chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic spontaneous urticaria, Mechanical urticaria, Pruritus, Skin swelling, Urticaria
Clinical narrative: 11 days after the vaccine I woke up itchy head to toe. When I itched my skin I would form hives and swollen scratch lines. I was diagnosed with dermagraphia and chronic spontaneous urticaria and possibly MCAS.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache
Clinical narrative: Extreme fatigue, mild headache, aching joints, loss of appetite.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Restart of menses after > 8 years of absence.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time shortened, Alopecia, Anal incontinence, Antinuclear antibody positive, Blood test abnormal
Clinical narrative: I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiolipin antibody positive, Cardiovascular disorder, Erythema, Hyperhidrosis, Hypertonic bladder
Clinical narrative: I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Menstruation delayed, Muscle atrophy, Musculoskeletal stiffness
Clinical narrative: I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic organ prolapse, Raynaud's phenomenon, Sensory disturbance, Skin discolouration, Thrombosis
Clinical narrative: I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis, Weight decreased
Clinical narrative: I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: I?ve had 4 injections. Last one being 10/2022. Left arm injection site periodically (2 a month) becomes sure. This started after second injection. No swelling. Aching soreness. Dr dismisses it when mentioned but don?t understand why I continue to experience.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered a Moderna Bivalent Booster dose of  0.25ml. They have only had 1 Pfizer Monovalent dose and have not completed the primary series.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated. Dose administered. Offered revax
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Patient had soreness/pain at the injection site the night of the injection. Still have pain at the same site as of today on and off taking motrin and alternating with tylenol. His doctor is aware of the situation.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 10.0
Sex: F
Vaccine: COVID19-2, FLU4, HPV9
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Vaccine was not diluted but administered. No adverse reactions yet.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram normal, Exposure during pregnancy, Tinnitus
Clinical narrative: 37yr old female around 30 weeks pregnant- received my covid booster on 6/12/2022. Developed tinnitus 2 weeks after. Went to ENT and completed audiograms, there is no hearing loss. Improved but not resolved in about 6 months. But then 1/22/2023 (post pardum 3.5months), I received by bivalent pfizer booster and 1 week later the tinnitus worsened greatly, which is why I now know it's from the vaccine which I did not initially know. This is why i'm reporting so late.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration/beyond-use date
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration/beyond-use date
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration/beyond-use date
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Dose administered past expiration/beyond-use date. Per Moderna lot administered maintained activity necessary to protect against SARS-CoV-2 (COVID-19) virus at time of administration. No need to repeat dose per CDC interim recommendation for vaccine administration errors and deviation.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Dizziness, Feeling abnormal, Headache
Clinical narrative: I had already taken my loratadine and I am glad.  My arm started really aching at about noon and moved into my neck and head with the pain, making me unable to concentrate, dizzy and spacey.  When my work shift was done I got on the bus and almost fell asleep but I thought it was the cold outside.  I got home got out of my coat, snowpants and boots and crawled into bed with a monster headache, an arm I couldn't lie down on and chills so bad that my bed shook and I couldn't get warm for about 6 hours about 11:00 pm.  I was dizzy and the room was spinning so I just had a glass of water and went back to bed.  I didn't wake up the next morning until 9:00 am and was still dizzy.  The room stopped spinning about 12:00 noon and I was not nauseous any more, but still dizzy and my whole body ached.  It wasn't like this with the first dose, I just felt a little like I had the flu then.  Good thing I had the day off so I went back to bed until about 6:00 am and went to work.  It took me most of today to feel like usual and well enough to submit this.   I didn't go to the hospital or bother trying because I got both the shingles booster and my tetnus shots on the last day my insurance was active.  No need to call the doctor since my throat did not close.  My face did swell up though, but not enough to warrant going back out in the cold and rack up a hospital bill I can't pay.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Swelling face, Vertigo
Clinical narrative: I had already taken my loratadine and I am glad.  My arm started really aching at about noon and moved into my neck and head with the pain, making me unable to concentrate, dizzy and spacey.  When my work shift was done I got on the bus and almost fell asleep but I thought it was the cold outside.  I got home got out of my coat, snowpants and boots and crawled into bed with a monster headache, an arm I couldn't lie down on and chills so bad that my bed shook and I couldn't get warm for about 6 hours about 11:00 pm.  I was dizzy and the room was spinning so I just had a glass of water and went back to bed.  I didn't wake up the next morning until 9:00 am and was still dizzy.  The room stopped spinning about 12:00 noon and I was not nauseous any more, but still dizzy and my whole body ached.  It wasn't like this with the first dose, I just felt a little like I had the flu then.  Good thing I had the day off so I went back to bed until about 6:00 am and went to work.  It took me most of today to feel like usual and well enough to submit this.   I didn't go to the hospital or bother trying because I got both the shingles booster and my tetnus shots on the last day my insurance was active.  No need to call the doctor since my throat did not close.  My face did swell up though, but not enough to warrant going back out in the cold and rack up a hospital bill I can't pay.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10-week limit
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Contusion, Rash
Clinical narrative: RASH ALL OVER BODY, AND BRUISING
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 103 F fever for 2 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Started to feel ill in the evening after the dose.  Low grade fever at first.  In the middle of the night ran a fever to 100 on Tyelenol.  Couldn't get out of bed the whole next day. Felt weak, light headed, headache, and no appetite.  The fever broke in 24 hours.  Felt tired the following day also.  Took several days to feel back to baseline.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pyrexia
Clinical narrative: Started to feel ill in the evening after the dose.  Low grade fever at first.  In the middle of the night ran a fever to 100 on Tyelenol.  Couldn't get out of bed the whole next day. Felt weak, light headed, headache, and no appetite.  The fever broke in 24 hours.  Felt tired the following day also.  Took several days to feel back to baseline.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Insomnia, Pyrexia
Clinical narrative: I ran a temp of 99.5 which came down to 99 with tylenol. The low grade fever and chills lasted 36 hours. My normal oral temp is 97. Had trouble sleeping. Two weeks later I developed a circular rash on my right arm where the vaccination was given. I am day 3 into the rash which is fading. No treatments were needed for the rash
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood pressure increased, Headache, Oropharyngeal pain
Clinical narrative: Blood pressure went up Joint, Headache Sore throat
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Onset of rash started on face with swelling of the eyebrows, cheeks and onto the neck. She sent pictures to her PCP and was given steroid BID for 7 days. Started a tapering dose of the medication and benadryl as needed. She was seen by Dermatology after steroid treatment. Steroid cream given (hydrocortisone) without improvement. She is using another steroid cream which seems to be working. Rash still present on the cheeks. She is now repeated another round of oral steroids.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Post vaccine patient became lightheaded O: unresponsive x 30 sec; HR 64 regular; O2 99% 1:50 pm BP systolic 100; diaphoretic; pale; RN present 1:55pm - color improving; answering questions correctly O2-4L nasal canuli; EMT RN present applied ice to neck 2:05pm - pt admits to h/o syncope with bld work HR - 68; radial BP 140/100 2:10p called for ambulance, patient denied medical attention. Patient spoke with wife, she'll escort patient home 2:30pm pt sitting comfortably with no problems S: I feel much better O: HR 72 BP 150/110 (radial) RR 12 O2 100% A/P: syncopal episode post vaccination provided H2O / apple juice ice to back of neck elevated legs check BP / HR q 15 min EMT/RN present discharged to wife to home encouraged patient to f/up with primary care MD for routine physical, annual bld work f/u with patient tonight via phone call discharged pt @ 3:30pm to daughter
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt appt for covid (Bivalent) vaccine. Pt in on 2/2/23 for Moderna Bivalent. Card was given to scheduler which showed patient had his first (2) Moderna vaccines in another state and third in this state. First 2 werent in the web so I did not check with scheduler about his vaccine card and I gave a prymary Moderna not Bivalent. So I inadvertly gave prymary Moderna vaccine #4 which should have been a Bivalent Moderna due to not looking at his covid card he had and not rechecking with scheduler here at clinic patient had gotten first 2 Moderna vaccines in another state wich werent in this states web just on patients card.
Age: 1.0
Sex: M
Vaccine: COVID19-2, FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer bivalent given as dose one of COVID-19 series. Mother notified. No adverse reaction noted. Nurse who administered vaccine counseled on CDC covid-10 schedule.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Vaccine was given at 4:38pm 2-3-23, per provider at site, best to wait to call patient next day to confirm any symptoms or adverse reactions noted. Attempted to call patient 3x today, no answer or VM option. Day of, after administration of vaccine patient was asked to wait 15 mins to ensure no adverse reactions, patient left with no symptoms/adverse reactions. Attempted to call patient by reaching mother, however no answer or VM option. I made two attempts on 2-3-23 @ 8:49am and again at 8:50am. Will continue trying later in the day.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Woke up in middle of the night with extreme chills and head, face. Hair completely soaked in sweat. Terrible headache. I thought I had a stroke or something. I was so out of it that I couldn't even figure out how to use my phone to call for help. Then I got the dry heaves for about a half hour. Was sick all day.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Retching, Sleep disorder
Clinical narrative: Woke up in middle of the night with extreme chills and head, face. Hair completely soaked in sweat. Terrible headache. I thought I had a stroke or something. I was so out of it that I couldn't even figure out how to use my phone to call for help. Then I got the dry heaves for about a half hour. Was sick all day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor
Clinical narrative: Shaking woke me up 0400. For next couple hours intermittent shaking then would have shaking less often and Last event time at 1430 pm same day.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, Myalgia, Fever, chills, fatigue, sore and red injection site Narrative:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, chills, fatigue, sore and red injection site Narrative:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: About 12 hours later, extreme heart palpitations. Lasted about 36 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 23Jul2021 at 10:00 as dose 1, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR. Past drug history included: Aspirin, reaction(s): "known allergies ; aspirin". The following information was reported: PALPITATIONS (non-serious) with onset 23Jul2021 at 22:00, outcome "recovered", described as "About 12 hours later, extreme heart palpitations. Lasted about 36 hours.". Therapeutic measures were not taken as a result of palpitations.  Additional information: Patient did not receive any other vaccine in four weeks but received Advair medication within two weeks. Patient did not have covid prior vaccination and was neither tested post vaccination.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Retching, Vomiting
Clinical narrative: Vomiting for 15 minutes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jan2023 at 13:00 as dose 4 (booster), single (Lot number: GK0928) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot number=30135BA, vaccine administration location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot number=EL3249, vaccine administration location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, lot number=EL9264, vaccine administration location: Left Arm), for Covid-19 immunization. The following information was reported: VOMITING (non-serious) with onset 26Jan2023 at 16:00, outcome "recovered" (2023), described as "Vomiting for 15 minutes.". Therapeutic measures were not taken as a result of vomiting.  Additional information: The 'covid prior vaccination', 'covid tested post vaccination', 'other vaccine in four weeks' was reported as 'no'. 'Other medications in two weeks' was reported as 'Yes'.
Age: 70.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting for 15 minutes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jan2023 at 13:00 as dose 4 (booster), single (Lot number: GK0928) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot number=30135BA, vaccine administration location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot number=EL3249, vaccine administration location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, lot number=EL9264, vaccine administration location: Left Arm), for Covid-19 immunization. The following information was reported: VOMITING (non-serious) with onset 26Jan2023 at 16:00, outcome "recovered" (2023), described as "Vomiting for 15 minutes.". Therapeutic measures were not taken as a result of vomiting.  Additional information: The 'covid prior vaccination', 'covid tested post vaccination', 'other vaccine in four weeks' was reported as 'no'. 'Other medications in two weeks' was reported as 'Yes'.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: right hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN, start date: 10Dec2021. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EV0181, thinks it is a V but may be a Y since its written, Expiration: unknown), administration date: 22Jun2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EW0198, Expiration: unknown), administration date: 13Jul2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 10Jun2022, outcome "unknown", described as "right hip replacement".   Clinical course: When querying other medications and medical conditions reports she had a right hip replacement in 10Jun2022, the medications she was given was pain pills, gabapentin and has not taken these medications in months. She was given gabapentin at different times. She has a bottle of gabapentin from 10Dec2021. She took a course of gabapentin after her surgery for a course of 3 or 4 weeks. Clarifies she does have a different bottle from after her surgery it is dispensed in pharmacy vial and cannot provide lot, expiration, ndc or manufacturer. She never had any intestinal issues at all in her entire life, bowel never constipated and is very regular.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hip arthroplasty
Clinical narrative: right hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN, start date: 10Dec2021. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EV0181, thinks it is a V but may be a Y since its written, Expiration: unknown), administration date: 22Jun2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EW0198, Expiration: unknown), administration date: 13Jul2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 10Jun2022, outcome "unknown", described as "right hip replacement".   Clinical course: When querying other medications and medical conditions reports she had a right hip replacement in 10Jun2022, the medications she was given was pain pills, gabapentin and has not taken these medications in months. She was given gabapentin at different times. She has a bottle of gabapentin from 10Dec2021. She took a course of gabapentin after her surgery for a course of 3 or 4 weeks. Clarifies she does have a different bottle from after her surgery it is dispensed in pharmacy vial and cannot provide lot, expiration, ndc or manufacturer. She never had any intestinal issues at all in her entire life, bowel never constipated and is very regular.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions.  Vaccines were administered to unknown patients on unknown dates.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (in; This spontaneous report has been received from a medical assistant, concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On unknown dates, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) subcutaneous injection as prophylaxis (lot number W026316 has been verified to be valid; expiration date reported and established as 18-FEB-2024), and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (lot number W021740 has been verified to be valid; expiration date reported and established as 10-JUL-2024) (doses, frequencies, vaccination schemes, routes of administrations, and anatomical locations were not provided). The administered doses of the vaccines were stored at a temperature of 1.1 degrees Celsius (C), during a time frame of 16 hours and 21 minutes. There was not a previous temperature excursion reported. There was no adverse effect reported.   This was a non-valid case due to the lack of patient's identifiers.  Follow up information has been received from the medical assistant on 11-JAN-2023 and 12-JAN-2023.   The medical assistant reported there were 8 patients who received vaccines after the temperature excursion occurred. One of them was a 12 month old male patient with no illness at time of vaccination. The patient had no siblings. On 02-JAN-2023, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M R II) (lot # W023072 exp date 05-APR-2024, dose not reported) subcutaneously in the left leg at a private hospital.   The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.  This case was previously considered non valid, but upon receipt of FU is considered valid due to patient identifiers were provided.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Headache, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Dizziness; Headache; Autonomic Dysfunction; Orthostatic Intolerence; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 27-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, orthostatic intolerance, autonomic nervous system imbalance, headache and dizziness.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007522: US-009507513-2301USA007498: US-009507513-2301USA007521:
Age: 2.0
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Intentional product misuse to child, No adverse event
Clinical narrative: No additional AE reported; Inbound call from medical assistant who reports she administered vaccines to a patient "that didn't need them"/AE is being filed for misuse outside the prescribing information; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown dates (reported as: at one year of age), the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, exact dose, lot #, expiry date, route of administration and anatomical site of vaccination were not provided) for prophylaxis; and with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (strength, exact dose, lot #, expiry date, route of administration and anatomical site of vaccination were not provided) for prophylaxis. On 23-JAN-2023, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot# W001520, expiration date 13-JAN-2024, (strength, exact dose, route of administration and anatomical site of vaccination were not provided); and with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot# W021741, expiration date 10-JUN-2024, (strength, exact dose, route of administration and anatomical site of vaccination were not provided). On the same day, the patient was administered sterile diluent (strength, dose, lot# and expiration date were not provided). According to the reporter, the patient "did not need" the second dose of the suspect vaccines (intentional product misuse to child). No additional adverse event (AE) was reported (no adverse event).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: The patient did not have any adverse effects; A patient received two doses of GARDASIL 9 from two different HCPs, at the same time.; The patient received second and third dose of Gardasil 9 at the samte time; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's concurrent conditions, drug reaction or allergies and pertinent medical history were not reported.   On unknown date, the patient was vaccinated with a first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (quantity dose, lot #, expiration date and route we not reported)  On 23-JAN-2023 from two different healthcare professionals, the patient received at the same time  two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 milliliter, for prophylaxis (lot #, expiration date and route we not reported). The patient was scheduled to receive the two-dose series (overdose and inappropriate schedule of product administration). Concomitant therapies included influenza vaccine.  The physician did not report any adverse effects (no adverse event) and nor product quality complain.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Expired PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U010533, expiration date: 29-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 1.25
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918:
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000401: US-009507513-2302USA000400:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: