chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neuropathy in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced neuropathy and tingling feet/hands. On an unknown date, the outcome of the neuropathy and tingling feet/hands were unknown. It was unknown if the reporter considered the neuropathy and tingling feet/hands to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced neuropathy, described as tingling in the hands and feet after receiving the FLUARIX QUADRIVALENT. The patient and product details were unknown but health care professional could be contacted by email for follow up.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Local swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 63-year-old female patient who received FLUARIX QUADRIVALENT. Concomitant products included ibuprofen and MICARDIS. On 18th November 2016 11:00, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 18th November 2016 11:01, 1 min after receiving FLUARIX QUADRIVALENT, the patient experienced burning sensation. On 18th November 2016 11:05, the patient experienced neck swelling. On an unknown date, the outcome of the burning sensation and neck swelling were not recovered/not resolved. The reporter considered the burning sensation and neck swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced burning in her shoulder and neck. On 18th November 2016, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced swelling in her neck. The patient reported that she went to the emergency room and was discharged home.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLUX, PPV, TDAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a 29-year-old female patient who received BOOSTRIX. Co-suspect products included Influenza vaccine and Pneumococcal vaccine. On 3rd October 2016, the patient received BOOSTRIX, Influenza vaccine and Pneumococcal vaccine. On an unknown date, less than a year after receiving BOOSTRIX, Influenza vaccine and Pneumococcal vaccine, the patient experienced adverse reaction. The patient was treated with prednisone. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX and Influenza vaccine. Additional details were provided as follows: The patient received BOOSTRIX, flu vaccine, and pneumonia vaccine and experienced some reaction. The reporter was not sure of any information on the reaction that occurred. It was unknown to the reporter what led to adverse reaction. The batch numbers and expiry dates of the vaccines were unknown. The vaccines were given at a different pharmacy.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLUX, PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a 29-year-old female patient who received BOOSTRIX. Co-suspect products included Influenza vaccine and Pneumococcal vaccine. On 3rd October 2016, the patient received BOOSTRIX, Influenza vaccine and Pneumococcal vaccine. On an unknown date, less than a year after receiving BOOSTRIX, Influenza vaccine and Pneumococcal vaccine, the patient experienced adverse reaction. The patient was treated with prednisone. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX and Influenza vaccine. Additional details were provided as follows: The patient received BOOSTRIX, flu vaccine, and pneumonia vaccine and experienced some reaction. The reporter was not sure of any information on the reaction that occurred. It was unknown to the reporter what led to adverse reaction. The batch numbers and expiry dates of the vaccines were unknown. The vaccines were given at a different pharmacy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Bilirubin urine present, Blood test, Blood urine present, Chromaturia, Protein urine
Clinical narrative: Information has been received on 21-NOV-2016 from a registered nurse referring to a 5 year old female patient. The patient's concurrent conditions and medical history were not reported. On 10-NOV-2016 the patient was vaccinated with PROQUAD lot # L045676, expiration 09-MAY-2017, 0.5 ml, subcutaneous. Other suspect therapies included FLUZONE and KINRIX administered during same office visit on 10-NOV-2016. Concomitant therapies included sodium fluoride, vitamins (unspecified). On 18-NOV-2016, the patient's mother contacted the office reporting that the patient experienced dark urine that was sinking to the bottom of the toilet. On 21-NOV-2016, the patient was seen by a physician's assistant and a urinalysis was done. The urinalysis results showed urine that was brown, turbid, bilirubin 1 +, blood 1+, protein 3+ and trace leukocytes. The registered nurse reported the patient was to return for unspecified blood tests and an ultrasound, later in the day, on 21-NOV-2016. The registered nurse reported the patient had not experienced pain or fever. No further information was provided. The outcome of the adverse events was unknown. The causality was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Ultrasound scan, White blood cells urine
Clinical narrative: Information has been received on 21-NOV-2016 from a registered nurse referring to a 5 year old female patient. The patient's concurrent conditions and medical history were not reported. On 10-NOV-2016 the patient was vaccinated with PROQUAD lot # L045676, expiration 09-MAY-2017, 0.5 ml, subcutaneous. Other suspect therapies included FLUZONE and KINRIX administered during same office visit on 10-NOV-2016. Concomitant therapies included sodium fluoride, vitamins (unspecified). On 18-NOV-2016, the patient's mother contacted the office reporting that the patient experienced dark urine that was sinking to the bottom of the toilet. On 21-NOV-2016, the patient was seen by a physician's assistant and a urinalysis was done. The urinalysis results showed urine that was brown, turbid, bilirubin 1 +, blood 1+, protein 3+ and trace leukocytes. The registered nurse reported the patient was to return for unspecified blood tests and an ultrasound, later in the day, on 21-NOV-2016. The registered nurse reported the patient had not experienced pain or fever. No further information was provided. The outcome of the adverse events was unknown. The causality was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain in left shoulder with abduction following flu vaccine administration. Pain estimated at level 6 or 7 (out of 10) with abduction. After 5 weeks, pain is improving but still present. Physician recommended anti-inflammatories prn, rest, warm and moist heat.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Influenza, Nausea, Pyrexia, Vomiting
Clinical narrative: Vaccines were given Dec. 1-2016. By Dec. 2, patient called stating she feels so weak. Nauseous and vomiting a lot, has fever and basically stated the she has the flu.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dryness, Injection site rash
Clinical narrative: Information has been received from a pharmacist via company representative referring to a 69 year old male patient with hypertension, diabetes and penicillin allergy. The patient's medical history included high cholesterol. On 17-NOV-2016 the patient was vaccinated with ZOSTAVAX (lot # M035147, expiration date May 2017). On 19-NOV-2016 the patient came into the pharmacy stating that he had a rash on his trunk area and the skin around the injection site felt hard to touch. Unspecified treatment was given for the events. No lab diagnostics studies were performed. The outcome was unknown. Additional has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Rash
Clinical narrative: Information has been received from a pharmacist via company representative referring to a 69 year old male patient with hypertension, diabetes and penicillin allergy. The patient's medical history included high cholesterol. On 17-NOV-2016 the patient was vaccinated with ZOSTAVAX (lot # M035147, expiration date May 2017). On 19-NOV-2016 the patient came into the pharmacy stating that he had a rash on his trunk area and the skin around the injection site felt hard to touch. Unspecified treatment was given for the events. No lab diagnostics studies were performed. The outcome was unknown. Additional has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to 3 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, two patients were each vaccinated with a dose of improperly stored M-M-R II (dose and route were unknown, lot # L049455 with expiration date 03-DEC-2017) and additional one patient was vaccinated with a dose of improperly stored M-M-R II (dose and route were unknown, lot # M000768 with expiration date 05-JAN-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no pertinent medical history and/or drug reactions/allergies reported. On 30-AUG-2016 the patient was vaccinated with ZOSTAVAX lot # M018453, expiration date: 28-JUN-2017, .65 ml, subcutaneous in an unspecified arm. Concomitant medication was not provided. The pharmacist reported that the patient had received an unspecified flu vaccine in the opposite arm on 30-AUG-2016. On an unspecified date, the patient experienced pain at the ZOSTAVAX injection site which wakes her up at night. The patient sought medical attention and it was reported that she contacted her pharmacist on 18-NOV-2016. No treatment was given for the event. The outcome of the ZOSTAVAX injection site pain which wakes her up at night was reported as not recovered/not resolved. Causality assessment was not provided. A PQC was not involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 26 year old female patient. No concomitant medications, pertinent medical history, and drug reactions and allergies were involved. On 04-NOV-2016 the patient was vaccinated with GARDASIL (dose, frequency, lot number and expired date were unknown) subcutaneously. The pharmacist reported that on unspecified day of November 2016 the patient experienced a "red, swollen lump" at the site of injection. The pharmacist reported that the patient stated "it was getting worse" and that the patient stated she intended to see her unspecified healthcare provider. The pharmacist reported that the patient "has big arms" and that it was possible it did not reach the muscle and might have been administered into the subcutaneous. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to less than 10 patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M009766, expiration date 13-FEB-2018 and lot # M024683 expiration date 18-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 23 degrees Fahrenheit for 40 hours which was detected by a data logger. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 21-year-old female patient who received RABAVERT (batch number 626011A, expiry date 31st March 2020). On 14th November 2016, the patient received the 1st dose of RABAVERT 1 ml. On 14th November 2016, 2 hrs after receiving RABAVERT, the patient experienced itchy rash. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the itchy rash was unknown. The reporter considered the itchy rash to be unlikely related to RABAVERT. Additional details were provided as follows: The patient was following pre-exposure schedule for RABAVERT vaccine. At 11:30 hours, the patient received 1st dose of RABAVERT in her left deltoid and experienced a rash on her belly and her hip. The rash was described as approximately six (6) separate pencil eraser sized marks which were itchy and raised. The reporter stated these six were a total between her hip and belly with majority on her belly. The patient was advised to tale ZYRTEC or BENADRYL and to call if she had respiratory issues.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified 15 year old patient. The patient's medical history, concurrent conditions and/or drug reactions/allergies were not provided. On an unspecified date the patient was vaccinated with GARDASIL, intramuscular (lot # / expiration date unknown) and 7 months later on 11-NOV-2016, the patient was vaccinated with GARDASIL 9, intramuscular (lot # / expiration date unknown). Concomitant medication was not provided. No adverse effects were reported. A PQC was not involved. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Impulsive behaviour
Clinical narrative: This spontaneous report was received from the patient's grandmother referring to her grandson a male patient of unknown age. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. In approximately 2010 (reported as "about six years ago"), the patient's mother received a dose of GARDASIL (route, dosage schedule, lot # and expiration date were not reported) while pregnant. The reporter also stated that since an unknown date (reported as "now") the patient was "acting out' (impulsive behavior). The outcome of the patient's impulsive behavior and was unknown at the reporting time. The reporter did not assess causality between the event and the use of GARDASIL. This is one of two reports received from the same reporter. The reporter considered the event to be a congenital anomaly. Additional information is not expected as the reported refused contact for follow up.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema at point of injection extending 4 cm - tender, warm, no induration. Pain extending up to shoulder and down to elbow.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Cold sweat, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Morning/day after 101.9 fever. Eating cause stomach pain. Second day nausea and vomiting. Clammy skin but no fever. No appetite.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Morning/day after 101.9 fever. Eating cause stomach pain. Second day nausea and vomiting. Clammy skin but no fever. No appetite.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Laboratory test normal, Oral pain, Productive cough
Clinical narrative: 20 mins after flu shot I had tightness in my chest. My breathing felt short. 3 days later in the roof of my mouth felt like a sore throat. Called Dr. next day. I had yellow color come up when I cough. I continued to cough and wheeze so then I went to my lung Dr. and he gave me Prednisone and antibiotics. I am taking Tussin DM cough medicine my self.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: 20 mins after flu shot I had tightness in my chest. My breathing felt short. 3 days later in the roof of my mouth felt like a sore throat. Called Dr. next day. I had yellow color come up when I cough. I continued to cough and wheeze so then I went to my lung Dr. and he gave me Prednisone and antibiotics. I am taking Tussin DM cough medicine my self.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Hives, itching, redness, warmth, swelling around injection site.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received on 23-NOV-2016 from a registered nurse referring to a 1 year old patient (gender unknown). The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 23-NOV-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot number and expiration date not reported) instead of VARIVAX. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in September 2015, the patient received the first dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported) and then on 14-NOV-2016, the second dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported) was administered. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to 8 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored VAQTA (dose and route were unknown, lot # M033611 with expiration date 02-MAR-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to 5 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (dose unknown, lot # M002254 with expiration date 15-NOV-2017) orally. No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 17-NOV-2016 via a field representative who received the information from a nurse. The nurse reported that on an unspecified date, an unspecified 15 year old patient was inadvertently administered a dose of PROQUAD (lot # and expiration date not reported). Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information provided. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Drug administered to patient of inappropriate age, Somnolence, Wrong drug administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drowsiness in a 4-month-old female patient who received KINRIX. On an unknown date, the patient received KINRIX. On an unknown date, less than a year after receiving KINRIX, the patient experienced drowsiness, appetite absent, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the drowsiness, appetite absent, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the drowsiness and appetite absent to be related to KINRIX. Additional details were provided as follows: The reporter stated that at his daughter's (patient) four month check-up she inadvertently received  the KINRIX vaccine instead of the PEDIARIX vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was administered 2 other shots and an oral intake vaccine as well on the same day. After receiving KINRIX the patient experienced drowsiness and lack of appetite. The batch number and expiry date were unknown. This case was not associated with product complaint. No additional details were provided. The reporter did not want to answer additional details on the adverse event report. The patient had denied the permission to contact their physician.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 38-year-old female patient who received TWINRIX adult. On an unknown date, the patient received the 3rd dose of TWINRIX adult. On an unknown date, less than a year after receiving TWINRIX adult, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to TWINRIX adult. Additional details were provided as follows: In 2015, the patient received the TWINRIX adult. In 2015, the patient experienced persistent soreness in arm. The reporter could not verify any information regarding this report. The reporter called another site to obtain additional information on the vaccination but there were no records that indicate that the event actually occurred. The reporter was requesting that this report be discarded.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Terminal insomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 37-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date 5th November 2017. On 9th November 2016, the patient received BOOSTRIX. In November 2016, less than a week after receiving BOOSTIRX, the patient experienced pain in arm, tingling of extremity, pain, awakening early and numbness in hand were unknown. It was unknown if the reporter considered the pain in arm, tingling of extremity, pain, awakening early and numbness in hand to be related to BOOSTRIX. Additional details were provided as follow: The patient received BOOSTRIX on her left arm. The patient experienced sore all the time in her hand and it hurt to lift it, patient also said that the last two nights the pain, numbness and tingling has woken her up. The patient had not contacted her doctor yet because she wanted to know if this were a normal side effect of the BOOSTRIX. The call was transferred to Medical Information for assistance with side effect information for the BOOSTRIX. No other information was provided prior to transfer to Medical Information.
Age: 0.8
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a currently 9 months and 17 days old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On an unknown date, at the age of 9 months and 17 days, the patient was vaccinated with a dose of PROQUAD (dose and route of administration were not reported) (lot # L032761 and expiration date 04-FEB-2017). It was stated that the patient has not experienced any adverse effects. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 10-NOV-2016, the patient received simultaneously a dose of PROQUAD (recombinant human albumin, rHA) (lot # M022402 with expiration date at 01-NOV-2017; dose and route of administration were not reported) and a dose of VARIVAX (lot # M025864 with expiration date at 24-MAY-2018; dose and route of administration were not reported). There were no adverse events reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus infection, Occupational exposure to product, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative referring to himself, a male patient of unknown age. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, it was reported that the patient developed blistering bumps on his finger the day after administering ZOSTAVAX (dosage regimen, route of administration, lot # and expiry date unspecified) to a patient. It was reported that the patient had worn gloves during the administration. The patient was diagnosed with herpes virus infection on his finger after consulting with an unspecified physician. It was reported that the lesions resolved in 3 weeks without requiring medical treatment. Outcome of herpes virus infection was recovered. Causality assessment was not provided by the reporter. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to 11 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, one patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route were unknown, lot # L016429 with expiration date 09-AUG-2017) and additional 10 patients were each vaccinated with a dose of improperly stored GARDASIL 9 (dose and route were unknown, lot # M024261 with expiration date 30-JUL-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 21-NOV-2016 from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-NOV-2016 the patient was vaccinated with an expired RECOMBIVAX HB lot # L010595, expiration date 12-NOV-2016 unknown route. No adverse effects were reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to 7 unspecified patients of unknown age and gender. Information about the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of RECOMBIVAX HB (dose and route were unknown, lot # M010671 with expiration date 02-JUN-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to less than 10 patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L044058, expiration date 02-MAY-2017; lot # M007962, expiration date 15-AUG-2017 and lot # M031942, expiration date 27-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 23 degrees Fahrenheit for 40 hours which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Herpes zoster
Clinical narrative: Information has been received from a 49 (currently 51) year old female patient concerning herself. Concomitant therapies included acyclovir. The patient did not have drug reactions and allergies. In November 2014 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route, lot# and expiration date were unknown), but right now the patient was experiencing shingles. She also reported that she took acyclovir to help with the shingles she had. The patient stated she was under stress, so she was not sure if this made her get shingles. The causality between ZOSTAVAX and the events was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a registered pharmacist via a company representative referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, route, dose and unit unknown). On an unknown date, the patient began experiencing "swelling from shoulder middle forearm on the arm the dose was administered". The patient was diagnosed with "over stimulation from the vaccine" by the physician. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. Improperly stored doses of GARDASIL 9 (dose and route were unknown; lot number was M009378 with expiration date 23-APR-2013), had been administered to unspecified patients on unspecified dates since 17-AUG-2016. The temperature and time frame of the vaccine storage was 34.2 F for 104 hours and 49.0 F for 39 hours. There was no previous temperature excursion. Data logger issue was involved. No adverse experience had been reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 69 year old female patient. There was no concomitant medication, medical history, nor drug reactions/allergies. The patient's concurrent condition was not provided. On an unspecified date in "2012", the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were unknown) intramuscularly. On 15-NOV-2016, the patient was inadvertently vaccinated with a second dose of PNEUMOVAX 23 (lot # M038216 with expiration date 09-MAY-2018, dose unknown) intramuscularly. On an unknown date in November 2016 after receiving the second dose of PNEUMOVAX 23, the patient developed "swelling, pain and warmth" at the injection site. The pharmacist reported that she recommended the patient ice affected area and take TYLENOL or ADVIL, but didn't know if the patient iced the area or took any medications. On 17-NOV-2016, the pharmacist called the patient back and the patient reported that she saw her physician and that no treatment was provided. On the same day, the patient reported to the pharmacist that the "swelling is going down and the warmth and pain are going away." No lab diagnostic studies was performed. The causality assessment between PNEUMOVAX 23 and "swelling, pain and warmth" at the injection site was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Was due Hepatitis A, MMR, Varicella - was given Hepatitis A, Varicella, MMRV. Notified mother and told of incident and symptoms to watch for.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Was due Hepatitis A, MMR, Varicella - was given Hepatitis A, Varicella, MMRV. Notified mother and told of incident and symptoms to watch for.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Developed hive like rash to face and arms later in the day which the vaccine was given on self treated with BENADRYL x 1, symptoms lasted 24048 hours. Pt. reported these symptoms to provider on 11/30/2016.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 24 plus hours after vaccine was given, school nurse noted 6-8 scattered nickel-sized hives on the arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site warmth, Pyrexia
Clinical narrative: Fever, rigors 2hr. post vaccine-warmth at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling x 2 days pt itching at site: RT. Dexamethasone 10 mg given in office (LT). Q-DRYL 7.5 mL orally, every 6 hrs, 5 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Fri. Nov 18, Shot was given around noon. 2:00 to 3:00 started feeling tired. 3:30 achy, increased malaise, sore arm, sinus drainage, rapid and labored respiration. 5:30 totally exhausted, chills, very achy, tightness and pain in throat and lower ribs, queasy, no appetite so no dinner; went to sleep, could hardly rise to the bathroom, slept for 12 hours. Sat. Nov 19, Still extremely tired, achy, queasy. Ate meals, but food did not taste good. Sun. Nov 20, Still tired, achy, queasy. Felt better in afternoon so was more active. Did not sleep well. Mon. Nov 21, Felt lousy again-very tired and achy. Tue. Nov 22, basically back to normal.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Fri. Nov 18, Shot was given around noon. 2:00 to 3:00 started feeling tired. 3:30 achy, increased malaise, sore arm, sinus drainage, rapid and labored respiration. 5:30 totally exhausted, chills, very achy, tightness and pain in throat and lower ribs, queasy, no appetite so no dinner; went to sleep, could hardly rise to the bathroom, slept for 12 hours. Sat. Nov 19, Still extremely tired, achy, queasy. Ate meals, but food did not taste good. Sun. Nov 20, Still tired, achy, queasy. Felt better in afternoon so was more active. Did not sleep well. Mon. Nov 21, Felt lousy again-very tired and achy. Tue. Nov 22, basically back to normal.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Paranasal sinus hypersecretion, Poor quality sleep, Respiratory rate increased, Throat tightness
Clinical narrative: Fri. Nov 18, Shot was given around noon. 2:00 to 3:00 started feeling tired. 3:30 achy, increased malaise, sore arm, sinus drainage, rapid and labored respiration. 5:30 totally exhausted, chills, very achy, tightness and pain in throat and lower ribs, queasy, no appetite so no dinner; went to sleep, could hardly rise to the bathroom, slept for 12 hours. Sat. Nov 19, Still extremely tired, achy, queasy. Ate meals, but food did not taste good. Sun. Nov 20, Still tired, achy, queasy. Felt better in afternoon so was more active. Did not sleep well. Mon. Nov 21, Felt lousy again-very tired and achy. Tue. Nov 22, basically back to normal.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Herpes zoster, Injection site erythema, Injection site urticaria, Musculoskeletal pain
Clinical narrative: 4" raise red hot welt below injection site, sore arm & shoulder no treatment, 10/17 bad muscle shoulder/neck pain left side only, muscle relaxant given heat compress no relief, 10/20 pain med given no relief, Ibuprofen & aspirin no relief, found small stinger in neck area removed, started cool compress with Benadryl, skin started burning and felt like small hair cactus thorns stuck in upper left side front below clavicle, intensified, 10/31 raw feel on chest to sternum & neck/shoulder continued pain; Gabapentin given, 2nd Dr and spine clinic diagnosed Shingles.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: 4" raise red hot welt below injection site, sore arm & shoulder no treatment, 10/17 bad muscle shoulder/neck pain left side only, muscle relaxant given heat compress no relief, 10/20 pain med given no relief, Ibuprofen & aspirin no relief, found small stinger in neck area removed, started cool compress with Benadryl, skin started burning and felt like small hair cactus thorns stuck in upper left side front below clavicle, intensified, 10/31 raw feel on chest to sternum & neck/shoulder continued pain; Gabapentin given, 2nd Dr and spine clinic diagnosed Shingles.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: At the time of the injection, I had an electric shock strike at the back of my lower neck, did not say anything at the time...was shocked!
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Intense pack pain, soreness to injection site (can not lift arm or touch the site), fatigue, feverish, chills.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Intense pack pain, soreness to injection site (can not lift arm or touch the site), fatigue, feverish, chills.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Child presents today with bilateral swelling of hands, associated with itching and wheals on the arms and back.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Rash erythematous, Scar
Clinical narrative: Bright red rash on facial cheeks, across eyelids and left rash scarring.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Facial paralysis, Lacrimation increased, Pharyngitis, Rhinitis allergic
Clinical narrative: PATIENT WAS SEEN AT PRIMARY CARE PROVIDER WHEN SYMPTOMS STARTED. MEMBER COMPLAINED OF EYE SWOLLEN AND WATERY EYES. PCP DISCUSSED ABOUT BELL'S PAULSY, PHARYNGITIS, AND ALLERGIC RHINITIS. PCP PRESCRIBED PREDNISONE 20MG, VALACYCLOVIR 500MG AND NATURAL TEARS(PF) .1%-.3% DROPS. MEMBER RECEIVED 2015 INFLUENZA WITH NO REACTION.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: THE PATIENT WENT TO EMERGENCY ROOM BECAUSE HE FELT HIS LEG GO NUMB AND JOINT PAIN. HE RECEIVED MEDICATION IV AND WAS DIAGNOSED GUILLAIN-BARRE SYNDROME WHICH THE DOCTOR ESTIMATED WAS DUE TO THE FLU VACCINATION.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: LEFT SHOULDER PAIN WHEN ARM IS MOVED UPWARD.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: PATIENT PRESENTED WITH A RASH ABOUT 1 INCH WIDE AROUND THE CIRCUMFERENCE OF HIS ARM AROUND THE INJECTION SITE. IT WAS NOT BOTHERING THE PATIENT IN ANY WAY.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt reported swollen arm from injection site down to the elbow in a "bar like" pattern.  Pt went to doctor for this reaction and was prescribed famotidine, ibuprofen and prednisone.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Muscle spasms
Clinical narrative: Severe cramps to left lower leg lasting approximately 20 min. Treated by donor with walking, rubbing, oral fluids.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: BUMPS NEAR INJECTION SITE. SPREAD TO COLLAR BONE DOWN TO BREAST AND OTHER AREAS FOR 3 DAYS.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: (BTW - don't know time of onset) I started noticing my shoulder was hurting and I could barely lift my arm.  I didn't have bad site pain initially so I didn't connect it at first to the vaccine.  I saw the doctor who was skeptical but I had done research and was pretty sure this was a vaccine injury.  I sent my doctor the information on frozen shoulder and vaccines.  The doctor I saw said if it didn't go away in a couple of weeks it might be an injury but he was very dismissing.  I doubt they are going to report it but it has been a month - I still can barely lift that arm and it is painful when I get to a certain point.  I think vaccines are worthwhile but I am not going to get a flu shot again.  From what I read this is going to take a year to get better and I am frustrated that my doctors are not paying any attention to it.  I think it makes more sense to see if this really is a vaccine injury and help the patient deal with it instead of disregarding the discomfort.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient was running a low-grade fever following receipt of 2 immunizations.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Swelling, redness and inflammation in arm where the shot was administered.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Mobility decreased, Night sweats, Pain
Clinical narrative: Aching/ throbbing in forearm, upper arm, shoulder, back, shoulder of injected arm. Chills, night sweats. Difficulty and pain when lifting or moving arm. Severe headache- not a migraine.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Antinuclear antibody negative, Arthralgia, Blood glucose abnormal, Computerised tomogram normal, Fatigue
Clinical narrative: Fever, fatigue and joint pain and moderate to severe neck pain.  Broke out with rash on all limbs and 60% of abdomen on 06/15/2016.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Neck pain, Pyrexia, Rash, Rheumatoid factor negative
Clinical narrative: Fever, fatigue and joint pain and moderate to severe neck pain.  Broke out with rash on all limbs and 60% of abdomen on 06/15/2016.
Age: 16.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Electrocardiogram, Laboratory test, Supraventricular tachycardia
Clinical narrative: Had an episode of SVT (previously healthy, no sx), 24-36 hrs after HPV and meningococcal vaccines.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Induration, Pain of skin, Rash erythematous, Skin swelling
Clinical narrative: 11/29 Red rash. 11/30 Horizontal linear rash lines (no fever) skin firmness (saw Rph). 12/1 Skin pain/increased hardening of linear rash. 12/2 spoke to staff-skin swollen/firm-housed to seek medical help-no fever. 12/3 Will wait to see MD-seems better/improving.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very sore-both arms - left arm worse - difficulty raisin arms - went to Dr and got steroid shots slowly getting better.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very sore both arms - difficulty raising arms - went to Dr and got steroid shots.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certified nurse practitioner referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (Lot number L043213, expiration date: 28-AUG-2017). The vaccines were exposure to 1 Celsius degree 2 hours. Data logger was involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm painful, warm to touch, redness 10x7 cm.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Muscle spasms
Clinical narrative: Patient had an adverse reaction 2 minutes after PNEUMOVAX 23 injection. She became dizzy and said she was having back spasms. Paramedics arrived within 5 minutes and checked her over. Vitals were ok. No sign of allergic reaction within 15 minutes. She was fine to go home.
Age: 26.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Large round swollen red welt, hot to touch near injection site. Painful.
Age: 26.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Pain, Urticaria
Clinical narrative: Large round swollen red welt, hot to touch near injection site. Painful.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: Got Chickenpox from vaccine.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Chills, Hyperhidrosis, Migraine
Clinical narrative: Severe onset migraine 10/10 pain scale; sweating and chills until following morning, pus-filled blisters: 6 on skin in pelvic area directly above labia, 4 on RIGHT underarm. All blisters extremely painful to the touch.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Influenza virus test negative, Irritability, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Inconsolable fussiness x 6 hours, fever 40 C (rectal) lasting 10 hours+ (not resolved at discharge).
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated his arm became sore and had difficulty moving arm.