chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Liquid product physical issue
Clinical narrative: I was preparing two doses of Abrysvo for two patients. I injected the sterile water through the provided adapter as usual (and recommended in product labeling), gently swirled the vials, and let the vials stand while I prepared the other immunization supplies. When I prepared to draw the reconstituted vaccine into the syringe, I noticed something in the liquid. I thought it was air bubbles at first, but I held the vials up to light and gently tilted them back and forth and confirmed that there was indeed particulate matter in the vaccine following reconstitution. The vials had been sitting reconstituted for about five minutes by now and all other Abrysvo doses I have prepared have dissolved very readily and I have never had issues with particulates. I repeated this with another two doses and the same thing happened. (This looked like anything from very tiny grains of sand to flakes resembling white paint). I tried again and finally got two vials that allowed complete dissolution. I let the four vials with particulates sit at room temperature since about 2:30-3PM (Currently 8:22PM) and just checked them and one appears to have some small particulate matter remaining even after sitting for hours. Two vials have potentials particulate matter 00 if they do, it's very small. One vial seems to have cleared up. All vials are from the same lot number and have the same expiration date. They came from different boxes but all have been store appropriately. (Lot HF5014 Ex[ 02-2025 for the vaccine and Lot GY5655 Ex[ 02-2025 for the sterile water diluent) I am not sure if the particulate matter was simply undissolved powder or if it was something else. The issue seems to have somewhat resolved but it took longer than the time to reconstituted vaccine can sit before administration.
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA". Clinical course: My husband had a TIA (Transient ischemic attack) right after getting the Covid shot. No residuals now.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough Dose 1: Pfizer, EN6209, 3/9/2021 Dose 2: Pfizer, ER8730, 3/30/2021 Dose 3: Moderna, No lot # given, 10/19/2021
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug ineffective
Clinical narrative: ineffective vaccine
Age: 59.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Leg amputation
Clinical narrative: Hospitalized for BKA then transferred to another hospital. Found to have asymptomatic Covid infection.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administration error
Clinical narrative: Administration Error
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out approximately 10 minutes after vaccine was administered
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given dose of flublok when she needed typhoid vaccine. Pt reported she already had the flu shot for the season. No adverse reaction
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Severe pain in arm.   Fever.  Headache.  Nausea.  Tingling in hands.  Vomiting
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe pain in arm.   Fever.  Headache.  Nausea.  Tingling in hands.  Vomiting
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administration error
Clinical narrative: Administration Error
Age: 11.0
Sex: F
Vaccine: HPV9, MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menquadfi was ordered for patient but pt received MMRV, parent's never reported any adverse events. This error was not know till now.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site warmth
Clinical narrative: patient informed temperature hot at injection site, and little bruise at injection site,  patient take ibuprofen and also recommend naproxen and heat pad, after followup with patient patient informed her bruise is getting better, advised to continue applying hot compress and take naproxen or ibuprofen
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Palpitations
Clinical narrative: Chest pain, palpitations, dizziness that is intermittent developing about a week after vaccination
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Immunisation reaction, Pyrexia, Rash
Clinical narrative: Fever 102.8 on 8/2/2023, fever 100.8 on 8/3/2023,  rash developed on 8/2/2023 to nose and face, and then down arms and chest, mother notes no seizure activity noted
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient experienced a headache and nausea/vomiting . Patient advised to take tylenol and increase fluids
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever (100.6), chills, muscle aches, dizziness , fatique
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hormone level abnormal, Thyroid hormones test
Clinical narrative: After I had my second Covid vaccine, I experienced amenorrhea.  My doctor had advised that this was being reported by women and research showed my menstural cycle should return to normal within a few months but I have not had a menstural cycle since.  Menopause age for maternal side ranges from 56-62 (mother, grandmother and great grandmother) and no other illnesses were identified.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Rash, Sleep disorder
Clinical narrative: Child received vaccine on 8-18-23 at her pediatrician's office. She came home and complained of being tired. She did not rest well that night, as well as the following 2 nights. Monday morning, she woke up with a rash on her arms and some bumps on her legs, and she was scratching them, making her arms red. The rash/bumps continued to grow and cover more surface area. Very noticeable by Wednesday on both arms and legs, and she was complaining that they hurt. 8-25-23 she went to the dermatologist, where he confirmed it was a reaction to the MMR vaccine. She was prescribed Triamcinolone Acetonide Cream 0.1%
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, painful, hot to the touch
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient experienced localized edema and redness around injection site. This presented the following day. Started small and then grew. At time of report the edema is at 7 cm by 8 cm. Patient did not present nor report and rapid heart beating and or shortness of breath.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient complained of Rt arm pain at recent PCP visit. States this has been ongoing since Flu vaccine admin on 3/7/23.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Redness with induration, swelling, itchy, and warm to the touch
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CLIENT HAD TWO DOCUMENTED DOSES OF VARICELLA AND WAS GIVEN A THIRD DOSE-NO ADVERSE REACTION
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray normal, Chest discomfort, Differential white blood cell count normal, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Great Heaviness in chest, sweating and nausea. Waited a while to see if it would improve.  Got a little lighter but still painful so went to  ER.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Full blood count normal, Hyperhidrosis, Lipase normal, Liver function test normal, Metabolic function test normal
Clinical narrative: Great Heaviness in chest, sweating and nausea. Waited a while to see if it would improve.  Got a little lighter but still painful so went to  ER.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Pain, Troponin T normal, Urine analysis normal
Clinical narrative: Great Heaviness in chest, sweating and nausea. Waited a while to see if it would improve.  Got a little lighter but still painful so went to  ER.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Tinnitus
Clinical narrative: Parent spoke to after hours provider 9/8/23, c/o severe arm pain, dizziness, ringing in the ears. Was advised to continue icing the arm, use tylenol or ibuprofen for pain, rest, fluids, preferably with electrolytes.  Patient will be seen in clinic this afternoon for recheck. Mom reportd this morning that the dizziness and ringing in her ears stopped. Patient was still having a sore arm and a little swelling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in ears
Age: 30.0
Sex: M
Vaccine: ANTH, JEV1, MNQ, RAB, TYP, YF
Symptoms: Inflammation, Rash erythematous, Rash papular
Clinical narrative: red, inflamed, raised rash to left tricep
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child present to clinic 9/5/23 for 15 months well and received above listed vaccines. 9/6/2023 evening developed area of erythema and some swelling without whelps to right upper anterior thigh at location around vaccines. Has developed to larger area over night.
Age: 47.0
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: Abdominal distension, Arthralgia, Fatigue, Myalgia
Clinical narrative: Chronic fatigue, chronic debilitating muscle and joint pain, bloating
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Drooling, Malaise, Nasal congestion
Clinical narrative: -patient developed nasal congestion, constant right sided drooling and malaise 3 hours after vaccination
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Death, Gait inability, Limb discomfort, Malaise
Clinical narrative: 1st injection hit her hard. 2nd injection really took her down. I took her for a walk, sat her down outside, and then suddenly she couldn't walk. I took her inside and sat her down. After that point, her thyroid meds went from 50-150micrograms and her blood pressure meds were raised as well. 4 months this went on. She had hospice care. Things weren't well. I took her to church on a Sunday and she had  a good day, saw her friends in the park. The next Sunday, I got her up for church and she threw up and was unwell. She went back to bed andShe lost blood flow in her left leg through the day, it was cold to the touch and she was having discomfort/pain in the leg.  Then the hospice nurse came and administered morphine around 11am-noon.   By 4:30 am she passed away, 9/9/2021.  She had been very active, still doing the books and working and writing her checks for monthly bills. After the vaccines her BP tripled and thyroid went out of wack and that was it.
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Poor peripheral circulation, Thyroid disorder, Vomiting
Clinical narrative: 1st injection hit her hard. 2nd injection really took her down. I took her for a walk, sat her down outside, and then suddenly she couldn't walk. I took her inside and sat her down. After that point, her thyroid meds went from 50-150micrograms and her blood pressure meds were raised as well. 4 months this went on. She had hospice care. Things weren't well. I took her to church on a Sunday and she had  a good day, saw her friends in the park. The next Sunday, I got her up for church and she threw up and was unwell. She went back to bed andShe lost blood flow in her left leg through the day, it was cold to the touch and she was having discomfort/pain in the leg.  Then the hospice nurse came and administered morphine around 11am-noon.   By 4:30 am she passed away, 9/9/2021.  She had been very active, still doing the books and working and writing her checks for monthly bills. After the vaccines her BP tripled and thyroid went out of wack and that was it.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Bilateral foot neuropathy
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: Pentacel was given in a partial dose. Only the HIB component was given with 1% Lidocaine.  Patient had no adverse reactions.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection.
Age: 68.0
Sex: F
Vaccine: HEPAB, RSV
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: She got her vaccine, it hurt a little bit, was burning.  It was more painful going in than the Heb A-B that she got on her left arm, and she had no problem with her left arm.  As the day went on it started to swell and get warm.  She had a bit of tiredness with it, nausea and a headache.  As the days went on since then she has gotten quite swollen on the arm, red and itchy and sore.  She has been taking her Tylenol with Codeine that she takes for her spine and neck, she did not take an antihistamine.  It's not a bad reaction for her as when she gets a bee sting or penicillin she gets anaphylaxis.  She saw the pharmacist and wanted her to see the reaction and she knew about it, and she reported it to VAERS on it.
Age: 68.0
Sex: F
Vaccine: HEPAB, RSV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: She got her vaccine, it hurt a little bit, was burning.  It was more painful going in than the Heb A-B that she got on her left arm, and she had no problem with her left arm.  As the day went on it started to swell and get warm.  She had a bit of tiredness with it, nausea and a headache.  As the days went on since then she has gotten quite swollen on the arm, red and itchy and sore.  She has been taking her Tylenol with Codeine that she takes for her spine and neck, she did not take an antihistamine.  It's not a bad reaction for her as when she gets a bee sting or penicillin she gets anaphylaxis.  She saw the pharmacist and wanted her to see the reaction and she knew about it, and she reported it to VAERS on it.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Altered state of consciousness, Asthenia, Dizziness, Heart rate decreased
Clinical narrative: 1min after vaccination patient experienced syncope and lost consciousness for <2 seconds. Pt then felt nausea, lightheaded, pulse slow and weak, skin pale. RN placed cool towel on back of neck and forehead. RN assisted client to supine position with elevated legs. Pt started to feel better after 3 minutes, then abdominal cramping started. Pt states cramping was moderate/severe and felt need to go to bathroom for a bowel movement. Pt assisted to bathroom and nurse at other side of door for easy assistance if she felt weak/or lightheaded. Pt also had alarm button w/in reach should assistance be needed. Pt continued to have cramping for 15 minutes. She requested to lay down in bathroom as she was frequently needing to have bowel movement, however was still feeling weak. Nurse at patient's side while laying down continuing to monitor status. Pt BP taken at intervals. Pulse after syncope was 52 and weak. Pulse remainder of recovery time 60-62 and strong. Patient given warm pack to place on abdomen for cramping and felt better with heat applied. After cramping resolved patient assisted to patient room and layed supine for 5 minutes. After full recovery pt then sat up on bed for further monitoring. Pt then moved to standing position with no return of symptoms. Patient felt she was ready to leave and was going to be one block away going to work. She states she still wanted to go to work, but when she arrived to work she would eat, hydrate, and sit for 20-30 minutes.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pallor
Clinical narrative: 1min after vaccination patient experienced syncope and lost consciousness for <2 seconds. Pt then felt nausea, lightheaded, pulse slow and weak, skin pale. RN placed cool towel on back of neck and forehead. RN assisted client to supine position with elevated legs. Pt started to feel better after 3 minutes, then abdominal cramping started. Pt states cramping was moderate/severe and felt need to go to bathroom for a bowel movement. Pt assisted to bathroom and nurse at other side of door for easy assistance if she felt weak/or lightheaded. Pt also had alarm button w/in reach should assistance be needed. Pt continued to have cramping for 15 minutes. She requested to lay down in bathroom as she was frequently needing to have bowel movement, however was still feeling weak. Nurse at patient's side while laying down continuing to monitor status. Pt BP taken at intervals. Pulse after syncope was 52 and weak. Pulse remainder of recovery time 60-62 and strong. Patient given warm pack to place on abdomen for cramping and felt better with heat applied. After cramping resolved patient assisted to patient room and layed supine for 5 minutes. After full recovery pt then sat up on bed for further monitoring. Pt then moved to standing position with no return of symptoms. Patient felt she was ready to leave and was going to be one block away going to work. She states she still wanted to go to work, but when she arrived to work she would eat, hydrate, and sit for 20-30 minutes.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: pt developed alopecia and saw dermatologist who believes may have been related to hpv vaccination.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: gave extra dose of polio
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Differential white blood cell count, Electromyogram, Electrophoresis protein
Clinical narrative: Bilateral stocking neuropathy
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count, Metabolic function test, Neuropathy peripheral, Protein albumin ratio, Red blood cell sedimentation rate
Clinical narrative: Bilateral stocking neuropathy
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Viral test, Vitamin B12
Clinical narrative: Bilateral stocking neuropathy
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient called next day to report that she is not feeling good, has shivers, chills, fever, and requested appropriate agency to reduce vaccine dose.
Age: 1.25
Sex: M
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered DTAP, for a 15 month patient. Patient was suppose to get DTAP,HIB, and Varicella. I confused the DTAP with TDAP. I administered TDAP to the patient on the right thigh and HIB on the left thigh. Varicella was not available at the time. An additional MA Verified me and did not catch the mistake either. These vaccines where administered on 09/01/2023 and the vaccine error was noticed on 09/08/2023. Mother has not reported any adverse events.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives approx 20 min after vaccine was given (pt did not leave the exam room). Benadryl given 9 ml po.  Hives resolved 15-20 min after Benadryl. Pt acting normal.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 9/7/2023.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: localized rash to chest per mom
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with 1 booster
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Stiffness in the upper body, headaches
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Heart rate irregular
Clinical narrative: IRREGULAR HEART BEATS AND A-FIB
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Echocardiogram, Electrocardiogram, Laboratory test, Pain
Clinical narrative: No adverse events from the actual injection, but developed bilateral PEs.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Ultrasound Doppler
Clinical narrative: No adverse events from the actual injection, but developed bilateral PEs.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine administered, should have received Bivalent adult dose (dark blue cap, 0.25ml), no adverse effect reported. Patient has since received correct vaccine at another pharmacy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Product preparation error, Pyrexia
Clinical narrative: Patient had received 2 diluents instead of the diluent and powder and reported side effects of fever, arm pain and fatigue.
Age: 28.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash
Clinical narrative: Patient with complaint of pruritis and rash present on neck, upper chest, and right axilla 35 minutes after vaccine dose. Patient denied shortness of breath. No blisters or drainage present with rash. Patient was ordered and administered Benadryl 50mg PO x 1. Within 45 minutes, patient reported feeling better, and that pruritis had subsided. Medical provider placed standing order for EpiPen. Patient requested EpiPen appx. 32 hours after vaccine administration due to return of itching and rash, which was administered by nursing staff. Medical provider reported verbally that dose was effective appx. 20 hours later.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 26.0
Sex: M
Vaccine: HEP, HEPAB, MMR
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Student was given Twinrix and Hep B instead of Hep A and Hep B. Extra Hep B dose given.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 6-7 hours after vaccine began to get rash on torso, upper right thigh and calves. Itchy red bumps. Treated with multiple antihistamines and prednisone. Three days later some rashes starting to fade.  Rash on right thigh got a little worse.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patient reported hives and swelling of the hands to the pharmacy on 9/8/23 that began in the morning the day after receiving the vaccine. She first used benadryl gel but said that did not help so she took 2 benadryl tablets and 1 pepcid tablet which helped. It is mostly resolved now.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: syncope after the shot
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bedridden, Cerebrovascular accident, Thrombosis
Clinical narrative: Clotted blood and four stroke. Currently my mother is bedridden and cannot speak. As time passes, the situation becomes very sad.
Age: 67.0
Sex: F
Vaccine: FLU4, UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: Patient was offered to be vaccinated against the Flu by the technician and she accepted. she also requested to have a covid booster. the FLU shot was processed through her insurance and a paid claim obtained. The pharmacist administered the Flu on the left arm and when trying to administer the covid on the right arm realized that she had  a bandage on. The pharmacist then asked why the bandage, it is then that she said she had a flu shot . on verifying from her profile, it was discovered that she had a flu on 09/03/23.  when the pharmacist tried to explain that she has been given two shots within a week, she seemed less bothered and left.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Patient reported lingering swelling at the injection site several days following injection. She also reported pain that radiated up into the shoulder causing restricted range of motion.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Vaccination error
Clinical narrative: Vaccine error: patient was listed in system twice, so when staff pulled the immunization history this vaccine was not listed on the profile, but it was listed on the other immunization profile. This vaccine was given twice, a month apart, in error.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood oestrogen increased, Blood testosterone decreased, Cognitive disorder, Contusion
Clinical narrative: Loss of feeling and range of motion in left foot along with phantom pins and needles pain in both legs. Shortness of breath, unable to climb stairs Strange bruising on legs and feet Lethargic, lack of energy Cognitive issues Low testosterone high estrogen discovered in 2023 Symptoms persistent until mid 2023 after addressing hormone levels and taking Nitric Oxide supplements.  Symptoms still exist but less pronounced.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Lethargy, Mobility decreased, Paraesthesia
Clinical narrative: Loss of feeling and range of motion in left foot along with phantom pins and needles pain in both legs. Shortness of breath, unable to climb stairs Strange bruising on legs and feet Lethargic, lack of energy Cognitive issues Low testosterone high estrogen discovered in 2023 Symptoms persistent until mid 2023 after addressing hormone levels and taking Nitric Oxide supplements.  Symptoms still exist but less pronounced.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Phantom limb syndrome
Clinical narrative: Loss of feeling and range of motion in left foot along with phantom pins and needles pain in both legs. Shortness of breath, unable to climb stairs Strange bruising on legs and feet Lethargic, lack of energy Cognitive issues Low testosterone high estrogen discovered in 2023 Symptoms persistent until mid 2023 after addressing hormone levels and taking Nitric Oxide supplements.  Symptoms still exist but less pronounced.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE case; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 21-JUL-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously, lot number x006983 with expiration date 07-MAR-2025 (dosage regimen was not reported). The vaccine had undergone a temperature excursion (TE) at a temperature of -12.48 degrees Celsius for 1 hour and 30 minutes with 0 seconds, there were no previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient that received PROQUAD during supported TE; This spontaneous report was received from a medical assistant concerning a 5-year-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On unknown date in August 2023, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, lot number X009130 with expiration date 24-SEP-2024, administered as prophylaxis (dosage regimen and route of administration were not reported). The vaccine had undergone a temperature excursion (TE) at a range of 6 to 14 degrees Fahrenheit for 21 hours, 48 minutes and 0 seconds (Product storage error).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA010852:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient that received VARIVAX during Supported TE; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On unknown date in August 2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot number W006413 with expiration date 23-FEB-2024, administered as prophylaxis (dosage regimen and route of administration were not reported). The vaccine had undergone a temperature excursion (TE) at a range of 6 to 14 degrees Fahrenheit for 21 hours, 48 minutes and 0 seconds (Product storage error).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA010842:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; inadvertent administration of expired PNEUMOVAX 23 to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-AUG-2023, the patient was vaccinated inadvertently with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #U034712, expiration date: 30-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).  There were no adverse events reported (no adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported; PROQUAD was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported; This spontaneous report was received from a licensed practical nurse referring to a 5-year-old patient of unknown age and gender. The patient's current conditions, medical history or concomitant therapies were not reported.  On 01-SEP-2023, the patient was vaccinated with a dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis, lot# X013909, expiry date: 10-NOV-2024, recombinant Human albumin (rHA) (dose, and route of administration were not provided) after a temperature excursion (TE) (product storage error) of 6°F for 20 minutes. There was no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient was inadvertently given a dose of MMR II  after it suffered a TE; This spontaneous report was received from an officer manager referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters/ series (lot #U039907 with an expiration date on 16-DEC-2023), administered for prophylaxis (strength, and route of administration were not provided) after it suffered temperature excursion.  The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to a temperature excursion of 50 degrees Fahrenheit (°F) during a time frame of 0 hours, 36 minutes, 0 seconds.  No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA001807: US-009507513-2309USA001850:
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No adverse event; HCP calling to report expired PROQUAD was administered to a patient inadvertently. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the vaccine. No additional AE/PQC.; This spontaneous report as received from a medical assistant refers to a 2-year-old male patient. The patient's medical history, concurrent conditions were not reported. Concomitant therapies included STERILE DILUENT.  On 05-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin)(PROQUAD), lot# W004026, expiration date: 02-AUG-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  It was reported that expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was administered to a patient inadvertently (expired product administered). The vaccine had no previous temperature excursions. No side effects reported with the vaccine. No additional adverse event reported (no adverse event).  Lot number W004026 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with albumin status rHA (recombinant Human albumin)(PROQUAD).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Medical assistant calls to report AE.  GARDASIL 9 given during a temperature excursion.  No further AE.  No PQC.  GARDASIL 9 was evaluated as supported see TE case 02465982.  TEs were on Aug 2, 2023 and Aug 4, 2023.  Called in on 9/6/2023.  AE cases; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #w026152, expiration date: 29-JAN-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On 02-AUG-2023, and 04-AUG-2023 administered dose of vaccine was exposed to the temperature excursion (product storage error). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report that a dose of PNEUMOVAX 23 that expired on 8/29/2023 was given to a patient on 9/6/2023. HCP reports no previous TEs. Permission to contact HCP given. No further AE details. No PQC.; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #U032086, expiration date: 29-AUG-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP calling to report she inadvertently administered PROQUAD and VARIVAX together. No side effects were reported. No additional information provided. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to an 1-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / first dose, lot #X011110, expiration date: 18-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). On 06-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / 1st dose, lot #W012163, expiration date: 12-APR-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called to report that she inadvertently administered PROQUAD and VARIVAX together. No side effects were reported. No additional information provided. No additional AE/PQC.  Lot Number W012163 is valid for Varivax. Lot Number X003061 is valid for 9395. Lot Number X011110 is valid for Proquad. Lot Number X011110 is rHA.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: temperature issue with Bexsero it was out of range for eight hours (67.5 high) (46.6 low) and also gave info from a previous temperature excursion; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: temperature issue with Bexsero it was out of range for eight hours (67.5 high) (46.6 low) and also gave info from a previous temperature excursion).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The provider called from to report a temperature issue with Bexsero it was out of range for eight hours (67.5 high) (46.6 low) and also gave info from a previous temperature excursion a power outage that caused the vaccine to become to warm (minimum temperature 46.2) (maximum temperature 62.6), which led to incorrect storage of vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 5 days afterwards; This non-serious case was reported by a consumer and described the occurrence of covid-19 virus test positive in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included levothyroxine, desvenlafaxine, acetylsalicylic acid (Aspirin) and nirmatrelvir + ritonavir (Paxlovid).   On 25-AUG-2023, the patient received Arexvy (intramuscular) .5 ml. On 28-AUG-2023, 3 days after receiving Arexvy, the patient experienced covid-19 virus test positive (Verbatim: tested positive for Covid 5 days afterwards).  The outcome of the covid-19 virus test positive was not resolved.   It was unknown if the reporter considered the covid-19 virus test positive to be related to Arexvy.     It was unknown if the company considered the covid-19 virus test positive to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-SEP-2023 It was reported that 5 days after receiving Shingrix shot, the patient tested positive for Covid. The was currently taking Paxlovid for her Covid.  The patient stated that she was just wondering if that made her Arexvy injection less effective for preventing RSV vaccine. The patient mentioned Thank you in advance for responding and that she had paid dollar 295.60 for the shot, and would like to thought it was money well spent.
Sex: U
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Hurt as much as the flu shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain.   On 30-AUG-2023, the patient received RSV vaccine. In AUG-2023, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: Hurt as much as the flu shot).The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to RSV vaccine.   It was unknown if the company considered the pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 31-AUG-2023 This case was reported by a patient via interactive digital media. The patient just received his/her RSV shot the day before reporting and told that it hurt as much as the flu shot, might be more.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 20 year old patient that received a pediatric dose of ENGERIX-B vaccine; 20 year old patient that received a pediatric dose of ENGERIX-B vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of adult use of a child product in a 20-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 20 year old patient that received a pediatric dose of ENGERIX-B vaccine) and underdose (Verbatim: 20 year old patient that received a pediatric dose of ENGERIX-B vaccine).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The physician on behalf of patient reported that he/she administered the pediatric dose of  Engirix-B vaccine (manufactured by Glaxosmithkline). The patients' demographics were unknown. No additional information was provided. The 20 year old patient administered pediatric ENGERIX-B which led to Adult use of a child product and underdoes. Consent to contact reporter was unspecified.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: freezing cold; shivering; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-AUG-2023, the patient received the 2nd dose of Shingles vaccine. On 27-AUG-2023, less than a day after receiving Shingles vaccine, the patient experienced feeling cold (Verbatim: freezing cold) and shivering (Verbatim: shivering).  The outcome of the feeling cold and shivering were not resolved.   It was unknown if the reporter considered the feeling cold and shivering to be related to Shingles vaccine.     It was unknown if the company considered the feeling cold and shivering to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-SEP-2023 The patient self-reported this case. It was reported that the patient got his/her Abrysvo (RSV vaccine) shot, and 2nd Shingles shot on 27 August 2023, and less than a day after vaccinations, was freezing cold and shivering even though it got up in the 100s on 27 August 2023. It was unknown if the reporter considered the adverse events related to Abrysvo.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain
Clinical narrative: Bone pain; This non-serious case was reported by a physician and described the occurrence of bone pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone pain (Verbatim: Bone pain).  The outcome of the bone pain was resolved.   It was unknown if the reporter considered the bone pain to be related to Shingrix.     It was unknown if the company considered the bone pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 It was reported that patient started feeling bone pain after the shot. The time until the bone pain started and stopped was unknown.