chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 4 year old female received Quadracel in left thigh,No AE; 4 year old female received two doses of Quadracel within 6 months,No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional (Medical assistant).  This case involves a four years old female patient who received two doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] one in Dec-2019 and other 0.5 ml on 29-Jun-2020 with lot number: C5688AA, expiry date 26-NOV-2021 via intramuscular route in the left thigh) within 6 months for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination on  29-Jun-2020.  It was an actual medication error case due to extra dose administered and vaccine administered at inappropriate site.  No adverse event symptoms occurred to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MEN
Symptoms: Rash
Clinical narrative: rash looked like flea bites, about 10 to 20 lesions; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case from the physician.  This case involves a 16-year-old female patient who experienced rash, which looked like flea bites, about 10 to 20 lesions (rash), while she received MENINGOCOCCAL VACCINE.  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious rash which looked like flea bites, about 10 to 20 lesions (rash), (unknown latency) following the administration of MENINGOCOCCAL VACCINE.  Details of laboratory data were not reported.  Final diagnosis was rash.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was administered without reconstituting with the Hib portion, only administering the DTap/IPV,No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a two months old female patient was administered a 0.5ml first dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACE] (lot number of (Hib): UJ229AAA, (diluent): UJ314AA and expiration date: 23-Apr-2021) without reconstituting with the HIB portion, the only part that was administered was DTaP/IPV, via intramuscular route in the left thigh for prophylactic vaccination on 30-Jun-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination on 30-Jun-2020.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 months old was given Quadracel/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5688AA, dosing details: single fourth dose 0.5 ml and expiry date 26-NOV-2021) via intramuscular route in the left thigh on 01-Jul-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on an unknown date for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 12 year old male patient was given Daptacel instead Adacel,No AE; a 12 year old male patient was given Daptacel, No AE; Initial information received on 02-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 year old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 02-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5611BA and expiry date: 03-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong product administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Immunization given after temperature excursion. No adverse reactions known at this time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Immunizations given were part of a temperature excursion, no know adverse side effects known at this time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Kidney bean shaped rash on right thigh, raised border, pink, variegated with the rash; also a satellite area to the left.  5 cm x 6.5 cm, somewhat urticarial
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Product administered at inappropriate site
Clinical narrative: Dose was given high (into the shoulder).  The patient says they couldn't move there arm for a day and were in a fair amount of pain initially.  As of 7/6/20 the patient's shoulder pain is significantly less and patient says that her discomfort has improved daily since the incident, but it still bothers her some.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Immunizations given after temperature excursion, no adverse side effects known.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Extra dose administered
Clinical narrative: Came to office for 11 year check-up. Child is extremely anxious and mom requested shots be given right away before anything else was done. Nurse gave Tdap and Menactra as standing order for 11 year PE. Child had Tdap 3 months previously for an injury. Mom forgot to mention before shot was given.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local rx w/redness and swelling at site of MMRV vaccine. Pt given ice and Benadryl 2.5 ml. Monitored in office for 30 mins with improvement.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Patient experienced a sncope episode after receiving vaccines. The patient was on the floor of the exam room, his legs were elevated and after symptoms improved he was given some juice to drink. The physician assessed him and found no injuries, after resting for 15 minutes, patient walked out of clinic with his mother.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspnoea, Erythema, Headache
Clinical narrative: My left arm was very swollen, red and painful within 6 hrs of shot and stayed that way for 3 days.  The morning after the immunization, I had 100.8 fever, weakness, sore throat, some shortness of breath and I stayed on the sofa as I was so weak with chills, shivering, weakness and headache. This lasted for 2 almost 3 days. I felt very ill. I thought it might be Covid 19.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: My left arm was very swollen, red and painful within 6 hrs of shot and stayed that way for 3 days.  The morning after the immunization, I had 100.8 fever, weakness, sore throat, some shortness of breath and I stayed on the sofa as I was so weak with chills, shivering, weakness and headache. This lasted for 2 almost 3 days. I felt very ill. I thought it might be Covid 19.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Cold sweat, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: Patient received the Tdap and Menveo vaccines, then mother request to get the Bexsero also. The Bexsero was then administered and patient immediately had a vasovagal syncope episode. She was out for a few seconds and then woke up. She was pale, clammy, and nauseated. We monitored her vitals while she drank some water and juice, then ate some cookies. Patient reported she had not had much to eat or drink beforehand. Within 30-40 min, she walked out of the clinic feeling back to normal.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Fall, Moaning
Clinical narrative: Patient received the Tdap and Menveo vaccines, then mother request to get the Bexsero also. The Bexsero was then administered and patient immediately had a vasovagal syncope episode. She was out for a few seconds and then woke up. She was pale, clammy, and nauseated. We monitored her vitals while she drank some water and juice, then ate some cookies. Patient reported she had not had much to eat or drink beforehand. Within 30-40 min, she walked out of the clinic feeling back to normal.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mydriasis, Pallor
Clinical narrative: Patient received the Tdap and Menveo vaccines, then mother request to get the Bexsero also. The Bexsero was then administered and patient immediately had a vasovagal syncope episode. She was out for a few seconds and then woke up. She was pale, clammy, and nauseated. We monitored her vitals while she drank some water and juice, then ate some cookies. Patient reported she had not had much to eat or drink beforehand. Within 30-40 min, she walked out of the clinic feeling back to normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test, Computerised tomogram, Decreased eye contact, Eye movement disorder, Glassy eyes
Clinical narrative: Child was lethargic, and fell asleep. Child woke up and began gagging, and trying to vomit. Child began to seize, and was not able to make eye contact, eyes were glassed over and looking off to one direction. Child was not responding to any communication, and was unresponsive to touch, or verbal commands, and began to gag/vomit again.  Child began to lose coloring, and was not able to keep eyes open.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lethargy, Pallor, Retching, Seizure, Somnolence
Clinical narrative: Child was lethargic, and fell asleep. Child woke up and began gagging, and trying to vomit. Child began to seize, and was not able to make eye contact, eyes were glassed over and looking off to one direction. Child was not responding to any communication, and was unresponsive to touch, or verbal commands, and began to gag/vomit again.  Child began to lose coloring, and was not able to keep eyes open.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Unresponsive to stimuli, Urine analysis, X-ray
Clinical narrative: Child was lethargic, and fell asleep. Child woke up and began gagging, and trying to vomit. Child began to seize, and was not able to make eye contact, eyes were glassed over and looking off to one direction. Child was not responding to any communication, and was unresponsive to touch, or verbal commands, and began to gag/vomit again.  Child began to lose coloring, and was not able to keep eyes open.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Throat irritation
Clinical narrative: Patient states 3-5 minutes after receiving vaccine her throat felt itchy. Patient then drank about 4 oz of water. States throat remained itchy for approximately 4 more minutes and then itching resolved. I looked at patient's throat at 15 minutes. No redness or swelling present and no more complaint of itching.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cold sweat, Pallor, Presyncope
Clinical narrative: Patient/family refused 15 minute post vaccine wait-time in exam room.  Patient with vaso-vagal episode and reception desk.  Slow decent to ground to sitting then lying position. Witnessed.  Did not strike head on floor.  No LOC. Skin pale, clammy.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Loss of personal independence in daily activities
Clinical narrative: pain around L shoulder joint x 1 week; deferred exercise since the adverse event started; recommended to start ibuprofen PRN per Dr. as of 7/6/20; relief from ibuprofen unknown at this time
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Three days after I had the vaccine, I broke out with a rash on my lower back. A few days after that I broke out with a rash on my right side. I called the doctors office and made an appointment on 11/14/2019. Doctor said it was Shingles. Prescribed Valtrex, Gabapentin, lidocaine  and calamine lotion. A few weeks after that I got a breakout all over my scalp and a month after that I got it in my left eye.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Pruritus
Clinical narrative: Patient reports that arm became red and painful and itchy starting the night of the shot.  She states it got worse the next day so she finally called her doctors office.  She took some benadryl during this time which she said helped some with the itching.  She was seen at the doctors today and given doxycycline for cellulitis.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: On 6/18/2020 Mom called c/o redness swelling and discomfort of Left upper extremity, at the injection site.  Mom instructed to apply ice to the area for 10 min every 2-4 hours. Patient diagnose with cellulitis and placed on Cephalexin 250 mg/5 ml by mouth every 12 hours. Mom instructed to call or take patient to ED if s/s of fever, condition worsens or s/s of dehydration.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Presyncope, Vomiting
Clinical narrative: Vasovagal response near syncope. Did not fall or hit head. Vomited twice immediately after getting vaccines. Monitored in office for a few minutes until patient felt better and then was allowed to go home with parent.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Rash, Swelling face
Clinical narrative: local leg swelling at site of MMR-Varicella (3 x 3 cm erythematous nodule on left thigh) and facial swelling/rash. First noticed when woke out of bed morning after vaccination and gradually improved to when saw the next day to only slight eyelid swelling with continued large nodule.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Swelling of eyelid
Clinical narrative: local leg swelling at site of MMR-Varicella (3 x 3 cm erythematous nodule on left thigh) and facial swelling/rash. First noticed when woke out of bed morning after vaccination and gradually improved to when saw the next day to only slight eyelid swelling with continued large nodule.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Urticaria
Clinical narrative: fluid fill, edema at site, hives around arm per daughter
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash papular
Clinical narrative: The rash  is described by mother as small red bumps which appeared the next day after vaccines. Mother believes that patient develops a rash "everytime" she gets vaccines. Papular rash noted on right extremities at exam.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Feeling hot, Headache, Hunger, Injection site swelling
Clinical narrative: at time of vaccination she became weak, hot, vision changes. Cold compresses given, feet up, water given. Waited 15 min. at the time she left  "able to go" visiting with family and staff. Mom called around 11 am.  Pt was vomiting, headache, arm swollen, fingers tingling.  Ice at site and pt rested.  When followed up she was doing well.  Woke at 3:30 this afternoon. Headache resolved, arm swollen at site only, hungry and tolerating food well.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Peripheral swelling, Visual impairment, Vomiting
Clinical narrative: at time of vaccination she became weak, hot, vision changes. Cold compresses given, feet up, water given. Waited 15 min. at the time she left  "able to go" visiting with family and staff. Mom called around 11 am.  Pt was vomiting, headache, arm swollen, fingers tingling.  Ice at site and pt rested.  When followed up she was doing well.  Woke at 3:30 this afternoon. Headache resolved, arm swollen at site only, hungry and tolerating food well.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Mass, Pain
Clinical narrative: Lump 3in wide and sore
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Nausea, Pyrexia
Clinical narrative: About 12 hours post vaccine, I felt a little dizzy and a little nauseous.  About 18 hours post vaccine I hade a fever and difficulty walking short distance.  All symptoms were gone by 22 hours post vaccine.  Felt fine.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site vesicles, Pyrexia
Clinical narrative: Patient received his second dose of Shingrix at aroung 11am later on that evening he started to feel a fever and pain at/around the injection site.  At the site he developed a rash and blisters. He called his Md and they told him to go to ER. His Md later prescribed Augmentin for him which he took. The issue is resolved and pt is better.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: High fever of 104.5 which lasted for 3-4 days.   It was reported to the pediatrician who advised us to use infant tylenol.  We were not told by the physician that we should not do the next series or do an alternative vaccine schedule.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: High fever of 104.5 which lasted for 3-4 days.   It was reported to the pediatrician who advised us to use infant tylenol.  We were not told by the physician that we should not do the next series or do an alternative vaccine schedule.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fever of 104.5 which lasted for 3-4 days.   It was reported to the pediatrician who advised us to use infant tylenol.  We were not told by the physician that we should not do the next series or do an alternative vaccine schedule.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Patient c/o pain to left leg all day 7/2/20. Mom examined at 7pm on 7/2/20 and took him to the ER. Positive for fever of 99, left thigh swelling, redness left anterior thigh, rash left anterior thigh. Given oral dexamethasone and diphenhydramine at ER.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Gait inability, Impaired driving ability, Vertigo, Vomiting
Clinical narrative: I was spinning so bad I couldn't walk and I was vomiting. My mecclizine did nothing to help. Dr. gave me a form of prednisone. It gave me energy, but did not stop the spinning. I couldn't drive for 5 weeks & even now only very short distances for a short period of time 6/29/20 - Going on 10 months & still having problems. It's questionable if I will ever take another vaccine with all the side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in 2011, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, Subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-JUN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis (lot # S005875 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 30-NOV-2020) (strength, dose and frequency were not provided).  The administered dose of the vaccine experienced a temperature below36 ° Fahrenheit (F) for 25 minutes. There was a digital data logger involved, and the previous temperature excursion was 36 °F for 1 hour and 24 minutes.  No additional adverse effects reported.; Sender's Comments:  US-009507513-2007USA000228:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; third dose of ROTATEQ was on 29-JUN-2020; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding concurrent conditions, concomitant therapies, medical history and historical drugs was not provided.   On 27-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength, dose, lot # and expiration date were not provided); second dose was administered on 25-FEB-2020.  On 29-JUN-2020, patient was vaccinated withh a dose (third dose) of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S005875, expiration date 30-NOV-2020 for prophylaxis following temperature excursions.  Temperature excursion was reported as below 36°F (34.8°F) for 25 minutes and a previous excursion below 36°F (34.5°F) for 1 hour and 24 minutes.  The call was made due to a digital data logger. No adverse effects were reported.  This is one of several cases from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S005875, with an expiration date in 30-NOV-2020), orally, for prophylaxis (strength, dose and frequency were not provided), that underwent a temperature excursion of 34.5 degrees Fahrenheit during a time frame of 1 hour and 24 minutes and another temperature excursion of 34.8 degrees Fahrenheit during a time frame of 25 minutes. Digital data logger was involved. No additional adverse effect were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA000228: US-009507513-2007USA000271: US-009507513-2007USA000228:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; An improperly stored dose of GARDASIL was administered; This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.      On 13-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # reported and validated as R028656, expiration date reported and validated as 37-JUL-2021, administered intramuscularly as prophylaxis (dose, dosage schedule and site of administration were not reported). The vaccine was at a temperature of 27 F for 3 hours, there were no previous excursions and the data was analyzed by a digital data logger (product storage error). No adverse symptoms were reported.  This is one of two cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA000707:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; on 5/18/2020 an improperly stored dose of GARDASIL 9 (lot S008151, expiration 11/20/2021) was administered to a patient; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 18-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S008151, expiration date 20-NOV-2021; dose detail and strength were not provided) intramuscularly for prophylaxis (product storage error). The temperature excursion included 27 fahrenheit degree for 3 hours. There was no previously temperature excursion. There was a data logger involved. The patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Muscular weakness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; This spontaneous report was received from a registered nurse referring to a 20-year-old male patient. The patient's pertinent concurrent conditions included crohn's disease, her medical history was not provided. The patient's concomitant medications included mesalamine (LIALDA) (reported as LIADIA) and vedolizumab (ENTYVIO) it was reported that, the patient had a previous drug reaction to morphine.  On 26-JUN-2020, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route as the patient was immunosuppressed (concentration, vaccination scheme frequency and anatomical location of administration were not reported; lot number T007790 and expiration date 03-DEC-2021).  On 26-JUN-2020 (reported as within an hour of the administration), the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected (erythema, muscular weakness, peripheral swelling, pain in extremity and feeling hot). The patient sought medical attention and was prescribed ice and acetaminophen (TYLENOL) and a routine blood work was performed on the same day and the result was normal. The patient was recovering with the prescribed treatment.  The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-0095075132007USA001706:
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported.       On 08-MAY-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # reported as "S006019" with expiration date reported as "27-FEB-2021"  and included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # and expiration date not reported); both for prophylaxis (strength, dose route of administration and anatomical location were not reported for the suspect vaccines). No additional adverse effect was reported. Concomitant therapies included sterile diluent(STERILE DILUENT) which was properly stored. It was stated that the vaccines were exposed to a temperature between 6 to 14 °F (10.4 °F) for 15 minutes. A previous temperature excursion was reported with a temperature between 6 to 14 °F (11.1 °F) for 15 minutes. A digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number S006019 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).; Sender's Comments:  US-009507513-2007USA001308: US-009507513-2007USA001612: US-009507513-2007USA001668: US-009507513-2007USA001240:
Sex: M
Vaccine: MEN
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Previously administered products included Meningococcal B vaccine with an associated reaction of ill-defined disorder (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2020AMR119696).   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell (serious criteria life threatening). Rechallenge with Meningococcal B vaccine was positive. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Meningococcal B vaccine, the patient got deathly ill.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR119696:same patient, 1st dose
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: circumstance or information capable of leading to medication error; extra dose; first dose before getting a transplant on 2018/ second dose on 26May2020; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included transplant.   On an unknown date, the patient received the 1st dose of Shingrix. On 26th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 26th May 2020, not applicable after receiving Shingrix and Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the shingles, drug dose administration interval too long, circumstance or information capable of leading to medication error and extra dose administered were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix before getting a transplant on 2018 and two years after that he developed Shingles that lasted for 22 days and after that the patient received the second dose of Shingrix, which led to lengthening of vaccination schedule. The patient might administer another dose. The reporter consented to follow up.  The reporter said she believed that patient received the first dose on another pharmacy but agreed to follow up. She reported to second line agent that she may administer an extra dose of Shingrix, which led to circumstance or information capable of leading to medication error and extra dose administered.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache
Clinical narrative: shivering, feeling tired and weak, headache, symptoms lasted about 24 hours treatment:  bed rest,
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Gait disturbance, Grip strength decreased
Clinical narrative: June 30, 2020   Shingrix 1st dose at 11:33 am 1:00 pm - 10 pm: arm sore; grew fatigued; queasy 10 pm - 2 am: in bed:  extreme cold, shivering. wool socks, flannels, down comforter, heating pad  2 am: nauseous, legs could barely hold me up, staggered to bathroom, urinated. didn't throw up 2:15 am:  severe coldness gone; slept without down comforter.  July 1, 2020: 7:00 am: up to take medicine. Husband helped me but only could stand for a minute or so. sat: shivering,         dry heaves, profusely sweating, threw-up some liquid. didn't take medicine. 7:30 am: slept in blue chair until 10 am 7: 30 am - 1 pm slept in bed. 1 pm: took medicine. extreme thirst. not hungry; left arm so sore couldn't hold anything in hand. 1:15 pm - 9:30 pm: mostly sat in chair; drank liquids. eggs for dinner 9:30 pm: bed; no coldness. slept July 2, 2020: 6:36 am: woke up.  left arm still very sore, but could hold plastic cup in hand.   took medicine.  very very fatigued.  July 3, 2020, July 4, 2020:   6 am: woke up left arm sore. very very fatifue.   Stayed inside.. napped 2 hours. July 5, 2020 left arm sore. able to walk on treadmill 45 minutes.  July 6, 2020 woke up with sore throat, nausea. very fatigued. mainly sat all day. couldn't sleep-- freezing cold again. not as bad as June 30 coldness, but I had to wear flannels, wool sock and use down comforter. finally got up at 3 am.  very fatigued. July 7, 22020 mild sore throat. congested. I have to keep clearing my throat. Sinuses clogged.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Insomnia, Loss of control of legs, Nausea, Oropharyngeal pain
Clinical narrative: June 30, 2020   Shingrix 1st dose at 11:33 am 1:00 pm - 10 pm: arm sore; grew fatigued; queasy 10 pm - 2 am: in bed:  extreme cold, shivering. wool socks, flannels, down comforter, heating pad  2 am: nauseous, legs could barely hold me up, staggered to bathroom, urinated. didn't throw up 2:15 am:  severe coldness gone; slept without down comforter.  July 1, 2020: 7:00 am: up to take medicine. Husband helped me but only could stand for a minute or so. sat: shivering,         dry heaves, profusely sweating, threw-up some liquid. didn't take medicine. 7:30 am: slept in blue chair until 10 am 7: 30 am - 1 pm slept in bed. 1 pm: took medicine. extreme thirst. not hungry; left arm so sore couldn't hold anything in hand. 1:15 pm - 9:30 pm: mostly sat in chair; drank liquids. eggs for dinner 9:30 pm: bed; no coldness. slept July 2, 2020: 6:36 am: woke up.  left arm still very sore, but could hold plastic cup in hand.   took medicine.  very very fatigued.  July 3, 2020, July 4, 2020:   6 am: woke up left arm sore. very very fatifue.   Stayed inside.. napped 2 hours. July 5, 2020 left arm sore. able to walk on treadmill 45 minutes.  July 6, 2020 woke up with sore throat, nausea. very fatigued. mainly sat all day. couldn't sleep-- freezing cold again. not as bad as June 30 coldness, but I had to wear flannels, wool sock and use down comforter. finally got up at 3 am.  very fatigued. July 7, 22020 mild sore throat. congested. I have to keep clearing my throat. Sinuses clogged.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Retching, Sinus congestion, Thirst, Vomiting
Clinical narrative: June 30, 2020   Shingrix 1st dose at 11:33 am 1:00 pm - 10 pm: arm sore; grew fatigued; queasy 10 pm - 2 am: in bed:  extreme cold, shivering. wool socks, flannels, down comforter, heating pad  2 am: nauseous, legs could barely hold me up, staggered to bathroom, urinated. didn't throw up 2:15 am:  severe coldness gone; slept without down comforter.  July 1, 2020: 7:00 am: up to take medicine. Husband helped me but only could stand for a minute or so. sat: shivering,         dry heaves, profusely sweating, threw-up some liquid. didn't take medicine. 7:30 am: slept in blue chair until 10 am 7: 30 am - 1 pm slept in bed. 1 pm: took medicine. extreme thirst. not hungry; left arm so sore couldn't hold anything in hand. 1:15 pm - 9:30 pm: mostly sat in chair; drank liquids. eggs for dinner 9:30 pm: bed; no coldness. slept July 2, 2020: 6:36 am: woke up.  left arm still very sore, but could hold plastic cup in hand.   took medicine.  very very fatigued.  July 3, 2020, July 4, 2020:   6 am: woke up left arm sore. very very fatifue.   Stayed inside.. napped 2 hours. July 5, 2020 left arm sore. able to walk on treadmill 45 minutes.  July 6, 2020 woke up with sore throat, nausea. very fatigued. mainly sat all day. couldn't sleep-- freezing cold again. not as bad as June 30 coldness, but I had to wear flannels, wool sock and use down comforter. finally got up at 3 am.  very fatigued. July 7, 22020 mild sore throat. congested. I have to keep clearing my throat. Sinuses clogged.
Age: 66.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Injection site erythema
Clinical narrative: Patient developed erythema at injections site about a week after receiving shingrix and prevnar in the same arm.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pain, Swelling
Clinical narrative: PAIN, SWELLING, PREGNANCY ISSUES
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient presented to the pharmacy on 07/07/20 at 9:40 am with a rash that presented as small series of collected dots on the upper back that circles around to the stomach. Patient said that it is only itchy, not painful and started the day after the immunizations were given. I advised patient to call doctor to be treated and for diagnosis.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Haematoma, Induration, Swelling
Clinical narrative: Hard swollen hematoma for 3 weeks after.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: Death, pending ME report
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Chills, Insomnia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Mother stated that her daughter had a lot of shaking & chills throughout the night that seemed quite severe. Then she began to develop a fever. Stated she administered Tylenol and fever began to break and symptoms improved. Kept her home today to rest. Stated her arm was sore and she was unable to sleep on that side during the night. Stated the one on the back of the arm below the armpit was the one that bothered her the most.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states he has had arm pain for 5 months since his injection
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported.; Nurse reported that the patient was "inadvertently administered an expired dose of ZOSTAVAX"; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 16-JUN-2020, the patient was inadvertently administered an expired dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination scheme and anatomical site of vaccination, were not reported; lot number N013274, which has been verified to be valid, expiration date reported and valid as 04-JUL-2018) as prophylaxis. No additional adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported.; The patient was administered the second dose of GARDASIL 9 on 6/17/2020 at 15 years of age; This spontaneous report was received from a nurse referring to a 15 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided.      On an unspecified date in 2015 (when the patient was 10-11 years old), 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) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 17-JUN-2020, 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) (lot# R003557, expiration date 20-NOV-2020; dose detail, strength and route were not provided) (inappropriate schedule of product administration). No additional adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; an expired dose of VAQTA given to 12 month old on June 23,2020; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 23-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot# S002505, expiration date 04-APR-2020, 0.5 milliliter; route was not provided) for prophylaxis (expired product administered). No additional adverse event was reported.