chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Heart rate, Heart rate increased
Clinical narrative: spike count in blood test still showing over 5000 years later/Spike protein in blood still over 5,000 years later; dealing with resting heart rate of 100 minimum and whenever I stand up. It jumps up to 140 bpm; chest pain/debilitating chest pain; trouble breathing/shortness of breath; bad fatigue/horrible fatigue on top of everything; chronic health issues; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Lot number: FC3181) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLOOD TEST ABNORMAL (medically significant), outcome "not recovered", described as "spike count in blood test still showing over 5000 years later/Spike protein in blood still over 5,000 years later"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "dealing with resting heart rate of 100 minimum and whenever I stand up. It jumps up to 140 bpm"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest pain/debilitating chest pain"; DYSPNOEA (non-serious), outcome "not recovered", described as "trouble breathing/shortness of breath"; FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/horrible fatigue on top of everything"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "chronic health issues". The patient underwent the following laboratory tests and procedures: Blood test: still over 5,000, notes: years later; still showing over 5,000, notes: years later; Heart rate: 100, notes: resting heart rate of 100 minimum; 140, notes: bpm; and whenever I stand up. It jumps up to 140 bpm. Clinical course: Patient did not receive any other vaccines on the same date as the Pfizer vaccine, was not taking any other medications within 2 weeks prior to the event onset and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not allergic to any previous vaccination, medication, food or other products and there were no other diagnosed illnesses/medical history/chronic health conditions to report. Patient was completely healthy prior to the vaccines after taking then he had chronic health issues. Also dealing with resting heart rate of 100 minimum and whenever he stand up. It jumps up to 140 bpm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400262099 same patient/product, different dose/event;US-PFIZER INC-PV202400108765 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Neoplasm malignant
Clinical narrative: immuno-compromised; cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre syndrome" (unspecified if ongoing), notes: had a history of Guillain-Barre syndrome. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immuno-compromised"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Patient wanted to know if the Pfizer covid vaccine 2024-2025 is being manufactured and produced the same as the previous Pfizer covid vaccines or has it changed. Patient said the reason she is asking for this information is because her PCP advised her many years ago not to take any vaccines for flu or RSV or anything because she has history of Guillain-Barre syndrome. Patient said she had never taken those but had taken Covid vaccine. She had taken the first 4 covid shots without incident and she never had covid because of the vaccine. She wanted to make sure that Pfizer manufactured previous covid vaccines the same. Patient said she is immuno-compromised she has cancer. Created manual AE form because caller said she had the first 4 previous Pfizer covid vaccine. Caller also mentioned she is immuno-compromised and had a history of Guillain-Barre syndrome.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: vaccine administered to pregnant patient (with no reported adverse event); Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 33 years old female patient who was exposed to vaccines Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] and Tdap (Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid) in context of vaccine administered to pregnant patient (with no reported adverse event).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine administered to pregnant patient (with no reported adverse event) occurred at 31 weeks of pregnancy and the patient was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine at 31 weeks of pregnancy and to TDAP at 28 weeks of pregnancy, during third pregnancy trimester for Influenza Usp Trival A-B Subvirion No Preservative Vaccine and Tdap.  The date of last menstrual period was reported as 25-Jan-2024. The estimated due date is 31-Oct-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 05-Aug-2024, the pregnant patient received a dose of suspect TDAP not produced by Sanofi Pasteur (, form, strength, lot number, expiry date: not reported) via intramuscular route in unknown administration site and on 28-Aug-2024, the patient received a dose of Suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, with no reported adverse event) (maternal exposure during pregnancy) (latency: same day) (strength: not reported) (lot: UT8423JA, Expiry date: 30-Jun-2025) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: inadvertent administration of the DTaP-IPV component of Pentacel separate from its Hib component with no reported adverse event; Based on additional information received on 04-Sep-2024 case was upgraded from  Non valid (31-Jul-2024) to Valid case.  Initial information received on 31-Jul-2024 regarding an unsolicited valid non-serious case received via Nurse.  This case involves a 4-year-old male patient who had an inadvertent administration of the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] separate from its hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an 15-Jul-2024, the patient had an inadvertent administration of the dtap-ipv component 1 Dosage form (DF) of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength: unknown) (lot: UJ9758A, expiry date: 23-Nov-2024) via unknown route in left vastus lateralis for Immunization separate from its hib component with no reported adverse event (single component of a two-component product administered) (latency: same day).  No adverse effects have been noted with this error.  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.  Additional information was received on 04-Sep-2024: patient demographic updated, onset date of vaccination and event was added, anatomical location of vaccination was added. Text amended.
Age: 1.67
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered to a patient which was not covered by the extended stability data post-excursion with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves Ipv (Vero) [Ipol] which was exposed to temperature excursion/temperature reached: max: 50.2°f for 1 hour & 55 minutes and was adminidtered to a 20 months old male patient, which was not covered by the extended stability data post-excursion, 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Influenza vaccine inact split 3v (Flulaval) for Immunisation.  On 10-Sep-2024, the patient administered with a dose of suspect IPV (VERO), Suspension for injection (strength: not reported), which was exposed to temperature excursion/temperature reached: max: 50.2°f for 1 hour & 55 minutes with no reported adverse event (poor quality product administered) (latency: same day) (lot: W1A191M, Expiry date: not reported) via intramuscular route in the right thigh for immunization.  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.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Eyelid function disorder, Lip blister, Oral mucosal blistering, Pustule
Clinical narrative: had blisters on the corner of his lips and eyelids/blisters on his mouth, stomach, and on his eye to the point that he cannot open his eye.arms; having blisters and pus; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 7 years old male patient who experienced had blisters on the corner of his lips and eyelids/blisters on his mouth, stomach, and on his eye to the point that he cannot open his eye arms and having blisters and pus after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Mar-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- U7928AA and expiry date- 23-NOV-2025) via unknown route in unknown administration site (strength: not provided) for Immunization.  On an unknown date in Mar-2024 the patient had blisters on the corner of his lips and eyelids/blisters on his mouth, stomach, and on his eye to the point that he cannot open his eye arms (blister) and having blisters and pus (pustule) (unknown latency).  Reportedly, the patient experienced adverse reactions such as having blisters and pus. He had blisters on the corner of his lips and eyelids. The next month, he had blisters on his mouth, stomach, and on his eye to the point that he cannot open his eye. Since then, patient went to his doctor every month to get antibiotic prescription. Patient was also given with Prednisone. However, there's a point that the antibiotic was not working anymore so he was given with a higher dosage. Caregiver called since it's getting out of hand. He's having blisters on his hand, arms, mouth, and stomach, and the problem is still on going.  Action taken- not applicable.  The patient was treated with Prednisone for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered, Medication error, Needle issue, No adverse event
Clinical narrative: injected a fourth dose of Daptacel to a patient, some medication spilled out from needle and was not administered/administered a partial dose of Daptacel in left leg with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 19 months old male patient who was injected with a fourth dose of diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel], some medication spilled out from needle and was not administered/administered a partial dose of daptacel in left leg with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2024, the patient received a dose of suspect Suspension for injection diphtheria-15/tetanus/5 ac pertussis vaccine (lot 3CA11C1, expiry date: 31-Dec-2025, dose, strength, route was unknown) in left leg as Immunization and was injected with a fourth dose of daptacel, some medication spilled out from needle and was not administered/administered a partial dose of daptacel in left leg with no reported adverse event (incorrect dose administered) (Latency; same day)   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.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone hd that was given to a patient that was below the age of 65 with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient where Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] that was given to a patient that was below the age of 65 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 0.5 ml dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot- UT8409AB and expiry date- 30-JUN-2025) via unknown route in unknown administration site (strength: not provided) for Immunisation and fluzone hd that was given to a patient that was below the age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  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 and Regulatory Authority 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: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: opened ipol was given to patient post excursion with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient where opened IPV (VERO) [IPOL] was given to patient post excursion 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 IPV (VERO) Suspension for injection (lot- W1C741M and expiry date- 17-NOV-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation and opened ipol was given to patient post excursion with no reported adverse event (poor quality product administered).  Reportedly, Reason: UNKNOWN, Max/low temperature reached: .8C degrees, Duration: 14 1/2 hours, Previous Excursion? NO Human error? UNKNOWN Administered post excursion? Yes  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: UNK
Symptoms: Blood pressure decreased
Clinical narrative: Blood pressure plummeted/ 60 over 48 the highest they could get it was about 72 over 52.; This spontaneous case  initially received on 16-Sep-2024, was reported by a non health professional and concerns an elderly female patient.  Drug history included Neomycin (Reaction: Allergy). At the time of the event the patient had High blood pressure. Concomitant medications: Medications for High blood pressure (not specified)  Administration of company suspect drug: On 16-Sep-2024 09:30, the patient received Fluad (TIV) for Flu immunization, Dose regimen: 0.5 ml, Lot number: No batch number available and will requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 16-Sep-2024 12:30, the patient experienced Blood pressure plummeted/ 60 over 48 the highest they could get it was about 72 over 52. (Medically Significant, outcome: Not recovered / Not resolved).   Event description: The reporter informed that her mom just had an adverse reaction, possibly, to her flu vaccination. She got it around 9:30 this morning, and around 12:30 her blood pressure plummeted to about, the reporter thought they said, 60 over 48, and the highest they could get it was about 72 over 52. In the past, the patient has been told not to take the vaccine that has neomycin in it because she's allergic to it, and the assisted living where she lives said that this did not have neomycin in it.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event Blood pressure plummeted/ 60 over 48 the highest they could get it was about 72 over 52 possibly related to the administration of Fluad (TIV) and considered the event serious.; Reporter's Comments: Causality: Related considering close temporal association with administration of product (3 hours after vaccine administration).
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Altered state of consciousness, Hypotonia, Pallor, Presyncope
Clinical narrative: pt also got a spikvax vaccine lot 8040748 at the same time. pt rec'ved  vaccines and another pt noticed he looked pale and was leaning. Tech called rph over we called 911 and gave oj. wife was there. he was kinda of in and out - closing his eyes and such. emt arrived and took him to er/hospital where he was checked out. called wife later and she said er/hospital said he had a vasovagal response after the vaccination.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: Patient started with back and hip pain after getting the vaccine.  Patient wasn't sure if this pain was a result of receiving the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Hearing a background hum, like a clothes dryer is running in the background. I already have Tinitis, and this is a lower pitch sound, and not isolated to an ear.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash appeared underneath armpits of both arms.  It traveled to stomach, to the back & onto my upper legs.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years old patient received 12+ covid Pfizer vaccine, there was no side effect at that moment
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: AE:  Hives.  Treatment:  Zyrtec, Famotidine & Prednisone.  Outcome:  resolved
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Patient complained of Migraines
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Skin warm, Temperature intolerance, Trigeminal neuralgia
Clinical narrative: Patient received NOVAVAX on 9/12/24 and waited in the pharmacy for 15 minutes, no adverse reaction. Patient went home and starting having trigeminal neuralgia flared up started 9/21/24 for about 3 - 4 days then subsided. The left arm (injection arm) starting experiencing an increased sensitivity to heat on the left arm started on Saturday 9/21/24 . Patient wen to the doctor and reported that is not critical but annoying. feels like very warm heat is on the left arm. Patient then came to the Pharmacy on 9/25/24 to report to the Pharmacist.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a Pfizer Covid 12yr + vaccine when the child was 9. Supposed to give Covid 5-11 yr vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient came in requesting flu shot, marked flu shot on vaccine intake form, and verbally confirmed flu shot right before we typed and prepared vaccine.  Vaccine was processed through insurance and was accepted at $0 copay.  Technician went out to give vaccine verified name, DOB, and vaccine being given, she confirmed.  Once technician injected the patient freaked out and said "did you say flu? I had my flu shot at pharmacy 2 days ago, I said COVID! I wanted covid!" We counseled on possible side effects and she left. Unsure of outcome as this just happened today.
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient received IMZ's and then shopped for approximately 1 hour. She then became lightheaded and needed to sit. After sitting she broke a sweat and then began to feel better. After sitting for a bit she then left to go eat.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: Medical Assistant gave patient shot in upper thigh and parent was holding patient's hands. Patients hand slipped out and almost grabbed syringe, medical assistant withdrew needle immediately and vaccine spilled out of patient's leg and patient did not receive full dose, vaccine squirted out as medical assistant withdrew needle.
Age: 32.0
Sex: F
Vaccine: FLU3, HEPA, IPV, MMR, TYP, VARCEL
Symptoms: Amnesia, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Muscle contractions involuntary
Clinical narrative: As i completed the six shot (Varivax), patient stated that she got nauseous and light headed and told me to stop. as i was watching her her hands stiffed up and she started seizing. the seizure lasted probably about 1 minute and she excessively started sweating and she coming back to normal self. patient does not have any recollection of what had happened to her.
Age: 32.0
Sex: F
Vaccine: FLU3, HEPA, IPV, MMR, TYP, VARCEL
Symptoms: Nausea, Seizure
Clinical narrative: As i completed the six shot (Varivax), patient stated that she got nauseous and light headed and told me to stop. as i was watching her her hands stiffed up and she started seizing. the seizure lasted probably about 1 minute and she excessively started sweating and she coming back to normal self. patient does not have any recollection of what had happened to her.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pain
Clinical narrative: Felt faint and body aches approximately 2 hours and 30 minutes after flu vaccination.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Patient was given Td vaccine intradermally instead of a TB skin placement. Patient has been notified of the error.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue
Clinical narrative: She also got a COVID-19 (Comirnaty lot: LM2222, left deltoid ) on the same day. she felt tired for 2 days. Then, she started having a shortness of breath. The ambulance came on 9/22, but she refused to go to ER. She finally saw her MD on 9/24 and currently taking antibiotic, steroid and nebulizer solution.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: At about 4:16 PM, patient was given 2 vaccines and  became immediately dizzy, faint, and nauseous after administration of both vaccines.  She remained seated, was given a plastic bag and  water to sip.  She remained seated and rested her head on her partner's shoulder   after having her head down between her legs for approximately 2 minutes.  Her breathing appeared  normal.  She was wearing a Dexcom CGM and blood sugar recorded was 176 mg/dL.  She remained seated until 4:30 PM and stated she felt better.  At this time, she and her partner felt fine to return home.   Pt was escorted outside the store and able to return to vehicle.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tinnitus
Clinical narrative: Tinnitus, began within an hour after vaccine administered. Continuous for 2 hours. Still has not gone away.
Age: 35.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient states that she has visibly swollen very painful lymph nodes in her left underarm area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Taste disorder
Clinical narrative: Patient presented to the pharmacy for her second shingles vaccine. About 30 seconds after receiving the vaccine, she reported having difficulty, unusual change in taste, and chest/back pain. EMS was contacted and patient was taken to the ER.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Spikevax administered 9/22/24. Pt stated symptoms of fever, headache, swollen arm, rash on the arm, area warm to the touch, redness. Pt was referred to be evaluated by provider when she called pharmacy on 9/25/24
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Skin warm
Clinical narrative: Spikevax administered 9/22/24. Pt stated symptoms of fever, headache, swollen arm, rash on the arm, area warm to the touch, redness. Pt was referred to be evaluated by provider when she called pharmacy on 9/25/24
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was accidentally given a second prevnar 20 vaccine rather than influenza vaccine requested.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient had already received Arexvy (rsv) 6/2023 so this was a second dose
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Paralysis
Clinical narrative: Wife reported to pharmacy today that patient had a reaction (symptoms of paralysis) about 8 hours after getting the vaccines.  She states he was taken to hospital by ambulance and admitted.  He was discharged after 3 days, and currently getting rehab treatment at home. He will be having a follow up visit with his neurologist.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: pt states the injection site became very red, warm to the touch, and hard (firm). The redness expanded to approx. 3.5 inches in diameter. Pt went to urgent care 9/25/24 and was told the site of injection was infected and that the dr would send in an antibiotic. Pt is to start abx 9/25/24 and monitor for symptom improvement.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PATIENT REPORTED PAIN IN HER SHOULDER
Age: 1.83
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Macular rash on back, chest, and abdomen, with transient fever to 102, noted beginning 7 days after vaccination.  Symptoms reported as resolving with supportive care over subsequent 4 days.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDNESS on injection site/ erythema-- not spreading ; still hot-tender to touch/ not spreading since date of administration
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paraesthesia, Product administered at inappropriate site
Clinical narrative: I received a flu shot today at Pharmacy and I have concerns regarding its administration.   Upon returning home, I observed that the shot was administered quite low in my bicep rather than in the deltoid muscle. I believe this may not have been administered correctly and have concerns about effectiveness and pain I have been experiencing. After arriving home, about twenty minutes following injection had pain in my lower arm when bent and tingly intermittently in hand.   Could you please provide guidance on whether I need to have the shot readministered? I was unclear how to also report this as I couldn?t find place on pharmacy website. I am an RN and recall previously using this site to report adverse reactions or administration errors during Covid vaccine administrations.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: I received a flu shot today at Pharmacy and I have concerns regarding its administration.   Upon returning home, I observed that the shot was administered quite low in my bicep rather than in the deltoid muscle. I believe this may not have been administered correctly and have concerns about effectiveness and pain I have been experiencing. After arriving home, about twenty minutes following injection had pain in my lower arm when bent and tingly intermittently in hand.   Could you please provide guidance on whether I need to have the shot readministered? I was unclear how to also report this as I couldn?t find place on pharmacy website. I am an RN and recall previously using this site to report adverse reactions or administration errors during Covid vaccine administrations.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Gingival erythema, Hypersensitivity, Oral mucosal eruption, Taste disorder
Clinical narrative: Rash in mouth, red gums, sensitivity to  spicy foods, taste affected.  Started about 12 hours after vaccines. Improving some each day.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: burning sensation at the left arm 5 days I think gabapentin will help No weakness, No signs of gillian barre
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Pharyngeal paraesthesia, Pruritus
Clinical narrative: patient was seen on 9/20/24 for Flu, COVID, SHINRIX vaccines. After 5 min. of vaccines patient well and experiencing tingling in the back of her throat. Dr. was called, patient started getting itchiness all over her body. Dr asked for nurse to administer shot of EPIPEN on (L) leg. 911 was called at 1453. They evaluated patient
Age: 2.25
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Cardiac pacemaker insertion, Weight increased
Clinical narrative: Weight gain (water) 3 month - heart failure Pacemaker - 3 yrs of in and out of hospitals Considered disabled by social security
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Asthenia, Dysphagia, Dyspnoea, Injection site bruising, Syncope
Clinical narrative: Husband received flu and Covid vaccine at local pharmacy. He became light headed and nauseous. The pharmacist administering the shot reported that my husband said he felt a nerve had been hit and felt a zing down to his fingers. When I came around, my husband had his head between his knees, said he didn't feel great. Within a second or two, his body started to droop, all muscles went slack. The pharmacist said he felt his body go stiff before he and I pulled my husband out of the chair and onto the floor. My husband passed out for about 20 seconds. The pharmacist attempted chest compressions, when my husband woke up asking where he was. Paramedics arrived and reported normal vitals and blood sugar. Urged us to take him to the hospital for a workup but we declined. I took him home where he promptly went to sleep
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Throat tightness, Unresponsive to stimuli
Clinical narrative: Husband received flu and Covid vaccine at local pharmacy. He became light headed and nauseous. The pharmacist administering the shot reported that my husband said he felt a nerve had been hit and felt a zing down to his fingers. When I came around, my husband had his head between his knees, said he didn't feel great. Within a second or two, his body started to droop, all muscles went slack. The pharmacist said he felt his body go stiff before he and I pulled my husband out of the chair and onto the floor. My husband passed out for about 20 seconds. The pharmacist attempted chest compressions, when my husband woke up asking where he was. Paramedics arrived and reported normal vitals and blood sugar. Urged us to take him to the hospital for a workup but we declined. I took him home where he promptly went to sleep
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Dizziness, Loss of consciousness, Musculoskeletal stiffness, Nausea, Nerve injury
Clinical narrative: Husband received flu and Covid vaccine at local pharmacy. He became light headed and nauseous. The pharmacist administering the shot reported that my husband said he felt a nerve had been hit and felt a zing down to his fingers. When I came around, my husband had his head between his knees, said he didn't feel great. Within a second or two, his body started to droop, all muscles went slack. The pharmacist said he felt his body go stiff before he and I pulled my husband out of the chair and onto the floor. My husband passed out for about 20 seconds. The pharmacist attempted chest compressions, when my husband woke up asking where he was. Paramedics arrived and reported normal vitals and blood sugar. Urged us to take him to the hospital for a workup but we declined. I took him home where he promptly went to sleep
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Neuralgia, Posture abnormal
Clinical narrative: Husband received flu and Covid vaccine at local pharmacy. He became light headed and nauseous. The pharmacist administering the shot reported that my husband said he felt a nerve had been hit and felt a zing down to his fingers. When I came around, my husband had his head between his knees, said he didn't feel great. Within a second or two, his body started to droop, all muscles went slack. The pharmacist said he felt his body go stiff before he and I pulled my husband out of the chair and onto the floor. My husband passed out for about 20 seconds. The pharmacist attempted chest compressions, when my husband woke up asking where he was. Paramedics arrived and reported normal vitals and blood sugar. Urged us to take him to the hospital for a workup but we declined. I took him home where he promptly went to sleep
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Cheilitis, Computerised tomogram, Limb mass, Lipase increased
Clinical narrative: she has little red spots on her lip and on her face.; she developed a lump underneath her leg and her leg was very itchy; her leg was very itchy/that itchiness has moved up to her face; serious back pain; lipase was elevated; red blood cell count was low; This spontaneous report has been received by a consumer, regarding herself, a 46-year-old non-pregnant female patient. The patient's medical history was not provided. The patient's concurrent conditions/allergies included sensitivity to latex gloves. The patient's concomitant medications included trazodone and desvenlafaxine (PRESTIQ).   On 09-SEP-2024, the patient was vaccinated with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, dose of .05 mL, intramuscularly administrated (strength, frequency, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a measles, mumps prophylaxis.    On unspecified date reported as recently, a computerized tomography (CT) scan was done (results not provided). On 12-SEP-2024, the patient experienced serious back pain to the point in which she sought medical attention and went to the emergency department. On unspecified date in September 2024 at the emergency department, the physician informed her that her lipase was elevated (lipase increased) and her red blood cell count was low. On 18-SEP-2024, she developed a lump underneath her leg (limb mass) and her leg was very itchy. However, the patient reported that there was no rash there, just felt very itchy (pruritus). On 19-SEP-2024, that itchiness had moved up to her face, and she had little red spots on her lip and on her face (rash macular). No other symptoms were reported by the patient. No treatment was given for the events. At the reporting time, the patient had not recovered from the reported events.   The action taken regarding suspect vaccine with the events was considered as not applicable.   The causal relationship between suspect vaccine with the events was not reported.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash erythematous, Red blood cell count decreased
Clinical narrative: she has little red spots on her lip and on her face.; she developed a lump underneath her leg and her leg was very itchy; her leg was very itchy/that itchiness has moved up to her face; serious back pain; lipase was elevated; red blood cell count was low; This spontaneous report has been received by a consumer, regarding herself, a 46-year-old non-pregnant female patient. The patient's medical history was not provided. The patient's concurrent conditions/allergies included sensitivity to latex gloves. The patient's concomitant medications included trazodone and desvenlafaxine (PRESTIQ).   On 09-SEP-2024, the patient was vaccinated with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, dose of .05 mL, intramuscularly administrated (strength, frequency, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a measles, mumps prophylaxis.    On unspecified date reported as recently, a computerized tomography (CT) scan was done (results not provided). On 12-SEP-2024, the patient experienced serious back pain to the point in which she sought medical attention and went to the emergency department. On unspecified date in September 2024 at the emergency department, the physician informed her that her lipase was elevated (lipase increased) and her red blood cell count was low. On 18-SEP-2024, she developed a lump underneath her leg (limb mass) and her leg was very itchy. However, the patient reported that there was no rash there, just felt very itchy (pruritus). On 19-SEP-2024, that itchiness had moved up to her face, and she had little red spots on her lip and on her face (rash macular). No other symptoms were reported by the patient. No treatment was given for the events. At the reporting time, the patient had not recovered from the reported events.   The action taken regarding suspect vaccine with the events was considered as not applicable.   The causal relationship between suspect vaccine with the events was not reported.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; a 6-month-and-4-day-old baby received a dose of GARDASIL 9 today, 24SEP2024; This spontaneous report has been received from a medical assistant (MA) regarding a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 24-SEP-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, 1 dose, administered for prophylaxis (route of administration and anatomical site of injection were not provided) (lot number X019196 has been verified to be a valid number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9], expiration date 25-APR-2025) (Product administered to patient of inappropriate age).   No additional adverse event was reported for this patient.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Patient states vaccine may have been administered a little low and inside towards bicep instead of deltoid. Shortly after vaccination patient described tingling in fingers of arm receiving vaccination. This tingling sensation was not present when I spoke with her the next day on 09/26/24. She did state there was slightly more pain than usual.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Patient states vaccine may have been administered a little low and inside towards bicep instead of deltoid. Shortly after vaccination patient described tingling in fingers of arm receiving vaccination. This tingling sensation was not present when I spoke with her the next day on 09/26/24. She did state there was slightly more pain than usual.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Acute lymphocytic leukaemia, Biopsy bone marrow abnormal, Blood test abnormal, Fatigue, Mass
Clinical narrative: Within a couple weeks after getting the vaccine, unusual symptoms started occurring. Lumps began forming, on head first, then neck. They grew and multiplied over the course of about two months. During this time, he was also getting unusually tired, had hives intermittently for no clear reason, and eventually developed nausea. We brought him to urgent care twice and the ER twice over two months. In May 2023 he was diagnosed with acute lymphoblastic leukemia.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck mass, Urticaria
Clinical narrative: Within a couple weeks after getting the vaccine, unusual symptoms started occurring. Lumps began forming, on head first, then neck. They grew and multiplied over the course of about two months. During this time, he was also getting unusually tired, had hives intermittently for no clear reason, and eventually developed nausea. We brought him to urgent care twice and the ER twice over two months. In May 2023 he was diagnosed with acute lymphoblastic leukemia.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Initial insomnia, Injection site pain
Clinical narrative: I had sufficient pain at the injection site, bad enough to disrupt my sleep on the first night. The next night, Tylenol was enough to keep it down, by the next night the pain was gone. But that's normal for a COVID shot.  That's not what I'm here to report. Last night, I had a really hard time falling asleep and staying asleep. I managed only about 3 hrs of actual sleep. I've been tired all day since. Today at work, around 10am, I started getting some fairly significant joint pain (knees, elbows, knuckles, back), which is unusual. After lunch, around 1:30, I started getting really bad acute back pain. I'm assuming it's muscular pain, but it could be deeper inside, and would be in the vacinity of my kidneys. I took two extra strength 8 hour Tylenols. After work, I came home, and I laid down on a heating pad for about 2 hours. 8 think I also slept off and on. The pain remains excruciating if I move, especially bending at the waist. Just sitting out lying down, it's noticable, but not nearly as bad. I'm going to take 2 more Tylenol and try to sleep. Hopefully it will feel better in the morning.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sleep disorder
Clinical narrative: I had sufficient pain at the injection site, bad enough to disrupt my sleep on the first night. The next night, Tylenol was enough to keep it down, by the next night the pain was gone. But that's normal for a COVID shot.  That's not what I'm here to report. Last night, I had a really hard time falling asleep and staying asleep. I managed only about 3 hrs of actual sleep. I've been tired all day since. Today at work, around 10am, I started getting some fairly significant joint pain (knees, elbows, knuckles, back), which is unusual. After lunch, around 1:30, I started getting really bad acute back pain. I'm assuming it's muscular pain, but it could be deeper inside, and would be in the vacinity of my kidneys. I took two extra strength 8 hour Tylenols. After work, I came home, and I laid down on a heating pad for about 2 hours. 8 think I also slept off and on. The pain remains excruciating if I move, especially bending at the waist. Just sitting out lying down, it's noticable, but not nearly as bad. I'm going to take 2 more Tylenol and try to sleep. Hopefully it will feel better in the morning.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Diarrhoea, Influenza virus test negative, Pain, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Sept 14-19,  my 12mo old had a moderate to high fever for 6 days straight, as well as very, very loose diarrhea. On 9/19 she had a fever of 104.9 and we took her to the emergency room. Extreme diarrhea (8+ diapers a day) has lasted over 2 weeks. Still no resolution. Fever will subside for a day then return. Diarrhea is consistent; causes rawness and pain.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: SARS-CoV-2 test negative, Skin erosion, X-ray
Clinical narrative: Sept 14-19,  my 12mo old had a moderate to high fever for 6 days straight, as well as very, very loose diarrhea. On 9/19 she had a fever of 104.9 and we took her to the emergency room. Extreme diarrhea (8+ diapers a day) has lasted over 2 weeks. Still no resolution. Fever will subside for a day then return. Diarrhea is consistent; causes rawness and pain.