chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Chronic idiopathic constipation; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3(booster), single (Lot number: FF8839) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; ASPIRIN (E.C.); FISH OIL; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; INFLUENZA VIRUS VACCINE, start date: 03Nov2021, stop date: 03Nov2021. Past drug history included: No, reaction(s): "Hypersensitivity". Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunization. The following information was reported: CONSTIPATION (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Chronic idiopathic constipation". Therapeutic measures were taken as a result of constipation.  Additional information:It was reported that patient did not  receive any other vaccines on the same date as the vaccine. The patient was taking any other medications within 2 weeks of the event starting. Fiber supplements and Miralax were taken as treatment for the event
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder, Intellectual disability
Clinical narrative: autism; He is retarded; This is a spontaneous report received from a Consumer or other non HCP.  An infant male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "not recovered", described as "autism"; INTELLECTUAL DISABILITY (medically significant), outcome "not recovered", described as "He is retarded".  Clinical course: Patient's mother stated, "I was just curious, I just recently had a child birth and I gave my kid the Pfizer Vaccine (Pfizer COVID-19 vaccine) and now he has autism. How you going to explain that?" Patient's mother further stated, "Yes, he got autism all of the sudden. He is retarded. I can't take it back." When vaccine name was clarified if Pfizer COVID-19 vaccine, patient's mother stated "Yes, he got the COVID vaccine and now he is retarded". When asked if want to report or have any question regarding it: Reporter stated, "Oh no he just like, he just like drools all day, I don't know. He is retarded. Yeah, the Pfizer vaccine gave him retard. How does this vaccine give him mental retardation?"  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site dryness
Clinical narrative: In my injection site it developed dry brown spots; In my injection site it developed dry brown spots; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) 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. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation, reaction(s): "In my injection site it developed dry brown spots", "In my injection site it developed dry brown spots"; Bnt162b2 (Dose 2, single), for COVID-19 immunisation, reaction(s): "In my injection site it developed dry brown spots", "In my injection site it developed dry brown spots". The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE DRYNESS (non-serious), outcome "not recovered" and all described as "In my injection site it developed dry brown spots". The event "in my injection site it developed dry brown spots" required physician office visit. Additional information: The patient had Pfizer vaccines for Covid. In the injection site, it developed dry brown spots and it doesn't heal. 3 different injections site. Patient was asking if there are any other complaints about this issue and is to see a dermatologist about this issue.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254624 Same patient, suspect drug and event; different dose;US-PFIZER INC-202400254625 Same patient, suspect drug and event; different dose;
Sex: F
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: she almost died last year when she took the medication while in the hospital; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Dec2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (life threatening, medically significant) with onset Dec2023, outcome "unknown", described as "she almost died last year when she took the medication while in the hospital". Clinical course: The caller said she had RSV vaccine in Dec of last year and she saw on TV a while ago about getting help with the medication and she needs help with it because she is on plain insurance, and the shot is very expensive. Resolution:- Created a manual precautionary AE form because the caller stated that she almost died last year when she took the medication while in the hospital.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: Inner part of arm itching/ skin is more itchy; rash keeps coining back with using dupixent/broke out in rash; furfur; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2021SA256995 (Sanofi).  A 47-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 23Mar2021 (ongoing)) at 300 mg (300 mg every other week), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Dermatitis atopic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Inner part of arm itching/ skin is more itchy"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "furfur"; RASH (non-serious) with onset 2021, outcome "recovered", described as "rash keeps coining back with using dupixent/broke out in rash". The events "inner part of arm itching/ skin is more itchy", "rash keeps coining back with using dupixent/broke out in rash" and "furfur" required physician office visit. The action taken for dupilumab was dosage not changed. Therapeutic measures were taken as a result of pruritus, rash, skin exfoliation. Additional information: On an unknown date, after an unknown latency, patient experienced that her skin is more itchy and rash keeps coming back with using Dupixent. Patient was recommended to discuss furfur with doctor; doctor was already aware and been prescribing other help her but gel was not helping her much. Patient reports experiencing side effects from medication, unknown type of side effects. Unknown if MD aware. Unknown onset of side effects, unknown if patient is currently experiencing reported side effects. It was unknown if the patient experienced any additional symptoms/events. Corrective treatment: Gel for inner part of arm itching/skin is more itchy and rash keeps coming back with using dupixent; unknown for broke out in rash.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 13.0
Sex: U
Vaccine: FLU3, FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered FLUBLOK instead of FLUZONE to patients aged 13 and 16 years old with no adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2024SA265202.  This case involves a 13 years old of unknown gender patient who was administered Influenza Trivalent Recombinant Vaccine [Flublok Tiv] instead of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no 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 Influenza Trivalent Recombinant Vaccine Solution for injection (lot number, expiry date, strength, and route) in unknown administration site for immunization instead of Fluzone to patients aged 13 and 16 years old with no adverse event (wrong product administered) (unknown-same day).   Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Pharmacist mentioned that the patients have not reported any adverse reactions since the vaccination happened a week and a half ago.   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.; Sender's Comments:  US-SA-2024SA265202:02211212
Age: 12.0
Sex: M
Vaccine: COVID19-2, FLU4, HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: IMMEDIATE SWELLING AT INJECTION SITE . No medical attention needed. No pain, no SOB, no mental status change, no physical strength change.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Tinnitus
Clinical narrative: Tinnitus, painful.  Left ear.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered Flublok instead of Fluzone. No adverse reaction as of this report. Notified mother and answered all questions.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Insomnia
Clinical narrative: Patient called via phone on September 13, 2024 complaining of trouble sleeping and a burning sensation of the hands and arms, beginning the evening of vaccination. Patient stated they will be seeing their primary care physician next week to discuss the issue and seek examination. Patient was advised to keep upcoming appointment with physician and to seek urgent care if problems worsen.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient has what appears to be a classic arthus reaction to DTaP vaccine. Mom noted possible low grade fever the night after vaccination (felt warm), but did not take temp or give antipyrretics. Skin reaction noted by Mom 18 hours after vaccine (when home from daycare). Red, swollen, hot, indurated area around injection site that extended from upper thigh to knee. Area continued to spread for 48 hours and then started to gradually improve (Mom has serial pictures to show spread). Primary care was seen 24 hours after reaction was noted and was diagnosed with cellulitis. However, Mom was sceptical and did not give the antibiotics prescribed. As of writing this it continues to improve but has not completely resolve
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Skin warm, Type III immune complex mediated reaction
Clinical narrative: Patient has what appears to be a classic arthus reaction to DTaP vaccine. Mom noted possible low grade fever the night after vaccination (felt warm), but did not take temp or give antipyrretics. Skin reaction noted by Mom 18 hours after vaccine (when home from daycare). Red, swollen, hot, indurated area around injection site that extended from upper thigh to knee. Area continued to spread for 48 hours and then started to gradually improve (Mom has serial pictures to show spread). Primary care was seen 24 hours after reaction was noted and was diagnosed with cellulitis. However, Mom was sceptical and did not give the antibiotics prescribed. As of writing this it continues to improve but has not completely resolve
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient (11 years old) was taken into pharmacy for a covid 19 vaccine. However, the associate processing the vaccine did not notice that the vaccine processed could only be used on patients 12 yrs or older. The vaccine was administered and the mistake was not discovered until our store was alerted via an email from corporate. Once the mistake was discovered, our store called the patient's parents and informed them of the situation. From what they have told us, the patient has suffered no adverse reactions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Electrocardiogram abnormal, Eye movement disorder, Hypotension, Loss of consciousness
Clinical narrative: Approximately 3 minutes post vaccination, the patient stated that she was starting to feel unwell. Her head tipped back, her eyes rolled back, and she lost consciousness. Nurses helped her to the floor and within approximately 3 or 4 seconds, she regained consciousness. Her vitals at this time were stable other than a low pulse rate (between 40-50 bpm) and she was alert and oriented to person, place, time and situation.  We continually monitored her vital signs and they remained within normal limits other than the pulse rate remaining between 40-50 bpm.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Sinus bradycardia
Clinical narrative: Approximately 3 minutes post vaccination, the patient stated that she was starting to feel unwell. Her head tipped back, her eyes rolled back, and she lost consciousness. Nurses helped her to the floor and within approximately 3 or 4 seconds, she regained consciousness. Her vitals at this time were stable other than a low pulse rate (between 40-50 bpm) and she was alert and oriented to person, place, time and situation.  We continually monitored her vital signs and they remained within normal limits other than the pulse rate remaining between 40-50 bpm.
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLU4, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: numbness right hand and right lower face
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no side effects
Age: 41.0
Sex: M
Vaccine: COVID19, FLU4, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Blood glucose normal, Pyrexia, Tremor
Clinical narrative: After an hour the patient started feeling feverish and started shaking terribly.
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Sex: M
Vaccine: FLU4, HEP
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: Newborn infant born on 9/XX/2024 accidentally given influenza vaccine instead of hepatitis B vaccine on day of birth in hospital.  Multifactorial opportunities include look-alike vaccine boxes stocked in the same refrigerator and nurse did not utilize barcode scanning prior to administration.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient (9 years old) was taken into pharmacy for a covid 19 vaccine. However, the associate processing the vaccine did not notice that the vaccine processed could only be used on patients 12 yrs or older. The vaccine was administered and the mistake was not discovered until our store was alerted via an email from corporate. Once the mistake was discovered, our store called the patient's parents and informed them of the situation. so far, we have not been able to reach the patient or their guardian after multiple attempts
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was giving Comirnaty (Pfizer) Covid shot that is approved for 12 and older and she is 7 years old
Age: 80.0
Sex: M
Vaccine: FLUA4, UNK
Symptoms: Peripheral swelling, Pruritus, Rash, Skin weeping, Urticaria
Clinical narrative: He came back to the pharmacy on 9/13/24 stating that he developed hives in his legs, with rashes that oozed clear liquid out, and he had some itchiness and slight leg swelling that developed.
Sex: U
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Patient received all 4 vaccines on 9/9/24. Developed Fever, Chills, Diarrhea the same night.  Fevers and Chills resolved after 1 day, but diarrhea persisted for 2 full days.  Diarrhea was severe where patient could not leave the house.  Treated with oral hydration and loperamide at home. Diarrhea resolved on 9/12/24. This is an unusual side-effect to these vaccines, and this is why I am reporting it.
Age: 70.0
Sex: F
Vaccine: FLUA4, FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: pain at injection site, very bad, hot to touch 12 hours duration. Acetaminophen taken, gradually pain subsided .
Age: 70.0
Sex: F
Vaccine: FLUA4, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pain at injection site, very bad, hot to touch 12 hours duration. Acetaminophen taken, gradually pain subsided .
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: pain in arm, shooting pain to shoulder, limited mobility
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Back disorder, Gait disturbance, General physical health deterioration, Hypoaesthesia, Nervous system disorder
Clinical narrative: Patient spose reports patient began having pain in bilateral thighs day after vaccine, then numbness in lower extremities and then numbness traveled upward to navel and spread down both arms. Patient went to doctor on 8/26/24. Doctor believed back issue and prescribed steroids. Condition worsened and patient having trouble walking without assistance. Was refereed to Spine and they believed was neurological. Patient was referred to neurologist who admitted him to hospital. Patient is correctly in hospital.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient spose reports patient began having pain in bilateral thighs day after vaccine, then numbness in lower extremities and then numbness traveled upward to navel and spread down both arms. Patient went to doctor on 8/26/24. Doctor believed back issue and prescribed steroids. Condition worsened and patient having trouble walking without assistance. Was refereed to Spine and they believed was neurological. Patient was referred to neurologist who admitted him to hospital. Patient is correctly in hospital.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: patient called stating the site of reaction was itching - she got the shot 8 hours ago and started getting itching on the site of reaction - patient had no breathing issues and only reported itching at site of reaction, mild redness at the site of injection
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate flu vaccine. First one was given on 07/29 and a second one was given on 09/12.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site erythema, Administration site rash, Administration site swelling, Administration site warmth
Clinical narrative: Patient called on 09-13-2024 stating that she had a rash about 4 fingers wide, that was red, slightly raised & a little warm to the touch in the area the vaccine was administered. The area does not itch.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports tender and soreness at site of injection in arm 6 weeks after receiving the vaccine
Age: 69.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Lymphadenopathy
Clinical narrative: swelling in lymph nodes under left arm
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Sore muscles, chills, sweating, fever of 101 degrees, headache the day after vaccine and the day after that. Additionally, breathing in deeply was very difficult and some chest pains.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sore muscles, chills, sweating, fever of 101 degrees, headache the day after vaccine and the day after that. Additionally, breathing in deeply was very difficult and some chest pains.
Sex: M
Vaccine: COVID19
Symptoms: Eye injury, Ophthalmological examination, Visual impairment
Clinical narrative: Back of his eye erupted; He was losing significant eye sight; This serious initial spontaneous safety report was received by Novavax on 11-Sep-2024 from a consumer or other non-health professional via Novavax Global Customer Experience Center (GCXC) (Case No. 00042853).  A Male of unspecified age was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot numbers were not provided in the report) on unspecified dates.  The following medical history was reported: AGE-RELATED MACULAR DEGENERATION.   No concomitant medications were reported.  On unspecified dates after vaccination the patient experienced, He was losing significant eyesight (PT: Visual impairment) (Serious: Medically significant) and Back of his eye erupted (PT: Eye injury).  Treatment for event Eye injury included repeated eye injections.  At the time of reporting, the event outcome of Visual impairment was Unknown and Eye injury was Recovered/Resolved.; Sender's Comments: This Male of an unspecified age experienced Visual impairment and Eye injury after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Visual impairment was reported as serious.  The event Eye injury was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Visual impairment and Eye injury is considered Possible.
Age: 10.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok was given to a 10-year-old with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10-year-old and unknown gender patient who was given influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Aug-2024, the 10-year-old patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection of lot TFAA2406 and expiry date: 30-May-2025 (strength: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) with no reported adverse event (product administered to patient of inappropriate age) (latency: on 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: 15.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently gave Flublok to a 15 year old, which is approved for 18 years and older instead of an age appropriate flu shot. Found error immediately following immunization and counseled father about the situation, Pediatrician has also been informed, it is highly unlikely of ill effects to occur afterwards, however father was counseled to watch out for any adverse effects and seek treatment if they occur.
Age: 15.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently gave Flublok to two 15 year old sisters, which is approved for 18 years and older instead of an age appropriate flu shot. Found error immediately following immunization and counseled father about the situation, Pediatrician has also been informed, it is highly unlikely of ill effects to occur afterwards, however father was counseled to watch out for any adverse effects and seek treatment if they occur.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Urticaria
Clinical narrative: Hives, diarrhea, headache
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Injection site swelling, Rash, Rhinorrhoea, Swelling
Clinical narrative: Pt had a rash on her face and her nose was swollen following the vaccine 24 hours later. She ended up getting a really bad runny nose and a the rash lasted for over 2 months. The bump on her leg did not go away until August of 2024.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Nausea
Clinical narrative: Chill, rigors, nausea which occurred two hours after taking  third dose. Lasted about one hour.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: Leakage of almost half of vaccine
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Given too early. No reaction reported
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood urine present, Injection site pain
Clinical narrative: Dark red blood in the urine that made the toilet water very red that sunk to the bottom of the bowl. The only other symptom is pain at the injection site. I did have a Flublok shot in my other arm at the same time, but according to my reading of the literature the most likely culprit is the covid-19 vaccination.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dyspnoea, Ear discomfort, Pyrexia, Vomiting
Clinical narrative: I violently threw up for over 3 hours starting at 7pm same night of vaccine. Akso had diarrhea, fever 99.4. Leading up to it I felt my short of breath, felt like my ears were filling up. Wanted to die. I've had a flu shot before with no issues. I'll never get 1 again
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient was administered a Boostrix vaccine on 9/10/24 at approx. 3:10pm. The patient contacted the pharmacy on 9/14/24 at approx. 9:15 am  stating that she experiencing a rash on her left forearm and her face that she could not explain to any other exposure to another substance. Patient was instructed to contact her provider and to take diphenhydramine if needed if the rash continues.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hallucination, Pyrexia
Clinical narrative: Patient described fever and chills starting 9/13/2024 about an hour after her vaccination, at around 8pm she stated that she experienced hallucinations and a fever. She did take Tylenol to help lower the fever and had her husband with her to help determine hallucinations or not. The morning of 9/14/24 at 9:30am when she called to report the reaction she stated that the hallucinations only happened last night.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever,  chills, muscle pain, headache
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Immediate post-injection reaction, Injection site pain, Myalgia, Vomiting
Clinical narrative: diarrhea beginning about 6 hours after vaccine administration, muscle soreness at injections site beginning immediately after administration, muscle soreness of whole body beginning about 9 to 12 hours after administration, vomiting at about 18 hours after administration.
Age: 21.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Diarrhoea, Eating disorder, Nausea
Clinical narrative: September 11th had intense nausea starting in the morning and lasting most of the day. Also had diarrhea throughout the day. September 12th diarrhea continued and began tracking it. Went 5 times. September 13th, had diarrhea three times. September 14th, had nocturnal diarrhea twice. Symptoms still persisting. Hydration fine but trouble with eating.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypotension
Clinical narrative: Patient describes having low blood pressure for 2 days after vaccine.  Reported 80/50 and 90/60.  She felt drained. She stopped her losartan the days she read her blood pressure low.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Gastrooesophageal reflux disease
Clinical narrative: Patient experienced, fever/chills, body aches, arm/shoulder pain, back pain, stomach upset and acid reflux
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Pain, Pyrexia
Clinical narrative: Patient experienced, fever/chills, body aches, arm/shoulder pain, back pain, stomach upset and acid reflux
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Tremor
Clinical narrative: At 8:30 that evening I started having uncontrollable violent shaking and tremors and could not control my hands, arms and legs.  These symptoms lasted from 20 to 25 minutes.  I took Aleeve and am not sure this helped or whether they just subsided.  It was terrifying.  I've had 4 previous injections with the last one being on 6/22/23 with no problems.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Spikevax administered is indicated for patients 12 years and older, patient was 11 years and 5 months at time of vaccine. Fluzone Trivalent also given at the time of vaccine, there is not an option to select the Trivalent formulation.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Headache
Clinical narrative: Low grade headache lasting over 24 hours even after taking Tylenol..
Age: 8.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Spikevax administered is indicated for patients 12 years and older, patient was 8 years and 11 months at time of vaccine. Fluzone Trivalent also given at the time of vaccine, there is not an option to select the Trivalent formulation.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient received the Fluzone HD instead of Flublok or Fluzone. She is under 65 years old.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity
Clinical narrative: Besides  a sore arm for 3 days which I expected, I had two blisters pop up (one on my leg and one on my back. Both were about the size of a cheerio and were watery.  I had gone to my dermatologist the day before and the two blisters were not there until the next morning.  No other blisters have appeared by day 4. I went to the pharmacy where I received my vaccination and talked to the pharmacist.  She advised that I report this incident to the CDC. I did not treat the blisters.   I did have a Tdap vaccination on 09/03/2024.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Swelling face
Clinical narrative: Coughing, shortness of breath, facial swelling
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Unevaluable event
Clinical narrative: I was not present at time of injection. Information given by patient. She received influenza and Covid at the same time.
Age: 57.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Pain in extremity, Radial nerve injury
Clinical narrative: When pt received the second vaccine, she stated that she "felt it" in her shoulder and down her arm. I stated that I might have hit a nerve. Pt called 4 days later to inform me that her radial nerve had been hit, that she was in pain from it, and that she would be getting a Cortisone shot.
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports arm swelling in the area, redness up to 2 inches from injection site, and hot to the touch. Says that this is a typical reaction after receiving COVID vaccines in the past.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Patient received vaccine, remembers it was "high" on the arm. Today, the day after, can't lift the arm, has bad pain in shoulder joint
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Swelling in left armpit area. Same side as injection.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Nausea, Seizure
Clinical narrative: Seizures, fatigue, nausea
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: rash on neck and body soreness
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect route of product administration
Clinical narrative: This vaccine was give as a subcutaneous shot and should have been given intramuscular
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received first dose of RSV on 10/11/2023.  Pharmacy was having a vaccination event on 09/14/2024 and patient requested RSV vaccine, not realizing that they had already gotten it.  Patient was inadvertently given second dose on 09/14/2024.  Patient was contacted by pharmacist and is feeling fine and not experiencing any adverse reactions.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received first dose of RSV on 10/20/2023.  Pharmacy was having a vaccination event on 09/14/2024 and patient requested RSV vaccine, not realizing that they had already gotten it.  Patient was inadvertently given second dose on 09/14/2024.  Patient was contacted by pharmacist and is feeling fine and not experiencing any adverse reactions.
Age: 87.0
Sex: F
Vaccine: FLUA4, PNC20, VARZOS, FLUX, PNC20, VARZOS
Symptoms: Alopecia, Muscle spasms, Muscular weakness, Pruritus
Clinical narrative: ITCHING ALL OVER BODY AND HEAD, MUSCLE WEAKNESS, CRAMPS HAIR LOSS - TOPICAL BENADRYL ALL TOLD WAS GIVEN BY MD
Age: 87.0
Sex: F
Vaccine: FLUA4, PNC20, VARZOS, FLUX, PNC20, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Urticaria
Clinical narrative: ITCHING ALL OVER BODY AND HEAD, MUSCLE WEAKNESS, CRAMPS HAIR LOSS - TOPICAL BENADRYL ALL TOLD WAS GIVEN BY MD
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure decreased, Chills, Lethargy, Pyrexia
Clinical narrative: chills, fever (101°), low blood pressure (80/76), lethargy, lasted about 18 hours.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea exertional, Fatigue, Injection site pain, Pain
Clinical narrative: That night I developed severe chills, fever, vomiting all night, aching, severe fatigue for several days. Then both my husband and I developed intermittent sharp pains in our left upper and lower arms, lasting for about 6 months along with severe fatigue which has persisted.. Now I have developed biapical pleural scarring with nodularity and a small pleural effusion . X-ray was normal 3 yrs ago. We both have extremely high titers to covid 3 years later. I have marked shortness of breath with exertion now.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pleural effusion, Pleural fibrosis, Pulmonary mass, Pyrexia
Clinical narrative: That night I developed severe chills, fever, vomiting all night, aching, severe fatigue for several days. Then both my husband and I developed intermittent sharp pains in our left upper and lower arms, lasting for about 6 months along with severe fatigue which has persisted.. Now I have developed biapical pleural scarring with nodularity and a small pleural effusion . X-ray was normal 3 yrs ago. We both have extremely high titers to covid 3 years later. I have marked shortness of breath with exertion now.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Viral titre increased, Vomiting
Clinical narrative: That night I developed severe chills, fever, vomiting all night, aching, severe fatigue for several days. Then both my husband and I developed intermittent sharp pains in our left upper and lower arms, lasting for about 6 months along with severe fatigue which has persisted.. Now I have developed biapical pleural scarring with nodularity and a small pleural effusion . X-ray was normal 3 yrs ago. We both have extremely high titers to covid 3 years later. I have marked shortness of breath with exertion now.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Overweight
Clinical narrative: Day 1 - about 30 mininutes after vaccine i had occasional pin prick feeling in various parts of my body.  Day 2 i had headache and minor muscle pain. Day 3 muscle pain left arm. Day 6  muscle pain right arm all of a sudden while sitting in a chair.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Hurting around the abdomen
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain lower, Back pain, Chest discomfort, Chest pain, Flushing
Clinical narrative: Patient came in for a high-dose flu and COVID vaccine. Immediately after providing these vaccinations the patient experienced facial flushing, slight chest tightness/pain, lower abdominal and back pain. She was monitored for a total of 40 minutes. I actively watched her for the first 5-10 minutes and offered her an antihistamine, water, a cool compress, and to call EMS. The patient declined all. I had an EpiPen on hand in case her condition worsened. I sat with her and her daughter for another 5-10 minutes and the flushing and chest pain/tightness started to subside. They moved into the waiting room and continued to sit. They were re-offered water (which they took), an antihistamine (they declined). The patient stated she was still experiencing the lower back and abdominal pain. Near the 40 minute mark I went back to talk with her and her daughter. Her daughter said she appeared to be doing better and wanted to take her home for further monitoring. She stated she would provide an antihistamine to her at home and watch her for the next few hours. I recommended that in addition to the antihistamine she needed to seek emergency medical care if her condition persisted or worsened. I will call the patient back to follow-up this afternoon and Monday.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Immediate post-injection reaction
Clinical narrative: Patient came in for a high-dose flu and COVID vaccine. Immediately after providing these vaccinations the patient experienced facial flushing, slight chest tightness/pain, lower abdominal and back pain. She was monitored for a total of 40 minutes. I actively watched her for the first 5-10 minutes and offered her an antihistamine, water, a cool compress, and to call EMS. The patient declined all. I had an EpiPen on hand in case her condition worsened. I sat with her and her daughter for another 5-10 minutes and the flushing and chest pain/tightness started to subside. They moved into the waiting room and continued to sit. They were re-offered water (which they took), an antihistamine (they declined). The patient stated she was still experiencing the lower back and abdominal pain. Near the 40 minute mark I went back to talk with her and her daughter. Her daughter said she appeared to be doing better and wanted to take her home for further monitoring. She stated she would provide an antihistamine to her at home and watch her for the next few hours. I recommended that in addition to the antihistamine she needed to seek emergency medical care if her condition persisted or worsened. I will call the patient back to follow-up this afternoon and Monday.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site reaction, Injection site warmth, Muscle twitching
Clinical narrative: Severe body aches and fever. Large welt at vaccination site. Itching at vaccination site. Extreme fatigue. Worse than Covid itself and I?ve had Covid twice.  Twitching and spasm in muscle subject to injection.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body aches and fever. Large welt at vaccination site. Itching at vaccination site. Extreme fatigue. Worse than Covid itself and I?ve had Covid twice.  Twitching and spasm in muscle subject to injection.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: wrong  dose of flu vaccine was given ( pt is 63 years old and received fluzone HD / pt is not having any issues at this time
Age: 68.0
Sex: F
Vaccine: COVID19, DTAP, HEPAB
Symptoms: Arthralgia, Feeling cold, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Chills, diaphoresis, headache, temp 99.6, muscle aches and pains, joint pain, nausea and vomiting, restlessness, itching.
Age: 68.0
Sex: F
Vaccine: COVID19, DTAP, HEPAB
Symptoms: Nausea, Pruritus, Restlessness, Vomiting
Clinical narrative: Chills, diaphoresis, headache, temp 99.6, muscle aches and pains, joint pain, nausea and vomiting, restlessness, itching.
Age: 28.0
Sex: M
Vaccine: COVID19, FLUC4, TDAP
Symptoms: Epistaxis
Clinical narrative: Nosebleed, lasting approximately 15 minutes. This is not a common occurrence for this patient. He believes it has been 2 years since his last nosebleed
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Nausea, Tremor, Vomiting
Clinical narrative: Blood pressure spiked 50 points, Shaking, nausea, vomiting.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient complained of pain in joints, knees and elbows, and severe burning sensation at injection site the morning after.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site haemorrhage, Nausea, Vomiting
Clinical narrative: Patient bled more than expected, subsequently felt nauseous and vomited after administration of the vaccine.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Altered state of consciousness, Blood pressure decreased, Feeling hot, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: At around 11:00 am, a pharmacy technician administered the vaccines to the pt. Pt reported immediate responses towards the shingle shot  on the left arm. He ran extremely hot and he was profusely sweating. He reported to be feeling very nauseous, losing consciousness, passing out in waves. He said he had vagal responses before, but nothing like that. About 10 minutes after calling EMS, medic arrived and monitor his pulse, bp, and sugar. Oxy and BP were low. He was told he was crashing. About 15 minutes later, he was let go.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Oxygen saturation decreased
Clinical narrative: At around 11:00 am, a pharmacy technician administered the vaccines to the pt. Pt reported immediate responses towards the shingle shot  on the left arm. He ran extremely hot and he was profusely sweating. He reported to be feeling very nauseous, losing consciousness, passing out in waves. He said he had vagal responses before, but nothing like that. About 10 minutes after calling EMS, medic arrived and monitor his pulse, bp, and sugar. Oxy and BP were low. He was told he was crashing. About 15 minutes later, he was let go.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received High dose flu vaccine even though patient is only 60 years old not 65 years old.  No other issues.
Age: 66.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two different flu shot doses of FLUAD on separate days.  The first dose was given on 8/6/24 and the second dose was given on 9/13/24. Patient was notified of the error but does not have any symptoms at this time. She was educated to call us if she has any adverse reactions.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received vaccine and tolerated it well. Sat down in waiting area for 10 min and then fainted. Per family has history of fainting post vaccine in past.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder spasm, Blood test, Urine analysis
Clinical narrative: Diagnosed as bladder spasms.  Treated at local ER. Prescribed meds. Symptoms ceased after 2 days of meds.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Comirnaty 12+ PFS 24-25 given to pt age 11
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt was given an RSV vaccine during a vaccination clinic. when asked, the patient stated that they had not received an RSV vaccine, so the vaccine was given. when inputting the vaccine, it was found that the patient had received it previously
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok is only indicated  for patients 18 years or old. However, Flublok was administered for this patient under 18 years old. No adverse effects were reported and family is aware of error and what to watch for.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt was given an RSV vaccine during a vaccination clinic. when asked, the patient stated that they had not received an RSV vaccine, so the vaccine was given. when inputting the vaccine, it was found that the patient had received it previously
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok is indicated for patients 18 years or older; however, it was administered to this patient under 18 years old. This vaccine error has been confirmed with parents not to have resulted in any adverse effects and they are aware of the error.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: WARM TO TOUCH, RASH ON ADMINISTRATION ARM, PATIENT CAME AFTER 6 DAYS AND STATED RASH HAS BEEN PRESENT THERE. NO OTHER SYMPTOMS.
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Chills, Discomfort, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: chills, uncontrollable shaking, feverish, joint pain, nausea, stuffy nose, very sore shoulder no treatment, acute phase lasted about 3 hours, discomfort lasted about 9 additional hours. stiff shoulder 2 days