chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 4-year-old male patient with allergies/reactions to dairy products. The patient had no medical history, or concomitant therapies. On 22-FEB-2017, the patient was vaccinated with PROQUAD subcutaneously (lot #, expiration date, and dose were not reported) for immunization. On the same date, shortly after the patient was vaccinated, he experienced an anaphylactic reaction. The patient was treated with EPIPEN intramuscularly (dose unknown by the reporter) and was sent to an emergency room where he fully recovered. There were no laboratory tests performed. No other information was available. No product quality complaint (PQC) was involved. The causality assessment between anaphylactic reaction and PROQUAD was not reported. The reporter considered that the anaphylactic reaction was a life threatening event. Upon internal review, the anaphylactic reaction was considered as a medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 4-year-old male patient with allergies/reactions to dairy products. The patient had no medical history, or concomitant therapies. On 22-FEB-2017, the patient was vaccinated with PROQUAD subcutaneously (lot #, expiration date, and dose were not reported) for immunization. On the same date, shortly after the patient was vaccinated, he experienced an anaphylactic reaction. The patient was treated with EPIPEN intramuscularly (dose unknown by the reporter) and was sent to an emergency room where he fully recovered. There were no laboratory tests performed. No other information was available. No product quality complaint (PQC) was involved. The causality assessment between anaphylactic reaction and PROQUAD was not reported. The reporter considered that the anaphylactic reaction was a life threatening event. Upon internal review, the anaphylactic reaction was considered as a medically significant event. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received on 03-MAR-2017 from a pharmacist regarding a 69 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 21-FEB-2017 at 3:15 pm, the patient was vaccinated with ZOSTAVAX lot # M028798 (expiration not reported), subcutaneous in the right arm for prophylaxis. The patient had no illness at the time of the vaccination. On 23-FEB-2017 the patient started having redness and puffiness around the injection site and the area was about 7.5 cm in diameter. The patient was recommended to take BENADRYL as directed. The outcome of injection site erythema and injection site swelling was reported as recovered/resolved on an unknown date. Additional information has been requested. Sender's Comments: US-009507513-1101USA00628.
Age: 31.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, soreness, swelling, itchiness all experienced in the evening hours of 20MAR17 and persist to 23MAR17 when presenting to clinic to address concerns.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 19 year-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA 25/0.5 (units not provided) (dose, frequency and route were not reported) lot # M036458 with expiration date of 02-MAR-2018, for prophylaxis.  No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 6 month-old male patient. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated in error with a dose of VARIVAX route reported as injection (dose, frequency, lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a nurse who is also the patient) via a company representative reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unspecified date in 2008, the patient was vaccinated with a dose of GARDASIL intramuscularly (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unknown date "it hurt" (pain).  The outcome of pain was reported as recovered on an unspecified date. No treatment was given for the adverse event. No product quality complain was involved.   The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a 51 year old female patient reporting on herself. The patient did not have medical history or concurrent conditions. The patient did not take concomitant medications. On 06-MAR-2017, the patient was vaccinated in her left arm with a dose of ZOSTAVAX lot number M038884 or M038894 (strength, dose number and route were not provided) for prophylaxis.   On 07-MAR-2016, the patient had redness and was really swollen at the injection site (injection site erythema and injection site swelling), she also stated that it almost looked like a rash (injection site rash). It was reported that treatment was given for the adverse events. The case did not involve cancer or overdose. At the time of the report, the outcome of injection site erythema, injection site rash and injection site swelling was reported as recovering. The reporter did not assess the relatedness between the event and suspect therapy. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot #: M027884 with expiration date: 19-APR-2019) (dose, strength, frequency and anatomical location were not reported), intramuscularly, for prophylaxis. The administered vaccine was improperly stored at temperature 29 °F for 2 hours and 40 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients younger than 50 year old of unknown gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with doses of ZOSTAVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reported stated that no adverse events were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse practitioner referring to a 36 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly, lot # M003659, expiration date on 20-SEP-2017 (strength, dose number and anatomical location were not provided) for Prophylaxis. The reported stated that no adverse event was reported. No product quality complain was involved.  Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 11-MAR-2017, the patient was vaccinated with M-M-R II (dose, strength, frequency, anatomical location, lot number and expiration date were not reported), intramuscularly, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 15-MAR-2017, the patient was vaccinated with expired dose of ZOSTAVAX (lot # L037791 with expiration date 30-DEC-2016) with diluent (lot# M041813 with expiration date 27-MAY-2019) (strength, frequency, route of administration and anatomical location were not provided), for prophylaxis. No side effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (strength and dose were not reported) (lot # M039061, expiration date 28-APR-2018; lot # M034799, expiration date 01-FEB-2018) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperatures excursions: 47 degrees Fahrenheit (F) to 77 F (9 degrees Celsius (C) to 25 C), and 31 F (-1 C) or colder. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a male physician who was also the patient reporting on himself, via a field representative. The patient's concurrent conditions included post herpetic neuralgia. The patient's medical history included shingles. The concomitant medications, drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot #, expiration date, dose, frequency, route of administration, anatomical location and indication were not provided). Then on an unspecified time after receiving the vaccine, the patient experienced a reduced frequency of post-herpetic neuralgia (Pre-existing condition improved). No further clarification or information was provided. The outcome of the pre-existing condition improved was unknown. The action taken with the ZOSTAVAX was not applicable. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. The patient's concomitant medication included unspecified birth control therapy. On 17-NOV-2016, the patient was vaccinated with her first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not specified) for human papillomavirus (HPV) vaccination. On 05-JAN-2017, the patient was vaccinated with her second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not specified) for HPV vaccination. On 16-MAR-2017, the patient was vaccinated with her third dose of GARDASIL 9(dose and route of administration were not provided, lot # M007728, expiration date: 21-MAR-2018), for HPV vaccination. On 16-MAR-2017, immediately after being vaccinated with the third dose of GARDASIL 9, the patient had a syncopal event that lasted for a few seconds. The physician stated that she gave the patient juice and crackers. No laboratory diagnostics studies were performed. At the time of the report, the patient was fully recovered from the syncopal event. The relatedness between GARDASIL 9 and the syncopal event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, medical history or concomitant therapy was not reported.  On 15-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# reported as M039453, expiration date 19-DEC-2017) for prophylaxis.  The patient had last received a dose of radiation treatment "10 weeks ago" instead of the recommended guideline of 3 months from the Advisory Committee on Immunization Practices (ACIP) and therefore may have been immunosuppressed at the time of administration.  No Adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an adult dose of RECOMBIVAX HB injection 10/1 microgram/ml (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, route were unknown) lot # M041507, expiration date: 09-APR-2018 for prophylaxis, which had a temperature exposure of 15°F to 49°F (-9°C to 8°C) for 8 hours. The temperature exposure was not detected due a data logger. There were no previous temperature excursion. This is one several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010168:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received form a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-MAR-2017, the patient inadvertently was vaccinated with 2 doses of PEDVAXHIB lot number reported as M034189 with expiration date 23-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose, route were unknown) lot # M038226, expiration date: 07-SEP-2018 for prophylaxis, which had a temperature exposure of 15°F to 49°F (-9°C to 8°C) for 8 hours. The temperature exposure was not detected due a data logger. There were no previous temperature excursion. This is one several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009928.
Age: 19.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, JEV1, SMALL
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: My son was born with imperforate anus. I have had at least 18 vaccination shots against my will from 09-13.
Age: 18.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: My son was born with imperforate anus.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, chills, muscle aches, severe pain in arm where shot was given, lightheadedness, severe headache. Last from 03/22/2017 until 03/23/2017 around 5:00 PM.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, chills, muscle aches, severe pain in arm where shot was given, lightheadedness, severe headache. Last from 03/22/2017 until 03/23/2017 around 5:00 PM.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Fatigue, Pruritus
Clinical narrative: Redness, itching, fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm, indurated, itching area at injection site, 2x3 inches. Although not reported to VAERS at the time, this also occurred after receiving pneumococcal 13 vaccine on 06/30/2016.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Significant pain in arm/muscle after injection. Pain continued and increased over next 5 days. Unable to lift arm, very limited motion without significant pain, interfered with sleep, pain radiates down to hand with some numbness. Used Ibuprophen with no relief. On 3/21 used Naproxin Sodium for pain, minimal relief.  On 3/22 re-visited clinic regarding symptoms. Was provided with MethyIPREDNIsolone 4mg dosepak and Tylenol w/ codeine for night time to sleep.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Significant pain in arm/muscle after injection. Pain continued and increased over next 5 days. Unable to lift arm, very limited motion without significant pain, interfered with sleep, pain radiates down to hand with some numbness. Used Ibuprophen with no relief. On 3/21 used Naproxin Sodium for pain, minimal relief.  On 3/22 re-visited clinic regarding symptoms. Was provided with MethyIPREDNIsolone 4mg dosepak and Tylenol w/ codeine for night time to sleep.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Tinnitus, Vertigo
Clinical narrative: Severe Tinnitus, vertigo, abnormal MRI with inflammation of the brain.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Nodule, Pain in extremity
Clinical narrative: KNOT ON ARM, ARM PAIN, STIFF SHOULDER.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 24 -year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-DEC-2016, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 02-MAR-02017, the patient was vaccinated with GARDASIL 9 for prophylaxis as her second dose (dose, route of administration, lot# and expiration date were not reported). No adverse effect were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 50 year old female patient referring herself. The patient did not have concurrent conditions, medical history, drug reactions or allergies. She was not taking concomitant therapies was provided. On 07-MAR-2017, the patient received one dose of ZOSTAVAX, subdermal (product use issue) in the left arm to prevent shingles (strength, frequency, lot # and expiration date were not reported). On 08-MAR-2017 (reported as "the morning after"), the patient developed a small dime size circle at the injection site, and on the same date by the afternoon, the circle turned into a swollen, hot, "golf ball" size lump (injection site mass, injection site swelling, injection site warmth). On an unspecified date, the patient talked to a pharmacist and an unspecified treatment for the adverse events was given; laboratory diagnostics studies were not performed. At the time of the report, the patient had not recovered from the events of injection site mass, injection site swelling, and injection site warmth  The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 10-MAR-2017 from a pharmacist regarding a male and female patient (age not provided) (this case refers to the female patient- see MARRS # 1703USA010583 for male patient case). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient received a dose of ZOSTAVAX for prophylaxis (dose, duration, and lot number not specified). On an unknown date, six months later, the patient received another dose of ZOSTAVAX (dose, duration, and lot number not specified). No adverse effects were reported. No other information was available. Additional information has been requested. Sender's Comments: US-009507513-1703USA010583.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a physician, via a company representative, concerning five or six patients between the ages of five and seven years old and of unknown gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Approximately in 2017 (reported as: administered within the last two weeks), the patients were vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On unspecified dates in 2017, the patients experienced mumps outbreak. The patients visited the doctor on unspecified dates and were treated with an unspecified antibiotic.   The reporter stated that the suspected cases of mumps outbreak were related to M-M-R II administration. The patients' outcome was reported as recovered. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008042:
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of around 30 years old and of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot number, expiration date, dose and route were unknown) for prophylaxis. The dose was administered for an unspecified physician. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient of age between five and seven years old and of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Approximately in 2017 (reported as: administered within the last two weeks), the patient was vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On an unspecified date in 2017, the patient experienced mumps outbreak. The patient visited the doctor on an unspecified date and was treated with an unspecified antibiotic. In reference to the mumps outbreak, the patient also visited a Hospital. The reporter stated that the mumps outbreak was related to M-M-R II administration. The patient's outcome was reported as recovered. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006841.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (strength reported as 5mcg/0.5ml, lot # M031574, expiration date 11-NOV-2018; dose and route of administration were not reported) for prophylaxis. The vaccine was improperly stored in the temperature from 47F to 77F for a few times, 5 hours in total. No adverse effects were reported. The call was made because of the data logger. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 10-MAR-2017 from a pharmacist regarding a male and female patient (age not provided) (this case refers to the male patient- see MARRS # 1703USA005786 for female patient case). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient received a dose of ZOSTAVAX for prophylaxis (dose, duration, and lot number not specified). On an unknown date, six months later, the patient received another dose of ZOSTAVAX (dose, duration, and lot number not specified). No adverse effects were reported. No other information was available. Additional information has been requested. Sender's Comments: US-009507513-1703USA005786.
Age: 0.17
Sex: M
Vaccine: DTAPH, RVX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 19.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Patient took oral typhoid over the course of 1 week as directed.  1 day after completion of the vaccine, patient had high fevers (103), rash and body aches.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erosion, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, erythema and warmth with some excoriation marks on left thigh lateral to PROQUAD site. Dr prescribed and discussed antihistamines for itching.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Asthenia, Decreased appetite, Fatigue, Full blood count, Loss of personal independence in daily activities
Clinical narrative: Patient was extremely exhausted. Had no energy. Unable to finish baseball games due to lack of energy. Pale and no appetite. Saw provider and had labs.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Metabolic function test, Mononucleosis heterophile test, Pallor
Clinical narrative: Patient was extremely exhausted. Had no energy. Unable to finish baseball games due to lack of energy. Pale and no appetite. Saw provider and had labs.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's medical history,concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On unknown dates (reported as a couple of years ago), the patient was vaccinated with a first and a second dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, on schedule.  On 03-MAR-2017, the patient was vaccinated with a third dose in GARDASIL series as GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The product quality complaint was not involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA002626:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Injury, Physical disability
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation. It is alleged in litigation that a female patient of unknown age in 29-AUG-2013, was inoculated with ZOSTAVAX (dose, route of administration, site of administration, lot number, expiration date were not reported) for the prevention of shingles. The vaccine was administered by an unspecified health care worker at the patient's pharmacy. Prior to receiving ZOSTAVAX vaccine, the patient has never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles". On or about 11-NOV-2015, the patient presented to her medical center with symptoms of a persistent, painful rash on her abdominal region. The patient was diagnosed by her physician with herpes zoster, the virus also known as shingles. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. The events of shingles on the herpes zoster and emotional distress were considered disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased, Rash
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation. It is alleged in litigation that a female patient of unknown age in 29-AUG-2013, was inoculated with ZOSTAVAX (dose, route of administration, site of administration, lot number, expiration date were not reported) for the prevention of shingles. The vaccine was administered by an unspecified health care worker at the patient's pharmacy. Prior to receiving ZOSTAVAX vaccine, the patient has never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles". On or about 11-NOV-2015, the patient presented to her medical center with symptoms of a persistent, painful rash on her abdominal region. The patient was diagnosed by her physician with herpes zoster, the virus also known as shingles. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. The events of shingles on the herpes zoster and emotional distress were considered disabling. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Injury, Neuralgia, Physical disability
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 29-AUG-2015, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 12-JUN-2016, the patient was treated by a health care professional for symptoms of a rash on his right anterior and posterior chest wall.  The patient was then diagnosed with an advanced case of herpes zoster, also known as a shingles outbreak. On or about 12-JUN-2016 the patient was prescribed valacyclovir (manufacturer unknown)  and grabapentin for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain were considered disabling. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Quality of life decreased, Rash
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 29-AUG-2015, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 12-JUN-2016, the patient was treated by a health care professional for symptoms of a rash on his right anterior and posterior chest wall.  The patient was then diagnosed with an advanced case of herpes zoster, also known as a shingles outbreak. On or about 12-JUN-2016 the patient was prescribed valacyclovir (manufacturer unknown)  and grabapentin for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain were considered disabling. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, a medical assistant was distracted, pulled a dose from the wrong box and vaccinated the patient with a dose of VARIVAX subcutaneously, lot number L029466 with expiration date 06-AUG-2017 (dose and anatomical location were not reported) for prophylaxis instead of ZOSTAVAX (wrong drug administered ). The patient had not experienced an adverse effect. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Cough
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program SNOW Patient Testimonial Recruitment . A non-contactable consumer reported for himself. This male patent received PREVNAR 13 via an unspecified route at single dose for immunization in Mar2017. The patient reported that his cough has come back and worse. No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Joint/muscle pain to extremity of injection site. Swelling,  redness, heat to upper arm between shoulder and elbow.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Crying, Decreased appetite, Depressed level of consciousness, Discomfort, Pyrexia
Clinical narrative: Slight fever, diminished appetite, hard to arouse when sleeping, and unable to move infant without her crying (discomfort).
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Mother reported nausea and fever of 100/F.  Student absent one day from school.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swelling, bright red circle appx 4" in diameter and hot to the touch, pain, fever of 102 lasting 4 days then 99-100 for 3 additional days. Today is 3/23/2017 and she is still in intense pain, her arm is still swollen although the circle has gotten smaller and the redness is gone, the circle is darker than her normal skin tone.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Patient experience severe arm pain (at injection site) (upper left arm).  She reports excessive swelling (twice the normal size).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Syncope
Clinical narrative: Soreness and syncope.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Drug eruption, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The rash started on or about 1-21-2017. Pt is concerned b/c he thinks he may have had a reaction to the Zoster vaccine. He presents with an itchy red raised rash to the trunk and lower bilateral arms. He thinks it started on his lip. The lip has resolved without any further involvement. He denies problems with chewing, swallowing, or breathing. He has not started any new medications or foods. Red raised coalescing rash to chest and, back and upper arms. Sparing the legs and face. There are a couple raised semicircular lines (welts vs scratch marks). Allergic rash c/w drug rash. Pt. will take OTC CLARITIN or ALLERGRA and BENADRYL. Skin rash. Zoster vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA lot # M012261, expiration date: 01-FEB-2018 (dose and route of administration were not reported). Temperature excursion ranged from 32 to 35 degrees Fahrenheit (from 0 to 1 degrees Celsius) for 2 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010600: US-009507513-1703USA010599:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-MAR-2017, the patient was vaccinated with the second dose of PEDVAXHIB injection, lot# M036612, expiration date: 19-MAY-2019 (dose and route of administration were not provided) which was improperly stored. The temperature excursion ranged to 43 degrees Fahrenheit for 24 hours. No adverse effects were reported. No product complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 10-MAR-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 10-MAR-2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # L032399 expiration 26-NOV-2016, unknown route for prophylaxis. No side effects reported. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 25 year old male patient. The patient's concurrent conditions, medical history and historical drugs were not reported.  On 10-MAR-2017 due to a computer error, the patient was vaccinated with M-M-R II expiration date of 11-MAR-2018 (dose, route and lot number were not reported), and VARIVAX expiration date of 23-NOV-2017 (dose, route and lot number were not reported) both for prophylaxis, and because he was ready to "go to school"; after the vaccination, it was discovered that the patient was already received doses of M-M-R II (dose, route and lot number and expiration date were not reported) on 03-DEC-1992, and VARIVAX expiration date of 18-APR-2015 (dose, route and lot number were not reported)on 31-DEC-2013; both for prophylaxis. The reporter did not have information about on the diluent used to prepared the doses, and it was reported that the patient did not received an extra dose of M-M-R II or VARIVAX, and had not experienced adverse effects. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning three 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 doses of VARIVAX (lot #: M028553 with expiration date: 07-JUN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature less than -14°C but greater than -10°C for 7 hours (digital data logger) without any previous temperature excursion. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009360.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a laboratory technician concerning unspecified 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 PROQUAD (lot #: M001150 with expiration date: 05-JUL-2017) (dose, strenght, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 6°F but less than 14°F for 15 minutes (no digital data logger involved) without any previous temperature excursion. No adverse effects were reported.  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009371:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from pharmacist who was also a district manager, regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 16-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L031271 with expiration date of 19-NOV-2016 (strength, dose, frequency, route of administration, anatomical location and indication were not provided), which was reconstituted with sterile water diluent (lot # reported as K014920 with expiration date 23-JUL-2017). No adverse effects were reported. No further details were provided. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning two 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 PROQUAD (lot #: M01733 with expiration date: 05-OCT-2017) (dose, strenght, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature less than -14°C but greater than -10°C for 7 hours (digital data logger issue) without any previous temperature excursion. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006850:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Nausea, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 21-MAR-2017 from an attorney in the form of an initial legal complaint. On or about 09-SEP-2013 a female patient (age not provided) received a ZOSTAVAX injection for the prevention of shingles. On or about 07-JUL-2015 the patient went to her primary care physician with complaints of sharp and throbbing pain. The patient was diagnosed with shingles and postherpetic neuralgia which was considered severe. The patient was prescribed ondansetron for nausea, ELAVIL, and LORTAB to treat the severe and ongoing pain associated with shingles and neuralgia. As a direct result of ZOSTAVAX, the patient suffered, is suffering and /or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. Additional information has been requested.