chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP, IPV, RV5
Symptoms: Bronchiolitis, Chest X-ray, Full blood count, Pyrexia
Clinical narrative: It began with normal fevers, and then they intensified, fever rose and fell. I took her to the facility so they can check her. The fevers rose to 102-104 degrees F. The fever was controlled and I would take her home, this continued for a week, and the week after she developed  Bronchiolitis.  For the fever they used Tylenol. For the bronchiolitis, they used Pulmacol therapies.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Myalgia, Rash erythematous
Clinical narrative: PATIENT DESCRIBED AND IT WAS SEEN A RASH WHICH WAS RED FROM SITE TO ELBOW WHICH WAS SWOLLEN AND WARM. PATIENT SAID SHE ALSO HAD SEVERE MUSCLE ACHES ALL OVER BODY; THE ARM WAS SWOLLEN AND WARM MORE THAN HER OTHER ARM ... PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION AND REPORT BACK.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth, Pain
Clinical narrative: Injection site reaction - swelling to 4cm wheal, with warmth, tenderness pain with moving left arm no fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Approx 48 hrs after Pt. was given QUADRACEL and PROQUAD vaccines in (L) lateral thigh, she developed large area of redness (7x9cm) warmth and pain around the inferiorly placed PROQUAD vaccine. Also with moderate thigh swelling. (+) Fever by mom's report. Starting Pt. On KEFLEX to treat for possible cellulitis. Will return in 48 hrs if not improving.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Cortical dysplasia, Electroencephalogram abnormal, Infantile spasms, Nuclear magnetic resonance imaging brain abnormal, Seizure
Clinical narrative: I have twins that were given their 2 month vaccinations. About a week later, both babies starting having seizures. They were diagnosed with infantile spasms. One was diagnosed with a cortical dysplasia as well.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number DK74P, expiry date unknown). The patient's past medical history included shoulder operation, cholesterol (be cholesterol issues and shoulder repair for respective historical sections), thyroidectomy and tonsillectomy (thyroid and tonsil taken out). Concomitant products included Aspirin, Levothyroxine, vitamin d and COQ10. On 17th February 2018, the patient received the 1st dose of SHINGRIX. On 18th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, back pain and pain in the arm. The patient was treated with TYLENOL and TAMIFLU. On 19th February 2018, the outcome of the fever, back pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, back pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received no other vaccines on the day of vaccination with SHINGRIX. The morning after the patient received SHINGRIX in her left deltoid she experienced pain in her back and arm. The reporter stated that she usually got this when she had a fever. Reporter stated that she had a high fever of 100.8 degree F despite taking TYLENOL. She visited a nurse practitioner at a clinic who prescribed her TAMIFLU. The reporter stated that she felt 100 percent by the morning of previous day before reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX (batch number T5242, expiry date 8th February 2019). On 9th February 2018, the patient received SHINGRIX. On 10th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved. The reporter considered the injection site pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The reporter was a pharmacist at the pharmacy where the vaccine was administered to the patient. On 11th February 2018, this pharmacist was notified last night by the consumer that an incredibly painful lump about 4 inches below the injection site just started yesterday morning. The administration site was the upper deltoid, but the pharmacist did not know which arm. The consumer had no other medications on her profile, and the reporter was unaware of any other concomitant medications or the vaccine's exact dosing, because the vaccine was administered by one of the other staff pharmacists. The reporter did not yet know which pharmacist administered the vaccine. The pharmacist already referred the consumer to her health care provider regarding the reported pain if necessary. The reporter suspects this was an injection site reaction but was not certain.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of female patient who received SHINGRIX (batch number 4492P, expiry date unknown). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, sleeplessness and tremor. On an unknown date, the outcome of the influenza-like symptoms, chills, sleeplessness and tremor were recovered/resolved. The reporter considered the influenza-like symptoms, chills, sleeplessness and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the 3 or 4 patients, she believed all to be female received the first dose of SHINGRIX and all were given 0.5ml dose in the left deltoid, and all patients experienced flu like symptoms on the evening of the vaccine. The reporter noted the events resolved after about 2 days. The reporter did not have patient's details. All the patients were back in to the see the nurse, but the physician saw them as well in the office. The reporter did not have patient's details. All the patients were back in to see the see the nurse, but the physician saw them as well in the office. The reporter was transferred to Immunization Information System to address if the second dose should be given. The reporter did not believe any had other vaccines on the same day or 4 weeks prior to. The patients visited emergency room.
Age: 8.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Arteriovenous malformation, Computerised tomogram head abnormal, Decreased activity, Gait disturbance, Haemorrhage intracranial
Clinical narrative: 8 yo male came to the clinic for the 1st time on Jan 03, 2018 for school physical. He had normal PE no past med history, no allergies. He was given Tdap and MMR, went home, no problem but that night he developed severe headache, vomited and passed out, brought to ER and had CT with Rt frontal intracranial hemorrhage-he had emergency surgery and was diagnosed to have AV malformation of the brain (arteriovenous malformation). He survived and has (L) sided weakness and will do therapies and rehab and has unsteady gait and decreased tolerance to activities. I know these are not adverse effects of the shots but just to inform you what happened and the sequence of events and for your file.
Age: 8.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Headache, Hemiparesis, Loss of consciousness, Surgery, Vomiting
Clinical narrative: 8 yo male came to the clinic for the 1st time on Jan 03, 2018 for school physical. He had normal PE no past med history, no allergies. He was given Tdap and MMR, went home, no problem but that night he developed severe headache, vomited and passed out, brought to ER and had CT with Rt frontal intracranial hemorrhage-he had emergency surgery and was diagnosed to have AV malformation of the brain (arteriovenous malformation). He survived and has (L) sided weakness and will do therapies and rehab and has unsteady gait and decreased tolerance to activities. I know these are not adverse effects of the shots but just to inform you what happened and the sequence of events and for your file.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced generalized rash and discomfort. On an unknown date, the outcome of the generalized rash and discomfort were unknown. It was unknown if the reporter considered the generalized rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: There were two reporters who were immunization program coordinators at the clinic who oversee the primary care Immunization program. They stated they received this information from other physicians and nurses regarding the consumer's product experience. Within about 12 hours after receiving the SHINGRIX vaccine, the consumer reported a non-injection site rash. The patient had a generalized rash across the body involving the trunk, described specifically as a flat itchy rash over the chest, back, arms and up the neck. Less than a week after receiving SHINGRIX, the patient had significant discomfort. The patient was alive at the time of reporting, and did not require overnight hospitalization for any of the reported symptoms. The reporter's grant permission to be contacted. The reporter's declined to provide concomitant medications or any further related details beyond what was documented above due to time constraints. This call was transferred to the medical information team. The supervising MD field name was for a Nurse Practitioner. It was unable to clarify what was meant by significant discomfort during the call due to time constraints.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. Concurrent medical conditions included anxiety (Diagnosed years before the reporting date) and migraine (Diagnosed prior to taking SHINGRIX). Concomitant products included PAXIL CR, TOPAMAX and XANAX. On an unknown date, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and general body pain. In February 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site erythema and general body pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine on Saturday in her right arm. The had general body aches for day or so after receiving SHINGRIX. The aching had stopped, but the paitnet stated that there was still a red spot there, but it appeared to be getting better. The patient had denied persission to contact their physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of urticaria in a 70-year-old female patient who received SHINGRIX. Previously administered products included methotrexate. On 29th January 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced urticaria. The patient was treated with Antihistamines. On an unknown date, the outcome of the urticaria was unknown. It was unknown if the reporter considered the urticaria to be related to SHINGRIX. Additional details were provided as follows: Initially spoke to physician via click to chat and then asked if call could be made regarding possible adverse event. The adverse event collected via phone. The patient stopped methotrexate for two months after their underlying condition of urticaria resolved. The patient received SHINGRIX on 29th January 2018 during this time. After receiving SHINGRIX the patient experienced another flare of urticarial at an unknown point in time. The physician reported that no other vaccines on that day, and only mentioned that the patient was on Antihistamines. The physician did not want to be data bank when being asked questions regarding adverse event, so the physician was transferred to a vaccine specialist before all questions could be asked. The physician was not asked for permission to be contacted by Safety.
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthritis, Bronchitis, Gait inability, Inflammation, Joint lock
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bronchitis in a 55-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included AFLURIA QUAD. On 29th January 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced bronchitis, knee lock, knee arthritis, inflammation localized, swelling and unable to walk. On an unknown date, the outcome of the bronchitis, knee lock, knee arthritis, inflammation localized, swelling and unable to walk were recovered/resolved. The reporter considered the bronchitis, knee lock, knee arthritis and inflammation localized to be possibly related to SHINGRIX. It was unknown if the reporter considered the swelling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The manufacturer of the flu vaccine was Seqirus. Ten days after receiving the vaccine, the patient had swelling in Achilles tendons, knees locking during sleep and inflammation in both knees and feet preventing him from walking in the morning. These symptoms all resolved within two days of their starting.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Right anterolateral thigh is very warm, edematous, erythematous, and indurated. Reaction started in the evening and has worsened. Non tender. Pt returned to office 2/21/18. AUGMENTIN prescribed.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Amyotrophic lateral sclerosis, Balance disorder, Confusional state, Death, Dysphagia
Clinical narrative: First symptoms experience on or about April 24, 2016: loss of balance, changes in speech patterns, confusion, difficulty swallowing, changes in vision, muscle twitches and muscle cramps, weakness in hands and arms, and chronic fatigue. Treatment continued during summer 2016 with PLEX resulting in temporary improvement.  Patient died on October 4, 2016 from complications related to motor neuron disorder/ALS.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Lumbar puncture, Motor neurone disease, Muscle spasms, Muscle twitching
Clinical narrative: First symptoms experience on or about April 24, 2016: loss of balance, changes in speech patterns, confusion, difficulty swallowing, changes in vision, muscle twitches and muscle cramps, weakness in hands and arms, and chronic fatigue. Treatment continued during summer 2016 with PLEX resulting in temporary improvement.  Patient died on October 4, 2016 from complications related to motor neuron disorder/ALS.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Speech disorder, Visual impairment
Clinical narrative: First symptoms experience on or about April 24, 2016: loss of balance, changes in speech patterns, confusion, difficulty swallowing, changes in vision, muscle twitches and muscle cramps, weakness in hands and arms, and chronic fatigue. Treatment continued during summer 2016 with PLEX resulting in temporary improvement.  Patient died on October 4, 2016 from complications related to motor neuron disorder/ALS.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site streaking, Pain in extremity, Pain of skin, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020). On 12th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 13th February 2018, the patient experienced touch sensitivity increased. On 16th February 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the touch sensitivity increased was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and touch sensitivity increased to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. On 13th February 2018, 22 hrs after receiving SHINGRIX, the patient experienced touch sensitivity increased. Limited information was provided by the pharmacist.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020). On 12th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 13th February 2018, the patient experienced touch sensitivity increased. On 16th February 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the touch sensitivity increased was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and touch sensitivity increased to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. On 13th February 2018, 22 hrs after receiving SHINGRIX, the patient experienced touch sensitivity increased. Limited information was provided by the pharmacist.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020). On 12th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 13th February 2018, the patient experienced touch sensitivity increased. On 16th February 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the touch sensitivity increased was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and touch sensitivity increased to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. On 13th February 2018, 22 hrs after receiving SHINGRIX, the patient experienced touch sensitivity increased. Limited information was provided by the pharmacist.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPAB, MMR, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: PT REPORTS HE STARTED WITH ITCHING AND RASH ON HIS ARMS, TRUNK, FOREHEAD AND LEGS THE NIGHT OF THE VACCINES.
Sex: F
Vaccine: VARCEL
Symptoms: Hydrocephalus, Mechanical ventilation, Mental status changes, Nuclear magnetic resonance imaging, Urinary tract infection
Clinical narrative: This spontaneous report was received from a physician and refers to a 67-year-old female patient. The patient did not have any known drug reactions and allergies and none pertinent medical history. On an unknown date in January 2018, the patient received a dose of VARIVAX for prevention of varicella (dose, route of administration, anatomical location, lot# and expiration date were not reported) with STERILE DILUENT (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included ampicillin, ceftriaxone, vancomycin and acyclovir. On 29-JAN-2018, the patient the began to experience an unspecified change in mental status. On the same day, she was diagnosed with a urinary tract infection by a healthcare provider at an emergency room and was prescribed an unspecified antibiotics as a treatment. On 02-FEB-2018, the patient was admitted to hospital with an unspecified change in mental status. During hospitalization, she had Magnetic Resonance Imaging (MRI) performed (results unspecified) (onset date in approximately February 2018). On an unknown date, the patient was diagnosed with hydrocephalus and on an unknown date, had external ventricular drain placed in an unspecified location (details were not provided). In approximately February 2018, the patient was placed on placed on a ventilator for an unspecified reason. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX and STERILE DILUENT was not reported. Upon internal review the event of hydrocephalus was determined to be medically significant. Upon internal review the unspecified reason was determined to be medically significant due to ventilator placement.
Sex: F
Vaccine: VARCEL
Symptoms: Ventricular drainage
Clinical narrative: This spontaneous report was received from a physician and refers to a 67-year-old female patient. The patient did not have any known drug reactions and allergies and none pertinent medical history. On an unknown date in January 2018, the patient received a dose of VARIVAX for prevention of varicella (dose, route of administration, anatomical location, lot# and expiration date were not reported) with STERILE DILUENT (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included ampicillin, ceftriaxone, vancomycin and acyclovir. On 29-JAN-2018, the patient the began to experience an unspecified change in mental status. On the same day, she was diagnosed with a urinary tract infection by a healthcare provider at an emergency room and was prescribed an unspecified antibiotics as a treatment. On 02-FEB-2018, the patient was admitted to hospital with an unspecified change in mental status. During hospitalization, she had Magnetic Resonance Imaging (MRI) performed (results unspecified) (onset date in approximately February 2018). On an unknown date, the patient was diagnosed with hydrocephalus and on an unknown date, had external ventricular drain placed in an unspecified location (details were not provided). In approximately February 2018, the patient was placed on placed on a ventilator for an unspecified reason. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX and STERILE DILUENT was not reported. Upon internal review the event of hydrocephalus was determined to be medically significant. Upon internal review the unspecified reason was determined to be medically significant due to ventilator placement.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 month old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported. On 09-JAN-2018, the patient was vaccinated with a first dose of  VAQTA lot # N020689, expiration date 22-OCT-2018 (dose not reported), route reported as "Left VL" for prophylaxis instead of a dose of RECOMBIVAX HB due to similarity of the boxes. Concomitant therapies included PENTACEL, PREVNAR 13 and ROTATEQ. No adverse reactions were reported.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N030111, expiry date: 21-APR-2019) (route: intramuscular) for pneumonia prevention. Concomitant therapies included levothyroxine sodium and VAGIFEM. On 18-FEB-2018, the patient experienced injection site pain. On 20-FEB-2018, the patient noticed redness on the upper part of the left arm, above the injection site. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medication included sterile diluent. On 12-FEB-2018 the patient was vaccinated with improperly stored one dose of PROQUAD injection (dose, frequency and route were not reported) (lot # N019248, expiry date 20-DEC-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PROQUAD was not provided. The vaccine was stored in temperature of -9 degree Celsius (C) to 8 degree C for 216 hours. There was previous temperature excursion reported -14 degree Celsius to -10 degree C for 1 hour. A digital data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018 the first patient was vaccinated with 2 doses of expired PNEUMOVAX 23 (dose, frequency, lot # and route were not reported) (expiry date: 04-FEB-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Immediate post-injection reaction, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The patient began vomiting directly after being administered the first dose in the GARDASIL 9 series. The patient's mother reported that, the patient "vomits a lot before she goes to school". The patient's mother reported the vomiting was "anxiety driven". The patient did not receive treatment for the events, on an unknown date. The outcome of vomiting and anxiety was unknown, at the time of the report. The patient had not sought medical attention, post visit. No product quality complaint was involved. The relationship between the events and GARDASIL 9 was not provided.
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an advanced registered nurse refers to a 44 year old female patient. The patient's concurrent conditions included hypothyroidism, deep vein thrombosis and pulmonary embolism. The patient had no drug reaction, allergies or concomitant therapies. On 30-JAN-2018, the patient was vaccinated with one dose of M-M-R II (dosing details, lot # and expiry date unknown) for immunization. On 05-FEB-2018, the patient was diagnosed with shingles. The patient was provided a 7 day treatment with VALTREX. The patient was reported to have recovered from the event on an unknown date in approximately 2018. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018 the second patient was vaccinated with 2 doses of expired PNEUMOVAX 23 (dose, frequency, lot # and route were not reported) (expiry date: 04-FEB-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: FLUX, HEP, HEPA, VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Sciatica
Clinical narrative: This spontaneous report was received from a 50 year old female patient who was also a pharmacist. The patient's pertinent medical history and drug Reactions/allergies were reported as none. Pharmacist reported that on unspecified dates in 2017, she had administered 4 doses of ZOSTAVAX (lot and expiry date not reported) (extra dose administered). Concomitant medications included flu vaccine, Hepatitis A vaccine (manufacturer unknown) and hepatitis B vaccine (manufacturer unknown). On an unspecified date, she began feeling muscle weakness, facial numbness, and sciatic leg pain on the right side of her body. Her primary physician referred her to an unspecified immunologist/allergist. On unspecified dates, she had received unspecified tests by the immunologist, starting 01-FEB-2018. Pharmacist reported that reaction subsided when she did not administer ZOSTAVAX. She also reported that it would take 6 months to a year for complete recovery. Outcome of the muscular weakness, hypoaesthesia and sciatica was recovering and their causality assessment was not reported.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018, the patient was ordered to receive PNEUMOVAX 23 for prophylaxis and inadvertently received a dose of PREVNAR 13 (lot 585205, Expiry date: December 2019) instead of PNEUMOVAX 23. There was no adverse event reported. No dose of PNEUMOVAX 23 was administered. There was no product quality compliant involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution quality issue, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution quality issue, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute (product reconstitution quality issue). The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Neuralgia
Clinical narrative: Left periorbital eye pain and facial nerve pain also on the left side - the patient does not have inflammation of the eye - gave VALTREX 1g tid for 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Eye pain, Fatigue, Immediate post-injection reaction
Clinical narrative: Left periorbital eye pain and facial nerve pain also on the left side - the patient does not have inflammation of the eye - gave VALTREX 1g tid for 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Intraocular pressure increased, Joint effusion, Myalgia, Nausea
Clinical narrative: Left periorbital eye pain and facial nerve pain also on the left side - the patient does not have inflammation of the eye - gave VALTREX 1g tid for 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmological examination normal, Rash vesicular, Sleep disorder
Clinical narrative: Left periorbital eye pain and facial nerve pain also on the left side - the patient does not have inflammation of the eye - gave VALTREX 1g tid for 10 days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Swelling face
Clinical narrative: PT C R cheek swollen, almost appearing as mumps.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Limb discomfort, Tenderness
Clinical narrative: Patient states that within a couple of days her left arm became painful to the touch and was heavy. She continue to have mild discomfort and reduced ROM in arm 2 months later. She also got a B12 shot that day, but in other arm.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Pt was 19 yr old female who came to clinic for Hepatitis B vaccination needed for nursing school. Had had titer drawn and was not showing immunity from previous childhood vaccinations per her report. Per vaccine insert information dose was given based off her age of 19 years and she received recommended pediatric dose of 0.5 ml or 10 mcg. After insurance denied payment upon further investigation found that the immunization dose should have been 1 ml or 20 mcg based off of a booster dose and different recommendations for persons 11 years and up to receive adult dose of 1 ml. No adverse reaction.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Electroencephalogram abnormal, Infantile spasms, Laboratory test, Nuclear magnetic resonance imaging abnormal, Seizure
Clinical narrative: Events: Infantile spasms, seizures; treatment: ACTH, Zantac; outcome: unknown at this time.
Age: 0.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: WRONG VACCINE ADMINISTERED TO PATIENT BY NURSE, NO ADVERSE REACTION NOTED.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the arm swelled, the whole arm swelled up. The patient recovered from the adverse event on an unspecified date. The information on the lot number has been requested.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had Tdap on 2-20-18. She started with some discomfort on 2-21-18. On 2-22-18 her arm became sore red and swollen around injection site. NP saw patient in office on 2-23-18 and has ordered prednisone for treatment and ice to area.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Patient arm is swollen, and red at the site of injection, and pt complains of severe pain in right arm and fevers.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Patient complained from spasm to his throat and right check around 9:10 pm 2-13-2018. R.ph injected him with BENADRYL 50 mg IM.
Age: 17.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site pain
Clinical narrative: Pt. received BEXSERO vaccine in (L) deltoid on 2/14/18. She awoke in early morning 2/15/18 C/O sharp pain in upper (L) arm, extending from shoulder to elbow. Pain was decreased with administration of heat and PO ALEVE. No neuro deficits noted on exam 2/15/18.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain, redness extending to elbow, joint pain or decreased ROM.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient got his 4 year vaccines 1 week ago. MMR-V was administered in his left thigh. He got KINRIX in his right thigh. He had some redness and swelling develop at the left thigh site on Saturday and Sunday which Mom attributed to the shot but then she noticed that the redness was getting worse on Wednesday. This redness had worsened significantly (doubled in size) when she got home from work on Thursday. The redness is still progressing. It is described as "itchy" and "it tickles" which is what he usually says when it's painful. It does sound like the predominant complaint is of itching, however. He has a history of some mild atopy - has reactive airway symptoms, was recently diagnosed with nummular eczema. He did seem to be fighting of a viral infection on Thursday of last week (the day before his WCC) and had a temp up to 100 but this didn't turn into a full-blown illness. He has also been exposed to his siblings who had flu recently. He has never had a reaction to a vaccine before and has no known allergies. Diagnosed as delayed hypersensitivity reaction.  Given 5-day course of oral orapred.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at the site of injection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: CSF culture, Computerised tomogram head, Culture urine, Electrocardiogram, Electroencephalogram
Clinical narrative: Fevers, sudden onset respiratory distress and emesis with asymmetric generalized seizures.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Full blood count, Lumbar puncture, Metabolic function test, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Fevers, sudden onset respiratory distress and emesis with asymmetric generalized seizures.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Respiratory distress, Respiratory viral panel, Seizure, Urine analysis, Vomiting
Clinical narrative: Fevers, sudden onset respiratory distress and emesis with asymmetric generalized seizures.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noticeable swelling, pain (difficulty moving the arm), and unusually warm skin at injection site. MOTRIN and TYLENOL didn't help. Applied ice. ARNICA topical gel seemed to provide the most relief. I believe this will resolve itself in the next day or two but she has never experienced a reaction to a vaccine such as this before this incident.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Feeling abnormal, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complained of feeling flushed and not "normal" which then followed up with complaint of feeling a flutter in her chest then numbness and tingling in the arm she received the shot.
Age: 2.0
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Injection site mass
Clinical narrative: Per mother, the only complaint is a lump at the site of injection. Per mother, she states she was applying hot and cold compresses to the site and now it is better.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture, Blood glucose increased, Culture urine, Diarrhoea, Exposure during pregnancy
Clinical narrative: 30 weeks pregnant, estimated delivery date 4/30/18, very healthy normal pregnancy thus far, morning sickness until about five months, but completely dissipated months ago. Dtap was suggested by my doctor, and I accepted, being told that it was recommended that women at my stage of pregnancy get it. I go about the rest of my day just fine, go to bed around 8:30. Wake up at 11:30pm vomiting. I am then experiencing uncontrollable vomiting and diarrhea every 15 - 20 minutes until 5:30am. I arrive at the ER shortly after, and am admitted to Labor and Delivery for monitoring and an IV drip. Blood and urine cultures are run, the only discrepancies in my blood are my WBC, a count of 21.7 and my glucose, reading 129. Upon following up with my doctor's office today (2/23/18), I'm told that it could in no way be an adverse reaction where I'm now able to keep fluids down.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count abnormal, Vomiting, White blood cell count increased
Clinical narrative: 30 weeks pregnant, estimated delivery date 4/30/18, very healthy normal pregnancy thus far, morning sickness until about five months, but completely dissipated months ago. Dtap was suggested by my doctor, and I accepted, being told that it was recommended that women at my stage of pregnancy get it. I go about the rest of my day just fine, go to bed around 8:30. Wake up at 11:30pm vomiting. I am then experiencing uncontrollable vomiting and diarrhea every 15 - 20 minutes until 5:30am. I arrive at the ER shortly after, and am admitted to Labor and Delivery for monitoring and an IV drip. Blood and urine cultures are run, the only discrepancies in my blood are my WBC, a count of 21.7 and my glucose, reading 129. Upon following up with my doctor's office today (2/23/18), I'm told that it could in no way be an adverse reaction where I'm now able to keep fluids down.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: Contacting MD PCP Dr. (Protocol). Left Message. Pt. going to MD for routine visit 2nd week of Feb.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was scheduled to receive VARIVAX to prevent against chickenpox and accidentally received ZOSTAVAX (dose, route of administration, lot # and expiry date were not reported). No adverse effect was reported.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapy, medical history and past drugs were not reported. On 22-JAN-2018, the patient was vaccinated with fourth dose of RECOMBIVAX HB lot # L048236, expiry date: 31-MAR-2018, intramuscularly (dose volume, strength, and frequency were not reported) for prophylaxis. No adverse effects was reported. No product quality complaint was reported.