, pneumococcal vaccine. The patient received Prevnar 20 and flu shot together and also, that she had experienced dizziness, lightheadedness, muscle fatigue and, itching in left arm, where it was administered. The patient went to Privacy, to get flu shot, was advised, she needed another one since, the Pneumovax was given in 2018 and, those are every 5 years. Agreed to that, told them she had had Prevnar 13 and Prevnar 20 and RSV. Was told she needed another pneumonia vaccine. They did not know she was given second dose Prevnar 20. The patient stated, she did not get itching, never had itching before. Did not know if from the flu vaccine with the Prevnar 20, hard to tell. That was why she did not get Covid vaccine at the same time, usually does.  Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: sore arm; diarrhea; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 76-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Sep2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE], start date: 2010 (ongoing); CELEXA [CELECOXIB], start date: 2010 (ongoing). The patient also took other concomitant therapy. The following information was reported: DIARRHOEA (non-serious) with onset 30Sep2024, outcome "recovered" (2024), described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2024, outcome "recovered" (2024), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, diarrhoea. Additional information: the sore arm began about an hour later and it was sore and then another hour later it was not sore at all and is not sore now and it was her left arm. The diarrhea began about noon on 30Sep2024 and it is not ongoing and was just the one time.Concomitant medications: medication patient took daily so before the shot there would have been a thyroid medication she took, Protonix, Celexa, and a vitamin and she began taking the thyroid medication in 1979 and the rest of the medications she began taking about in 2010.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea, Night sweats
Clinical narrative: Diarrhea 4 times within 30 minutes; abdominal cramps; nausea; Night sweats; This is a spontaneous report received from a Nurse.  A 60-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Sep2024 at 13:15 as dose 1, single (Lot number: LM2211) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "provoked DVT" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 13Sep2024 as dose number unknown, single. The following information was reported: NIGHT SWEATS (non-serious) with onset 30Sep2024, outcome "unknown"; DIARRHOEA (non-serious) with onset 01Oct2024 at 06:00, outcome "unknown", described as "Diarrhea 4 times within 30 minutes"; ABDOMINAL PAIN (non-serious) with onset 01Oct2024 at 06:00, outcome "unknown", described as "abdominal cramps"; NAUSEA (non-serious) with onset 01Oct2024 at 06:00, outcome "unknown". Therapeutic measures were not taken as a result of diarrhoea, abdominal pain, nausea, night sweats.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: illness; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in May2024 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 (life threatening), outcome "unknown". It was unknown if therapeutic measures were taken as a result of illness. Additional information: Life threatening illness (immediate risk of death from the event)  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Micturition disorder, Tremor
Clinical narrative: Knocked OUT; Flu; Shaking; Fast Urination; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: MICTURITION DISORDER (non-serious) with onset 2024, outcome "unknown", described as "Fast Urination"; INFLUENZA (non-serious) with onset 2024, outcome "unknown", described as "Flu"; FATIGUE (non-serious) with onset 2024, outcome "unknown", described as "Knocked OUT"; TREMOR (non-serious) with onset 2024, outcome "unknown", described as "Shaking".  Additional information: The reporter informed that her mother who received COVID-19 vaccine got very sick (flu, shaking, fast urination, and knocked out).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, White coat hypertension
Clinical narrative: Blood pressure was 160 over 90; White coat syndrome; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; estrogens conjugated (PREMARIN), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure was 160 over 90"; WHITE COAT HYPERTENSION (non-serious), outcome "unknown", described as "White coat syndrome". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for estrogens conjugated was unknown. Additional information: phone call was received regarding a refill for estrogens conjugated (PREMARIN) cream. The patient came from the doctor's office and they (doctor's office) said that the patient can get the Pfizer shot. The patient thought that that was the one that s/he wanted because there was no, very little side effects from it. The patient also stated "It was no wonder my blood pressure was 160 over 90...Well, I take it at home and everything and I kept a log of it, and I showed it to him." The patient said that it was either the white coat syndrome or all the things that the patient had been put up through.  The information on the batch/lot number for BNT162b2 omicron (kp.2), estrogens conjugated will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthropod bite, Pruritus, Urticaria
Clinical narrative: he has noticed that if he gets bitten by a bug, the bug bites are more reactive; the bug bites are now itchy and leaving welts on his skin; the bug bites are now itchy and leaving welts on his skin; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single); inclisiran sodium (LEQVIO). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPOD BITE (non-serious), outcome "unknown", described as "he has noticed that if he gets bitten by a bug, the bug bites are more reactive"; PRURITUS (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "the bug bites are now itchy and leaving welts on his skin". The action taken for inclisiran sodium was unknown.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Paralysis
Clinical narrative: He got ALS; he is paralyzed and close to dying; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 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. Vaccination history included: Bnt162b2 (Caller got vaccinated back in 2021 with a double vaccine), administration date: 2021, for COVID-19 immunization. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (life threatening), outcome "unknown", described as "He got ALS"; PARALYSIS (life threatening), outcome "unknown", described as "he is paralyzed and close to dying".  Clinical course: Caller got vaccinated back in 2021 with a double vaccine. After he got the second vaccine. He got ALS and now he is paralyzed and close to dying. He said that he doesn't want to die. He is asking if Pfizer has an anti vaccine - a vaccine that counteracts the covid vaccine reverse. Submitted AE because the caller said when he got his Pfizer vaccine for second dose he got ALS and now he is completely paralyzed and close to dying  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I had lost all the hair on my body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 09Oct2021 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset Dec2021, outcome "unknown", described as "I had lost all the hair on my body".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave an expired FLUZONE HD QIV (with no reported adverse event); Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 78 years old female patient who was administered with an expired Influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2024, the patient received 0.7 ml of expired Influenza quadrival A-B high dose HV vaccine (formulation, strength- high dose, lot U28104BA and expiry date- 30-Jun-2024) via intramuscular route in the left deltoid for influenza with no reported adverse event (expired product administered) (latency- same day).  Reportedly, the nurse was asking how soon can the nurse give the correct vaccine shot.   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: RAB
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: felt like she had an allergic reaction; got dizzy; Initial information received on 19-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to 2024SA285980 and 2024SA285966 (Cluster cases).  This case involves an unknown age female patient who experienced felt like she had an allergic reaction and got dizzy after receiving Rabies (HDC) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Sep-2024, the patient received a unknown (dose 1) dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization. On 16-Sep-2024 she also received a 1 ml (dose 2) dose of same vaccine (frequency: once, strength: standard, expiry date: 31-Oct-2025 and lot number: W1C931M via intramuscular route in the arm NOS as immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 09-Sep-2024 the patient developed allergic reaction (hypersensitivity) and got dizzy (dizziness) (same day latency).  Action taken: not applicable.  The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Dizziness.  At time of reporting, the outcome was Unknown for both events.
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: fever; Initial information received on 19-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases- US-SA-2024SA285980 and US-SA-2024SA286193  This case involves an unknown age female patient who had fever after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Sep-2024, the patient received dose 1 RABIES (HDC) VACCINE Powder and solvent for suspension for injection for Immunization (strength, dose, batch and expiry unknown). On 16-Sep-2024 the patient received dose2 of same vaccine 1 ml (twice) Powder and solvent for suspension for injection lot W1C931M  expiry-31-Oct-2025 via intramuscular route in unknown administration site. (strength unknown)   On an unknown date in 2024 the patient had fever (pyrexia) (unknown latency).  Reportedly, Nurse vaccinated 18 students.She reported one had a fever but all the rest were fine.The nurse told them that most likely it was the 2nd dose. The nurse mentioned the patient could have taken Tylenol but she isn't sure  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (fever).  At time of reporting, the outcome was Unknown for the event; Sender's Comments:  US-SA-2024SA285980:
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD TIV injected to pregnant women (with no reported adverse event); Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age female patient who was exposed to Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] in context of fluzone hd tiv injected to pregnant women (with no reported adverse event). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On an unknown date, the pregnant female patient received a unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization (exposure during pregnancy) (same day latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Off label use, Product preparation issue
Clinical narrative: Reconstitute the vaccine using only the diluent supplied (0.6 mL single dose vial of Sodium Chloride Injection USP for single dose vial of vaccine, with no reported adverse event; Initial information received on 20-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had reconstitute the Yellow Fever Vaccine -  [YF-VAX] using only the diluent supplied (0.6 ml single dose vial of sodium chloride injection usp for single dose vial of vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Yellow Fever Vaccine -  (Solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and reconstitute the vaccine using only the diluent supplied (0.6 ml single dose vial of sodium chloride injection usp for single dose vial of vaccine, with no reported adverse event (off label use) (unknown latency). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Breath sounds abnormal, Depressed level of consciousness, Dizziness, Dyskinesia, Dysphonia
Clinical narrative: Tunnel vision; She was unconscious and semi conscious no control of her body; Two min after the injection she started feeling dizziness; Her body was super cold within 5; She was shaking; She was making harsh voice; She was breathing like she was snoring but awake. Head tilted backwards; This spontaneous case, initially received on 24-Sep-2024, was reported by a health professional and concerns an adult female patient.  Medical History: On 14-Sep-2022 she had mild dizziness with the same vaccine (Flucelvax Quadrivalent, lot number 942389), so it looks like it was progressing. Last year when she took the same vaccine (Flucelvax Quadrivalent on 17-Sep-2023 lot number 944447, she had dizziness but not this violent, she was not unconscious, lightheaded.  Concomitant Medications: no other medications.  Administration of company suspect drug(s): On 22-Sep-2024, the patient received Flucelvax (TIV) for influenza immunization, Dose regimen: 0.5 ml, route of administration Not reported, Lot number: 946583. The reported lot number not matched with company batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Sep-2024, the patient experienced tunnel vision (Medically Significant, outcome: Recovered / Resolved), she was unconscious and semi conscious no control of her body (Medically Significant, outcome: Recovered / Resolved), two min after the injection she started feeling dizziness (outcome: Recovered / Resolved), her body was super cold within 5 (outcome: Recovered / Resolved), She was shaking (outcome: Recovered / Resolved), she was making harsh voice (outcome: Recovered / Resolved), she was breathing like she was snoring but awake. Head tilted backwards (outcome: Recovered / Resolved). They called the ambulance.  Flucelvax (TIV) action taken: Not Applicable.  Treatment measures associated with event: Ambulance was called and came, they checked her vitals.  Reporter assessment: The reporter considered events two min after the injection she started feeling dizziness, tunnel vision, she was unconscious and semi conscious, no control of her body, her body was super cold within 5 min, she was shaking, she was making harsh voice, she was breathing like she was snoring but awake. Head tilted backwards as non-serious and causality was not reported.; Reporter's Comments: Causality: Unassessable for tunnel vision and Loss of consciousness.The information provided is insufficient to perform a more in-depth analysis (exact duration and time for recovery, treatment details, medical history and final diagnosis not provided). Related for rest of the events due to close temporal relationship (within 2 min and 5 min after vaccine administration). of note, medical history of mild dizziness after previous vaccination considered as risk factor.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Loss of consciousness, Posture abnormal, Tremor, Tunnel vision
Clinical narrative: Tunnel vision; She was unconscious and semi conscious no control of her body; Two min after the injection she started feeling dizziness; Her body was super cold within 5; She was shaking; She was making harsh voice; She was breathing like she was snoring but awake. Head tilted backwards; This spontaneous case, initially received on 24-Sep-2024, was reported by a health professional and concerns an adult female patient.  Medical History: On 14-Sep-2022 she had mild dizziness with the same vaccine (Flucelvax Quadrivalent, lot number 942389), so it looks like it was progressing. Last year when she took the same vaccine (Flucelvax Quadrivalent on 17-Sep-2023 lot number 944447, she had dizziness but not this violent, she was not unconscious, lightheaded.  Concomitant Medications: no other medications.  Administration of company suspect drug(s): On 22-Sep-2024, the patient received Flucelvax (TIV) for influenza immunization, Dose regimen: 0.5 ml, route of administration Not reported, Lot number: 946583. The reported lot number not matched with company batch list.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Sep-2024, the patient experienced tunnel vision (Medically Significant, outcome: Recovered / Resolved), she was unconscious and semi conscious no control of her body (Medically Significant, outcome: Recovered / Resolved), two min after the injection she started feeling dizziness (outcome: Recovered / Resolved), her body was super cold within 5 (outcome: Recovered / Resolved), She was shaking (outcome: Recovered / Resolved), she was making harsh voice (outcome: Recovered / Resolved), she was breathing like she was snoring but awake. Head tilted backwards (outcome: Recovered / Resolved). They called the ambulance.  Flucelvax (TIV) action taken: Not Applicable.  Treatment measures associated with event: Ambulance was called and came, they checked her vitals.  Reporter assessment: The reporter considered events two min after the injection she started feeling dizziness, tunnel vision, she was unconscious and semi conscious, no control of her body, her body was super cold within 5 min, she was shaking, she was making harsh voice, she was breathing like she was snoring but awake. Head tilted backwards as non-serious and causality was not reported.; Reporter's Comments: Causality: Unassessable for tunnel vision and Loss of consciousness.The information provided is insufficient to perform a more in-depth analysis (exact duration and time for recovery, treatment details, medical history and final diagnosis not provided). Related for rest of the events due to close temporal relationship (within 2 min and 5 min after vaccine administration). of note, medical history of mild dizziness after previous vaccination considered as risk factor.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: chills; body aches; injection site pain; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Sep2024 at 14:00 as dose 1, single (Lot number: Im2221) at the age of 39 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic bronchitis" (unspecified if ongoing). Concomitant medication(s) included: NUVARING; EMERGEN C; INFLUENZA VACCINE taken for immunisation, on 17Sep2024; CENTRUM WOMEN. Past drug history included: Percocet, reaction(s): "Allergy". Vaccination history included: comirnaty (2023-2024 formula) (dose 1 (TOPPAC); single, Lot number: HG4680, intramuscular, in right arm), administration date: 23Sep2023, when the patient was 38-year-old, for covid-19 immunization, reaction(s): "Chills", "headache", "body aches in the lower back, spine, and shoulders", "body aches in the lower back, spine, and shoulders", "body aches in the lower back, spine, and shoulders", "debilitating pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2024 at 02:00, outcome "recovered" (30Sep2024 at 17:00), described as "injection site pain"; PAIN (non-serious) with onset 29Sep2024 at 05:00, outcome "recovered" (30Sep2024), described as "body aches"; CHILLS (non-serious) with onset 29Sep2024 at 09:00, outcome "recovered" (29Sep2024 at 12:00). Therapeutic measures were not taken as a result of vaccination site pain, pain, chills. Additional information:  the patient was taking the Elderberry EMERGEN C. The patient did not receive any other vaccines on the same date as BNT162b2 omicron (kp.2). At 2am, 12 hours woke up with injection site pain, lasted 39 hours, stopped around 5pm on 30Sep2024. At 5am, 15 hours body aches started, lasted at least 17 hours, stopped during overnight sleep. At 9am, 19 hours chills started, lasted 3 hours until 12pm on 29Sep2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310753 same patient, different dose/event;
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: patient called friday 10-4 stating that she had a painful, red, warm arm after receiving 2 vaccines on 9-30. there is also streaking down her arm and it is spreading significantly.  i was unable to ascertain the level of her injury over the phone, she said she would present to the pharmacy later this afternoon but i did not see her.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, Influenza like illness
Clinical narrative: mild flu like symptoms after repeated flu shot in one year
Age: 87.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: fever, left arm and leg weakness,
Age: 77.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood glucose decreased, Loss of consciousness
Clinical narrative: Patient pass out after 5 minutes of getting vaccine but patient is diabetic and was suspecting got it due to low blood sugar level
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient is 11 years old and was given the 12 and older vaccine. he did not experience any adverse effect from this
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Erythema, Rash, Urticaria
Clinical narrative: Patient was working in the Pharmacy on 10/1/2024 & walked to Occupational Health and received Covid vaccine around 2:30pm. I walked back to the pharmacy and continued working. Around 3:15pm my ears turned red and were on fire, then my face turned red and I was huffing and puffing, having difficulty breathing. At that point I took Benadryl 50mg and Pepcid 20mg and the symptoms continued so my co-workers called the Response team. They administered an epi-pen after evaluating me. Then then took me to the Emergency Room for further monitoring. I was there for about 2 hours and symptoms resolved. They gave me Dexamethasone 8mg and took vitals one more time and discharged me around 6:30pm. |  |Anaphylaxis response- red burning ears, red face, huffing/puffing- trouble breathing, rash and hives.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: vomiting, mild abdominal pain; treated with anti-emetic; started about 5-6 hours after vaccination, improving at time of evaluation about 36h
Age: 26.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Disorientation, Dizziness, Pallor, Syncope
Clinical narrative: After the second vaccine was provided, the patient became clammy, light-headed, and pale. The patient had fainted and became disoriented. We was monitored during the time and 911 was called. His parents were contacted by his friend that was with him. He slowly recovered and was monitored, offered a cold towel, and water. He improved and returned home with his mother driving.  We recommended that the patient sees his primary care physician.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, FLU3
Symptoms: Wrong product administered
Clinical narrative: This writer was helping another nurse administer vaccines for this patient. The provider had ordered COVID-19 Tris-Sucrose Formulation (Pfizer 12+ years) and Flu High-Dose Trivalent (Fluzone) to be given to patient. The other nurse had pulled the vaccines from the Omnicell and this writer did not correctly verify the correct vaccines were pulled. This writer administered the ordered Flu High-Dose Trivalent (Fluzone) and instead the incorrect correct order of Flu Adult Trivalent (Fluarix). The patient then left the outpatient clinic and went to Pharmacy to pick up her medication. This writer immediately recognized her mistake, informed the provider, and called the patient. The patient returned to clinic, was informed of vaccine administration error and was administered the COVID vaccine that was also ordered. The patient denied any signs/symptoms/adverse effects when she returned for the COVID vaccine. Patient left the outpatient clinic in stable condition.
Age: 17.0
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted.  Patient lowered to ground and elevated feet.  Patient woke up later and was feeling better.  Drank 2 cups of water and walked out of clinic with school nurse.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: Thirty seconds after receiving COVID vaccine fainted briefly for about 10 seconds.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Sent my blood sugar level over 500
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: The patient developed a large red swollen rash at the injection site. She came back to pharmacy on 10/4/24 at approx. 3pm and showed the Pharmacist on duty. The Pharmacist, advised the patient to go to Urgent Care.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Erythema, Inappropriate schedule of product administration, Rash, Swelling
Clinical narrative: Patient was scheduled for travel vaccines. Patient had 2 appointments for 2 separate vaccines. (Japanese Encephalitis and MMR Dose #2).  The first appointment on 9/25/2024 was scheduled to be for just the Japanese Encephalitis vaccine and the 2nd appointment on 10/03/2024 was for the MMR vaccine. Orders were clearly written that MMR vaccine was to be given on the 10/03/2024 appointment date due to patient already having received the 1st dose on 9/04/2024.  Nurse did not read instructions/orders and gave the MMR vaccine too early. Per mother, as written in an email to pediatrician, patient experienced "elevated body temperature, some rash and some red swelling on her back."
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Colonoscopy, Erythema, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Patient got vaccine 9/30 at around 4pm, says the next day 10/1 she had a fever, body aches. 10/3 she said it started feeling hot and looked red and raised at least 30-45% of her arm. She had a colonoscopy today and presented to the pharmacy at 6:10pm. I called her primary doctor who did not answer. I showed her some benedryl, tylenol and famotidine. I told her to put cool cloth or ice 10 mins on and 10 mins off.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Patient got vaccine 9/30 at around 4pm, says the next day 10/1 she had a fever, body aches. 10/3 she said it started feeling hot and looked red and raised at least 30-45% of her arm. She had a colonoscopy today and presented to the pharmacy at 6:10pm. I called her primary doctor who did not answer. I showed her some benedryl, tylenol and famotidine. I told her to put cool cloth or ice 10 mins on and 10 mins off.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: hives to body, especially neck, back, and arms
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the second havrix dose after 3 months instead of 6 months.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the second vaccine after 3 month instead of the required 6 months.