chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Urticaria, Vomiting
Clinical narrative: About 10 min after the shot Patient developed hives and complained about throat pain. BENADRYL given, vomited some and half given back. Hives got slightly better but he still got throat pain. EPI PEN Jr given. Hives disappeared in 5 min and throat pain is gone. Watched Patient for another 30 min and D/C home in stable condition. In the future, all flu shots in allergy clinic.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Asthenia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Weakness, fever, headaches, vomiting, body aches, and fatigue for 3 days.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Weakness, fever, headaches, vomiting, body aches, and fatigue for 3 days.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Adverse Event: Righ arm swelling, warmth, itching in site of immunization (Varicella) two days ago. Treatment: KEFLEX 500 mg capsule. Outcome: No evidence of ongoing infection. Provider plan: Ice, NSAID, or Acetaminophen if arm feels sore, and return precautions discussed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 69-year-old male patient who received SHINGRIX (batch number 179603 ?, expiry date June 2018, GSK note: the reported lot number did not match with any GSK lot number). On 27th December 2017, the patient received SHINGRIX (subcutaneous). In December 2017, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and injection site erythema. On 27th December 2017, the patient experienced intramuscular formulation administered by other route. On 28th December 2017, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On 30th December 2017, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site swelling and injection site erythema to be possibly related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient was administered SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The patient subsequently reported swelling, redness and soreness. The healthcare professional was uncertain of the reaction onset time, whether emergency room or doctor visit was required, whether the patient was hospitalized, disabled, or whether the adverse event jeopardized the patient or required intervention to prevent these outcomes.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Pain, Restlessness, Vomiting projectile
Clinical narrative: She was administered the shot at 11 am and at 3 pm she started being restless and acting like she was in pain. Then at about 4 pm she started projectile vomited and struggled to breathe. The vomiting lasted for about a week and the struggling to breathe lasted about 2.5 weeks.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, X-ray normal
Clinical narrative: Pain in shoulder, limiting arm movement laterally. Two months after flu shot, went to Dr, had xray (negative), received cortisone shot in shoulder. Pain worse for 2 days, then reverted to prior condition (painful lateral movement). Still the same pain 10 weeks after flu shot.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt developed scattered urticaria and itching. No oral involvement or respiratory difficulty. Resolved within 24 hrs with 2 doses of BENADRYL.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cough, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pt reports onset of fever to 102-103F, full body aches, headache, sniffles, cough. Pt denies any injection site redness/swelling/pain but does note some L axillary lymphadenopathy (same side where flu/pneumonia shot given).
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Rhinorrhoea
Clinical narrative: Pt reports onset of fever to 102-103F, full body aches, headache, sniffles, cough. Pt denies any injection site redness/swelling/pain but does note some L axillary lymphadenopathy (same side where flu/pneumonia shot given).
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Feeling drunk, Nausea
Clinical narrative: Complained of feeling "loopy", which he described as feeling drunk, nausea and metallic taste in mouth. Symptoms resolved on their own at 10:40 a.m. which was 23 minutes after onset.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt states that pain in arm started evening after injection was given. Pt states that she could not lift arm and that it was so painful that she went to the emergency room. Notes provided of encounter below: History of Presenting Illness: The patient is a 72 Year Old Female who presents to the ED with complaints of left arm pain that started the evening after she received a pneumonia vaccine. Patient states that she has use hot packs and TYLENOL which was effective in relieving the pain for a while. She states she has increased pain with movement. She denies any fevers, chills, nausea or vomiting. She is not having any shortness of breath or chest pain. She states she has never had an issue after receiving vaccines in the past. ED Course: 72-year-old female presents with left arm pain that started after receiving a pneumonia vaccine. She does not have any other associated symptoms, she has not had any injury to the area. Most likely these symptoms are caused from the injection. She can continue trying hot packs and TYLENOL for the symptoms. I do not see any reason for further testing at this time. We did discuss return precautions. If she develops any fevers, chills, chest pain, shortness of breath or any other new or concerning symptoms she is to return for recheck. Patient is comfortable with this plan and is discharged in stable condition. Pt stated via follow up phone call today, 01/05/2018: Pain in arm went away for a couple of days but after sleeping on couch for the night pain came back and cannot lift arm again. Pt states that she is actually unsure if this is connected to vaccine or not, states she may have "torn rotator cuff". Pt states that if symptoms persist she will make an appointment with PCP on Monday.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Induration, Injection site erythema, Oedema, Pruritus
Clinical narrative: Erythema on left upper arm, temp 100.4 by ear thermometer, mild warmth, pruritic, edema, induration, mild tenderness was on 1/4/18. Erythema improving per mother on 1/5/18 with continued mild warmth, induration, mild edema, no tenderness, continued pruritic. Mother gave TYLENOL and applied hydrocortisone cream.  Recommended may also apply ice, BENEDRYL as needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Erythema on left upper arm, temp 100.4 by ear thermometer, mild warmth, pruritic, edema, induration, mild tenderness was on 1/4/18. Erythema improving per mother on 1/5/18 with continued mild warmth, induration, mild edema, no tenderness, continued pruritic. Mother gave TYLENOL and applied hydrocortisone cream.  Recommended may also apply ice, BENEDRYL as needed.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Pruritus.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. called stating arm sore, swollen, a little warm and hard, pain from middle of upper arm. Shoulder to middle of upper arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain in left arm after injection of BEXSERO. Rash on left arm 2 days after vaccine given.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Peripheral swelling
Clinical narrative: Total arm swollen and limited use for a week.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Neck pain, Pain in extremity
Clinical narrative: Arm and neck pain radiating down right arm and a feeling of "not well". Patient took some TYLENOL and started to feel better.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject who was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 2nd January 2015. The subject's estimated date of delivery was 19th February 2015. The subject received BOOSTRIX at week 33 of the pregnancy and during the third trimester of pregnancy. On 2nd January 2015, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Reporter is the patient. She works at Pharmacy. Another pharmacist gave her the BOOSTRIX while being pregnant. No symptoms reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: 12/19/17 site was swollen, lump, painless and itchy. (right arm) -size: slightly larger than a quarter.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt experiencing arm pain. 7 days after vaccination. Pain in shoulder. Unable to raise arm above head.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Rotator cuff syndrome
Clinical narrative: Rotator cuff issues, hurts to sleep on, get dressed, etc. Patient said she felt pain immediatly upon receiving shot.
Age: 62.0
Sex: M
Vaccine: TDAP, PPV, TDAP
Symptoms: Encephalopathy, Injection site pain, Seizure
Clinical narrative: Pain in left shoulder where administered, Diagnosed with Encephalopathy. Started having seizures a week later.
Age: 62.0
Sex: M
Vaccine: TDAP, PPV, TDAP
Symptoms: Encephalopathy, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pain in left shoulder where administered, Diagnosed with Encephalopathy. Started having seizures a week later.
Age: 62.0
Sex: M
Vaccine: TDAP, PPV, TDAP
Symptoms: Encephalopathy, Injection site pain, Seizure
Clinical narrative: Patient's daughter reported "red rash and bulge to left upper arm". Patient was diagnosed with encephalopathy at Medical Center.
Age: 62.0
Sex: M
Vaccine: TDAP, PPV, TDAP
Symptoms: Encephalopathy, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient's daughter reported "red rash and bulge to left upper arm". Patient was diagnosed with encephalopathy at Medical Center.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dry skin, Rash erythematous, Rash pruritic
Clinical narrative: Rash began to appear on left inner aspect of arm. It is the only place the rash developed. Had a red dry appearance. Was itchy. Patient came out of the room to inform the nurse. The doctor was notified immediately as well as an extensive reparatory assessment. No wheezing, cough, or vomiting presented while patient remained in the office. 50mg BENADRYL given PO in office and hydrocortisone ointment prescribed script sent to the pharmacy. All activity occurred over about 30 min.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager 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 an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, (strength, dose and frequency were not provided) lot # N020617, expiration date 22-JAN-2019, for prophylaxis. The doses of PROQUAD were exposed to a temperature excursion of -14°Celsius (°C) to -10°C, during a time frame of 2 hours; -9°C to 8°C (4.48 °C) during a time frame of 4 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 6 month old female patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. The reporter informed that the patient had completed a hepatitis B series with hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule and lot number were not reported) which was administered on 02-JUN-2004, 30-NOV-2004 and 08-MAR-2005. On an unspecified date (reported as "before August 2017"), the patient's had hepatitis B titers drawn and were not where the doctor wanted them to be. The patient did not seek medical attention, but she received treatment for the adverse event. No studies or diagnostic tests were carried out. Then on 18-AUG-2017, the patient was vaccinated with RECOMBIVAX HB lot number: N006321 (expiration date: 08-NOV-2019) and on 20-OCT-2017, the patient received another dose of RECOMBIVAX HB lot number: N002920 (expiration date: 30-SEP-2018). The outcome of hepatitis b surface antibody negative was unknown. The reporter did not assess the relatedness of RECOMBIVAX HB with hepatitis b surface antibody negative.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient developed urticaria on trunk and extremities within 1.5 hours of receiving the vaccine. Patient went to ER on 1/3/18 and was diagnosed with allergic reaction, prescribed prednisolone. Patient never took the medication prescribed. Patient was seen in my office by me on 1/4/2018 and did have mild urticaria on exam, BENADRYL was prescribed.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an 81 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-NOV-2017, the patient was co-administrated a dose (reported as "one shot") of PNEUMOVAX 23 (strength, route of administration, lot number and expiration date were not reported) for prevention of pneumonia and an unspecified "high dose flu vaccine" (manufacturer unknown).The reporter also stated that both vaccines were administered in the same arm, but it was unknown whether were administered in the left arm or the right arm. On an unknown date in 2017, the patient developed feelings of weakness and achiness as well as red, painful swelling at the injection site. The patient sought medical attention by seeing the physician and was given an unspecified treatment for the events. The outcome of the events was unknown. The reporter's causality assessment between the events and the PNEUMOVAX and unspecified flu vaccine was not reported. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA003096:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 21-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M007279 with an expiration date in 09-FEB-2018), for prophylaxis that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 14 year old male patient with drug reactions/allergies to penicillin. The patient's medical history was not reported. Concomitant medications included unspecified Inhaler for asthma. On 10-NOV-2017,  the patient was vaccinated with his first dose of GARDASIL 9 intramuscular route  (dose, frequency and anatomical location were unknown) with lot # N019923 and expiration date 28-APR-2019 recommended for prevention of Human papillomavirus (HPV). On an unknown date (reported as "few days later"), the patient developed doubled over intermittent abdominal pain, nausea, vomiting and diarrhea, these events continued since then and appeared  about once or twice a week. No laboratory diagnostics or studies were performed. The patient sought medical attention an visited the physician on 05-DEC-2017. The reporter did not mention the causality assessment between the aforementioned events and GARDASIL 9.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a  61 years old male patient. On 08-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (strength, dose and frequency were not reported), lot # M037656, expiration date 29-NOV-2017, for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On 06-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001528  expiration date 13-JAN-2018, (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature ranges between 6°F to 14°F (9.3°F) during a time frame of 13 hours. Previous temperature excursions included 6°F to 14°F (8.1°F) during a time frame of 12 hours which were called by a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-DEC-2017, the patient received an expired dose of properly stored VARIVAX injection, 0.5 ml, subcutaneous route, lot # L048466, expiration date 02-DEC-2017, for prophylaxis. It was reported that the VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) lot number M023895, expiration date 18-JAN-2019. No adverse effects reported.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse regarding to a patient (gender not reported). No concomitant medications, concurrent conditions nor medical history were reported. On 15-JUN-2015, at the age of 20 years old the patient was vaccinated with a dose of GARDASIL (site, lot number and expiration date not reported) for prophylaxis. In approximately 2017 (reported as "aged 22 years"), the patient was vaccinated with a dose of GARDASIL 9 (site, lot number and expiration date not reported) for prophylaxis. No adverse effects were reported.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse referring to a 23 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. Concomitant therapies included PROZAC 20 mg and an unspecified birth control pill. On 02-FEB-2015, the patient was vaccinated with one dose of ZOSTAVAX, 19400 plaque-forming unit (PFU), lot number K018172 (expiration date: 02-DEC-2015), subcutaneously, for prophylaxis (dosage schedule was not provided); instead of intended VARIVAX. Other suspect therapies included sterile diluent (MERCK). On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced nasal congestion, cough and sore throat. The patient was seen by the physician for these symptoms on 11-DEC-2015, but it was unknown if she received any treatment. No studies or diagnostic tests were carried out. The outcome of nasal congestion, cough and sore throat was reported as recovered. The reporter did not assess the relatedness of ZOSTAVAX with the adverse events.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 27-DEC-2017, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml, once, (lot number and expiration date were not reported) instead of an adult dose, for prophylaxis. The reporter denied any adverse effects reported by the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Vaccination complication, Vaccination site infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 54-year-old female patient with unspecified concomitant medications and unspecified pertinent medical history. The patient's concurrent conditions included food-related allergy. On 29-DEC-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number N028099 with expiration date 06-JAN-2019 (dose not reported), as vaccine. The ZOSTAVAX was reconstituted with sterile diluent (MERCK), subcutaneously, (dose, frequency, lot number and expiration date were not reported) for prophylaxis. On 30-DEC-2017, the patient returned to the pharmacy with site reaction which was red and warmth to touch. Then, on an unspecified date in December 2017, the patient went to an urgent care and was informed that she had infection due to ZOSTAVAX which was administered too close (about an inch) to a scar; the urgent care prescribed the patient KEFLEX as treatment which was administered. At the time of the report, the patient did not recover from the vaccination site infection. The reporter considered vaccination site infection to be related to ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose the prevention of shingles. As a direct result of ZOSTAVAX, on 18-NOV-2015 the patient experienced a shingles outbreak in addition to chronic pain, rash, and lesions to various parts of his body. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. As a direct and proximate consequence, the patient has sustained serious personal injuries and related losses, including but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Shingles outbreak and chronic pain were considered disabling. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 61 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N013521 with an expiration date in 23-JAN-2019 or lot # N029303 with an expiration date in 21-APR-2019), for prophylaxis, that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
Age: 47.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 47 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 11-NOV-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N013521 with an expiration date in 23-JAN-2019 or lot # N029303 with an expiration date in 21-APR-2019), for prophylaxis, that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 26-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377:
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 5 weeks old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 04-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 10 weeks old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001570: US-009507513-1801USA001572: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 17-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377:
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received a spontaneous report on 12JAN2017, 13JAN2017 and 18JAN2017 from personnel. The physician reported that on 09JAN2017, a patient who was traveling soon, was administered a dose of BIOTHRAX which had expired on 07JAN2017. The subject did not experience any adverse events. Further information was not available.
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received a spontaneous report on 12JAN2017, 13JAN2017 and 18JAN2017 from personnel. The physician reported that on 11JAN2017, employee was to leave soon, was administered a dose of BIOTHRAX which had expired on 07JAN2017. The subject did not experience any adverse events. Further information was not available.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist, based on the information received by Merck & Co., Inc. (manufacturer control number: 00689118). A patient of unspecified age, ethnicity, and gender received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size. Therapeutic measures were taken as a result of red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size and included treatment with BENADRYL and TYLENOL. The clinical outcome of the event, red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size, was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX, PNC13, FLU4, PNC13
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: This is a Spontaneous report from a contactable consumer (the patient), from a Pfizer sponsored program. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on 12Oct2017 at single dose for immunization (pneumonia shot), and INFLUENZA QUADRIVALENT VACCINE, via an unspecified route of administration on 12Oct2017 at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got pneumococcal 13-val conjugate vaccine (dipht crm197 protein) along with the influenza quad vaccine. The patient told the doctor that she had already had the shot but he gave it to her anyway. In addition, after four days she started developing pain in her left leg. The outcome of the events was unknown.
Sex: F
Vaccine: FLUX, PNC13, FLU4, PNC13
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Differential white blood cell count normal
Clinical narrative: This is a Spontaneous report from a contactable consumer (the patient), from a Pfizer sponsored program. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on 12Oct2017 at single dose for immunization (pneumonia shot), and INFLUENZA QUADRIVALENT VACCINE, via an unspecified route of administration on 12Oct2017 at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got pneumococcal 13-val conjugate vaccine (dipht crm197 protein) along with the influenza quad vaccine. The patient told the doctor that she had already had the shot but he gave it to her anyway. In addition, after four days she started developing pain in her left leg. The outcome of the events was unknown.
Sex: F
Vaccine: FLUX, PNC13, FLU4, PNC13
Symptoms: Full blood count normal, Gait disturbance, Malaise, Metabolic function test normal, Muscular weakness
Clinical narrative: This is a Spontaneous report from a contactable consumer (the patient), from a Pfizer sponsored program. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on 12Oct2017 at single dose for immunization (pneumonia shot), and INFLUENZA QUADRIVALENT VACCINE, via an unspecified route of administration on 12Oct2017 at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got pneumococcal 13-val conjugate vaccine (dipht crm197 protein) along with the influenza quad vaccine. The patient told the doctor that she had already had the shot but he gave it to her anyway. In addition, after four days she started developing pain in her left leg. The outcome of the events was unknown.
Sex: F
Vaccine: FLUX, PNC13, FLU4, PNC13
Symptoms: Myalgia, Night sweats, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: This is a Spontaneous report from a contactable consumer (the patient), from a Pfizer sponsored program. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on 12Oct2017 at single dose for immunization (pneumonia shot), and INFLUENZA QUADRIVALENT VACCINE, via an unspecified route of administration on 12Oct2017 at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got pneumococcal 13-val conjugate vaccine (dipht crm197 protein) along with the influenza quad vaccine. The patient told the doctor that she had already had the shot but he gave it to her anyway. In addition, after four days she started developing pain in her left leg. The outcome of the events was unknown.
Sex: F
Vaccine: HEPA
Symptoms: Autism spectrum disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autism in a child female patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced autism (serious criteria GSK medically significant). On an unknown date, the outcome of the autism was unknown. The reporter considered the autism to be almost certainly related to HAVRIX. Additional details were reported as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient was diagnosed with autism. The reporter firmly believed that the aluminum contained in HAVRIX caused her daughter to be diagnosed with autism. The reporter did not wish to participate in the safety report.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Patient reports a "couple hours" after receiving vaccination she noted that her whole right arm hurt. Patient reports that she did not sleep well that night due to the pain. Patient reports next day she notice that her arm was swollen from injection sight to elbow, it was also red and warm to the touch.  Patient reports as the day went on the pain lessened and is now gone. Patient called clinic today 1/5/17 to notify of reaction. Pain is now gone, swelling and redness have started to fade.
Age: 6.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Right deltoid cellulitis.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain in extremity, Speech disorder, Vomiting
Clinical narrative: Within hours of received the BEXSERO vaccine the patient developed an extreme headache, vomited x1, and reports that she had difficulty forming sentences. Patient reports the symptoms lasted approx 8 hours and she gradually recovered over the next day. She also reported left arm soreness for about 1 week.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: Approx 10-14 days after vaccination, patient developed 10 "pox" lesions on face, torso, and legs. He was not seen by a physician for evaluation of rash. Reaction was reported to me at 15 month checkup.
Age: 75.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: Pt developed rash and warm upper arm later in day after vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Grip strength decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: As the nurse put the injection in my arm it hurt more than usual. Then within hours it started hurting more and more. It hurt so bad that I had to take off work for two weeks, I couldn't even raise my arm up I couldn't hold a bottle of water with that hand this went on for over 2 weeks. Even after going back to work I had to alter my routines and make it easy on my shoulder. It's now been months and I still have pain in that shoulder I can't lift heavy things with that arm can't sleep on that arm it still hurts more than right after the average flu shot. Both my family doctor and a nurse at the health department said the shot was put way too high. My family doctor said if the pain continues after I have my baby that she will have x-rays and stuff done to see if she can help the pain at all. This is my fourth pregnancy I am due February 3rd. The pregnancy has been a normal healthy pregnancy.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: As the nurse put the injection in my arm it hurt more than usual. Then within hours it started hurting more and more. It hurt so bad that I had to take off work for two weeks, I couldn't even raise my arm up I couldn't hold a bottle of water with that hand this went on for over 2 weeks. Even after going back to work I had to alter my routines and make it easy on my shoulder. It's now been months and I still have pain in that shoulder I can't lift heavy things with that arm can't sleep on that arm it still hurts more than right after the average flu shot. Both my family doctor and a nurse at the health department said the shot was put way too high. My family doctor said if the pain continues after I have my baby that she will have x-rays and stuff done to see if she can help the pain at all. This is my fourth pregnancy I am due February 3rd. The pregnancy has been a normal healthy pregnancy.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Developmental delay, Migraine, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: The day after the vaccine was administered, patient starting having high fevers, hives and seizures (or what they thought were true neurological seizures). We rotated TYLENOL and MOTRIN that was recommended by doctor. He had high fevers, hives and seizures for a month. Once the high fevers and hives finally went away, patient still had the seizure episodes and started to have behavioral problems, delays, speech problems and was beyond in his milestones. He was diagnosed with a Sensory Processing Disorder at 2.5 years old and still has what doctors are calling mimicking seizures now caused by migraines but they have not been able to pinpoint exactly what the episodes are or what is causing them.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Seizure, Seizure like phenomena, Sensory processing disorder, Speech disorder, Urticaria
Clinical narrative: The day after the vaccine was administered, patient starting having high fevers, hives and seizures (or what they thought were true neurological seizures). We rotated TYLENOL and MOTRIN that was recommended by doctor. He had high fevers, hives and seizures for a month. Once the high fevers and hives finally went away, patient still had the seizure episodes and started to have behavioral problems, delays, speech problems and was beyond in his milestones. He was diagnosed with a Sensory Processing Disorder at 2.5 years old and still has what doctors are calling mimicking seizures now caused by migraines but they have not been able to pinpoint exactly what the episodes are or what is causing them.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Vaccination error
Clinical narrative: Staff erroneously administered pediatric 0.25 ml dose to patient who is 65 years old. Staff called the health dept for advice and was advised to administer a regular adult dose 0.5 ml flu shot. Pt was called back in and additional dose was administered same day.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Pt stated that night she developed whelps / Hives over her body. The injection site had swollen up.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV
Symptoms: Injection site urticaria
Clinical narrative: Local hive adjacent to vaccine injection site on left leg.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Cough, Influenza virus test negative, Oropharyngeal pain, Pain
Clinical narrative: 12/19/2017, Tuesday, developed dry cough when went to bed, throat mildly sore in middle of night, next day developed 100.6 fever in afternoon, body aches, cough was persistent but not very productive, still had 100.6 fever next day but by Friday, fever went away but cough didn't and then on Christmas Day, kept coughing and fever went up to 102.9, as of today, all fever is gone but still have persistent dry cough.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 12/19/2017, Tuesday, developed dry cough when went to bed, throat mildly sore in middle of night, next day developed 100.6 fever in afternoon, body aches, cough was persistent but not very productive, still had 100.6 fever next day but by Friday, fever went away but cough didn't and then on Christmas Day, kept coughing and fever went up to 102.9, as of today, all fever is gone but still have persistent dry cough.