chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Chest X-ray, Chills, Dyspnoea, Dyspnoea exertional, Headache
Clinical narrative: Patient developed headache, body aches 1-2 hours after vaccination. The next day he developed dyspnea on exertion, fever and chills. There were wheezings heard over LLL. Radiograph of the chest demonstrated. Patient was treated with Zithromycin PO.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Patient developed headache, body aches 1-2 hours after vaccination. The next day he developed dyspnea on exertion, fever and chills. There were wheezings heard over LLL. Radiograph of the chest demonstrated. Patient was treated with Zithromycin PO.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient  developed redness, warmth, and tenderness with itching at the injection site 2 days after the injection was administered. In the office she had 12cm x 15cm area of erythema, warmth and mile tenderness on the left upper arm. Diagnosis: cellulitis versus local allergic reaction. Treatment: Cephalexin 500 mg by mouth TID for 10 days. OTC CLARITIN daily to help with itching fro 3-5 days.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient  developed redness, warmth, and tenderness with itching at the injection site 2 days after the injection was administered. In the office she had 12cm x 15cm area of erythema, warmth and mile tenderness on the left upper arm. Diagnosis: cellulitis versus local allergic reaction. Treatment: Cephalexin 500 mg by mouth TID for 10 days. OTC CLARITIN daily to help with itching fro 3-5 days.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Pt received PREVNAR 13 vaccine prior that day at approx. 9 am via her doctor. Reported L arm (elbow up to shoulder) swollen around 4 pm 5/23, red, tight, itchy symptoms began day of administration-cont'd to following day. Pharmacist had her follow-up w/PCP-she took Ibuprofen 400mg and iced. Still slightly swollen and red at 130 pm (5/25).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Immediate post-injection reaction, Inflammatory marker test, Injection site pain, Mobility decreased
Clinical narrative: Patient noticed vaccine burned at time of administration but no other immediate symptoms. Later that day started getting very achy all over and arm started hurting. By evening could not lift arm. Then pain extended to hand accompanied with tingling. Ended up in ER. Improving not all the way better.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, X-ray limb normal
Clinical narrative: Patient noticed vaccine burned at time of administration but no other immediate symptoms. Later that day started getting very achy all over and arm started hurting. By evening could not lift arm. Then pain extended to hand accompanied with tingling. Ended up in ER. Improving not all the way better.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: Patient arm was swollen near elbow to upper arm on inside of arm. It was not swollen near injection site. Hot to the touch and very red. Suggested patient go to urgent care and get checked out.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling, Pain, Pruritus
Clinical narrative: Immediately felt pain and itch. Within 30 minutes, injection site had severe swelling and itching on (L) arm. At hospital was given BENADRYL and TORADOL injections. Kept getting worse. Back to hospital, given prescriptions.
Age: 18.0
Sex: M
Vaccine: TYP, YF
Symptoms: Syncope
Clinical narrative: Syncopal episode. Tx: supine position-feet elevated ice pack to head. Pulse monitored. Patient fully recovered.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Differential white blood cell count, Full blood count normal, Gait disturbance
Clinical narrative: Patient complained (L) arm hurt right after HPV injection at (L) upper arm. She can not fully lift her left arm next day. She presented (L) leg hurt and limping 2nd days after injection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Patient complained (L) arm hurt right after HPV injection at (L) upper arm. She can not fully lift her left arm next day. She presented (L) leg hurt and limping 2nd days after injection.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Balance disorder, Blood pressure decreased, Dizziness, Pallor
Clinical narrative: Patient experienced lightheadness and was dizzy and unbalanced. Blood pressure fell to 93/46 P=69. Complexion was pale. Had patient site. Gave cold water and Snickers bar. She felt better after 10 minutes. BP returned to 98/74 P=81.
Age: 72.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Abdominal pain, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Abdominal pain x weeks, nausea, muscle aches, chills, severe fatigue x weeks. Responded to corticosteroid IV.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Very hard, red, hard, itch.
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Hypoaesthesia, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Radiculitis brachial
Clinical narrative: This medically confirmed health authority report (initial receipt 09-May-2016) concerns a 58 year old female patient. The patient has no medical history and had no current illness at the time of vaccination. Concomitant medications include salbutamol, fexofenadine, diltiazem, mometasone, epinephrine hydrochloride, levothyroxine, escitalopram oxalate, atorvastatin calcium, montelukast and ergocalciferol. On 23-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch number: 10849211A) to the right arm (RA). On 30-Oct-2015, the patient complained of several intermittent episodes of right arm numbness and tingling down to her fingers; lateral 3 fingers. It progressed over time. The patient was seen by a neurosurgeon and sent to a neurologist. The patient had an MRI scan for head, neck and shoulder. Then an EMG study revealed delayed conduction and pattern changes consistent with brachial neuritis on right. The outcome was missing. Reporter comments: The health authority assessed the events as non-serious (emergency room visit).
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: This medically confirmed health authority report (initial receipt 09-May-2016) concerns a 26 year old male patient. The patient had no current illness, concomitant medications or medical history at the time of vaccination. On 05-Dec-2015, the patient received AFLURIA injection (batch number: U56606) via 'SYR' route to the arm (AR). On 05-Dec-2015, the patient had a four minute seizure within two hours after the flu shot. The patient has had 4 other seizures to date. The outcome was not recovered. Reporter's comments: The health authority assessed the events as serious (life-threatening, permanent disability, hospitalisation and emergency room visit). VAERS ID: 628680.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came home from school and I notices arm was red, hot, swollen and sore. It took a week for swelling to decrease.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Burning sensation, Feeling hot, Insomnia, Oral discomfort, Paraesthesia
Clinical narrative: Tingling and hot burning feeling all through my body and mouth and throat it's worst at night cant sleep feel like my insides on fire.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Throat irritation
Clinical narrative: Tingling and hot burning feeling all through my body and mouth and throat it's worst at night cant sleep feel like my insides on fire.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incomplete course of vaccination, Infertility female
Clinical narrative: This spontaneous report was received from a pharmacy student referring to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. Approximately in May 2016 (reported as about a year ago), the patient was vaccinated with the first dose of VARIVAX (lot #, dose, route and site of administration and expiration date were not reported) for prevention of chicken pox. On an unknown date in May 2017 (reported as recently), the patient had unspecified titers drawn which exhibited that she was not protected from varicella virus. The patient did not receive the second dose of VARIVAX because she was trying to get pregnant and was undergoing in vitro fertilization (IVF) cycles. Reporter did not disclose whether potential difficulty with becoming pregnant initiated prior to or after receiving VARIVAX. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician assistant via company representative, concerning an 80 year old male patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On approximately 2012 (reported as: about 5 years ago), the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided) for prevention of shingles. Other suspect therapies included sterile diluent (DILUENT MRK) (indication, formulation, strength, dose, route of administration, lot number and expiration date were not provided). On 03-MAY-2017, the patient was seen by the physician assistant in his office because, since an unknown date, the patient was experiencing one of the most severe cases of shingles the physician assistant had seen; there was a rash on the patient's left neck and chest area. Therefore, the physician assistant immediately started a course of antivirals, as treatment, to the patient during the visit,, but no intervention to prevent serious criteria was performed. At the time of the report, the outcome of the patient regarding the shingles and the causal relationship between the event and the ZOSTAVAX were not provided. Additional information is not expected because there was no consent to contact the reporter.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner, concerning a 16 year old patient of an unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, when the patient was 14 year old, he/she was vaccinated with the first dose of GARDASIL 9 (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. Then, 2 years later (reported as: at "16 years old"), the patient was vaccinated with the second dose of GARDASIL 9 (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # M018958, with expiration date reported as 03-MAR-2018,  for prophylaxis (dose and frequency were not reported). No adverse effect was reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature of - 1 Celsius degree (°C) or bellow (-1.1 °C) for 285 hours, and 0C for 3 hours. The call was placed because of a Digital Data logger report. Additional information is not expected as the reporter did not consent for further follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. On 15-MAY-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB with lot number: N002202 and expiration date: 04-NOV-2019 (dose, anatomical location and route were not provided). The RECOMBIVAX HB doses were exposured to a temperature ranges between 32° (F) fahrenheit and 35 °F, during a time frame of 2 hours which were called by a data logger, then returned back in range. There were not previous temperature excursions. No adverse effects were reported. This is one of several cases from  the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009811: US-009507513-1705USA009812: US-009507513-1705USA009810:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. The patient did not have any known allergies. On 19-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). The dose of the vaccine given was reported as "expired 2 years ago", according to the nurse. No adverse effect was reported. 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 administrator referring to multiple unspecified patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M043731, expiration date: 22-JUN-2019; dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 23 hours and 40 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000062.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist reporting on a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist reported that the patient called and reported having a rash that appeared two weeks after the administration of ZOSTAVAX, it was reported that the rash was "over a lot of the body" and it was "not itchy" (rash generalized). The outcome of the rash generalized and the causal relationship between the event and therapy with ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of VAQTA injection (dose, frequency and route were not reported) lot # M009377 with expiration date of 17-JUN-2017, for prophylaxis. The temperature of the VAQTA was of 35 °F for a time frame of 72 hours. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000027:
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of an unknown age (reported as the nurse's mother's neighbor's daughter). There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies.  On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (IM) (strength, dose, frequency, anatomical location, lot number, and expiration date were not provided) for the prevention of human papillomavirus (HPV) and other diseases. On an unknown date, the patient experienced seizures. It was reported that the patient sought medical attention through a visit that she made to a neurologist. At the time of reporting, it was unknown whether the patient recovered or not from the event of seizures. The neurologist considered the event of seizures to be related to the therapy with GARDASIL 9. The primary reporter did not assess the relationship between the event and suspect therapy. No product quality complaint was involved. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided.  It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 20-AUG-2012 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  On or about 04-JAN-2016, the female patient was treated by an unspecified health professional (It was not clear if physician) for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed FAMIR (It is unclear if this is famciclovir (FAMVIR)) for management of her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via Poison ad Drug Center refers to a 22 year old female patient. The patient's medical history and concurrent conditions were not reported. On 28-MAY-2017, the patient received an expired dose of GARDASIL (lot # M014929, expiry date: 27-MAY-2017), (route: intramuscular). No additional adverse effects were reported. As of 28-MAY-2017 it is unknown if the patient continued to receive another GARDASIL and the outcome of receiving an expired dose is unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M006708 with expiration date of 02-JUN-2018 and lot # L040458 with expiration date of 04-FEB-2018, for prophylaxis. The temperature of the RECOMBIVAX HB was of 35 °F for a time frame of 72 hours. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013166:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to multiple unspecified patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were administered improperly stored doses of ROTATEQ orally (lot# M032636, expiration date: 06-APR-2018; dose was not provided) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 23 hours and 40 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010392:
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Axillary pain, Injection site swelling, Tenderness
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 22-May-2017. This case involves a 12-year-old male patient, who was vaccinated with a first dose of Adacel (Batch number, expiry date and dose were not reported) intramuscularly in right deltoid, a first dose of Menactra (Batch number, expiry date and dose were not reported) intramuscularly in left deltoid and with a dose of Gardasil (Batch number, expiry date, dose, dose in series and route of administration were not reported) in right deltoid on 28-Apr-2017. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were none. Concomitant medications were not reported. On 28-Apr-2017, same day following the vaccination, the patient had armpit pain and tenderness. On an unknown date, following the vaccination, the patient had developed large bump on the right arm at injection site on deltoid the size of a baseball. It was reported that on 20-May-2017, the patient showed large bump to mother which was stated by the mother was occur overnight. Laboratory investigations and corrective treatments were not reported. Patient recovered from the events armpit pain and tenderness on an unspecified date after 4 days. The patient not recovered from the event large bump on the right arm at injection site on deltoid the size of a baseball. List of the documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Fever, sweats, headache, chills, shortness of breath, fast heartbeat, weakness, loss of appetite. The course would be on and off for 8 days.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, sweats, headache, chills, shortness of breath, fast heartbeat, weakness, loss of appetite. The course would be on and off for 8 days.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA at single dose; and meningococcal quadrivalent conjugate (MCV4), in different arm, both for immunization, route of administration, therapy dates, and dose were unspecified. The patient's medical history was and  concomitant medications were not reported. The patient experienced swelling, rash, and urticaria on an unspecified date. Outcome of the events was unknown.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 08-MAY-2017 from a Licensed Practical Nurse regarding a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The reporter did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004963: US-009507513-1705USA004961: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004962: US-009507513-1705USA004967: US-009507513-1705USA004964: US-009507513-1705USA004952: US-009507513-1705USA004960: US-009507513-1705USA004965:
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received via Poison & Drug Center from a physician concerning a 26 year old female patient who started PROQUAD, once on 12-APR-2017, (lot # unknown), unknown dose and route, for work. Her relevant medical and past drug histories and concomitant medications are unknown. On 12-APR-2017, this 26 year old patient received her first dose of PROQUAD, which is outside of the age-range for this product. On 10-MAY-2017, after received her second dose of PROQUAD (lot #L045678; unknown dose and route), it was noticed that the vaccine expired on 09-MAY-2017. On 10-MAY-2017, at an unknown time and after being told it was okay, the patient received another, unexpired dose of PROQUAD (lot #M039914, expiration date 26-SEP-2018), dosage and route of administration not provided). Lot numbers and expiration dates for the diluents were not obtained. The physician reported that the patient did not experience any adverse events from the expired vaccine or the same-day revaccination. It is unknown if there is any relevant laboratory data. As of 10-MAY-2017, it is unknown if the patient will continue to receive PROQUAD; the patient did not experience any adverse events from the expired vaccine or the same-day revaccination, and the outcome of vaccination outside the age-range for the product is unknown. Lot #L045678 has been verified to be a valid lot number for PROQUAD. Lot #M039914 is an invalid lot number for PROQUAD. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. The temperature excursion was detected by a 'Digital Data Logger'. The specific temperature and time frames were not reported. There were no previous temperature excursions. The product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided.  It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) in 2013 at her primary care facility (medical group), as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  Throughout the years of 2014 and 2015, the female patient was treated on multiple occasions at the primary care facility (medical group) for vesicular outbreaks that were diagnosed as severe shingles.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Central nervous system lupus, Colostomy
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on 24May2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and race received PREVNAR 13 for immunization on unknown date at single dose. Relevant medical history and concomitant medications were unknown. After receiving the injection, the patient wound up with central nervous system lupus and was hospitalized for this event, she was unable to walk and now she had a colostomy bag. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Anti-thyroid antibody positive, Blood thyroid stimulating hormone, Inflammation, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 66 year old female patient received, on an unspecified date, in Nov2015, PREVNAR 13 single dose, and flu vaccine, in the arm, both for immunization. Relevant medical history included breast cancer (radiation treatments and ARIMIDEX for 5 years from 2010 to Oct2015), blood cholesterol abnormal, hole in heart, blood pressure. Past drug included ALLEGRA 180 mg 3 times a day. Concomitant medications included oral losartan 50 mg, once daily, for blood pressure; oral fish oil 1600 mg, daily, from an unspecified date to Dec2015, for blood cholesterol abnormal; oral NIACIN) 1500 mg, once daily, from an unspecified date to Dec2015, for blood cholesterol abnormal; and oral ASPIRIN 325 mg, once daily, from an unspecified date to 23May2017, for hole in heart. On an unspecified date, in Nov2015, the patient experienced hives on her legs and it then spread to her whole body and on an unspecified date itching. Treatment was received. The patient did not recover from hives, while clinical outcome of the other event was unknown. Then she went to her endocrinologist and was put on levothyroxine. She was on the levothyroxine for a month; from Apr2016 at 75 mcg dose.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Erythema, Headache, Laboratory test, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received TRUMENBA (Lot# N16808, Exp date Jul2017), via an unspecified route of administration, on 24May2017 at about 02:30 PM, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medication included NORETHIN, from 24Aug2016 and ongoing, for birth control. The patient experienced fever as high as 103.1, joint pain, muscle pain, redness of the ears and severe headache all in May2017 with outcome of not recovered. The reporter stated that pretty soon after vaccination the patient had fever and headache. The patient underwent lab tests and procedures which included body temperature: 103.1 in May2017, laboratory work (they were ordered on 25May2017). Therapeutic measures were taken as a result of fever as high as 103.1 and included treatment with TYLENOL about every 4 hours. The reporting nurse considered the event fever related to meningococcal group b rlp2086.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received TRUMENBA (Lot# N16808, Exp date Jul2017), via an unspecified route of administration, on 24May2017 at about 02:30 PM, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medication included NORETHIN, from 24Aug2016 and ongoing, for birth control. The patient experienced fever as high as 103.1, joint pain, muscle pain, redness of the ears and severe headache all in May2017 with outcome of not recovered. The reporter stated that pretty soon after vaccination the patient had fever and headache. The patient underwent lab tests and procedures which included body temperature: 103.1 in May2017, laboratory work (they were ordered on 25May2017). Therapeutic measures were taken as a result of fever as high as 103.1 and included treatment with TYLENOL about every 4 hours. The reporting nurse considered the event fever related to meningococcal group b rlp2086.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Patient called in on 5/17/17 reporting that her arm was still very sore from her shoulder to her thumb. Patient stated that she felt very weak and could hardly move her arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Musculoskeletal pain, Nausea, Pyrexia, Rash
Clinical narrative: Severe shoulder pain, nausea, headache, rash across chest, neck, arms, back and abdomen.  Fever of 100.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In 2007, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided). Information regarding diluent was not provided. On an unknown date in April 2017, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event and the causality assessment were not provided. No product quality complaint was involved. Additional information is not expected as the reporter declined to participate in answering questions within the adverse event.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-MAY-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # M016191, expiry date 26-MAY-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case, initially received on 13-Jul-2016, was reported by a health professional and concerns a patient of unknown age and gender. Concomitant medication: Unknown, Drug reactions/allergies: Unknown. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced an anaphylactic reaction (medically significant, outcome: not reported). Follow-up information received 22-Jul-2016: The identity of the flu vaccine administered to the patient is unknown, no further information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Slight redness about 3/4 inch radius still remains at injection site one week post injection.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after administration of TDaP Patient fainted for about 10 sec, and recovered her own. She was on exam table sitting and her mother was with her. No injury. Patient had late breakfast but no lunch.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Pt concerned that smallpox immunization and anthrax immunizations x3 In 2004 caused him to have myocarditis diagnosed in 2014. Causality assessment shows temporally unrelated. Where immunized not know. Vaccine lots not know.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Arm swelling, warmth, pain, itching at site of injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-05-30.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Sharp pain at injection and continued pain for several months; several visits and treatments tried to alleviate pain....somewhat reduced but continues with bouts of sharp pain and moreso at nighttime.
Age: 0.5
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Rash, Scab
Clinical narrative: Light breakout of rash with crusting 20.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Pt. here for well check 9:10 AM appt. She had not eaten or drank anything that morning. Had blood draw also. Lightheaded after shot/blood draw - pt laid down, given juice. Seemed fine when left clinic then fainted when getting out of elevator. Returned to clinic - vitals stable - observed, given food and juice - pt. recovered.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild erythema, moderate tenderness, and mild swelling of vaccine injection site 7d after vaccine. Afebrile.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Intussusception, X-ray abnormal
Clinical narrative: 4 month old with intussusception-4 days after oral ROTATEQ (#2 dose).
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Donor seated on exam room table with the MSA conversing with her. When the employee didn't answer a question the MSA looked up and saw employees eyes closed. No response when called by name and employee began to have seizure which lasted approximately 10 seconds. She stopped seizing at that point but still didn't open her eyes for 20 seconds. 911 was called at 10:57 and they arrived at 11:02. The employee had fully recovered and refused transport to the ED.
Age: 1.5
Sex: F
Vaccine: DTP, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue
Clinical narrative: Chronic arthralgias and fatigue began 6 mons. post anthrax immunization. Impression - unrelated to immunizations.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to herself, a female of unknown age No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-MAY-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot number and expiration not reported) for prophylaxis. On 18-MAY-2017, the patient experienced pain at the injection site. No further information was provided. The outcome of injection site pain is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M005972 with expiration date: 02-FEB-2018; lot # M043581 with expiration date: 28-SEP-2018 and lot# M047660 with expiration date: 02-DEC-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT), which were properly stored. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°F (-11.5°C) for 18 days with previous temperature excursion at temperature greater than -9°C but less than 8°C (-9°C) for 1 hour and 14 minutes; this information was registered in a digital data logger. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015810: US-009507513-1705USA015757:
Age: 60.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Based on the additional information received on 23-MAY-2017, the report previously considered as non-valid became valid (identifiable patient was reported). Initial unsolicited report received from a nurse on 01-MAY-2017. This was an invalid case as no patient identifiers were reported. This case involves a dose of DIPHTHERIA/TETANUS ADSORBED TOXOIDS THIOMERSAL FREE ADULT (TDAP) (batch number, expiry date, route and site of administration were not reported) was administered on an unspecified date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, unspecified adverse event occurred (it was reported as "caller said she has some questions about an AE with TDap vaccine"). Lab data and corrective treatment were not reported. The event outcome was not reported. Follow-up information received from a nurse in the United States on 23-MAY-2017. This case involves a 60-year-old patient (unknown gender) who received a 0.5 ml intramuscular dose of TDAP vaccine batch number: U5604BA, on 26-APR-2017 at 3 pm. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Adverse event following prior vaccination was also reported as none. On 26-APR-2017, few hours following the vaccination, the patient experienced shoulder sore that night. On 27-APR-2017, one day following the vaccination, the patient's arm below injection site inflamed, swollen and painful. On 29-APR-2017, three days following the vaccination, the patient experienced inflamed to inner arm, increased swelling. It was reported that the patient required emergency room/doctor visit. The patient did not have any lab data. On 28-APR-2017, the patient called doctor's office and was told to use ice, TYLENOL or MOTRIN. The patient also received steroids and cephalexin. On an unspecified date, the patient recovered from the events (reported as 'on 17-MAY-2017 followed up to patient, arm slightly pink, pain and swelling resolved'). List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Urticaria
Clinical narrative: Pt. noted hives on (L) foot night of 4/11/17 - AM of 4/12/17, hives spread to her legs and face. She took BENADRYL and subsided some, but coming back on arms, face, abdomen and back. DX allergic urticaria - possibly from TRUMEMBA or a viral rash.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Bumpy rash on bilateral thighs. No redness noted. No open area, no drainage. Mom denied fever or any other symptoms.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left lower extremity reassurance observation warm compress TYLENOL per pain. Follow up if not better.
Age: 1.17
Sex: M
Vaccine: MMR, PNC13
Symptoms: Erythema, Full blood count normal, Petechiae, Pyrexia, Rash
Clinical narrative: 2-15-17 fever x 2 days rash x 1 week under chin both arm and legs. Moderate rash, redness petechiae noted to both cheeks, arms and legs.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Large area of erythema extending from superior portion of left shoulder down to left elbow with associated warmth, lymphadenopathy, myalgia and malaise. Patient has had this reaction repeatedly with his annual booster for 5 years. Patient had reported to local medical authority every year and it was watched locally, not reported.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccine positive rechallenge
Clinical narrative: Large area of erythema extending from superior portion of left shoulder down to left elbow with associated warmth, lymphadenopathy, myalgia and malaise. Patient has had this reaction repeatedly with his annual booster for 5 years. Patient had reported to local medical authority every year and it was watched locally, not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000291: US-009507513-1704USA014383: US-009507513-1706USA000289: US-009507513-1706USA000290:
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to concerning a 20 months patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2017, the patient received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014383: US-009507513-1706USA000288: US-009507513-1706USA000290: US-009507513-1706USA000291: