chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Dyspnoea, Headache, Heart rate irregular, Injection site erythema
Clinical narrative: After vaccination at pharmacy on 12/21/2017 2:55PM the patient went to Doctor's office for appoitment at around 4 pm. The doctor notice some abnormal heart beats, blood pressure raised... and the patient went home feeling headache, itching at site. the morning next day  the patient woke up and saw a huge swollen, red ring theat covered bid part of upper arm spreading down up to elbow. Patient had difficult with breathing as had to use albuterol in nebulizer. The pharmact contacted back on 12/26 6 pm and the patient said the problem is almost dissolved but she is scared.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: After vaccination at pharmacy on 12/21/2017 2:55PM the patient went to Doctor's office for appoitment at around 4 pm. The doctor notice some abnormal heart beats, blood pressure raised... and the patient went home feeling headache, itching at site. the morning next day  the patient woke up and saw a huge swollen, red ring theat covered bid part of upper arm spreading down up to elbow. Patient had difficult with breathing as had to use albuterol in nebulizer. The pharmact contacted back on 12/26 6 pm and the patient said the problem is almost dissolved but she is scared.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Herpes zoster
Clinical narrative: Patient reports developing shingles after receiving the flu shot.
Age: 1.75
Sex: M
Vaccine: FLUX
Symptoms: Blood test normal, Chest X-ray normal, Eye movement disorder, Fall, Febrile convulsion
Clinical narrative: Patient received his flu shot on 12/21/2017. At the time he had a clear runny nose and cough, no fever. He had received this vaccination last season with no problems. On 12/22/2017 he was running a mild fever (100.5). Dad gave TYLENOL and gave him a nap. He then informed mom that patient was getting worse with his cold symptoms and request that mom take him in to get the flu test. Mom arrived home and got patient up from his nap. He was warm but decided to not dispense TYLENOL because the fever was a low grade temp. Pediatrician looked him over and he had a temp of 100.6 and flu and strep tests were both negative. She decided patient had a virus and sent us home. Upon arriving home, mom opened the passenger side door to take patient out of his car seat. When she opened the door she noticed patient's eyes were rolled back and his body was stiff and convulsing. She screamed for dad to call 911 and removed him from the car seat, took him inside and held him close to her on his side. He proceeded to seize until the ambulance arrived (about 3-4 minutes). Paramedics temped him and his fever was 101. They went to Hospital where the parents were told it was a febrile seizure. Chest X-Rays, blood work and urine tests were ran and everything came back good. It took patient 36 hours to start walking without falling several times and as of today, 12/26/2016, he is still barely eating or drinking.
Age: 1.75
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Influenza virus test negative, Musculoskeletal stiffness, Nasopharyngitis, Pyrexia
Clinical narrative: Patient received his flu shot on 12/21/2017. At the time he had a clear runny nose and cough, no fever. He had received this vaccination last season with no problems. On 12/22/2017 he was running a mild fever (100.5). Dad gave TYLENOL and gave him a nap. He then informed mom that patient was getting worse with his cold symptoms and request that mom take him in to get the flu test. Mom arrived home and got patient up from his nap. He was warm but decided to not dispense TYLENOL because the fever was a low grade temp. Pediatrician looked him over and he had a temp of 100.6 and flu and strep tests were both negative. She decided patient had a virus and sent us home. Upon arriving home, mom opened the passenger side door to take patient out of his car seat. When she opened the door she noticed patient's eyes were rolled back and his body was stiff and convulsing. She screamed for dad to call 911 and removed him from the car seat, took him inside and held him close to her on his side. He proceeded to seize until the ambulance arrived (about 3-4 minutes). Paramedics temped him and his fever was 101. They went to Hospital where the parents were told it was a febrile seizure. Chest X-Rays, blood work and urine tests were ran and everything came back good. It took patient 36 hours to start walking without falling several times and as of today, 12/26/2016, he is still barely eating or drinking.
Age: 1.75
Sex: M
Vaccine: FLUX
Symptoms: Seizure, Streptococcus test negative, Urine analysis normal, Viral infection
Clinical narrative: Patient received his flu shot on 12/21/2017. At the time he had a clear runny nose and cough, no fever. He had received this vaccination last season with no problems. On 12/22/2017 he was running a mild fever (100.5). Dad gave TYLENOL and gave him a nap. He then informed mom that patient was getting worse with his cold symptoms and request that mom take him in to get the flu test. Mom arrived home and got patient up from his nap. He was warm but decided to not dispense TYLENOL because the fever was a low grade temp. Pediatrician looked him over and he had a temp of 100.6 and flu and strep tests were both negative. She decided patient had a virus and sent us home. Upon arriving home, mom opened the passenger side door to take patient out of his car seat. When she opened the door she noticed patient's eyes were rolled back and his body was stiff and convulsing. She screamed for dad to call 911 and removed him from the car seat, took him inside and held him close to her on his side. He proceeded to seize until the ambulance arrived (about 3-4 minutes). Paramedics temped him and his fever was 101. They went to Hospital where the parents were told it was a febrile seizure. Chest X-Rays, blood work and urine tests were ran and everything came back good. It took patient 36 hours to start walking without falling several times and as of today, 12/26/2016, he is still barely eating or drinking.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Eye movement disorder, Incoherent, Loss of consciousness, Visual impairment
Clinical narrative: PT AMBULATED FOR A TDAP VACCINE. HE HAD A HX OF PASSING OUT FROM VACCINES IN THE PAST, SO PHARMACIST SENT HIM OVER. PT SAID THE LAST EPISODE WAS WHEN HE WAS A KID. HIS PEDIATRICIAN HAD HIM LAY DOWN FOR A WHILE AND HE RECOVERED WITHIN A FEW MINUTES. HIS PEDIATRICIAN NEVER TOLD HIM THAT HE WAS ALLERGIC TO ANY VACCINE  AND CONTINUED VACCINATING HIM AS A CHILD. HAD PATIENT LIE DOWN ON THE EXAM TABLE WITH HOE 45 DEGREES. TDAP GIVEN RIGHT DELTOID. PT WAS FINE AND BREATHING NICE AND SLOWLY. 1 MINUTE LATER. HE SAID "OH NO. NOW I SEE STARS." HIS FACE TURNED BEEFY RED, EYE BALLS ROLLED UP BRIEFLY, SPEECH BECAME INCOHERENT FOR 10 SECONDS. AFTER BP WAS TAKEN, HE SLOWLY REGAINED CONSCIOUSNESS. BP 141/62, HR 59. RR 20. HE LAID DOWN FOR 10 MINUTES, SAT UP FOR 10 MINUTES, HAD 2 SMALL CUPS OF WATER, AND LEFT AMBULATORY WITH WIFE HOME. INSTRUCTED PT TO REPORT THE REACTION TO NEW PCP AND NOT TO VACCINATE TDAP AGAIN. IF HE HAS SIMILAR REACTION TO ALL VACCINES, THEN HE SHOULD NOT RECEIVE ANY VACCINE.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The left arm hurts and is unable to lift above shoulder level.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Administration site rash
Clinical narrative: Small rash around administration site.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash erythematous
Clinical narrative: Small rash around administration site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site warmth, Oedema
Clinical narrative: Rec'd 5yr IMM and Flu vaccine in office 12/18/17 at check-up. S/S began next day=erythema, edema and hot to touch; (+) Fever to 102 degree max that day. Seen in office 12/21/17 -> (RT) arm with edema/redness in a 1-2 inch band around upper arm with area SL. warmth; afebrile; denies pain. Tx with BENADRYL and to monitor.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Rec'd 5yr IMM and Flu vaccine in office 12/18/17 at check-up. S/S began next day=erythema, edema and hot to touch; (+) Fever to 102 degree max that day. Seen in office 12/21/17 -> (RT) arm with edema/redness in a 1-2 inch band around upper arm with area SL. warmth; afebrile; denies pain. Tx with BENADRYL and to monitor.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Vomiting
Clinical narrative: Dizziness, vomiting, difficult breathing (per RPh gave out vaccine).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Antiacetylcholine receptor antibody positive, Arthralgia, Autonomic nervous system imbalance, Complex regional pain syndrome
Clinical narrative: It was reported in a Letter to the Editor that a 14-year-old girl with similar symptoms to those described in other patients (dysautonomia including postural tachycardia syndrome (POTS) and gastrointestinal (GI) dysmotility, in addition to neuropathy/complex regional pain syndrome (CRPS)), was tested positive for nicotinic acetylcholine ganglionic receptor autoantibodies, B2-adrenergenic and muscarinic M2 receptor autoantibodies and alfa-adrenergenic receptor autoantibodies, two weeks after her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (vaccination date, dose, route of administration, lot # and expiration date were not provided), began to experience fatigue severe enough to warrant evaluation for Epstein Barr virus infection, hypothyroidism, and rheumatologic disorders (work-up was negative). She also complained of stomach pain after eating, but had no vomiting. Her right knee, intermittently painful for many years, became painful although a physical exam of her right knee at that time was normal, as was an magnetic resonance imaging (MRI). Ten days after her second human papillomavirus (HPV) vaccine, which was administered one year after her initial vaccine, her right knee became so painful that she had difficulty sleeping and she was ultimately diagnosed with neuropathy/complex regional pain syndrome (CRPS) of her right lower extremity. Her stomach pain after eating worsened, and within 3 months of the second vaccine she had lost 10 pounds, requiring hospitalization for evaluation and rehydration. Around this time, she began experiencing pre-syncope and syncope and was diagnosed with POTS by a cardiologist. All of the patient's symptoms significantly improved (but were not completely eliminated) with immunosuppression (RITUXAN and mycophenolic acid), intravenous immunoglobulin, and intermittent therapeutic plasma exchange. The authors considered the event of dysautonomia to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Upon internal review, the event of dysautonomia was determined to be medically significant due to the treatment with immunosuppression, intravenous immunoglobulin and intermittent therapeutic plasma exchange.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Epstein-Barr virus test negative, Fatigue, Immunoglobulin therapy, Immunosuppression
Clinical narrative: It was reported in a Letter to the Editor that a 14-year-old girl with similar symptoms to those described in other patients (dysautonomia including postural tachycardia syndrome (POTS) and gastrointestinal (GI) dysmotility, in addition to neuropathy/complex regional pain syndrome (CRPS)), was tested positive for nicotinic acetylcholine ganglionic receptor autoantibodies, B2-adrenergenic and muscarinic M2 receptor autoantibodies and alfa-adrenergenic receptor autoantibodies, two weeks after her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (vaccination date, dose, route of administration, lot # and expiration date were not provided), began to experience fatigue severe enough to warrant evaluation for Epstein Barr virus infection, hypothyroidism, and rheumatologic disorders (work-up was negative). She also complained of stomach pain after eating, but had no vomiting. Her right knee, intermittently painful for many years, became painful although a physical exam of her right knee at that time was normal, as was an magnetic resonance imaging (MRI). Ten days after her second human papillomavirus (HPV) vaccine, which was administered one year after her initial vaccine, her right knee became so painful that she had difficulty sleeping and she was ultimately diagnosed with neuropathy/complex regional pain syndrome (CRPS) of her right lower extremity. Her stomach pain after eating worsened, and within 3 months of the second vaccine she had lost 10 pounds, requiring hospitalization for evaluation and rehydration. Around this time, she began experiencing pre-syncope and syncope and was diagnosed with POTS by a cardiologist. All of the patient's symptoms significantly improved (but were not completely eliminated) with immunosuppression (RITUXAN and mycophenolic acid), intravenous immunoglobulin, and intermittent therapeutic plasma exchange. The authors considered the event of dysautonomia to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Upon internal review, the event of dysautonomia was determined to be medically significant due to the treatment with immunosuppression, intravenous immunoglobulin and intermittent therapeutic plasma exchange.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Laboratory test abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Plasmapheresis
Clinical narrative: It was reported in a Letter to the Editor that a 14-year-old girl with similar symptoms to those described in other patients (dysautonomia including postural tachycardia syndrome (POTS) and gastrointestinal (GI) dysmotility, in addition to neuropathy/complex regional pain syndrome (CRPS)), was tested positive for nicotinic acetylcholine ganglionic receptor autoantibodies, B2-adrenergenic and muscarinic M2 receptor autoantibodies and alfa-adrenergenic receptor autoantibodies, two weeks after her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (vaccination date, dose, route of administration, lot # and expiration date were not provided), began to experience fatigue severe enough to warrant evaluation for Epstein Barr virus infection, hypothyroidism, and rheumatologic disorders (work-up was negative). She also complained of stomach pain after eating, but had no vomiting. Her right knee, intermittently painful for many years, became painful although a physical exam of her right knee at that time was normal, as was an magnetic resonance imaging (MRI). Ten days after her second human papillomavirus (HPV) vaccine, which was administered one year after her initial vaccine, her right knee became so painful that she had difficulty sleeping and she was ultimately diagnosed with neuropathy/complex regional pain syndrome (CRPS) of her right lower extremity. Her stomach pain after eating worsened, and within 3 months of the second vaccine she had lost 10 pounds, requiring hospitalization for evaluation and rehydration. Around this time, she began experiencing pre-syncope and syncope and was diagnosed with POTS by a cardiologist. All of the patient's symptoms significantly improved (but were not completely eliminated) with immunosuppression (RITUXAN and mycophenolic acid), intravenous immunoglobulin, and intermittent therapeutic plasma exchange. The authors considered the event of dysautonomia to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Upon internal review, the event of dysautonomia was determined to be medically significant due to the treatment with immunosuppression, intravenous immunoglobulin and intermittent therapeutic plasma exchange.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Rheumatoid factor negative, Syncope, Thyroid function test normal, Weight decreased
Clinical narrative: It was reported in a Letter to the Editor that a 14-year-old girl with similar symptoms to those described in other patients (dysautonomia including postural tachycardia syndrome (POTS) and gastrointestinal (GI) dysmotility, in addition to neuropathy/complex regional pain syndrome (CRPS)), was tested positive for nicotinic acetylcholine ganglionic receptor autoantibodies, B2-adrenergenic and muscarinic M2 receptor autoantibodies and alfa-adrenergenic receptor autoantibodies, two weeks after her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (vaccination date, dose, route of administration, lot # and expiration date were not provided), began to experience fatigue severe enough to warrant evaluation for Epstein Barr virus infection, hypothyroidism, and rheumatologic disorders (work-up was negative). She also complained of stomach pain after eating, but had no vomiting. Her right knee, intermittently painful for many years, became painful although a physical exam of her right knee at that time was normal, as was an magnetic resonance imaging (MRI). Ten days after her second human papillomavirus (HPV) vaccine, which was administered one year after her initial vaccine, her right knee became so painful that she had difficulty sleeping and she was ultimately diagnosed with neuropathy/complex regional pain syndrome (CRPS) of her right lower extremity. Her stomach pain after eating worsened, and within 3 months of the second vaccine she had lost 10 pounds, requiring hospitalization for evaluation and rehydration. Around this time, she began experiencing pre-syncope and syncope and was diagnosed with POTS by a cardiologist. All of the patient's symptoms significantly improved (but were not completely eliminated) with immunosuppression (RITUXAN and mycophenolic acid), intravenous immunoglobulin, and intermittent therapeutic plasma exchange. The authors considered the event of dysautonomia to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Upon internal review, the event of dysautonomia was determined to be medically significant due to the treatment with immunosuppression, intravenous immunoglobulin and intermittent therapeutic plasma exchange.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong immunization given.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Irritability, Nasopharyngitis, Product storage error
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M043836 with an expiration date in 17-JUN-2018) orally for prophylaxis. The vaccine was exposed to temperature excursion of 28.1 degrees Celsius for 48 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Follow-up information has been received from the physician on 05-DEC-2017, referring to the 4 months old female patient. The patient had no brothers or sisters. There was no illness at time of vaccination. On 27-NOV-2017, the patient was vaccinated with ROTATEQ (lot # N005972). On the same day, the patient was vaccinated with other suspect therapies, including hib conj vaccine (unspecified carrier) (lot# UI804AA, intramuscular, at Right Vastus Laterali (RVL)), PEDIARIX (lot # 92443, intramuscular, RVL) and PREVNAR 13 (lot # S35326, intramuscular, Left Vastus Lateralis (LVL)).  The vaccines later found to have been stored outside of accepted temperature range due to faulty thermostat on fridge. On the same day, upper respiratory infection (URI) was evident at time of Well-Child Care (WCC). The next day (on 28-NOV-2017), the patient had elevated temperature maximum 101 (unit not provided), vomited one time and had some diarrhea. The patient was fussier next few days, and developed cold symptoms. They did not want to repeat the vaccines but would continue as usual schedule. There was no prescription drug treatment for the experienced required. The outcome of the events was unknown. The causality between the suspect therapies and the events was unknown.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M043836 with an expiration date in 17-JUN-2018) orally for prophylaxis. The vaccine was exposed to temperature excursion of 28.1 degrees Celsius for 48 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Follow-up information has been received from the physician on 05-DEC-2017, referring to the 4 months old female patient. The patient had no brothers or sisters. There was no illness at time of vaccination. On 27-NOV-2017, the patient was vaccinated with ROTATEQ (lot # N005972). On the same day, the patient was vaccinated with other suspect therapies, including hib conj vaccine (unspecified carrier) (lot# UI804AA, intramuscular, at Right Vastus Laterali (RVL)), PEDIARIX (lot # 92443, intramuscular, RVL) and PREVNAR 13 (lot # S35326, intramuscular, Left Vastus Lateralis (LVL)).  The vaccines later found to have been stored outside of accepted temperature range due to faulty thermostat on fridge. On the same day, upper respiratory infection (URI) was evident at time of Well-Child Care (WCC). The next day (on 28-NOV-2017), the patient had elevated temperature maximum 101 (unit not provided), vomited one time and had some diarrhea. The patient was fussier next few days, and developed cold symptoms. They did not want to repeat the vaccines but would continue as usual schedule. There was no prescription drug treatment for the experienced required. The outcome of the events was unknown. The causality between the suspect therapies and the events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report was received from a nurse, referring to a nurse of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 27-NOV-2017, a droplet of PROQUAD lot # N020010, expiration date 13-JAN-2019 (strength, dose, route, frequency and indication were not reported) flew out and landed in the right eye after flicking syringe to get air bubble out (occupational exposure to product and exposure via eye contact). The patient experienced a slight burning sensation (eye irritation). The patient sought medical attention and was advised that the eye be flushed with water for 15 minutes and upon flushed the eye, the nurse no longer experienced the burning sensation. It was unknown if diagnostic laboratories were performed. The action taken with PROQUAD was not applicable. At the time of reporting, the outcome of eye irritation was reported as recovered on 27-NOV-2017. Additionally, the causality assessment between eye irritation and PROQUAD was not provided.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccines were administered; This non-valid spontaneous report has been received from a nurse 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 unspecified dates from 16-OCT-2017 through 04-DEC-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N012093, expiration date 13-JAN-2020 (dose and route of administration were not reported), of ROTATEQ orally, lot # reported as N046006, expiration date 28-JUN-2018 (dose was not reported) and LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.7 degrees Fahrenheit for 25 minutes. Digital data logger was involved. There were no previous excursions reported.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: CSF lymphocyte count increased, Dizziness, Headache, Meningitis, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 31 year old female patient. None pertinent medical history and none drug reactions or allergies were reported. Concomitant therapies included WELLBUTRIN, levothyroxine sodium (manufacturer unknown) and TOPAMAX. On 30-NOV-2017, the patient was vaccinated with a dose of M-M-R II injection, lot # M036544, expiration date 15-AUG-2018 (formulation and dose number were not reported) for prophylaxis (reported as "she needed a booster, her levels were low" (Measles antibody negative, Mumps antibody test negative, Rubella antibody negative). Other suspect therapy included sterile diluent (indication, formulation, dose number, lot number and expiration date were not provided). On 04-DEC-2017, the patient went to the Emergency Room because she developed "headaches, dizziness and neck stiffness". She added that the patient refused to be hospitalized that day. Due to mentioned adverse events, the patient had a lumbar puncture performed days later (in 2017) and the results showed elevated lymphocytes, the patient was then diagnosed with meningitis. The nurse reported that the patient's symptoms have improved but she still had occasional headaches and dizziness. The outcome of the patient's meningitis, measles antibody levels negative, mumps antibodies negative and rubella antibodies negative was reported as recovering. The nurse did not assess a causal relationship between the patient's adverse events and M-M-R II and sterile diluent. Upon internal review, the patient's meningitis was considered medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 52-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA injection (dose and route of administration were not reported) lot # N002921 with expiration date on 08-APR-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 21-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA injection (dose and route of administration were not reported) lot # N002921 with expiration date on 08-APR-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 4-month-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (dose was not reported) lot # N004812 with expiration date on 04-OCT-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Encephalitis, Pyrexia, Rash, Seizure
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a male patient about 1 year of age. The patient's medical history, concurrent conditions and concurrent medications were unknown by the reporter. On an unknown date, the patient was vaccinated with the first dose of M-M-R II for prophylaxis, subcutaneously, Lot# and expiration date were not provided. On an unknown date, after his vaccination, the patient experienced, 2 seizures, pyrexia and rash secondary to encephalitis. The patient was hospitalized for 2 days on an unknown date, and was treated with antiseizure medication. It was unknown if laboratory diagnostic studies were performed. The reporter stated that the outcome of encephalitis, 2 seizures, pyrexia and rash secondary to encephalitis was fully recovered. It was unknown if the patient will continue with vaccinations with M-M-R II. The relatedness of M-M-R II and the events encephalitis, 2 seizures, pyrexia and rash secondary to encephalitis as unknown. Upon internal review, the events encephalitis and seizures were considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical, drug and allergy history were not provided. On 17-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (strength, dose, frequency, lot number and expiration date were not reported), for prophylaxis (indication reported as "pneumococcal"). Concomitant therapies included phenobarbital. It was reported that the patient went to the pharmacy due to experiencing soreness at the injection site on 17-NOV-2017, 12 hours after receiving PNEUMOVAX 23, as well as dizziness 36 hours after receiving the vaccine, on an unspecified date in November 2017. It was reported that the patient did not received treatment and she did not seek medical attention. Lab diagnostics or studies were not performed.  The outcome of dizziness and vaccination site pain was reported as resolved.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not provided.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 one single injection, lot# N020352 and expiration date: 10-APR-2020 (route of administration was not reported). The reporter denied any adverse effects.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a curently 3 months old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored ROTATEQ orally, lot # N013885 (dose was not provided). Data logger was not involved. No adverse event was reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004451: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a curently3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004451: US-009507513-1712USA012873: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a curently 7 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878: US-009507513-1712USA004451:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ lot # N010709 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012877: US-009507513-1712USA012878: US-009507513-1712USA004451.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: Approximately 15 minutes after Influenza, HepB, PCV13, DTaP-IPV/Hib and RV5 were administered, the patient's mother noticed that the patient's chest and right and left buttocks were covered in red, non-raised spots. Provider CNP was notified and evaluated the patient. CNP advised to monitor the spots for 15 more minutes. CNP reevaluated and then instructed the parents to look for anaphylactic signs and symptoms and seek immediate assistance if any of these signs and/or symptoms should appear. CNP recommended that the patient return in 4 weeks for the 2nd influenza vaccination, and that this appointment should coincide with a provider visit. Parents were in agreement with this plan.
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 74 year old male patient. In approximately October 2017 (reported as October or November 2017, "after the hurricane"), the patient was vaccinated with PNEUMOVAX 23 (lot number, dose, route and site of administration were not reported) for prophylaxis. In 2017, the patient experienced redness, but not in the vaccination area. The redness was closer to the elbow. The patient self-treated with ice. The outcome of redness was reported as resolved in approximately 2017. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA009288:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 4 years old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, frequency and route of administration were not provided) lot# N020011 and expiration date: 13-JAN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). Data logger was not involved. No adverse event was reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012878: US-009507513-1712USA004451.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 4 years old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, frequency and route of administration were not provided) lot# N020011 and expiration date: 13-JAN-2019. The PROQUAD was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). Data logger was not involved. No adverse event was reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004451: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012873:
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme increased
Clinical narrative: Elevated liver enzymes, 2 days after immunization. Incidental finding when elevated for another problem 12/17/17. Report enzymes on 12/20/17 significantly improved.
Age: 45.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Eyelid ptosis, Laboratory test
Clinical narrative: Ptosis -right eye. Has seen optometrist and ophthalmologist. Referred to neurologist.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 12/9-Received call states 24 hours post vaccine she developed hives to upper body, denied DIB. Took BENADRYL and applied hydrocortisone to areas. Has improved.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Pneumo vaccine PPSV23 on 12/21/17 @ 9am. Pt came in 12/22/17 @ 211pm with Swollen, red left upper arm with two raised areas. Pt states reaction started yesterday night. No difficulty swallowing at this time. Advised pt to go to Urgent Care and take BENADRYL for reaction.  Offered pt follow up appt with PCP on 12/26/17 and pt refused stating reaction resolved and is no longer an issue.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Bronchiolitis, Malaise, Respiratory syncytial virus infection
Clinical narrative: Starting a week after his 12mo visit and injections, he came down with  bronchiolitis for 4 whole entire months. He'd get real sick for 2 weeks, start to recover, only to get worse for another 2 weeks, etc. By his 15 mo check up (12/06/2017) he was finally feeling better only to get sick again and is still currently sick with bronchiolitis. I refused any shots for that visit as his immune system was still overloaded. He is now on plumicort daily until further notice (I was told at least until spring starts) and Albutoral when needed to help him breathe. This all started when he got RSV back to back last dec (2016) which severely weakened his lungs. After which I was told vaccines were still safe to give so I listened. I have so much regret. He was also saying several words prior and now only says 1 word and started flapping his hand near his face.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Extra dose administered
Clinical narrative: Child presented for well child exam 15 month and vaccines with twin sister. PREVNAR-13 was inadvertently given 2x to 1 child.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Sleep disorder
Clinical narrative: Injection site became very swollen, red and hot to the touch. Over the period of a week, redness "bled" to inner arm, down towards inner elbow with some tenderness to touch and warmth. Injection site remained swollen (raised area about 3" x 4") hot and very tender touch for about a week. Could not sleep on that arm.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, concerning unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II lot # M015931 and expiration date 30-MAR-2018 (dose, frequency and route of administration were not provided) for prophylaxis which was reconstituted with a properly stored dose of sterile diluent. Furthermore, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot #N013276 with expiration date 21-JAN-2020 (dose, frequency and route of administration were not provided) and ROTATEQ orally, lot # M041768 with expiration date 25-JUN-2018 (dose and frequency were not provided). The vaccine of M-M-R II was stored at a temperature and time frame of 47 Fahrenheit to 77 Fahrenheit (48 Fahrenheit) for 1 hour and 25 minutes, previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit (53 Fahrenheit) for 2 hours, 35 Minutes. Digital Data logger was involved. The vaccine of GARDASIL 9 and ROTATEQ were stored at a temperature and time frame of 47 Fahrenheit to 77 Fahrenheit (48 Fahrenheit) for 1 hour, 25 minutes, no previous temperature excursion. Digital Data logger was involved.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 68 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot number N024384, expiration date 18-MAY-2019 (strength, dose and route were not reported) for prophylaxis. On the same date, after vaccination, the patient had a red, swollen right arm near injection site and down the right arm. At the time of the report, the outcome of the event was unknown. The causality between the events and the PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1711USA013931.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot number N025656, expiration date: 19-APR-2019 (strength, dose and route were not reported) for prophylaxis. On the same date, after vaccination, the patient had a red, swollen left arm near injection site and down the left arm. At the time of the report, the outcome of the events was unknown. The causality between the events and the PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1711USA013799.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, lot # N019921, expiration date 05-JUL-2018, for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion between 6 to 14 degrees Fahrenheit degrees for 12 hours. No previous temperature excursions were reported. Digital data logger was involved in recording the excursion details. No adverse effects were reported.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 63-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot# M037656 and expiration date: 29-NOV-2017 (dose and route of administration were not reported) reconstituted with sterile diluent which was not expired. There were no adverse effects reported.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an 11 months female patient. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patient was vaccinated with doses of improperly stored ROTATEQ lot # M045545 and expiration date of 10-JUN-2018, orally (anatomical location was not reported) for prophylaxis, which were stored in the range of 47 Fahrenheit degrees to 77 Fahrenheit degrees (75 Fahrenheit degrees) for 6 hours and 46 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA011911.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Fatigue, Headache, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Pneumo 23: Severe decrease in ROM of extremity could not lift arm. Upper arm swollen but no redness. Painful. HD FLUZONE: fever-low grade temp, general malaise, severe fatigue, arthralgias, persistent headache, nausea. Bad leg and foot cramps. Addendum: Resolved by 12/27/17.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Muscle spasms, Nausea, Pain, Pyrexia
Clinical narrative: Pneumo 23: Severe decrease in ROM of extremity could not lift arm. Upper arm swollen but no redness. Painful. HD FLUZONE: fever-low grade temp, general malaise, severe fatigue, arthralgias, persistent headache, nausea. Bad leg and foot cramps. Addendum: Resolved by 12/27/17.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: My arm started swelling the day after the shot was given, then later the same day felt warm to the touch and turned red. I went to urgent care, on 12-8-17, they diagnosed my arm (left) with "cellulitis" and prescribed 2 antibiotics: cephalexin 500 mg (generic for KEFLEX 500 mg SMZ/TMP DS 800 - 160 tab AMN (generic for BACTRIM DS 800 - 160 tab.