chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 month old patient received an expired ACTHIB with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 month old patient received an expired acthib 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, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 13-Sep-2023, the patient received 0.5 ml (1X)  dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ798AB, expiry: 11-Sep-2023 via intramuscular route in the left thigh for immunization (strength: unknown), patient received an expired acthib with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered   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: 0.25
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered an expired Pentacel vaccine to a patient with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who was accidentally administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine to patient 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 hepatitis b vaccine (hepatitis b [hepatitis b vaccine]) for prophylactic vaccination; and meningococcal vaccine (meningococcal vaccine) for prophylactic vaccination.  On 18-Sep-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: V7331AA, Expiry date: 16-Sep-2023) (Strength:Standard, Frequency: Once) via unknown route in unknown administration site for Immunization.  On 18-Sep-2023, the who was accidentally administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine to patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse called in to report that they accidentally administered an expired PENTACEL vaccine to a patient and wants to know if it's considered a valid dose or if they should re-administer it. She declined to share the details for administering licensed practitioner.  Action taken: not applicable.  Outcome: Unknown   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: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: the IPOL was no longer suitable for use after the excursion, but was administered to two patients post excursion with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA287198(CLUSTER).  This case involves a 5 years old female patient and reporter reported that the Ipv (Vero) [Ipol] was no longer suitable for use after the excursion, but was administered to two patients 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) For Immunisation.  On 12-Sep-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect Ipv (Vero) Suspension for injection (strength: not reported, expiry date: 01-Jun-2024 and lot V1B891M) via intramuscular route in the left thigh as Immunization and was no longer suitable for use after the excursion, but was administered to two patients post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 68.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue and GI upset (nausea, emesis, watery brown diarrhea)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Patient approached the pharmacy counter 9/22/23 after receiving vaccination from 9/20/22  with redness at the injection area , told her not sure if its a rash or cellulitis. Patient decided to go to urgent care and was diagnosed with cellulitis.
Age: 62.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse outcome - just not the correct vaccine for age range
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Injury associated with device, Occupational exposure to product
Clinical narrative: needlestick to technician after administering
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 79.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient has a rash that is red and itchy on her right arm and right side of face. Started 9/21 and got worse over the next day. Recommended OTC hydrocortisone cream.
Age: 57.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Wrong product administered
Clinical narrative: The patient came to the pharmacy to receive the COMIRNAT COVID vaccine. Her partner was to receive RSV, COVID, and flu. When compounding the RSV vaccine that meant for her partner, the vaccine was accidentally given to the patient, so she received RSV instead of COVID.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Impaired driving ability, Presyncope, Slow response to stimuli
Clinical narrative: Patient received 3 shots of vaccines.  Boostrix in the left arm, Fluzone Quad and Engerix-B in the right arm.  After the boostrix, patient started to pass out. I checked her pulse.  She was breathing normally and conscious. She was responsive but not fully.  I gave her 10 ml of benadryl (25mg). Patient stayed in the imz booth with a technician for 15 minutes.  Patient relative came and picked her up because she did not fill comfortable to drive home.  Called patient 4 hours later to check on her.  She said she took a nap and was perfectly fine now.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Feeling hot, Headache, Somnolence
Clinical narrative: Donor received the 1st dose of the rabies immunization shot on 09/15/2023 however, states that on 09/17/2023 he starts with headaches, tiredness, feeling warmth to his body, and feeling sleepy. Donor states that the headaches come and go but they are every day since 09/17/2023 states has been taking OTC Tylenol or Advil. Donor states that the warmth feeling began yesterday on 09/21/2023 for 2 to 3 minutes to the entire body. Donor received the 1 st dose of the Imovax rabies vaccine on 09/15/2023 and states starting having symptoms on 09/17/2023. Donor states that he follow up with his PCP on 09/21/2023 and his PCP advise he that it might of been the vaccine
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 21.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: After giving both vaccines in each arm. Pt went to have a seat in the waiting area, moments later the person with him came to the pharmacist window and stated they were fainting. I went out and assessed and they did seem pale but were coherent and lucid and stated they were not having trouble breathing and did not want to be administered an epipen. I stood by observing and gave some candy and water the pharmacy had and they started improving within 30 minutes. They stated they previously had a phobia of needles and were not sure if they had completely overcome the phobia yet. I suggested emergency services and they declined insistently.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: fever, chills, lethargic, swollen glands, swollen arm
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse events
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Received new Spikevax by Moderna. Patient immediately passed out from receiving shot. Pharmacist caught her (she was sitting down). He got her down to the floor. She was out for less than 1 minute, came too very quickly. She did not hit her head. He had time to make sure she was breathing/pulse then started answering his questions. When she completely came to, she informed us about previous syncopal events from receiving vaccines related to an unknown event in her life. She has not had it happen in several years so did not think to mention before. Has received other vaccines recently with no issues.  We called 911 and she was talking and we were able to get some answers while on phone with operator. Did not go to hospital. EMT's asked her questions and did not feel she needed to once she was feeling better. She was able to walk out on her own with us walking with her and was able to drive home.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No signs of symptoms at the moment
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years old but accidentally received Flublok which is approved for 18 and over.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Received a pediatric vaccine instead of an adult vaccine
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Incorrect product administered
Age: 70.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Erythema, Localised infection, Peripheral swelling
Clinical narrative: PT had infection swollen red arm on the right side went in and was prescribed antibiotics
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Received incorrect product
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Pink rash 2? in diameter at injection site. Painful and warm to touch.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site rash, Injection site warmth
Clinical narrative: Slight rash at injection site. Warm to the touch. Only uncomfortable when touched with slight force.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Balance disorder, Biopsy muscle, Electromyogram, Gait disturbance, Magnetic resonance imaging
Clinical narrative: Thigh muscle issues causing muscle fatigue after the first two doses, balance issues after the third dose, and an inability to walk independently after the fourth dose
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Muscle fatigue
Clinical narrative: Thigh muscle issues causing muscle fatigue after the first two doses, balance issues after the third dose, and an inability to walk independently after the fourth dose
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Vaccine was given after FDA deauthorization
Age: 80.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: 2 RSV vaccines were accidentally given
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient mistakenly received 2 doses of Arexvy vaccine approx. 1 week apart (1st dose 9/11/23 at another pharmacy). This patient scheduled an appointment with us to get his dose of Arexvy and was given it by staff who believed it was his 1st and only dose. It was discovered later that he had received it previously from another one of our pharmacies where he had scheduled an appontment with them for this vaccine as well.  No actual adverse reactions as of yet as a result of these vaccinations.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling
Clinical narrative: The pharmacist that administered the vaccination did not go into the muscle. The vaccine infiltrated subcutaneously. I am a physician and I knew immediately because it took about 10 to 15 seconds for her to push it all in and it was not quick and not in my muscle. I had pain that I have never had with vaccination before  as I left pharmacy and swelling visible when I got home. I am worried this person doesn?t know how to administer vaccines !
Age: 33.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Injection site rash, Injection site warmth
Clinical narrative: About 26 hour s after vaccination a large red , warm and tender rash appeared on left deltoid spreading circumferential ly  medialy.  Associated symptoms included chills, rigors, body aches and pressure headache in the frontal and occipital areas.. About 36 hours after vaccination the patient developed  a fever up to 103.7.  Initial treatments included 1000 mg of acetaminophen. Fever did not break and was followed by 400 mg ibuprofen. The patient developed full body sweats. The  patients rash spread across the left arm only. The next day the fever cycle continued to a temperature max of 104.7 F. The patient saw his local urgent care  nurse practitioner who  recommended alternating acetaminophen and ibuprofen as dosages above not to exceed 3000 mg (pt hx of Non alcoholic fatty liver disease) of acetaminophen and 1200 mg of ibuprofen in 24 hours. A warm compression the rash area as well as diphenhydramine oral or topical was recommended. This
Age: 33.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test
Clinical narrative: About 26 hour s after vaccination a large red , warm and tender rash appeared on left deltoid spreading circumferential ly  medialy.  Associated symptoms included chills, rigors, body aches and pressure headache in the frontal and occipital areas.. About 36 hours after vaccination the patient developed  a fever up to 103.7.  Initial treatments included 1000 mg of acetaminophen. Fever did not break and was followed by 400 mg ibuprofen. The patient developed full body sweats. The  patients rash spread across the left arm only. The next day the fever cycle continued to a temperature max of 104.7 F. The patient saw his local urgent care  nurse practitioner who  recommended alternating acetaminophen and ibuprofen as dosages above not to exceed 3000 mg (pt hx of Non alcoholic fatty liver disease) of acetaminophen and 1200 mg of ibuprofen in 24 hours. A warm compression the rash area as well as diphenhydramine oral or topical was recommended. This
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Fatigue, Incorrect dose administered, Pain in extremity
Clinical narrative: Same patient given Arexvy twice on the same day in different arms. Patient noted sore arms and tiredness the next day. Checked status of patient one week later with no change in status and doing fine.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose was accidently given instead of adult dose.   No side effect
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Asthenia, Autoantibody positive, Blood test
Clinical narrative: Numbness and tingly down both arms starting June/July 2021 that transitioned to small joint aches in elbows, hands, fingers, and toes starting Sept/Oct 2021 that continue to this day (09/2023). Aches include joint stiffness, swelling, tingling, sharp aches from use, excessive heat and redness and loss of strength.   Vaccine was received while pregnant in 04/2021. Pregnancy was through with birth of healthy baby boy (8lbs 6oz). Please note that the inflammatory antibodies have persisted with little to no relief since 2021. Second child born (4lbs 3oz) and died 06/03/2023 due to Neonatal Hemochromatosis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Feeling hot, Hypoaesthesia, Joint stiffness, Live birth
Clinical narrative: Numbness and tingly down both arms starting June/July 2021 that transitioned to small joint aches in elbows, hands, fingers, and toes starting Sept/Oct 2021 that continue to this day (09/2023). Aches include joint stiffness, swelling, tingling, sharp aches from use, excessive heat and redness and loss of strength.   Vaccine was received while pregnant in 04/2021. Pregnancy was through with birth of healthy baby boy (8lbs 6oz). Please note that the inflammatory antibodies have persisted with little to no relief since 2021. Second child born (4lbs 3oz) and died 06/03/2023 due to Neonatal Hemochromatosis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Rheumatoid factor negative, Swelling
Clinical narrative: Numbness and tingly down both arms starting June/July 2021 that transitioned to small joint aches in elbows, hands, fingers, and toes starting Sept/Oct 2021 that continue to this day (09/2023). Aches include joint stiffness, swelling, tingling, sharp aches from use, excessive heat and redness and loss of strength.   Vaccine was received while pregnant in 04/2021. Pregnancy was through with birth of healthy baby boy (8lbs 6oz). Please note that the inflammatory antibodies have persisted with little to no relief since 2021. Second child born (4lbs 3oz) and died 06/03/2023 due to Neonatal Hemochromatosis.
Age: 76.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Injection site vesicles
Clinical narrative: PATIENT NOTICED A BLISTER LOOKING AT THE INJECTION SITE OF HIS LEFT ARM, WHERE HE GOT RSV SHOT, ON SEPTEMBER 19TH (A WEEK FROM RECEIVING HIS SHOTS). HE CLAIMS THAT THIS BLISTER HAS BEEN POPPED AFTER HE NOTICED BUT DOES NOT FEEL ANY PAIN NOR SWELLING HAS SHOWN
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: A bivalent Pfizer vaccine was administered one day after the announcement.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Incorrect vaccine administered. She should have gotten regular dose Influenza quadrivalent vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: A bivalent Pfizer vaccine was administered one day after the announcement.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Resident vomited x 1, temp of 102
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; Vaccines administered experienced a temperature excursion; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 21-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) Injection, as prophylaxis (lot number: U7374BA, which was determined to be valid, with an expiration date on 06-MAY-2025) (strengths, doses, schemes, routes of administration were not reported) (Product storage error).  The administered doses underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of several reports from the same reporter.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion.; No side effects reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) (V419) (lot number U7374BA has been verified to be a valid lot number, expiration date reported and validated as 06-MAY-2025) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) ) (lot number W026137 has been verified to be a valid lot number, expiration date reported and validated as 05-FEB-2024) after a temperature excursion (product storage error) at 8.74 centigrade degrees (C) with a timeframe of 35 minutes. Both vaccines were administered as prophylaxis (strength, dose, if a digital data logger was involved, vaccination scheme, route of administration and anatomical location were not provided). Additionally, there was no previous temperature excursion, and no effects were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Heavy menstrual bleeding
Clinical narrative: Prior to receiving my first vaccine, I had gone into peri-menopause, skipping menstrual periods for months at a time and when I would have them, they were pretty light and short (~3 days). In late April 2021, I began having menorrhagia, debilitatingly heavy menstrual periods, where I haven't been able to leave the house for the first 3 days, using overnight pads and changing them every 1-2 hours, bleeding through tampons and pads together onto clothes. I had this happen once in my early 20s so just thought it was something that would pass, but it's been this way since, following my first vaccine. I hadn't put it together (to report) until recently when I started having conversations with friends about it who are also having/had similar issues. I read an article on a website that encouraged reporting this to vaers, so I'm doing that now. Has been difficult to get in to see a doctor about it due to a health care shortage in our area where I moved last year, but I have an appointment in November to see a gynecologist.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Gait disturbance, Limb discomfort, Surgery
Clinical narrative: I started to feel tightness in my calves.  Thought it was muscle pulls from my soccer games.  Got worse and worse until I could barely walk
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Migraine, Nausea, Pain in extremity
Clinical narrative: Extreme migraine. Nausea. Vomiting. Pain at injection site. Entire left arm is sore and movement is restricted. Muscle pain at injection site and itching as well.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vomiting
Clinical narrative: Extreme migraine. Nausea. Vomiting. Pain at injection site. Entire left arm is sore and movement is restricted. Muscle pain at injection site and itching as well.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: After all of my COVID vaccinations I have experienced fever/severe body muscular pains,insomnia for 48 hours after the shot. Not able to do  anything.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Spikevax given to patient that is 8 years old.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Nausea, Palpitations, Pyrexia
Clinical narrative: Fever 101.4, severe shivering, nausea, few palpitations. Improved with Acetaminophen and aleve. Temp this am 100.3
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Vaccination site mass, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Patient advised day of the vaccine had a large lump at vaccination site (9/21/23), then day 2 lump gone but red rash that is warm to touch formed at vaccination site (9/22/23). Patient marked rash and applied cool compresses. Today (9/23/23) presented with rash spreading outside of marked site and nurse advised her possible allergic reaction to take Benadryl but to call md if that does not stop rash for an appointment.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: The day after the vaccination my upper left arm was a little sore and tender. I had some joint aching  in arms and hips, not too bad. A few inches below the injection site there was a large (3 inches x 2.5 inches) itchy red patch of skin. it is still there, still itching, 48 hours later. Have not treated it with anything, but took 12.5 mg of Benedryl sleep aid last night to relieve the itch. Have not consulted a doctor.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Patient complained of pain at time of injection. Later, she reported a small nodule at the site that showed erythema, itchiness, and pain when at rest. There was no blood loss so I ruled out a hematoma (plus, it likely would not have been itchy). Additionally, SIRVA is unlikely since it was far enough from her acromion process/capsule and she retained full ROM. My unofficial diagnosis is an unintentional subcutaneous injection (patient is very overweight and her anatomy was hard to visualize) leading to localized chemotaxis. Incidence is around 2 or 3 per 10,000 and is mostly seen with SQ injections. In the future, we will use 1.5 inch needles and will use better techniques to visualize her anatomy. Despite the fact that this is not life-threatening and most cases resolve spontaneously without intervention I instructed her to reach out to her provider for f/u.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Swelling face
Clinical narrative: Left arm swelled, face swelled, rash on right breast. They said to take Benadryl and keep an eye on it and make sure it doesn?t effect my breathing.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Heart rate increased
Clinical narrative: Dizziness, balance issues, high heart rate.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Patient requested the Abrexvy RSV vaccine via prescription that was given to him by his nurse practitioner. Patient made an appointment via our digital scheduler and selected the only RSV vaccine we offer at our location which was the Abrysvo RSV vaccine. Patient handed the prescription to the technician the technician thought patient was looking for any RSV vaccine. Patient was processed for the Abrysvo RSV vaccine. Patient is aware of error and so is NP.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills
Clinical narrative: Severe Chills
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Lethargy, Pain, Pyrexia, Respiratory tract infection
Clinical narrative: Fever chills, respiratory infection, body aches, cough, lethargic
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever chills, respiratory infection, body aches, cough, lethargic
Age: 78.0
Sex: M
Vaccine: FLUR4, RSV
Symptoms: Malaise, Myalgia, Nasal disorder, Pain, Paralysis
Clinical narrative: Patient came in the pharmacy on 09/22/2023 at 10:00 to report his experiences: 09/18/2023  He was just laying in bed not feeling well. 09/19/2023  He got paralysis, fever, pain, muscle aches and nasal symptoms. (took Tylenol) 09/22/2023  He is fine now.  He said the reactions are from the RSV Patient received Flublok in 08/30/2021 and 09/28/2022 without any complication.
Age: 78.0
Sex: M
Vaccine: FLUR4, RSV
Symptoms: Pyrexia
Clinical narrative: Patient came in the pharmacy on 09/22/2023 at 10:00 to report his experiences: 09/18/2023  He was just laying in bed not feeling well. 09/19/2023  He got paralysis, fever, pain, muscle aches and nasal symptoms. (took Tylenol) 09/22/2023  He is fine now.  He said the reactions are from the RSV Patient received Flublok in 08/30/2021 and 09/28/2022 without any complication.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Headache, severe muscle aches and joint pain, diarrhea, chills and swelling and redness at injection site  Took tylenol to reduce the joint and muscle pain and headache. Symptoms resolved the next day
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Headache, severe muscle aches and joint pain, diarrhea, chills and swelling and redness at injection site  Took tylenol to reduce the joint and muscle pain and headache. Symptoms resolved the next day
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: pt experienced severe pain in the right arm a couple hours after shingrix administration. Pt said they started to "ache all over" and it was followed by severe nausea, vomiting and diarrhea. Called pharmacy on 9/23/23 to report symptoms. pt said arm is still very sore and ache all over but the vomiting and diarrhea stopped. Pt did not think they needed to see a physician since symptoms are starting to improve. pt has hx of shingles in the past with last outbreak 3 months ago per patient.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Laboratory test abnormal, Rash, Urticaria
Clinical narrative: Developed hives itching and rash all over. Have since received diagnosis of chronic spontaneous urticaria, taking xolair to control it.  Dr says no more COVID vaccinations
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Herpes zoster, Psoriasis
Clinical narrative: Approxiamately 6 months after shjot I developed Shingles on my scalp and Scalp Psoriasis. I nevered had any signs of shingles and scap psoriasis in my life. Still struggling with it. Just recieve the additional booster on Sept 21, 2023. Just keep on getting the shots hoping one of them will adjust my immune system to get rid of these things. When I asked my doctors if the Covid shots caused this outbreak, they where reluctant to admit it but said it was a possibility. Primary Care Physiscan and dermatologist.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinsonism
Clinical narrative: Development of Parkinsonism, ongoing follow-up to determine if PD or atypical Parkinsonism
Age: 92.0
Sex: M
Vaccine: FLU4
Symptoms: HIV test, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Injury associated with device
Clinical narrative: accidental needle stick in provider after vaccination given .
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Fever 100 degree, chills, muscle pain, diarrhea, headache,, fatigue
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever 100 degree, chills, muscle pain, diarrhea, headache,, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: redness and pain at the shot site. it?s about a 2 inch circle. feels a little itchy. That?s all?no other symptoms. it?s still itchy and red today 16 hrs later but i feel otherwise normal.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Urticaria
Clinical narrative: Hives on neck and chest Throbbing headache
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: left thigh, red, hot, and painful. induration. approx 10cm
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient given flubok. No adverse reaction after receiving injection. She should have received fluzone for her age according to CDC guidelines.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Hyperhidrosis, Syncope, Visual impairment
Clinical narrative: Severe diarrhea event followed by sweating, degradation of vision and fainting. Occurred at approximately 2 a.m. Slept on bathroom floor for indeterminate length of time. Woke up dripping sweat on the floor.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Malaise, Nasal congestion, Pain
Clinical narrative: 9/23/23 Resident reports feeling unwell, general fatigue, body aches and nasal congestion.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 9/23/23 Resident reports feeling unwell, general fatigue, body aches and nasal congestion.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Patient contacted the pharmacy the day after she received her shot that she had fever/chills/extreme nausea. She reported that it had started around 11 am that day. Advised patient to take anti-pyrogenic medication and rest and to follow up with either the pharmacy or her physician if her symptoms did not resolve within approximately 24-48 hours. Patient has not yet contacted the pharmacy to follow up at this point but asked that her symptoms be reported.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incomplete course of vaccination, Product availability issue
Clinical narrative: Administered covid bivalent unnecessarily. The FDA pulled the bivalent covid vaccine from the market in the middle of my daughter's vaccination. My daughter received the first dose of the covid bivalent vaccine and we schedule her second. Our appointment for the second dose was canceled a few days prior because the FDA pulled the bivalent vaccine from the market without any recommendations or alternatives. As parents we have been trying to do what is best for our daughter, but the government makes it tougher and tougher. We wanted to get our daughter vaccinated finally and tried, as that is the suggestion of most doctors and the government so why would they pull the vaccine from market and not allow children in the middle of vaccination to receive their second or final doses and get fully vaccinated. This is ridiculous isin't something better than nothing. Further the newest vaccine is not available and is not yet fully tested, but approved only for emergency use for children. To make it even worse the FDA made these changes and has never tested the effectiveness or safety of administering the bivalent vaccine with the newest vaccine so you have no clue whether or not this will increase any risks or whether it will be effective at all. This is sad, what type of circus is being run. No common sense. Our daughter today has also missed her window to get a second dose as it should be administered within 8 weeks, but who can we complain to...the government. Our daughter continues to be a high risk for covid going into the fall and unable to get fully vaccinated because the FDA does not know what they are doing. What a joke!
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Last year patient had a reaction to the vaccine in his upper left arm. It was swollen, warm when palpating and minimal mobility at right elbow. He also had very itchy skin. Yesterday he was given a flu shot in his right thigh and is having the same reaction. Red, swelling, and guarding leg, except no itching this time.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching
Age: 73.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Hypotension, Laboratory test normal, Loss of consciousness, Syncope
Clinical narrative: Received the vaccines at about 10.45 AM was ok until evening then started feeling Dizzy and light headedness, after dinner felt dizzier and passed out at the counter, wife was beside him and able to hold him and called 911. Symptoms looks like Vasovagal syncope.
Age: 73.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Chills, Injection site pruritus, Injection site warmth, Migraine, Nausea
Clinical narrative: PATIENT REPORTS WAKING UP THE NEXT MORNING WITH MIGRAINE, FULL BODY ACHES, CHILLS, NAUSEA WHICH LASTED FOR 12 HOURS PRIOR TO FEELING BETTER.  PATIENT BELIEVES THAT THIS WAS FROM THE RSV AND NOT BOOSTRIX SINCE ALL HER SYMPTOMS WERE SAME AS THOSE LISTED FOR RSV.  PATIENT DID NOT TAKE ANY MEDICATIONS FOR SYMPTOM CONTROL.  ALSO, ITCHING AND WARM TO TOUCH AT THE INJECTION SITE WITH STARTED ON MONDAY (3 DAYS) AFTER RSV AND RESOLVED ON IT'S OWN IN 5 DAYS.
Age: 73.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Pain
Clinical narrative: PATIENT REPORTS WAKING UP THE NEXT MORNING WITH MIGRAINE, FULL BODY ACHES, CHILLS, NAUSEA WHICH LASTED FOR 12 HOURS PRIOR TO FEELING BETTER.  PATIENT BELIEVES THAT THIS WAS FROM THE RSV AND NOT BOOSTRIX SINCE ALL HER SYMPTOMS WERE SAME AS THOSE LISTED FOR RSV.  PATIENT DID NOT TAKE ANY MEDICATIONS FOR SYMPTOM CONTROL.  ALSO, ITCHING AND WARM TO TOUCH AT THE INJECTION SITE WITH STARTED ON MONDAY (3 DAYS) AFTER RSV AND RESOLVED ON IT'S OWN IN 5 DAYS.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy spot size of baseball about 1 inches below injection site
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Cardiac disorder, Chest discomfort, Condition aggravated, Cough
Clinical narrative: Chest and heart congestion, chest tightness, coughing, nausea, sleeping difficulties, diarrhea, weakness, flare up of acid reflux, and extreme muscle fatigue and pain making it difficult to walk last 2 to 3 days. She rested alot and  is finally feeling back to normal 7 days later.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Feeling abnormal, Gait disturbance, Gastrooesophageal reflux disease, Insomnia
Clinical narrative: Chest and heart congestion, chest tightness, coughing, nausea, sleeping difficulties, diarrhea, weakness, flare up of acid reflux, and extreme muscle fatigue and pain making it difficult to walk last 2 to 3 days. She rested alot and  is finally feeling back to normal 7 days later.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Muscle fatigue, Myalgia, Nausea, Respiratory tract congestion
Clinical narrative: Chest and heart congestion, chest tightness, coughing, nausea, sleeping difficulties, diarrhea, weakness, flare up of acid reflux, and extreme muscle fatigue and pain making it difficult to walk last 2 to 3 days. She rested alot and  is finally feeling back to normal 7 days later.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Pallor, Tremor
Clinical narrative: Dizziness Paleness Weakness Shaking
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Sensory disturbance, Syringe issue, Underdose
Clinical narrative: When injection was being given, I felt a burst of cold liquid on my arm.  I assumed it was blood, but it was the vaccine dripping down my arm.  The pharmacist started blotting it up and said it had happened to her once before in a nursing home setting.  She said it might not have been screwed on tight enough, (it wasn?t a traditional syringe, but rather the retractable needle type).  I was concerned about how much of the vaccine didn?t get into my arm and she said just a tiny amount would be sufficient.  I have no soreness or redness in my arm ? which I always have with vaccinations.  I also got a Fluzone 65+ in my other arm at the same time, which now presents with the usual soreness and redness.
Age: 77.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Rash
Clinical narrative: rash on face 24 hours after vaccination
Age: 71.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Spoke w/ patient. She received Fluzone HD and Prevnar20 on the same arm on 9/19. She wanted them in the same arm because she didn't want both arms to be sore. She says she began having soreness later that day and it progressed to a stiff neck (she's having trouble moving the neck). It's begun to get better, but she wasn't sure if it was related to the vaccination. We discussed that going forward, we should avoid more than 1 vaccine at a time and possibly consider Flublok or regular dose Fluzone instead of Fluzone HD. She said she just wanted to report it, is not seeking any compensation or further care.
Age: 75.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: patient came in tuesday to report that the saturday/sunday after receiving the RSV vaccine on 9/07 her Right Arm that she received the RSV vaccine in became, red, itchy and warm. Upon looking at the arm when arrived - it was slightly red and looked raised.  Patient said she applied Ice and took a benadryl. She did not receive both vaccines in the same arm.  I told patient noticed that the redness started to travel that it could be cellulitis and would need an antibiotic from the doctor office.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Painful very large swelling in left armpit against breast (lymph)
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: Fevers, sore arm, rash to left arm, headache, shivers, shaking
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Fevers, sore arm, rash to left arm, headache, shivers, shaking
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Flushing
Clinical narrative: Patient received flu vaccine in left arm...moved to right arm to administer arexvy.  Within 5 seconds of administration patient complained of dizziness and flushing type feelings.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Balance disorder, Bedridden, Erythema, Headache
Clinical narrative: First 12 hrs, normal arm soreness/redness. Second 12 hrs, severe upset debilitating  equilibrium, bedridden. Third 12 hrs, mild headache.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: First 12 hrs, normal arm soreness/redness. Second 12 hrs, severe upset debilitating  equilibrium, bedridden. Third 12 hrs, mild headache.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient complains of redness and swelling at injection site all the way down to her elbow. That evening and all of last night her right hand from the wrist down to her fingertips were numb and painful. She experienced nausea as well.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient complains of redness and swelling at injection site all the way down to her elbow. That evening and all of last night her right hand from the wrist down to her fingertips were numb and painful. She experienced nausea as well.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Biopsy skin, Erythema, Full blood count, Headache, Pain in extremity
Clinical narrative: Sore left arm and red streaks down left arm for first 8 days after shot.  Full body rash began on day 9 after shot (Sept 9th) and is continuing as of today. .  Headache began on day 17  after shot (Sept 16th) and is continuing as of today.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Sore left arm and red streaks down left arm for first 8 days after shot.  Full body rash began on day 9 after shot (Sept 9th) and is continuing as of today. .  Headache began on day 17  after shot (Sept 16th) and is continuing as of today.