chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose normal, Eye movement disorder, Fall, Musculoskeletal stiffness, Tremor
Clinical narrative: She was in the shower with mom and all of a sudden fell backwards.  Mom picked her up and she kept falling again.  She was then stiff, eyes rolling to the side, had whole body shaking and stiffness.  Mom took her after the shower and watched her.  She remained unresponsive for about 10 minutes.  They called EMS.  They checked her blood sugar in the ambulance and it was 130.  She was drowsy for about 1 hour after the event.    They transported her to ED where she was evaluated and felt to be fine.  She was discharged home in good condition.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: She was in the shower with mom and all of a sudden fell backwards.  Mom picked her up and she kept falling again.  She was then stiff, eyes rolling to the side, had whole body shaking and stiffness.  Mom took her after the shower and watched her.  She remained unresponsive for about 10 minutes.  They called EMS.  They checked her blood sugar in the ambulance and it was 130.  She was drowsy for about 1 hour after the event.    They transported her to ED where she was evaluated and felt to be fine.  She was discharged home in good condition.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling abnormal, Headache, Presyncope
Clinical narrative: Client became near syncopal complained of "not feeling good" and "headache" 2-5 minutes post vaccination. According to mother, client had not eaten yet that morning. Gave candy cane and water and carried to exam room and layed flat on exam table. applied cold/cool compress to neck and forehead. Client recovered within 15 minutes but still complained of headache. Was able to leave ambulatory with parent. Advised parent to make sure child ate as soon as possible. Called parent 3:50pm same date child ate and had no further incident up to that time. Advised parent to follow up with physician especially if episodes recurred.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site infection
Clinical narrative: Pt reported infection at injection site.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Lacrimation increased, Malaise, Sneezing
Clinical narrative: Pt reports he was sick with the flu. Reports coughing, sneezing, feeling ill, and tearing from his left eye.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: PT HAD ARM PAIN THROUGHOUT THE ENTIRE ARM 3 HOURS POST VACCINE.  AT AROUND 5 HOURS POST VACCINE PT STATES SHE ALMOST FAINTED AND WAS NAUSEOUS.  HER ARM WAS SLIGHTLY SWOLLEN AND RED.
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Flushing, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient began to have red flat rashes on chest and abdomen with itching. This progressed to face and bilateral inner arm. Patient also had facial flushing. The ems were called but patient and his parents declined help. The patient stated that he felt better right before he left the health department.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Altered state of consciousness, Cold sweat, Deafness, Dizziness, Pallor
Clinical narrative: I got really dizzy, almost passed out. Loss hearing for a moment and could only hear it from far away. Clammy and paleness.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Very stiff shoulder continuing for several months. Gradually improving with stretching. Still pain when stretching.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: At onset: stiffness, pain, swelling, redness in arm. Next morning and for 36 hours following: fever, severe pain/stiffness/redness--which was spreading significantly--and swelling in arm. Difficulty in moving or lifting arm. Went to ER morning of Nov. 12 and diagnosed and treated for cellulitis. Kept in hospital for 36 hours for treatment and observation. At end of treatment, attending decided not cellulitis, but cellulitis-like reaction. Redness and swelling in arm remained for another full day.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: At onset: stiffness, pain, swelling, redness in arm. Next morning and for 36 hours following: fever, severe pain/stiffness/redness--which was spreading significantly--and swelling in arm. Difficulty in moving or lifting arm. Went to ER morning of Nov. 12 and diagnosed and treated for cellulitis. Kept in hospital for 36 hours for treatment and observation. At end of treatment, attending decided not cellulitis, but cellulitis-like reaction. Redness and swelling in arm remained for another full day.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea and vomiting, achiness, dizziness, headache, fever 99.5 (3 days after vaccine). Lasted only 3 hours.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting, achiness, dizziness, headache, fever 99.5 (3 days after vaccine). Lasted only 3 hours.
Age: 1.07
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Electroencephalogram abnormal, Febrile convulsion
Clinical narrative: Started having multiple febrile seizures 12-13 hrs after vaccinations 1st one was 10-15 minutes at home 2nd one in the ambulance around 10 minutes was evaluated at local hospital (postictal) then transferred to another hospital one more seizure there responded to treatment discharged on 1/6/16.
Age: 1.07
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain normal, Postictal state
Clinical narrative: Started having multiple febrile seizures 12-13 hrs after vaccinations 1st one was 10-15 minutes at home 2nd one in the ambulance around 10 minutes was evaluated at local hospital (postictal) then transferred to another hospital one more seizure there responded to treatment discharged on 1/6/16.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Unknown time of onset. Patient called our clinic reporting she had develop redness, tenderness, and pain at injection site after the pneumonia vaccine was administered. Patient reported she was seen by her PCP who declared the reaction an allergic response to the vaccine.
Age: 25.0
Sex: F
Vaccine: HEP, HPV4, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: PATIENT RECEIVED VACCINATIONS.  SHE THEN ASKED QUESTIONS ABOUT OTHER MEDICAL SERVICES AND NEXT APPOINTMENT.  ABOUT 5 MINUTES AFTER THE IMMUNIZATIONS SHE AROSE AND WALKED TOWARD THE WAITING ROOM.  IN THE HALLWAY, SHE WALKED INTO A WALL AND FAINTED.  CLINICIAN WAS BEHIND HER AND CAUGHT HER AND KEPT HER UPRIGHT AND WITH HER AUNTS HELP CARRIED HER TO A PADDED CHAIR AND INSTRUCTED HER TO BEND FORWARD AND PUT HER HEAD BETWEEN HER KNEES.  THE AUNT TRIED TO KEEP PATIENT'S HEAD UP.  WITH TRANSLATION AND BY CLINICIAN DEMONSTRATING, PATIENT BENT FORWARD ON THE CHAIR AND PUT HER HEAD DOWN NEAR HER KNEES.  CLINICIAN DEMONSTRATED FOR HER TO TAKE SOME DEEP BREATHS.  AFTER ABOUT 10 BREATHS CLINICIAN HELPED HER TO SIT UPRIGHT AND HAD A DRINK OF WATER BROUGHT TO HER WHICH SHE DRANK.  AFTER MONITERING HER FOR ANOTHER 5 MINUTES, CLINICIAN PUT A CHAIR NEXT TO PATIENT AND HAD HER RELATIVE SIT BY HER AND HOLD HER HAND AND WATCH HER FOR FAINTING FOR ANOTHER 15 MINUTES.  CLINICIAN CHECKED ON HER AND AFTER 15 MINUTES WITH PATIENT STATING SHE FELT FINE NOW, CLINICIAN LET HER LEAVE WITH HER RELATIVES.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Hallucination, auditory, Hyperhidrosis, Influenza, Injection site discolouration
Clinical narrative: 8 hours after shot was given, patient said he felt like he had the flu. For the next 48 hours, patient had a high temperature and took acetaminophen and then felt fine. He reports that his temp broke, then spent 20 minutes sweating. He rested for 48 hours (bedrest) and said a rash appeared on the injection site. He said it was a raised rash (4-6 inches length, 4 inches wide around injection site). Then for 3 days, he experienced paranoia and schizophrenia (these are underlying conditions), had severe hallucinations (voices) for 1 hour. The 2nd day and 3rd day he continued to experience the voices but they diminished over time. The injection site is still slightly discolored from previous rash and has a noticeable border upon observation on 1/6/15 by pharmacy.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Paranoia, Pyrexia, Schizophrenia
Clinical narrative: 8 hours after shot was given, patient said he felt like he had the flu. For the next 48 hours, patient had a high temperature and took acetaminophen and then felt fine. He reports that his temp broke, then spent 20 minutes sweating. He rested for 48 hours (bedrest) and said a rash appeared on the injection site. He said it was a raised rash (4-6 inches length, 4 inches wide around injection site). Then for 3 days, he experienced paranoia and schizophrenia (these are underlying conditions), had severe hallucinations (voices) for 1 hour. The 2nd day and 3rd day he continued to experience the voices but they diminished over time. The injection site is still slightly discolored from previous rash and has a noticeable border upon observation on 1/6/15 by pharmacy.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Severe muscle pain in left arm from shoulder to elbow. Could not move left arm without lifting it with right hand because of pain. Severe pain for 4 days. Could not drive because of pain. Began to use  left arm on 5th day. Took Naproxen Sodium 220mg for pain but only eased the pain slightly. Two months later I still have muscle pain and take Naproxen Sodium 220 mg so I can sleep at night.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Mom called. Left leg swollen thigh to knee. Warm to touch, painful to walk on it. Warm and cool compresses, Tylenol and ibuprofen as needed. Swelling better on 1/7/16 and pain resolved.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in left arm. Unable to raise arm. Pain still persists to this day 01/07/2016. I have seem primary Dr and am scheduled to see specialist on 01/15/2016. Pharmacist remarked that he thought he hit my bone when I told him of my pain.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal sensation in eye, Dizziness, Hyperhidrosis, Hypopnoea, Limb discomfort
Clinical narrative: Sweating, Dizzy, blurry vision, legs heavy, eyes felt tight and blurry, Right neck pain down right shoulder an muscle spasm in stomach and throat area extreme, Shallow breathing for air and nausea..Later that night vision was almost blind.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle spasms, Musculoskeletal pain, Nausea, Neck pain, Vision blurred
Clinical narrative: Sweating, Dizzy, blurry vision, legs heavy, eyes felt tight and blurry, Right neck pain down right shoulder an muscle spasm in stomach and throat area extreme, Shallow breathing for air and nausea..Later that night vision was almost blind.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Sweating, Dizzy, blurry vision, legs heavy, eyes felt tight and blurry, Right neck pain down right shoulder an muscle spasm in stomach and throat area extreme, Shallow breathing for air and nausea..Later that night vision was almost blind.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Lymphadenitis
Clinical narrative: Pt reports lymphadenitis on axillae and neck, left side only, and a headache. No injection site reaction.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a lawyer via call center representative and described the occurrence of Guillain Barre syndrome in a female patient who received FLUARIX QUADRIVALENT (batch number 57C93, expiry date unknown). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was previously reported to VAERS. The patient received a dose of FLUARIX QUADRIVALENT, and experienced Guillain Barre syndrome. The reporter wanted to know whether the FLUARIX vaccine contained egg.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (exact dose, route, lot # and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Nausea, Pruritus, Vomiting
Clinical narrative: Lethargy, nausea/vomiting, itchy.
Age: 0.28
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 03-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.15
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 03-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.39
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 15:55 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-DEC-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) injection, lot # L026410, expiry date: 15-FEB-2017 (route, dose and strength were unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011325, expiry date: 08-APR-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 11:58 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of GARDASIL (Batch and Lot No. K010215, exp. 05-MAY-2017) (dose, site and route not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001942, 1601USA001943 and 1601USA001944 from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (Lot# K018181, expiry date 04-JUN-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 03-SEP-2015 at 12:05 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.13
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 14:29 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot# K016966, expiry date 10-MAY-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # L013190, expiry date 16-NOV-2016 and lot #L013192, expiry date 19-NOV-2017), oral. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-DEC-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L026410, expiry date: 15-FEB-2017 (route, dose and strength were unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 13-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a male patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL and on an unspecified date in June 2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date were not provided) dose, route and anatomical location were unknown. On 30-DEC-2015, the patient was in the physician's office intending to receive his third dose of GARDASIL, but at the time of the report it had not yet been administered (inappropriate schedule of drug administration). No concomitant therapies were provided. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PROQUAD (Merck) lot # K010211 expiration date 17-JAN-2016, lot # L003222 expiration date 30-JUL-2016 and lot # L007228 expiration date 03-SEP-2016 (dose and route were not reported), were given to unspecified patients on unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved.  This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015 at 12:24 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical assistant concerning multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of VAQTA (Batches and Lot numbers K018181, exp. 04-JUN-2017 and L015460, exp. 20-JUL-2017) (dose, site and route not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001943, 1601USA001944 and 1601USA000936 from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB (Batch and Lot No. L025738, exp. 14-AUG-2017; L029631, exp. 14-AUG-2017) (dose, route and site not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001942, 1601USA001943, 1601USA001944 and 1601USA000936 from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored dose of PNEUMOVAX 23 (single dose vials) lot # L013428, expiration date 03-FEB-2017, (dose and route were not reported), was given to unspecified patients on unspecified dates. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of GARDASIL 9 (Batch and Lot No. L020015, exp. 16-AUG-2017) (dose, site and route not reported). No adverse effects were reported. This report is linked to MARRS 1601USA000936, 1601USA001941, 1601USA001942, 1601USA001943 and 1601USA001944. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, reported as in the past, the patient was vaccinated with two doses of VARIVAX (dose, route, anatomical location or lot# were not informed). Concomitant medications were not provided. On an unknown date, also reported as in the past, the patient experienced chickenpox. The outcome of chickenpox was unknown. The relatedness between the event and VARIVAX was not provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Incorrect product storage
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 09-SEP-2015 at 08:25 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.57
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month-old female infant. There was no pertinent medical history, concurrent medications, concurrent conditions or drug allergies/drug reactions described. On 09-SEP-2015 at 08:54 hours, the patient was vaccinated with a dose of improperly stored, oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostic test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.28
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 09-SEP-2015 at 10:28 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: ZOSTAVAX at pharmacy 12-28-15. Rash appears (R) abdomen 1-1-16. Seen by Dr 1-4-16.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Culture negative, Injection site abscess sterile
Clinical narrative: Sterile abscesses formed at each injection site 1 mo after vaccines were administered. Three cultures have been sent - all of which were negative. Abscesses are still present (-) this time.
Age: 0.12
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015 at 12:39 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of M-M-R II lot # L001336 expiration date 13-JAN-2017 (dose and route were not reported) and lot # L009213 expiration date 17-MAR-2017 (dose and route were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored dose of VARIVAX (Merck) lot # L018001, expiration date 19-MAY-2017, (dose and route were not reported), was given to unspecified patients on unspecified dates. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a register nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 18-DEC-2015 the patient was vaccinated with an expired dose of VARIVAX (lot number reporter as 0494AE, expiration date 7-MAR-2014) (strength and frequency were not provided). Concomitant therapies were not provided. In additional to this, the registered nurse stated that she did not know if the product had any previous temperature excursions. No adverse symptoms reported. PQC was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Contraindication to vaccination, Rheumatoid factor increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old patient who underwent an unspecified chemotherapy for unspecified condition; this was a chemotherapeutic agent that the patient received every 3 weeks. The patient received ZOSTAVAX (dose, route, lot # and expiration date were not reported) within the last 10 days (14-DEC-2015 to 23-DEC-2015). So, chemotherapy and vaccination occurred in same time frame. The pharmacist stated patient "likely considered immunosuppressed" which was contraindication to receiving ZOSTAVAX. The pharmacist also reported, that the patient was being treated by an unspecified physician who had completed unspecified lab work at an unspecified time either prior to or after ZOSTAVAX vaccination (pharmacist was unable to confirm), that revealed elevation in unidentified "rheumatologic values" (values and units not reported) (laboratory test abnormal). The treatment had not bee initiated based on recent ZOSTAVAX vaccination and ongoing chemotherapy regimen. The outcome of laboratory test abnormal was unknown. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain at injection site. Fever and chills. Swelling at injection site. Tx: Ibuprofen and ice packs as needed. Documented on chart to no longer give Tdap but Td.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patients medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 30-DEC-2015, the patient was inadvertently vaccinated with an expired dose of GARDASIL, lot number J002641, expiration date 10-DEC-2015, (dose, route and anatomical location were not reported). No adverse effects were reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult patient of unknown age (no demographics information were reported). The patient medical history and concurrent condition were not provided. On an unknown date in June 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (route, dosage, dose number and lot number unknown). On 15-DEC-2015, the patient was vaccinated with RECOMBIVAX HB dose 2, 1 ml, intramuscular (lot number, expiration date and anatomical location were not provided). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 10-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # and expiry date not reported). Other co-suspect or concomitant medications were not reported. On an unknown date, the patient experienced mild reaction to PNEUMOVAX 23: redness, swelling, and warmth. The outcome of swelling, feeling hot and erythema was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Patient was given a DTaP on 1-5-16 at 5:00PM. Mom reports swelling, redness w/splotchyness down past in his left knee on the night of 1-6-16. Mom brought patient to clinic 1-7-16 for evaluation. At this time, swelling and redness extended to left knee from upper thigh.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site injury, Vaccination complication
Clinical narrative: Shoulder (L) injury due to flu vaccine.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Back pain, Dissociation, Dizziness, Dyskinesia
Clinical narrative: Began complaining of nausea and severe dizziness upon leaving the doctor's office. One hour post vaccine began having uncontrolled movements in legs and neck. As of 1/8/2016 the symptoms have progressively worsened. Involuntary movements have also spread to the rest of the body, including facial and vocal tremors. Frequent episodes of dizziness and fatigue. Constant nausea. On 12/17/15 began having stabbing pains in her head that result in severe weakness. There have also been occasions of brain fog as well as disassociation with environment. Has also been complaining of random pains in back, calves, and pelvis. Currently being treated for POTS.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: Began complaining of nausea and severe dizziness upon leaving the doctor's office. One hour post vaccine began having uncontrolled movements in legs and neck. As of 1/8/2016 the symptoms have progressively worsened. Involuntary movements have also spread to the rest of the body, including facial and vocal tremors. Frequent episodes of dizziness and fatigue. Constant nausea. On 12/17/15 began having stabbing pains in her head that result in severe weakness. There have also been occasions of brain fog as well as disassociation with environment. Has also been complaining of random pains in back, calves, and pelvis. Currently being treated for POTS.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Pelvic pain, Postural orthostatic tachycardia syndrome, Tremor
Clinical narrative: Began complaining of nausea and severe dizziness upon leaving the doctor's office. One hour post vaccine began having uncontrolled movements in legs and neck. As of 1/8/2016 the symptoms have progressively worsened. Involuntary movements have also spread to the rest of the body, including facial and vocal tremors. Frequent episodes of dizziness and fatigue. Constant nausea. On 12/17/15 began having stabbing pains in her head that result in severe weakness. There have also been occasions of brain fog as well as disassociation with environment. Has also been complaining of random pains in back, calves, and pelvis. Currently being treated for POTS.