chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea
Clinical narrative: Patient said  she "couldn't breath and went to the hospital"
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Lump on arm at site of injection, painful
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: PATIENT AND SPOUSE WANTED TO LEAVE AFTER ABOUT 10 MINUTES AND SHE FELT FAINT AFTER TAKING A FEW STEPS. HER SPOUSE HAD HER SIT DOWN IMMEDIATELY. SHE ALTERNATED BETWEEN APPEARING "SPACED OUT"  WITH NO LOSS OF CONCIOUSNESS AND  AWARENESS  EVERY 10 SECONDS OR SO FOR ABOUT 1-2 MINUTES  THEN SHE CAME TO AND STATED THAT SHE FELT FAINT. WE APPLIED A COOL PACK TO HER NECK AND SHE DRANK A FEW SIPS OF WATER AND STARTED FEELING MUCH BETTER. AFTER ABOUT 10 MINUTES, SHE SAID SHE FELT FINE. SHE REMAINED SEATED FOR ANOTHER 10 MINUTES OR SO BEFORE LEAVING WITH HER SPOUSE.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Thyroxine free
Clinical narrative: Thyroid Stimulation Hormone less than 0.01, thyroid med decreased, no change
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Eczema, Follicular eczema, Psoriasis, Rash
Clinical narrative: 2 weeks after vaccine I started experiencing eczema & psoriasis, specifically follicular eczema/psoriasis. Started off as little acne like breakouts on legs and started spreading. Now on face, arms, legs.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Borrelia test negative, Chills, Pain, Peripheral swelling
Clinical narrative: Total body aches, shivering, h and swelling but went away,
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mania
Clinical narrative: Approximately 36 hours following vaccine, I experienced a hypomanic episode lasting about 18 hours. My bipolar II disorder has been successfully regulated for more than 10 years, with very rare depressive breakthrough. My last manic episode was more than 5 years ago. I notified both the pharmacist and my psychiatrist. Because the episode resolved in less than 24 hours, no further medical intervention was required.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypomania
Clinical narrative: Approximately 36 hours following vaccine, I experienced a hypomanic episode lasting about 6 hours. My bipolar II disorder has been successfully regulated for more than 10 years, with rare depressive breakthrough. My last manic episode was 36 hours after my first Shingrix dose, 3/9/23. Prior to that, my previous manic phase was more than 5 years ago. I notified both the pharmacist and my psychiatrist. Because the episode resolved in less than 24 hours, no further medical intervention was required.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Very high fever, severe headache.  Took 2 Tylenol, fever subsided.  Fatigue and nausea for several days.
Age: 40.0
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: MEN ARE D
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient presented with red, erythematous rash approximately 3.5 inches x 3 inches in size on left arm around injection site. The center of rash was slightly raised and slightly lighter in color.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Depressed mood, Discomfort, Emotional distress
Clinical narrative: I?ve been experiencing extremely bad left shoulder and upper back pain, for more than a year,  I?ve done multiple treatments, muscle relaxers, corticoide shots, nerve block, chiropractor, physical therapy, massages, lifestyle changes, etc. nothing has worked so far. This affects my life lots, working is hard because I?m in pain all day, sleeping is hard as well as when I move it hurts any my back cracks, I have to stretch all day, even when I?m out let?s say in a restaurant, which is embarrassing, I?m uncomfortable all day, i had to stop working out due the pain, now I only do stretches or easy yoga. I feel lost and depressed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Feeling abnormal, Impaired work ability, Joint noise, Loss of personal independence in daily activities
Clinical narrative: I?ve been experiencing extremely bad left shoulder and upper back pain, for more than a year,  I?ve done multiple treatments, muscle relaxers, corticoide shots, nerve block, chiropractor, physical therapy, massages, lifestyle changes, etc. nothing has worked so far. This affects my life lots, working is hard because I?m in pain all day, sleeping is hard as well as when I move it hurts any my back cracks, I have to stretch all day, even when I?m out let?s say in a restaurant, which is embarrassing, I?m uncomfortable all day, i had to stop working out due the pain, now I only do stretches or easy yoga. I feel lost and depressed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Myositis, Pain, Sleep disorder, Ultrasound scan normal
Clinical narrative: I?ve been experiencing extremely bad left shoulder and upper back pain, for more than a year,  I?ve done multiple treatments, muscle relaxers, corticoide shots, nerve block, chiropractor, physical therapy, massages, lifestyle changes, etc. nothing has worked so far. This affects my life lots, working is hard because I?m in pain all day, sleeping is hard as well as when I move it hurts any my back cracks, I have to stretch all day, even when I?m out let?s say in a restaurant, which is embarrassing, I?m uncomfortable all day, i had to stop working out due the pain, now I only do stretches or easy yoga. I feel lost and depressed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: I?ve been experiencing extremely bad left shoulder and upper back pain, for more than a year,  I?ve done multiple treatments, muscle relaxers, corticoide shots, nerve block, chiropractor, physical therapy, massages, lifestyle changes, etc. nothing has worked so far. This affects my life lots, working is hard because I?m in pain all day, sleeping is hard as well as when I move it hurts any my back cracks, I have to stretch all day, even when I?m out let?s say in a restaurant, which is embarrassing, I?m uncomfortable all day, i had to stop working out due the pain, now I only do stretches or easy yoga. I feel lost and depressed.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy, Breast cyst, Breast mass, Breast pain, Cyst aspiration
Clinical narrative: Woke up with pain in my right breast and subsequently noticed a lump near a known cyst. I had a mammogram and ultrasound on 3/1/2023  and the result was that the cyst was larger than it had been at my mammogram on 10/20/2022. The doctor recommended a cyst aspiration followed by a biopsy if necessary. Both were done, with the aspirated fluid being a dark bloody color. The biopsy pathology showed no evidence of cancer.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mammogram, Pathology test, Ultrasound scan
Clinical narrative: Woke up with pain in my right breast and subsequently noticed a lump near a known cyst. I had a mammogram and ultrasound on 3/1/2023  and the result was that the cyst was larger than it had been at my mammogram on 10/20/2022. The doctor recommended a cyst aspiration followed by a biopsy if necessary. Both were done, with the aspirated fluid being a dark bloody color. The biopsy pathology showed no evidence of cancer.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Skin induration, Sleep disorder, Vaccination site erythema
Clinical narrative: THERE IS A REDISH DISCOLORATION ABOUT 3 INCHES IN DIAMETER NEAR THE SITE OF VACCINATION.  UPON TOUCH, THE SKIN FEELS SLIGHTLY HARDER THAN SURROUNDING SKIN.  PATIENT REPORTS NO PAIN OR IRRITATION AND SHE HAS FULL MOBILITY OF HER ARM.  SHE REMARKS IT ONLY CAUSES PAIN WHEN SHE PUTS PRESSURE ON IT OR SLEEPS ON HER RIGHT SIDE.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: Patient was seen on 6/18/23 and received the third dose of the HPV vaccine in error due to the immunization record in the EMR not being completely up to date. Patient had already received two doses of the HPV vaccine (on 08/11/2020,  03/10/2021) at another location. There was no adverse reaction.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal X-ray, Abdominal distension, Chest X-ray normal, Chills, Computerised tomogram
Clinical narrative: 6/8: received SHINGRIX at Dr's office 6/10 (6PM): unable to eat any food (d/a nausea, abdominal bloating, pain, shivering, discomfort, couldn't sleep) 6/11: went to Emergency Room  -  took EKG and troponin test, which ruled out heart issues; abdominal and chest X-ray (ruled out "lung consolidation, pleural effusion, or pneumothorax... nonobstructive bowel gas pattern"); CT scan, which ruled out "obstruction, abdominal bloating with decreased activity"  - patient received Gas-X (1 tablet TID)  Within a week (clarified as "after 06/14/2023"), patient recovered
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Electrocardiogram, Feeding disorder, Full blood count, Insomnia
Clinical narrative: 6/8: received SHINGRIX at Dr's office 6/10 (6PM): unable to eat any food (d/a nausea, abdominal bloating, pain, shivering, discomfort, couldn't sleep) 6/11: went to Emergency Room  -  took EKG and troponin test, which ruled out heart issues; abdominal and chest X-ray (ruled out "lung consolidation, pleural effusion, or pneumothorax... nonobstructive bowel gas pattern"); CT scan, which ruled out "obstruction, abdominal bloating with decreased activity"  - patient received Gas-X (1 tablet TID)  Within a week (clarified as "after 06/14/2023"), patient recovered
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Troponin, X-ray
Clinical narrative: 6/8: received SHINGRIX at Dr's office 6/10 (6PM): unable to eat any food (d/a nausea, abdominal bloating, pain, shivering, discomfort, couldn't sleep) 6/11: went to Emergency Room  -  took EKG and troponin test, which ruled out heart issues; abdominal and chest X-ray (ruled out "lung consolidation, pleural effusion, or pneumothorax... nonobstructive bowel gas pattern"); CT scan, which ruled out "obstruction, abdominal bloating with decreased activity"  - patient received Gas-X (1 tablet TID)  Within a week (clarified as "after 06/14/2023"), patient recovered
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site exfoliation, Injection site pruritus
Clinical narrative: THERE WAS AN RED, SCALLY SPOT AT THE INJECTION SITE. IT WAS ITCHY SO PATIENT THOUGH SHE TOOK BENADRYL. IT LASTED AROUND 1 WEEK TO DISAPPEAR.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: ERYTHEMA OR REDNESS AROUD THE INJECTION SITE. NO SWELLING. NO FEVER. SORE ARM.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Patient stated that she felt an immediate rush like 1/2 her body was going to be paralyzed.  She stated that the first Covid shot looked different than her second shot as it had a greyish blue tinge to it.  She did get the second shot, but filled out paperwork as she had no reactions to previous immunizations.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was 12 days expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Diplopia, Hyporeflexia, Muscle spasms, Tinnitus
Clinical narrative: Didn?t know these could vax related at the time: Chronic tinnitus to this day, double vision (somewhat better but still bad days), leg cramping, but unusual--starts at lower calf and I feel it crawling up. Foot at 45° angle and won't flex until I stand on toes then force my knee down.  Then it goes away.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was  expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was accidently administered. Vaccine was expired at the time of vaccination. No reports of adverse events, will offer re-vaccination at the recommendation of Moderna
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Blood iron abnormal, Blood test abnormal, Burning sensation
Clinical narrative: Total body numbness including head and tongue, worse in limbs, burning, prickling, pain, feels like finger are in ice yet they are warm to the feel. finger joints stuff and painful, feet feel like I?m walking on rocks or cactus. Balance affected have to use walker or fall.  Hemoglobin dropped to 8  all iron tests abnormal. Most blood test abnormal suddenly. Had 2 infusions of Iron.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Hypoaesthesia, Hypoaesthesia oral, Joint stiffness, Mineral supplementation
Clinical narrative: Total body numbness including head and tongue, worse in limbs, burning, prickling, pain, feels like finger are in ice yet they are warm to the feel. finger joints stuff and painful, feet feel like I?m walking on rocks or cactus. Balance affected have to use walker or fall.  Hemoglobin dropped to 8  all iron tests abnormal. Most blood test abnormal suddenly. Had 2 infusions of Iron.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Total body numbness including head and tongue, worse in limbs, burning, prickling, pain, feels like finger are in ice yet they are warm to the feel. finger joints stuff and painful, feet feel like I?m walking on rocks or cactus. Balance affected have to use walker or fall.  Hemoglobin dropped to 8  all iron tests abnormal. Most blood test abnormal suddenly. Had 2 infusions of Iron.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Sensory disturbance, Walking aid user
Clinical narrative: Total body numbness including head and tongue, worse in limbs, burning, prickling, pain, feels like finger are in ice yet they are warm to the feel. finger joints stuff and painful, feet feel like I?m walking on rocks or cactus. Balance affected have to use walker or fall.  Hemoglobin dropped to 8  all iron tests abnormal. Most blood test abnormal suddenly. Had 2 infusions of Iron.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Pain in spinal column and feet and hands.  Today is the 6th day after the shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Frequent bowel movements, Headache, Injection site erythema
Clinical narrative: Redness, swelling at injection site. 10 hours post injection, headache, shivering, stomach pain, vomiting, bowel movements for 4-5 hours. (1st injection in Feb 2023 only had redness, swelling at site)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Redness, swelling at injection site. 10 hours post injection, headache, shivering, stomach pain, vomiting, bowel movements for 4-5 hours. (1st injection in Feb 2023 only had redness, swelling at site)
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; The caller said an expired dose was administered to a patient; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age or gender. Information regarding the patient's medical history, current conditions, concomitant therapies and historical drugs was not provided.  On 17-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T036444, expiration date: 09-APR-2023 (expired product administered), administered for prophylaxis (strength, and route of administration were not provided).  No adverse symptoms were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 03-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # X004813 with expiration date: 28-JUL-2024; 0.5 milliliter/once, formulation prefilled syringe, strength and route were not provided) for prophylaxis (product storage error).  Administered doses of hepatitis a vaccine, inactivated (VAQTA) experienced the temperature excursion below 46.74 Fahrenheit degrees (F) for 2 minutes. No previous temperature excursions reported. No additional adverse eventes were reported, no further information provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-MAY-2023, the patient received an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter/once, lot # X004813 with expiration date of 28-JUL-2024, for prophylaxis (route of administration and anatomical location were not provided).  The improperly storage lasted 2 minutes at temperature of 46.74 F. No previous temperature excursion and no additional adverse events were reported.
Age: 45.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: patient received 1st dose on 11/3/2022 at 45 years old, and 2nd dose on 5/17/2023 at 46 years old. Also, 2nd dose was given at 6 months after 1st dose instead of the rec; patient received 1st dose on 11/3/2022 at 45 years old, and 2nd dose on 5/17/2023 at 46 years old; This spontaneous report was received from a pharmacist and refers to a 46-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiration date, and route of administration were not provided).  On 17-MAY-2023 at 46-years old, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml  (strength, lot #, expiration date, and route of administration were not provided) (Product administered to patient of inappropriate age). The 2nd dose was given at 6 months after 1st dose instead of the recommended 2 months after first dose (Inappropriate schedule of product administration).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her first dose last year in June of 2022 by a different provider, but missed her subsequent doses; This spontaneous report was received from Pharmacist and refers to a 45-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in June 2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but missed her subsequent doses and was seeking to finish the vaccination series (Inappropriate schedule of product administration).
Age: 2.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered on 06/01/2013; administered on 08/20/2004; This spontaneous report has been received from an other health professional, via a medical record from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2303USA000299), concerning 26-month-old female patient.  Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis B vaccine, hib vaccine, measles vaccine live (enders-edmonston) (+) mumps vaccine live (jeryl lynn) (+) rubella vaccine live (wistar ra 27/3) (M M R II), pneumococcal vaccine conj 13v (crm197) (13 VALENT PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE), and polio vaccine inact (IPV). Concurrent condition and medical history were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis a vaccine, inactivated (manufacturer unknown), and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).  On 20-AUG-2004, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose, route, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age). On 01-JUN-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose, route, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age).  This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2303USA000299: US-009507513-2306USA002994:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Product was administered after TE.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-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) (strength, dose, route, frequency, lot number and expiration date were not provided) for prophylaxis (product storage error).   No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Cognitive disorder, Memory impairment
Clinical narrative: cognitive issues/has a lot of slowing in the cognitive area; had difficulty finding words she wants to say; she is forgetful, cannot think of the next word she was going to say; This spontaneous report has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   In December 2022 (reported as last December), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (one dose), strength, lot#, expiration date, route and anatomical location were unknown) for prophylaxis at her pediatrician.  On an unknown date, the patient began experiencing cognitive issues (cognitive disorder). The patient had difficulty finding words she wanted to say (aphasia), and she was forgetful, could not think of the next word she was going to say (memory impairment), and just had a lot of slowing in the cognitive area. No additional information was provided to further clarify this statement. The patient's father asked the reporter if they were possible adverse effects from receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient did not receive any additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for the events was withdrawn. The outcome of the events was not reported.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all the events was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Viral titre
Clinical narrative: Lack of Efficacy; Initial Report Received on 14-Apr-2023 and 17-Apr-2023  A patient reported that she, a 47-year-old female patient (race and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a negative titer.   Medical history and concomitant medications at the time of vaccination were not reported. Allergies included penicillin (unknown reaction) and Neosporin (neomycin-bacitracin-polymyxin) (caused severe rash).  On 07-Nov-2022, the patient received the first dose of HEPLISAV-B vaccine (Lot #, expiration date, an NDC # unknown) in the left bicep.  On 07-Dec-2022, 1 month after receiving the first dose, the patient received the second dose of HEPLISAV-B vaccine  (Lot #, expiration date, NDC #, and injection site unknown) in the left bicep.  On 01-Mar-2023, 115 days after the first dose of HEPLISAV-B and 85 days after the second dose of HEPLISAV-B, the patient had a titer drawn and it was negative. On an unknown date, at "the end of March" another titer was redrawn and it was still negative. The patient did not report any adverse effects related to HEPLISAV-B.  No additional information was provided.  Company Comment: The company assessed the event as non-serious. The event was not immunologically confirmed since the serological test was not specified.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed since the serological test was not specified.
Sex: U
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Little diarrhea; A spontaneous report was received from a physician assistant on 19APR2023 regarding a patient of unknown age and gender who experienced "little diarrhea" (PT: Diarrhoea) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.   The patient's medical history, concomitant medications, or known allergies were not reported.   It was reported that the patient received Vivotif following which the patient had little diarrhea. Reportedly, Vivotif was well tolerated by the patient.  The outcome of the reported event was unknown, at the time of this report.    The action taken with Vivotif with respect to the reported event was unknown.    No additional information was reported.  Based on the information available in the document three individual case safety reports 23000151 (patient-1), 23000152 (patient-2) and 22000250 (patient-3) were created and cross-linked in the database.  Company comment: It was reported that a consumer took Vivotif for immunisation and experienced little diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif for immunisation and experienced little diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non serious as per medical assessment. 23000152:Linked case (Patient 2) 22000250:Linked case (Patient 3)