chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Bruise around the injection site and redness about 3 inches down the upper arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Throat tightness, Wheezing
Clinical narrative: Audible wheeze, chest and throat tightness that lasted about 24 hours. Took Zyrtec. Some lessening of symptoms.  Pt is a Nurse Practitioner.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Limb injury, Nuclear magnetic resonance imaging
Clinical narrative: Just below the shoulder where the vaccine was administered it started hurting and couldn't raise my arm to use it - pain continued it was so bad I went back to the doctor numerous times for scans, xrays, blood tests, etc. - still can not raise arm past shoulder without pain.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Scan, X-ray
Clinical narrative: Just below the shoulder where the vaccine was administered it started hurting and couldn't raise my arm to use it - pain continued it was so bad I went back to the doctor numerous times for scans, xrays, blood tests, etc. - still can not raise arm past shoulder without pain.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Local reaction, Vaccination site pain
Clinical narrative: C/O pain in arm where vaccinated. No redness, swelling or heat. Was seen at Urgent Care x 2. Dx with local vaccine reaction.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: +5 inch diameter rash at injection site with additional rash of 2 inch diameter on inside arm. Left arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M019707, expiration date 25-OCT-2017, lot # M017514, expiration date 07-NOV-2017 or lot # reported as M006111, expiration date 18-NOV-2017 (dose was not reported). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 11 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L040054, expiration date 26-DEC-2017 or lot # M009378, expiration date 23-APR-2018 (dose, route and site of administration were not reported). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 1 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route and site of administration were not reported), lot #M008551 (expiration date 02-JUN-2018), lot # L048236 (expiration date 31-MAR-2018), lot # M010671 (expiration date 02-JUN-2018) or lot # M020926 (expiration date 11-AUG-2018). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 11 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # reported as M027879, expiration date 24-JAN-2018, or lot # L015460, expiration 20-JUL-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 11 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unknown patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB 5 mcg/0.5 ml intramuscular injection (lot # L045117 with expiration date 06-OCT-2018, lot # M001578 with expiration date 02-NOV-2018; dose and route were unknown). The vaccines were exposed to temperature excursion of 47.8 degrees Fahrenheit for 67 hours. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. 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 medical assistant concerning multiple unknown patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid (lot # L035636 with expiration date 21-MAY-2017, lot # L033694 with expiration date 16-JUN-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 47.8 degrees Fahrenheit for 67 hours. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Adverse reaction, Chills, Local reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 52 year male patient. The patient had no pertinent medical history. The patient had drug allergies to ibuprofen and aspirin. On 31-AUG-2016 the patient was vaccinated with ZOSTAVAX, 0.5 ml ("half cc", incorrect dose administered) subcutaneous. The patient received an unspecified flu shot (influenza virus vaccine (unspecified) on his other arm on the same day he received ZOSTAVAX). It was not specified which arm received the ZOSTAVAX and which arm received the flu shot. Concomitant therapies included "Senobirate", lisinopril, losartan (manufacture unknown), lycopene, multivitamin, propranolol, simvastatin (manufacture unknown), ascorbic acid (vitamin C), vitamin D and ZYRTEC. On an unknown date in 2016 after receiving the vaccine, the patient developed "general and local reactions" (local and general reactions were not specified), a fever and chills. The patient received unspecified treatment. There was no lab performed. The patient was at medical office at the reporting time and was currently recovering. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 06-SEP-2016, the patient was vaccinated with the first dose of VARIVAX (dose, route and indication were not reported, lot # M010481 with expiration date: 01-MAR-2018). On 08-SEP-2016, the patient received a second dose of VARIVAX (dose, route and indication were not reported, lot # M010481 with expiration date: 01-MAR-2018). No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hives in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, 1 day after receiving MENVEO, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. 24 hours after receiving MENVEO the patient experienced hives on arms and face. The GSK sales representative called to report adverse event reported by a health care professional . The reporter had no product or patient information and requested to be contacted by e-mail.
Age: 0.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 6 month old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 13-SEP-2016, the patient was vaccinated with a dose of M-M-R II (lot # L027591 with expiration date 23-JUL-2017; dose and route were not reported) and a dose of VARIVAX (lot# M023383 with expiration date 11-AUG-2018; dose and route were not reported) (product use issue). No adverse effect was reported. There was no product quality complaint (PQC) reported. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patients experienced injection site pain and injection site redness. On an unknown date, the outcome of the injection site pain and injection site redness were unknown. It was unknown if the reporter considered the injection site pain and injection site redness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination of the patients were not reported. The reporter indicated that there were several patients who experienced pain and redness at the injection site right after the injection. The field representative was unable to provide any further details. The field representative advised to contact another nurse to obtain further details and the contact details were provided for the same. The nurse usually did not come in to the office until 3:00 pm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M000756, expiration date 06-JAN-2018; site, doses and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent for follow up.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a female patient of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dosing details were not reported). The nurse practitioner stated that a medical assistant misunderstood some patient information and the second dose of GARDASIL 9 intramuscularly, was given 25 days after the first dose instead of required 2 months later. No adverse effect reported at this time. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, 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 or allergies and concomitant medications were not reported. On an unspecified date, the patient received an improperly stored dose of ZOSTAVAX (19400 plaque-forming units, PFU) (lot # M019646, expiration date: 18-JUL-2017) injected subcutaneously. The administered dose of vaccine was exposed to a temperature of 6.8 Fahrenheit degrees for 1 hour and 30 minutes. It was reported that the temperature was back in ranges. Data logger was used to track the temperature. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender, reporting on him/herself. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot #, expiration date, dosage and route, were not provided). On an unspecified date, the patient experienced herpes zoster reported as "it was the worst pain that the patient have ever had". The patient reported that she sought medical attention as "the physician instructed her to stay home and avoid contact with others". At the time of the report, the outcome of herpes zoster was unknown. the relationship between the vaccine and the herpes zoster was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 74 year old female patient. Current conditions included hypertension. The patient's medical history was not reported. On 09-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M007768, expiration date: 27-JUN-2017, second dose, 0.5 ml, intramuscular in the left deltoid (concentration was not reported). Information regarding concomitant medications included enalapril maleate, hydrochlorothiazide (manufacturer unknown), amlodipine, atenolol and simvastatin (manufacturer unknown). On 09-SEP-2016, the patient experienced swelling below the injection site, trouble lifting the arm and soreness in muscle below the injection site. It was also stated that on 12-SEP-2016, the patient reported some improvement in the soreness and that she had taken BENADRYL, additionally, the pharmacist advised the patient to use ibuprofen and warm compresses to the site. At the time of the report, the outcome of swelling below the injection site, trouble lifting the arm and (musculoskeletal disorder) was unknown. On the other side, the outcome of injection site pain was reported as recovering. The causality between PNEUMOVAX 23 and swelling below the injection site, trouble lifting the arm and soreness in muscle below the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (rHA) (Lot# L034730, expiry date 09-SEP-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site bruising, Injection site pain, Injection site reaction
Clinical narrative: She said the shot hurt and it felt like a cramp in her left arm where shot given.  she got chills and a headache later that night. she also got soreness at the back of her neck. her arm is still bruised at the site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Neck pain
Clinical narrative: She said the shot hurt and it felt like a cramp in her left arm where shot given.  she got chills and a headache later that night. she also got soreness at the back of her neck. her arm is still bruised at the site.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Amyotrophic lateral sclerosis, Decreased appetite, Electroencephalogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pain, tingling in rt leg, collapsed rt lung, problem diaphragm, drop rt foot, Nerve tingling in rt chest extending up to rt shoulder to back of head and rt cheek. This lasted about 20 sec but happened about 20 to 30 times a day, weight loss @ 24 lbs. loss of appetite and lethargic, was diagnosed with Guillain-Barre, then ALS and MS various flu symptoms and wanting to sleep all the time. Numbness in rt shoulder. Lost 2.5 inches in height dropped one shoe size in rt foot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Lethargy, Multiple sclerosis, Pain, Paraesthesia
Clinical narrative: Pain, tingling in rt leg, collapsed rt lung, problem diaphragm, drop rt foot, Nerve tingling in rt chest extending up to rt shoulder to back of head and rt cheek. This lasted about 20 sec but happened about 20 to 30 times a day, weight loss @ 24 lbs. loss of appetite and lethargic, was diagnosed with Guillain-Barre, then ALS and MS various flu symptoms and wanting to sleep all the time. Numbness in rt shoulder. Lost 2.5 inches in height dropped one shoe size in rt foot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Peroneal nerve palsy, Pneumothorax, Respiratory rate, Somnolence, Weight decreased
Clinical narrative: Pain, tingling in rt leg, collapsed rt lung, problem diaphragm, drop rt foot, Nerve tingling in rt chest extending up to rt shoulder to back of head and rt cheek. This lasted about 20 sec but happened about 20 to 30 times a day, weight loss @ 24 lbs. loss of appetite and lethargic, was diagnosed with Guillain-Barre, then ALS and MS various flu symptoms and wanting to sleep all the time. Numbness in rt shoulder. Lost 2.5 inches in height dropped one shoe size in rt foot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Pain, tingling in rt leg, collapsed rt lung, problem diaphragm, drop rt foot, Nerve tingling in rt chest extending up to rt shoulder to back of head and rt cheek. This lasted about 20 sec but happened about 20 to 30 times a day, weight loss @ 24 lbs. loss of appetite and lethargic, was diagnosed with Guillain-Barre, then ALS and MS various flu symptoms and wanting to sleep all the time. Numbness in rt shoulder. Lost 2.5 inches in height dropped one shoe size in rt foot.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hot flush, Malaise, Pyrexia
Clinical narrative: Fever of 101; chills, hot flashes, general malaise.  Took Tylenol.  Still experiencing symptoms 24 hours after shot.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: Right arm tender to the touch. Warm, hard.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site reaction
Clinical narrative: Local reaction at injections site (right deltoid).
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Scan normal
Clinical narrative: Pt exhibiting stroke like symptoms with previous history of heart attack and a fib.  Presented to hospital and had heart and head scans - all clear but dehydrated. Once rehydrated, released and returned to work next day.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test abnormal, Dizziness, Psoriatic arthropathy, Renal impairment
Clinical narrative: Pneumovax 23, lot L031459 (0.5mg) causing Joint pain, hands, wrists, shoulders, knees, dizziness, blurred vision.  Went to Urgent Care, Dr. prescribed Meloxicam, 25 mg.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Vision blurred
Clinical narrative: Pneumovax 23, lot L031459 (0.5mg) causing Joint pain, hands, wrists, shoulders, knees, dizziness, blurred vision.  Went to Urgent Care, Dr. prescribed Meloxicam, 25 mg.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient reported redness in a 4 inch line on her arm. She stated it is slightly warm to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 27-SEP-2016, the patient received an improperly stored dose of ZOSTAVAX (lot number # L039096, expiration date 08-JAN-2017, dose and route not provided). Concomitant therapies were not provided. No adverse effects were reported. Temperature: 15 F; Time Frame: 45 minutes; Was call because of a data logger? Yes; Was it administered (AE)? Yes; Was previous temperature excursion? No Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: 1 hour after administration tongue, teeth, fingers & lips started feeling numb and tingly.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Palpitations
Clinical narrative: 9/20/16 Received Flu shot, left deltoid. Within 3-4 mins sensation periodical numbness, tingling arms - fingers. Took ZYRTEC 10 mg po 15 mins. Later palpitations and difficulty swallowing - took PEPCID 10 g po. Co-workers note rash on face and neck (hives). Return of numbness fingers, toes took DECADRON 4g PO, Albuterol 2 puffs x1, EMS called. BENADRYL 25g PO to ER and discharged. Return of numbness in fingers x15-20 mins that evening and next morning perioral numbness x 15 mins after ZYRTEC 10mg.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Rash, Urticaria
Clinical narrative: 9/20/16 Received Flu shot, left deltoid. Within 3-4 mins sensation periodical numbness, tingling arms - fingers. Took ZYRTEC 10 mg po 15 mins. Later palpitations and difficulty swallowing - took PEPCID 10 g po. Co-workers note rash on face and neck (hives). Return of numbness fingers, toes took DECADRON 4g PO, Albuterol 2 puffs x1, EMS called. BENADRYL 25g PO to ER and discharged. Return of numbness in fingers x15-20 mins that evening and next morning perioral numbness x 15 mins after ZYRTEC 10mg.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 26-SEP-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # 010440, expiry date: 22-JUL-2016). Medical assistant reported that the vaccine was always stored properly. No adverse effects were reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Flu Immunization given in (R) deltoid 9/26/16. Pt seen in clinic on 9/27/16 with c/o swollen lymph node under arm of (R) side/chest area. Painful to touch. Voluntarily went to ER.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Urticarial rash, throat swelling sensations.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Dyspnoea, Hypoaesthesia, Paraesthesia
Clinical narrative: Facial tingling, generalized weakness (sudden), numbing legs, slight SOB.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Injection site pain, Paraesthesia, Restlessness
Clinical narrative: Patient awoke this morning with soreness at the site of injection; feeling of weakness in her upper body, tingling in her right leg; did work today and now all has resolved except for the tingling and tightness in her right leg, no weakness feels restless.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Administered 09-26-16. Patient reported red streaks and swelling in administration arm 9-27-16. Patient was referred to Physician. Patient saw physician 09-28-16. Per patient physician diagnosed as allergic reaction and prescribed cetirizine. Per patient 9-29-16 the site is improving.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Tremor
Clinical narrative: Mom states that patient c/o pain at site nearly all evening, after shot given: Awoke at 5AM morning following flu shot and had uncontrolled shaking. No fever. Mother hugged tightly until shaking stopped. Back to sleep, awoke at 7:30AM and was 'fine".
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Continuous positive airway pressure, Infantile apnoea
Clinical narrative: Immunizations given 9/24. On 9/24 at 2120 became apneic and needed PPV C positive pressure ventilation) a few times. Then after recovered placed in nasal cannula and then at midnight 9/25 placed back on NCPAP. After 33 hours was able to come off cpap and go back to room air.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Pt was present at office for physical exam on 9/23/16 and was given MENACTRA and Flu vaccine on Right Deltoid arm. Patient came back two days later on 9/27/16 complaining of pain from fingers to right arm. Right hand weakness and loss of strength some at vaccination. No prior reaction to vaccines, no fever, no swelling, at site of injections.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Erythema, Headache, Insomnia, Pain
Clinical narrative: This is a spontaneous report from a contactable a retired nurse reporting on herself. An 81-year-old female patient received PREVNAR 13, intramuscular in left arm on 22Jul2016 at single dose for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced swelling on 22Jul2016 with outcome of not recovered, redness/redness at the same spot, a little lower/redness increased with fever 101°F/ redness was from my shoulder to my elbow and all around on 22Jul2016 with outcome of recovering, redness increased with fever 101 (condition aggravated) on an unspecified date with outcome of unknown, pain/very painful on 22Jul2016 with outcome of not recovered, fever on 22Jul2016 with outcome of recovered, insomnia on 22Jul2016 with outcome of recovering, appetite went away on 23Jul2016 with outcome of recovering, headache on 23Jul2016 with outcome of not recovered, feeling sleepy on 23Jul2016 with outcome of recovering. She uses a cold compress that helps with and sometimes relieves the pain. Follow up (23Sep2016): New information obtained from a contactable nurse includes: event's details. Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence, Swelling
Clinical narrative: This is a spontaneous report from a contactable a retired nurse reporting on herself. An 81-year-old female patient received PREVNAR 13, intramuscular in left arm on 22Jul2016 at single dose for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced swelling on 22Jul2016 with outcome of not recovered, redness/redness at the same spot, a little lower/redness increased with fever 101°F/ redness was from my shoulder to my elbow and all around on 22Jul2016 with outcome of recovering, redness increased with fever 101 (condition aggravated) on an unspecified date with outcome of unknown, pain/very painful on 22Jul2016 with outcome of not recovered, fever on 22Jul2016 with outcome of recovered, insomnia on 22Jul2016 with outcome of recovering, appetite went away on 23Jul2016 with outcome of recovering, headache on 23Jul2016 with outcome of not recovered, feeling sleepy on 23Jul2016 with outcome of recovering. She uses a cold compress that helps with and sometimes relieves the pain. Follow up (23Sep2016): New information obtained from a contactable nurse includes: event's details. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Injection site pain, Irritability, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported 3 reports for different patients. This is the 2nd of 3 reports. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot M68769, Expiration date 30Apr2017), intramuscular in left deltoid, on 22Aug2016 6:45 pm, at 0.5ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, irritability, headaches, sore throat, body aches and soreness at injection site on unknown date, and streptococcal pharyngitis on 24Aug2016. Streptococcal pharyngitis was treated with ZITHROMAX for 5 days. The events were considered non serious. Laboratory data included body temperature 102 at unknown date and 99.3 on 24Aug2016. Physical examination on unknown date included positive erythema posterior pharynx, rapid strep positive, no swelling or redness at injection site. Outcome of the events was unknown. Follow-up (16Sep2016): New information received from a contactable physician includes: vaccine lot number and expiration date, additional events (sore throat, body aches and soreness at injection site), seriousness of the events (non-serious), laboratory data. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016402384 Same reporter/drug/event, different patient; US-PFIZER INC-2016402459 Same reporter/drug/event, different patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pharyngeal erythema, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported 3 reports for different patients. This is the 2nd of 3 reports. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot M68769, Expiration date 30Apr2017), intramuscular in left deltoid, on 22Aug2016 6:45 pm, at 0.5ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, irritability, headaches, sore throat, body aches and soreness at injection site on unknown date, and streptococcal pharyngitis on 24Aug2016. Streptococcal pharyngitis was treated with ZITHROMAX for 5 days. The events were considered non serious. Laboratory data included body temperature 102 at unknown date and 99.3 on 24Aug2016. Physical examination on unknown date included positive erythema posterior pharynx, rapid strep positive, no swelling or redness at injection site. Outcome of the events was unknown. Follow-up (16Sep2016): New information received from a contactable physician includes: vaccine lot number and expiration date, additional events (sore throat, body aches and soreness at injection site), seriousness of the events (non-serious), laboratory data. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016402384 Same reporter/drug/event, different patient; US-PFIZER INC-2016402459 Same reporter/drug/event, different patient.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified ethnicity and age (described as 67 no units provided) received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient could not move her arm after receiving the vaccine. The outcome was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cardiac disorder, Cardiac failure, Decreased appetite, Dyspnoea
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (daughter) reported that a female patient of unknown age and race received on 15Dec2015 a single dose of PREVNAR 13 for immunization. Concomitant medication and medical history were not reported. It was mentioned that the patient received the shot on 15Dec2015 and since after that (date not specified), she has had breathing problems and keeps falling. Her heart was not pumping fluid like it should, she was on oxygen and very weak and fatigued. She had also lost her appetite. Outcome was not provided. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Fall, Fatigue
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (daughter) reported that a female patient of unknown age and race received on 15Dec2015 a single dose of PREVNAR 13 for immunization. Concomitant medication and medical history were not reported. It was mentioned that the patient received the shot on 15Dec2015 and since after that (date not specified), she has had breathing problems and keeps falling. Her heart was not pumping fluid like it should, she was on oxygen and very weak and fatigued. She had also lost her appetite. Outcome was not provided. No follow up attempts possible. No further information expected.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Aphonia, Blood test, Bronchitis chronic, Chest X-ray
Clinical narrative: This is a spontaneous report received from a contactable female consumer reported for herself. A 72-year-old female patient received PREVNAR 13 at single dose for immunization, via an unspecified route, on unknown date at 71 years old on 07Nov2015. On unknown date the patient developed chronic bronchitis, joint swelling, couldn't walk, coughing, she lost her voice on 16Sep2016 and she got tired and she needed to lie down. Medical history included high blood pressure since 2000 and mitral valve prolapse both ongoing and she was fat. Her husband had brain, bone, and prostate cancer. The vaccine was administered at the pharmacy. The patient had seen the pulmonary doctor, the family Doctor and cultures and X-rays were taken. The outcome of the event chronic bronchitis was reported as not recovered with seriousness of disability, the outcome of the event loss of voice was reported with outcome of recovered with sequel. The outcome of the other events was unknown. The patient stated that at the end of Nov2015 or beginning of Dec2015 she lost her voice and was not able to speak. She also developed chronic bronchitis and from that couldn't walk or do anything. The patient went to the Emergency Room on 24Jan2016 and they didn't admit her, but she was there for about 7 or 8 hours. When she left, she couldn't even cross the street. When in the Emergency Room on 24Jan2016, they did take her blood pressure, temperature, do a chest x-ray, and blood work tests with unknown results. Recently had a pulmonary test and her lungs were clear.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Cough, Culture, Fatigue, Hypertension
Clinical narrative: This is a spontaneous report received from a contactable female consumer reported for herself. A 72-year-old female patient received PREVNAR 13 at single dose for immunization, via an unspecified route, on unknown date at 71 years old on 07Nov2015. On unknown date the patient developed chronic bronchitis, joint swelling, couldn't walk, coughing, she lost her voice on 16Sep2016 and she got tired and she needed to lie down. Medical history included high blood pressure since 2000 and mitral valve prolapse both ongoing and she was fat. Her husband had brain, bone, and prostate cancer. The vaccine was administered at the pharmacy. The patient had seen the pulmonary doctor, the family Doctor and cultures and X-rays were taken. The outcome of the event chronic bronchitis was reported as not recovered with seriousness of disability, the outcome of the event loss of voice was reported with outcome of recovered with sequel. The outcome of the other events was unknown. The patient stated that at the end of Nov2015 or beginning of Dec2015 she lost her voice and was not able to speak. She also developed chronic bronchitis and from that couldn't walk or do anything. The patient went to the Emergency Room on 24Jan2016 and they didn't admit her, but she was there for about 7 or 8 hours. When she left, she couldn't even cross the street. When in the Emergency Room on 24Jan2016, they did take her blood pressure, temperature, do a chest x-ray, and blood work tests with unknown results. Recently had a pulmonary test and her lungs were clear.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Pulmonary function test normal, Speech disorder
Clinical narrative: This is a spontaneous report received from a contactable female consumer reported for herself. A 72-year-old female patient received PREVNAR 13 at single dose for immunization, via an unspecified route, on unknown date at 71 years old on 07Nov2015. On unknown date the patient developed chronic bronchitis, joint swelling, couldn't walk, coughing, she lost her voice on 16Sep2016 and she got tired and she needed to lie down. Medical history included high blood pressure since 2000 and mitral valve prolapse both ongoing and she was fat. Her husband had brain, bone, and prostate cancer. The vaccine was administered at the pharmacy. The patient had seen the pulmonary doctor, the family Doctor and cultures and X-rays were taken. The outcome of the event chronic bronchitis was reported as not recovered with seriousness of disability, the outcome of the event loss of voice was reported with outcome of recovered with sequel. The outcome of the other events was unknown. The patient stated that at the end of Nov2015 or beginning of Dec2015 she lost her voice and was not able to speak. She also developed chronic bronchitis and from that couldn't walk or do anything. The patient went to the Emergency Room on 24Jan2016 and they didn't admit her, but she was there for about 7 or 8 hours. When she left, she couldn't even cross the street. When in the Emergency Room on 24Jan2016, they did take her blood pressure, temperature, do a chest x-ray, and blood work tests with unknown results. Recently had a pulmonary test and her lungs were clear.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer, reporting for herself. This 81 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified day in Feb2016 at the age of 80 years for pneumococcal immunisation.  The patient medical history and concomitant medications were not reported.  The patient had a bad case of pneumonia on 22Aug2016. She stated that she was not hospitalized and she has not reported it to her doctor. Outcome was unknown.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented with diagnosed outbreak of shingles on face. Is currently under unknown treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen on rt upper arm tense and red where DTaP/IPV was given.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Nausea, Rash
Clinical narrative: PPV administered 1st, then MCV4. 1 min after MCV4 admin, Pt developed mid sternal chest pain, difficulty breathing, nausea/vomiting, diaphoresis, and rash to chest, legs and arms. EMS activated. O2 provided via non-rebreather plus EPI pen administered.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Vomiting
Clinical narrative: PPV administered 1st, then MCV4. 1 min after MCV4 admin, Pt developed mid sternal chest pain, difficulty breathing, nausea/vomiting, diaphoresis, and rash to chest, legs and arms. EMS activated. O2 provided via non-rebreather plus EPI pen administered.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Gastritis, Headache, Migraine, Nausea
Clinical narrative: Headache - Triggered 1st migraine - 5 days of nausea, headache and dizziness. Missed 5 days of school, 2 office visits for evaluation and 1 emergency room visit for migraine abortant therapy. Continues Gastritis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Redness at site within 2-3 hours, down to elbow, with hot to touch. Itching started 10 hours later and lasted 30 hours. Put ice on it.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Hyperhidrosis, Paraesthesia, Tension, Tremor
Clinical narrative: 12 hours after injection (Tdap) awoke to whole body shaking, mouth felt "locked shut" x 10 minutes. Pt. layed down had 2nd episode of "body tingling". Lasted 3 minutes. 1 hour later body felt tense/light, sweating. Pt. did not check temp. Took TYLENOL.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain normal, VIth nerve paralysis
Clinical narrative: A few weeks after 4 month vaccines (pediatric, hib, prevnar, rotateq) had left abducens nerve palsy thought to be viral lasting 1 month.  Then after 6 month vaccines (pediarix, prevnar, rotateq) the left abducens nerve palsy returned a couple later, but resolved more quickly.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN ARM AROUND INJECTION SITE FROM SHOULDER DOWN TO ELBOW.  WENT TO DR. AND GOT STEROID SHOT.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: Abducens never palsy 3 weeks after 4 month shots, 3 months after 6 months shots.  1 year old shots given.
Age: 45.0
Sex: M
Vaccine: FLUR3, PPV
Symptoms: Arthralgia, Chills, Impaired work ability, Local swelling, Mobility decreased
Clinical narrative: Pain develop in left wrist, traveling up to arm. Unable to type due to pain, noticed swelling in shoulder that extends into neck. Fever and chills. Neck swollen and in pain, difficult to move left. Subtle swelling between mid neck and collar bone on left.
Age: 45.0
Sex: M
Vaccine: FLUR3, PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Pain develop in left wrist, traveling up to arm. Unable to type due to pain, noticed swelling in shoulder that extends into neck. Fever and chills. Neck swollen and in pain, difficult to move left. Subtle swelling between mid neck and collar bone on left.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: Swelling at injection spot. Headache. Fever of 99 degrees.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling from shoulder to elbow.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: Pt. was walking dog, felt hot, dizzy, nauseous, sob.  Went to Urgent Care and received an injection of a steroid, symptoms improved within 10-20 minutes. Pt received Prevnar 13 in right deltoid and Fluzone High-dose in left arm. Has had flu injection in past with no adverse reaction.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Lymphadenopathy, Muscle spasms, Pain
Clinical narrative: Within an hour of injection body aches (including lower back) and swollen lymph nodes in throat noted. By Sunday 09/25/2016 pain remained in lower back. Morning of 09/26/2016 pain located in mid back on the right side. Felt like muscle spasm. Sharp pain on inhalation and when turning to the right. Treating with Ibuprofen and TYLENOL (rotating), ice/heat, Epsom salt bath, and chiropractic visit in the late afternoon of 09/28/2016. Still experiencing pain on the morning of 09/29/2016...visit to Employee Health MD. Will continue to monitor over weekend as MD feels the reaction should subside over time. Told to continue home treatment of Ibuprofen/TYLENOL/Ice/Heat.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Pain in extremity
Clinical narrative: The morning after receiving the Influenza and Prevnar vaccines she developed a fever (101.7 and above), chills, and headache associated with diarrhea. Soreness of the right arm greater than left was also reported. Physical exam noted mild dime-sized erythema at the right deltoid injection site. She denied a lumbar puncture for meningeal workup. She was treated with Tylenol and an outpatient course of Keflex for 7 days due to questionable cellulitis of the arm.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: The morning after receiving the Influenza and Prevnar vaccines she developed a fever (101.7 and above), chills, and headache associated with diarrhea. Soreness of the right arm greater than left was also reported. Physical exam noted mild dime-sized erythema at the right deltoid injection site. She denied a lumbar puncture for meningeal workup. She was treated with Tylenol and an outpatient course of Keflex for 7 days due to questionable cellulitis of the arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Red and inflamed 7 inches and sore the day before.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was over vaccinated.  He was already given a dose of Prevnar 13 in March and again on 9/28/2016.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Erythema, Headache, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm, followed by fever, headache, neck pain, swollen arm with bright red patches, joint pain.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Severe pain in arm, followed by fever, headache, neck pain, swollen arm with bright red patches, joint pain.