chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in early July 2017, the patients were vaccinated an improperly stored doses of with M-M-R II  injection, lot number N013276, expiration date 21-JAN-2020 (dose and route of administration were  not reported) for prophylaxis. It was reported that sterile water diluent  properly stored was reconstituted with M-M-R II. The temperature of excursion with M-M-R II  was 47 to 77 Fahrenheit degrees during 5 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA011512: US-009507513-1709USA011240:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in early July 2017, the patients were vaccinated with an improperly stored doses of with ROTATEQ orally, lot number M045544, expiration date 23-JUN-2018 (strength and dose were not reported) for prophylaxis. The temperature of excursion with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was 47 to 77 Fahrenheit degrees during 5 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-1709USA011240: US-009507513-1709USA011511:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # N001348, expiration date 31-OCT-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 1.9 degrees Celsius (°C) for 30 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009392:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates (reported as on unspecified dates or after 05-JUN-2017), the patients were vaccinated with improperly stored doses of ROTATEQ lot # M040267, expiration date 14-MAY-2018 and lot # M041184, expiration date 31-MAY-2018, orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 8 hours. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA011077.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M043836 with expiry date 17-JUN-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M035456 with expiry date 01-MAY-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M035456 with expiry date 01-MAY-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011733: US-009507513-1709USA011734:  US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011737: US-009507513-1708USA003070.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M040267 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1708USA003070.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 2 hours. There were previous excursions reported: between 6 to 14 degrees Fahrenheit for 6 hours and 30 minutes. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011066.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt faint after about 10-15 minutes, we placed him in a chair then laid him on the floor and gave ice paks and water and slowly sat him up until he felt better it took about 20 minutes for him to feel better.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Cold sweat, Disorientation, Syncope
Clinical narrative: Patient was given her flu shot she sat and we talked for about 10-15 minutes, her daughter met her back by the pharmacy, they left the store and as she was getting into their van she fainted in front of our store, I was called and ran out, she was clammy, and out of it for a little while, she was breathing fine pulse was good she was a little disoriented, she came back to it and was talking to us and answering our questions an ambulance was called and I went back into the store at the time the paramedics arrived she was taken to the hospital for further evaluation, I am calling family to follow up with them.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Mom reported at 1:50 AM that patient woke up crying with difficulty breathing. Mom gave BENADRYL and prepped to go to ER but didn't go because patient symptoms decreased before leaving house. Spoke to mom at 9:11 AM following day (9/22/17) and patient is okay with no problems.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness on Left Upper thigh in region of MMRV vaccine; did not appear until 6 days after vaccination per mom. No spreading of erythema. Focal. Non tender.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Chest X-ray, Febrile convulsion, Urine analysis
Clinical narrative: Febrile seizure. Admission for IV fluids, workup.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Bone pain, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Low grade fever 101-102; aches in bones and muscles all over body similar to the flu, low energy, headache, sweats at night. Lasted 4 days. Reported to nurse- advised to take Tylenol 1000mg TID and Benedryl if rash. Rash/redness appeared on left arm at site with itching.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Myalgia, Night sweats, Pyrexia
Clinical narrative: Low grade fever 101-102; aches in bones and muscles all over body similar to the flu, low energy, headache, sweats at night. Lasted 4 days. Reported to nurse- advised to take Tylenol 1000mg TID and Benedryl if rash. Rash/redness appeared on left arm at site with itching.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: After injection very bad pain in left deltoid. Pain noted to radiate to neck and shoulder. Painful to lift left arm. Extreme pain upon waking. Left arm extremely weak.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash starting 1 week after vaccine received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 18-SEP-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M040138 and expiration date of 28-SEP-2018, (route of administration and anatomical location were not reported), for prophylaxis, reconstituted with properly stored sterile diluent (lot # M034781 and expiration date 11-APR-2019) The vaccine was stored in the range of 40 Fahrenheit degrees for an hour. No previous temperature excursion was reported. No adverse effects were reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever. Arm pain hurt so bad. Could not move arm. It is now the 25th of September, 16 days after the shot and my arms (both) still are painful to use.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Child received flu vaccine on 9/22/17 AM and that same evening at 10pm the child's mother called saying he developed hives diffusely on his body. He was itchy and was given one dose of benadryl with relief. No other signs or symptoms developed.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash, Skin irritation
Clinical narrative: Rash, Skin irritability.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Irritability, Rash
Clinical narrative: Rash, Skin irritability.
Age: 52.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Rash, Skin irritation
Clinical narrative: Rash, skin, irritability.
Age: 52.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Irritability, Rash
Clinical narrative: Rash, skin, irritability.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the arm.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweating/Chills. Stiffness in neck. Cough, headache, fatigue, runny nose soreness where the shot was given. Went to Occupational Health Services/but no response.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Musculoskeletal stiffness, Rhinorrhoea
Clinical narrative: Sweating/Chills. Stiffness in neck. Cough, headache, fatigue, runny nose soreness where the shot was given. Went to Occupational Health Services/but no response.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M034583, expiration date 27-JUL-2018 or lot # M040139 with expiration date of 28-SEP-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT). There were no adverse effects reported. Administered doses of vaccines underwent the temperature excursions from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour 10 minutes and from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes (date unspecified). Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA002957:
Age: 76.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 14-SEP-2017, the patient received an improperly stored dose of ZOSTAVAX 19400 plaque-forming units (PFU) (lot # M037013 with expiration date at 22-NOV-2017; for prophylaxis; route of administration and anatomical location were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # M024781 with expiration date at 21-FEB-2019). The administered dose of vaccine was exposed to a temperature between 6 Fahrenheit (F) degrees and 14 Fahrenheit (F) degrees for 11 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved.   Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Vaccination site induration, Vaccination site warmth
Clinical narrative: (R) upper arm - 6 inch diameter - redness, induration, warmth around vaccine site. No tenderness. Area of redness increased to 8 inches on day #2.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: On the right arm where pt. received immunization there is a large rash under location of shot.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Neuralgia, Paraesthesia
Clinical narrative: Inflammation x 1-2 days, neuralgia in upper trunk and shoulder starting approximately 72 hours after administration and worsening, no rash, tingling comes and recedes.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear pain, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes - slight pain in ears.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatitis, Leukopenia, Neutrophil count decreased
Clinical narrative: Prolong fever >7 days, leukopenia, hepatitis.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: Prolong fever >7 days, leukopenia, hepatitis.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling developed 3 days after immunization.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: Mother states the child was inconsolable and screamed continuously for the entire evening after the two-month vaccines were given (PENTACEL, PCV13, RV5). Mom states this is very unusual behavior for the child, as the child is very calm and quiet usually. Mom states the child had a worse reaction after the four-month vaccines and the screaming continued all evening into the next day.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Limb discomfort, Pain in extremity, X-ray limb
Clinical narrative: The patient had limited range of motion, pain, and discomfort in the left arm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness and swelling around injection area on Saturday evening, then on Sunday, the area became warm and hard. On Monday morning, she went to the Doctors office and they have her a shot and a Medrol Dosepak. That afternoon, she came to the pharmacy to show me.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 year old female patient who refers to herself. The patient had no pertinent medical history and did not receive any concomitant medications. The patient had drug reactions and allergies to penicillin, codeine and rifamycin. In September 2012, reported as about 5 yers ago, the patient was intravenously vaccinated with a single dose of ZOSTAVAX (dose, lot# and expiration date were not reported) for shingles prevention. Since September 2013, about a year after receiving ZOSTAVAX, the patient experienced shingles 4 times. The patient sought medicall attention. She received treatment all four times and used topical creams and 800 mg of acyclovir. No lab diagnostic studies were performed. The outcome of shingles was unknown. The relatedness between the event of shingles and ZOSTAVAX was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored M-M-R II lot # M035389 with expiration date on 02-AUG-2018 and lot # M045394 with expiration date on 14-NOV-2018, (dose and route of administration were not reported) for prophylaxis. The doses of M-M-R II were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1709USA010570:US-009507513-1709USA010723:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017 (reported as between 01-MAR-2017 and 01-SEP-2017), the unspecified number of improperly stored doses of M-M-R II lot number L047133 with expiration date 24-NOV-2017 (doses, routes of administration and anatomical locations were not reported) were administered to the patients. The doses were reconstituted with improperly stored sterile water diluent (MRK) lot# reported as M012217 (lot# invalid for sterile water diluent (MRK)) with expiration date 19-SEP-2017. The doses were stored in temperature of -59 degrees Fahrenheit for 6 months. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This was one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA011984:
Sex: U
Vaccine: RV5
Symptoms: Malaise, Vomiting
Clinical narrative: This spontaneous report has been received from a nurse practitioner via company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 20-SEP-2017, the patient was vaccinated with ROTATEQ dose 2, orally (strength, lot# and expiration date were not reported) for prophylaxis. It was reported that the patient's mother called to stated that on 20-SEP-2017, the patient vomited throughout the night (vomiting ) and was not doing well throughout the night (malaise). The patient's outcome for vomiting and malaise were unknown. At the time of this report, the causality between the events and ROTATEQ was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011988: US-009507513-1709USA011986.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017 (reported as between 01-MAR-2017 and 01-SEP-2017), the unspecified number of improperly stored doses of RECOMBIVAX HB lot number M046373, expiration date 04-NOV-2018 (doses, routes of administration and anatomical locations were not reported) were administered to the patients. The doses were stored in temperature of -59 degrees Fahrenheit for 6 months. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This was one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011984.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011849: US-009507513-1709USA011988: US-009507513-1709USA011986.
Age: 66.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Soreness at injection site and radiahy redness down arm and on left side of chest. Injection site on left arm. As of 9/25/2017 Pt says its much better.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Arm red swollen from shoulder to elbow on left arm (cellulitis). Given cetirizine for swelling and cephalexin for infection.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Severe itchiness, swollen, hot to touch on and around the area, red in color, dizziness.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site rash, Skin warm
Clinical narrative: Patient stated that arm started to become warm that evening of the injection, then on the following day, there was a rash and inflammation from site to elbow. She came in on Saturday (9/23) and pharmacist told her to take some APAP and to put ice on the area through out the day. Husband had no adverse reaction from his shot given the same day.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient developed a rash shortly after receiving the PNEUMOVAX 23 vaccine. Her right arm is red, swollen and radiating heat. I spoke to her Dr. and he is going to see the patient at 1 pm today.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Vaccine was not properly mixed-Liquid (Dtap, IPV) was not mixed with powder (HIB) and pt only received Dtap & IPV of the PENTACEL component. Patient has been notified and appointment has been scheduled to return to clinic for HIB vaccine.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Redness, induration, hot to the touch, pain at injection site.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse reaction, patient received pneumonia vaccine when not indicated.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Pain
Clinical narrative: Patient developed a yellowish bruise in the left arm at the site of injection. It is still a little sore 9 days later.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Joint hyperextension, Neuropathy peripheral, Skin discolouration
Clinical narrative: Pt has h/o neuropathy; saw neurologist as routine after the shot given; had some numb strange sensations; he told her she had an ulnar neuropathy; she then kept the arm straight and a little hyperextended. She later noticed duskiness in the hand.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, redness, and pain. Patient went to the urgent care and was prescribed prednisone.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysgeusia, Paraesthesia oral, Pruritus generalised
Clinical narrative: Pt received dose #2 of Varicella vaccine at 0923 AM on 09/25/2017, pt was asked to stay in the waiting room for 15 minutes to be observed for adverse reactions. Pt reports back at 0953 AM and c/o generalized itching all over body, tingling on his lips and a metallic taste in his mouth. Pt was escorted back into treatment room where he received 50mg of Diphenhydramine, 2L of O2 via nasal cannula. Vitals were taken and Physician at bedside.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient experienced a swollen, itchy red welt around the injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed a red, itchy patch (about 2 inches by 2 inches in size) at the site of vaccine administration the day following the vaccine. It is not swollen or warm to the touch. It has not gotten any worse since it first developed, but it has not really improved since then as well.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle spasms
Clinical narrative: Back spasms requiring patient to lie down. Patient was unable to get up for a few minutes. 911 alerted and fire department came and her vitals were normal. Patient was then able to sit up.
Age: 55.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Blood pressure increased, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: About 4 and 1/2 hours after immunization, patient experienced redness, swelling and pain at injection site. The area of redness enlarged over the next few days. She used cold compress and began taking Benadryl on the day following the immunization. By 9/25/17, 4 days after injection, the redness and swelling continued and there was a nodule at injection site. She went to her primary care nurse practitioner that day for examination and was give Prednisone 10mg daily for 3 days and Cephalexin 500mg twice daily for 7 days. She began taking meds that same day.
Age: 9.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MENACTRA WAS GIVEN TO A PATIENT THAT WAS TO YOUNG TO RECEIVE-PATIENT HAS BEEN NOTIFIED AND WILL NEED IT TO BE REPEATED WHEN SHE IS 12 YEARS OF AGE. TDAP WAS GIVEN TO A PATIENT THAT WAS TO YOUNG TO RECEIVE. PATIENT HAS BEEN NOTIFIED AND WILL NOT HAVE TO HAVE TDAP REPEATED.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye discharge, Eyelid margin crusting, Fatigue, Feeling abnormal
Clinical narrative: Symptoms as described by the patient: "goop in my RT. eye  and feeling kind of weird/tired the day of the shot, next day called in sick and sleep most of the day, I've been waking  up every morning with crust in both my eyes, feeling very tired all day and a little cough and congested and headache." Treatment: none Outcome: resolved as of 9/22/17.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Impaired work ability, Respiratory tract congestion, Somnolence
Clinical narrative: Symptoms as described by the patient: "goop in my RT. eye  and feeling kind of weird/tired the day of the shot, next day called in sick and sleep most of the day, I've been waking  up every morning with crust in both my eyes, feeling very tired all day and a little cough and congested and headache." Treatment: none Outcome: resolved as of 9/22/17.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient showed up at pharmacy with a swollen area of her arm, not the injection site but on the underside of her arm lower near her elbow on 9/20/2017.  She was advised to go the the ER and she did.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Wed: approx 3-4 hrs post-vaccination, arm became hot/swollen, extending into the lymph nodes under arm, into breast. Applied ice. Thurs: next day experienced more of the above, with mild fever. Fever spiked to 102 degrees that night, unrelieved by ADVIL. Fri: next day (called physician's office). Began taking ADVIL alternating with TYLENOL. Fever improved, then went back up to 101 degrees. Sat: arm still red, hot, swollen, sore area traveling distally. Mild fever. Sun/Mon (today): arm STILL red, hot, swollen, sore.  **I would not have gotten this vaccine had I known!!**
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Wed: approx 3-4 hrs post-vaccination, arm became hot/swollen, extending into the lymph nodes under arm, into breast. Applied ice. Thurs: next day experienced more of the above, with mild fever. Fever spiked to 102 degrees that night, unrelieved by ADVIL. Fri: next day (called physician's office). Began taking ADVIL alternating with TYLENOL. Fever improved, then went back up to 101 degrees. Sat: arm still red, hot, swollen, sore area traveling distally. Mild fever. Sun/Mon (today): arm STILL red, hot, swollen, sore.  **I would not have gotten this vaccine had I known!!**
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Left upper arm swelling that extended down beyond elbow. Some pain but no redness or fevers.  Started on 9/20/2017 and worsened over the first 24-36 hours. Seen in office on 9/21/2017.  Treated with supportive care of Benadryl and cold packs as needed. Swelling improved after visit at the office without further interventions.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Bronchial wall thickening, C-reactive protein, Chest X-ray abnormal, Chest pain
Clinical narrative: Patient had sudden onset chest pain and shortness of breath diagnosed with acute pericarditis on 9/15/17 admitted to hospital center, treated and discharged.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Echocardiogram, Leukocytosis, Metabolic function test, Pericarditis
Clinical narrative: Patient had sudden onset chest pain and shortness of breath diagnosed with acute pericarditis on 9/15/17 admitted to hospital center, treated and discharged.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Prothrombin time, Troponin, White blood cell count increased
Clinical narrative: Patient had sudden onset chest pain and shortness of breath diagnosed with acute pericarditis on 9/15/17 admitted to hospital center, treated and discharged.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Oropharyngeal pain, Syncope
Clinical narrative: Patient fainted while attempting to stand shortly after receiving this vaccination. Patient regained consciousness within a few seconds, but fell forward into a shelf partition when he fainted. After he regained consciousness patient stated that he felt ok, except for a mild sore throat. EMS was contacted immediately and responded within minutes. While waiting for EMS patient consumed a small amount of drinking water. Patient remained seated until EMS arrived. EMS took patient vitals and transported to a nearby hospital. EMS did not share findings for vitals.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
Clinical narrative: Day after vaccination large area of redness and induration noted approximately 8cm diameter around vaccination site on lateral right thigh. It increased over the following 24 hours to approximately 9.5cm diameter on re-presentation to our office on 9/25/17. The area is discretely bounded, firm, light red, non tender, minimally itchy.  No fever or change in activity or other symptoms present.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Seizure
Clinical narrative: Approximately 6 hours after receiving her vaccines, she had a seizure that lasted about 20-30 seconds. She was evaluated at the ER that day and a CT scan showed a healthy brain. Two weeks later she had an EEG done which showed no signs or propensity for epilepsy. No subsequent events or treatments have occurred.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Patient noticed rash on arms and legs approx 4 pm on 9/20/17. Patient took one children's Benadryl at approx 6 pm. At 10 pm, patient noticed large, red hives all over his back. He took two adult Benadryl. Rash was gone by next morning. In the afternoon on 9/21/17, rash had returned, but only on patient's arms. He took two adult Benadryl. Rash did not return after that point.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dyspnoea, Impaired work ability, Nausea, Pain
Clinical narrative: Symptoms as described by patient: "arm is pulsing  and  sore with radiation down tricep" also "whole body weakness, had throbbing arm right after shot; unable to lift shoulder without pain. Had felt weak, SOB and nauseated for about 4 days. Missed 2 days of work." Treatment: none attempted at the time of report; first aid options described and encouraged Outcome: still complaining of arm soreness.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Symptoms as described by patient: "arm is pulsing  and  sore with radiation down tricep" also "whole body weakness, had throbbing arm right after shot; unable to lift shoulder without pain. Had felt weak, SOB and nauseated for about 4 days. Missed 2 days of work." Treatment: none attempted at the time of report; first aid options described and encouraged Outcome: still complaining of arm soreness.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Took the flu shot and my neck and back became stiff and in severe pain. This is still happening to me, some 4 weeks after the shot.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site rash, Injection site urticaria
Clinical narrative: 4 cm rash c hives, pustules, erythema, pain and urticaria to injection site.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Blood glucose normal, Blood pH normal, Computerised tomogram head normal, Depressed level of consciousness, Disorientation
Clinical narrative: The patient was given his 2 injections in the R Deltoid and then went to collect a urine sample. Subsequently he became flushed and light-headed. He was given some fluid and shortly felt somewhat better. Next, as he was leaving the facility, he became disoriented and pre-syncopal. He was guided back to the exam table where he proceeded to lose consciousness. He maintained this altered sensorium for roughly 2 hours before gradually returning to a normal level of consciousness. A Code Blue was called in the office. He was taken to our Emergency facility with stable vital signs but still poorly responsive roughly 1 hour after the initial event. Labs were all unremarkable with the exception of a positive urine screen for THC. He was admitted for observation.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Drug screen positive, Electrocardiogram normal, Flushing, Full blood count normal
Clinical narrative: The patient was given his 2 injections in the R Deltoid and then went to collect a urine sample. Subsequently he became flushed and light-headed. He was given some fluid and shortly felt somewhat better. Next, as he was leaving the facility, he became disoriented and pre-syncopal. He was guided back to the exam table where he proceeded to lose consciousness. He maintained this altered sensorium for roughly 2 hours before gradually returning to a normal level of consciousness. A Code Blue was called in the office. He was taken to our Emergency facility with stable vital signs but still poorly responsive roughly 1 hour after the initial event. Labs were all unremarkable with the exception of a positive urine screen for THC. He was admitted for observation.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Hyporesponsive to stimuli, Loss of consciousness, Metabolic function test normal, Presyncope
Clinical narrative: The patient was given his 2 injections in the R Deltoid and then went to collect a urine sample. Subsequently he became flushed and light-headed. He was given some fluid and shortly felt somewhat better. Next, as he was leaving the facility, he became disoriented and pre-syncopal. He was guided back to the exam table where he proceeded to lose consciousness. He maintained this altered sensorium for roughly 2 hours before gradually returning to a normal level of consciousness. A Code Blue was called in the office. He was taken to our Emergency facility with stable vital signs but still poorly responsive roughly 1 hour after the initial event. Labs were all unremarkable with the exception of a positive urine screen for THC. He was admitted for observation.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager refers to unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 lot # N012093, expiration date: 13-JAN-2020, (route unspecified) for prophylaxis. Temperature: 32 ° F to 35 ° F, time frame: 37 hours. There was no previous temperature excursion. No adverse effects reported. Call was because of a data logger. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012033.