chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2016496457 for PNEUMOVAX 23. This was originally reported by a pharmacist via Pfizer company representative referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. Approximately in April 2016 (reported as "six months ago"), the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number, lot number and expiration date were not provided). The patient concomitant medications were not reported. On the same date, after being vaccinated by a pharmacist, the patient was hurt with limitation of the ram movement and pain when the patient moved the arm. The reported stated, that in June 2016 (reported as "about 2 or 3 months after the patient was vaccinated, there was still limitation in the arm movement and when moved the arm it still hurt. At the time of the report, the outcome of pain in extremity, injected limb mobility decreased and pain was reported as not recovered. Additionally, the reporter considered injected mobility decreased to be related to PNEUMOVAX 23. The reporter did not provide for a causality between pain and pain in extremity and vaccination with PNEUMOVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Influenza like illness, Pain in extremity, Photophobia
Clinical narrative: I started feeling itchy all over an hour or so after the injection. My arm was extremely sore and hot. I iced it by 4:00 pm and felt dizzy. I threw up for the next three days. I had 99 - 100 degree fever 4 days. Flu-like symptoms still have dizziness and chills, sensitive to light.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Pyrexia, Skin warm, Vomiting
Clinical narrative: I started feeling itchy all over an hour or so after the injection. My arm was extremely sore and hot. I iced it by 4:00 pm and felt dizzy. I threw up for the next three days. I had 99 - 100 degree fever 4 days. Flu-like symptoms still have dizziness and chills, sensitive to light.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt become weak, Diaphoretic, and almost passed out. Pt was assisted to the laying position. Vitals were taken, Juice was offered and declined. Pt stated she just had a smoothie.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Angioedema, Rash
Clinical narrative: Angioedema, rash.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Nausea, Nodule, Pyrexia
Clinical narrative: Approximately 24 hours later became nauseated and fever went to 101 degrees F. Temp stayed elevated until 11/166 in the evening went down to 99.6 F. Injection site hurts and there is a knot. Also has a knot underneath armpit.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L045956, expiration date:17-NOV-2017 (Strength, dose, frequency and route were not reported), which experienced temperature excursion of -12.9 Celsius degrees, for 16 hours and -14.2 Celsius degrees for 14 hours and 30 minutes on unknown dates. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Induration, Skin warm, Urticaria
Clinical narrative: Started with bruising with increase in induration, warm to touch and elevated wheal; max size noted 5 cm L x 5 cm W x 0.5 cm (elevation of skin). (1) Hydrocortisone 1% applied BID, (2) BENADRYL 12.5 mg Q 6 hours P.O., (3) BACTRIM DS 1 tab Q 12 hours x 7 D as RX by PCP.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, reporting about a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route were not reported) with lot number M033096 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Blood pressure decreased, Dizziness, Fatigue, Musculoskeletal stiffness
Clinical narrative: Had 2 brief episodes - body stiffened, clenched arms, some shaking. Lasted about 2-3 seconds. Was tired afterwards. BP lower than normal. Felt dizzy. Was monitored laying down for 30 min., then sitting for 20 min. Vital were taken every 30 min. During episodes, she was not responsive to name, or communication. Brief altered level of consciousness.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: Had 2 brief episodes - body stiffened, clenched arms, some shaking. Lasted about 2-3 seconds. Was tired afterwards. BP lower than normal. Felt dizzy. Was monitored laying down for 30 min., then sitting for 20 min. Vital were taken every 30 min. During episodes, she was not responsive to name, or communication. Brief altered level of consciousness.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. It was reported that an unspecified number of improperly stored doses of GARDASIL 9, lot M018810, expiration date 28-MAY-2018, might have been administered to the patients on unspecified dates. The excursion was: temperature 34.7 Fahrenheit for 30 hours. The report was not due to data logger. There were no previous excursions. No adverse effects reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Erythema palm site at the YF inj. site (L) lat. arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Neck pain
Clinical narrative: Patient states she had soreness off and on at her collar bone and neck. It lasted for 2 days.
Sex: U
Vaccine: MMR, TDAP
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 10-NOV-2016, the patient was vaccinated with a dose of M-M-R II (dose not reported), lot # L028273, expiry date: 28-JUL-2017, intramuscularly to the left deltoid in error. The pharmacist believes that he made the error because he also administered a dose of BOOSTRIX (dose, route, lot number and expiry date were not reported). There is no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Myalgia, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: Muscle soreness day of injection. Next afternoon arm a bit puffy, red, warm, stinging and prickly.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: Muscle soreness day of injection. Next afternoon arm a bit puffy, red, warm, stinging and prickly.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site mass
Clinical narrative: Lumps at each site where vaccines were given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness, warm, itching, dizziness, pain.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: Headache, malaise, Fatigue, chills, flu like symptoms, prolong Fatigue , feeling unwell, chills.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Rotator cuff syndrome, Vaccination complication
Clinical narrative: My left deltoid region started to get really sore and tender. The next day, I had about an inch of swelling coming up off my deltoid region. The pain was limiting and I could not lift my arm over my head due to pain. It has been improving over the last three days and the swelling is gone.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Endotracheal intubation, Febrile convulsion
Clinical narrative: Complex Febrile Seizure requiring intubation.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Blood test, Fall, Pallor, Seizure
Clinical narrative: After receiving shots, pt turned pale, fell backwards and started seizing for 15-30 seconds. Resolved.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, swelling, sensitive to touch, and warm skin.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Arm sore at injection site. Can't raise arm without pain. Can't sleep on left side (side of injection).
Sex: F
Vaccine: HPVX
Symptoms: Wheelchair user
Clinical narrative: This spontaneous report was received from a consumer and refers to a young female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with HPV vaccine (manufacturer unknown) (dose, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. Since unknown date, after getting a HPV vaccine (manufacturer unknown), the patient became a wheelchair user. The patient's outcome was not reported. Relatedness between the adverse event an the vaccination with HPV vaccine (manufacturer unknown) was not reported. Upon internal, the adverse event of becoming a wheelchair user was considered to be disabling. This is one of several reports from the same reporter. Additional information is not expected, because there is no contact details with the reporter.
Age: 81.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: Flu like symptoms in 5 hours. Injection site reaction.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration
Clinical narrative: Large, red area near injection site. No pain. Was hard, but improved some. Advised patient to contact her physician.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from office manager via field Representative refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot number/expiry date not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected, as there is no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (incorrect product storage) (lot #, expiry date unspecified) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 6 Fahrenheit (F) for 1 hour. Previous temperature excursion was reported on an unknown date, at a temperature of 22.6 F, for a duration of 13 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA011550 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (route, frequency, batch/lot number, expiration date were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PROQUAD (lot # M004893, expiration date 26-JUL-2017 and lot # M017335, expiration date 05-OCT-2018) administered subcutaneously (dose and anatomical location were not reported). No adverse effects were reported. Temperature Excursion Details: Temperature:-13.3 Celsius (C). Time frame: 4 hours. Previous temperature excursion? No. No data logger was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-NOV-2016, the patient was vaccinated with an expired dose of VAQTA 25/0.5, intramuscularly, lot # L032749 with an expiration date of 04-NOV-2016. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history included cataract operation approximately in 2008 (reported as "8 years ago") and macular degeneration diagnosed approximately in 2009 (reported as "7 years ago"). The patient did not have any drug reactions or allergies. On 03-NOV-2016 the patient was vaccinated with ZOSTAVAX injection (dose, route and frequency were not reported). Concomitant therapies included tramadol hydrochloride (indicated for her seizures), calcitonin (indicated for her osteoporosis), vitamin D (unspecified), "eye" vitamins (unspecified) and Fish oil. On an unspecified date in November 2016 (reported as "over the weekend,") the patient's eyes became bloodshot. No treatment was given for the event and no laboratory diagnostic studies were performed. The patient made an appointment at an unspecified time with her "eye doctor," in the event her eyed did not recover. No product quality complaint (PQC) was involved. At the reporting time, the outcome of ocular hyperaemia was reported as not recovered. The reporter did not provide a causality assessment between the event and ZOSTAVAX. Additional information is not expected, because the reporter declined to provide contact information for herself or her physician.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician and refers to a 16 year old male patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On an unspecified date in August 2016, the patient was vaccinated with GARDASIL 9 intramuscularly (dose and frequency were not reported. The patient did not take any concomitant medications. On an unspecified date in 2016, 3 to 5 days after vaccination, the patient experienced dizzy spells. The reporter stated that sometimes the dizzy spells occurred daily and sometimes they occurred every other day. The patient did not seek medical attention, no treatment was given for the event and no laboratory diagnostic studies were performed. At the reporting time, the patient recovered from the event on an unspecified date in 2016 (reported as "3 or 4 weeks.") The reporter did not provided a causality assessment between the event and the GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD, lot # M033216, expiration date 09-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was 10.6 F for 98 hours 51 minutes. No digital data logger was involved and no previous excursions were performed. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M018436, expiration date 13-APR-2017, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was 10.6 F for 98 hours 51 minutes. No digital data logger was involved and no previous excursions were performed. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: The spontaneous report concerning a female patient of unknown age was received from the patient's father. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with her fourth dose of GARDASIL, intramuscularly, (lot #, expiration date and anatomical location of administration were unknown), by an anonymous physician. Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Presyncope, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 14 years old female patient. The patient had none concomitant medication, pertinent medical history or drug reactions or allergies. On 31-OCT-2016, the patient was vaccinated intramuscularly with dose of GARDASIL (lot number: 014929, expiration date: 27-MAY-2017) (dose was not reported). On 31-OCT-2016 (reported as "few hours after vaccination"), the patient experienced fever, a chest pain and a near syncopal episode. The patient went to the emergency room and was given antibiotics. The patient was not admitted to the hospital and no laboratory diagnostics were performed. On approximately 02-NOV-2016 ("reported as "within 48 hours") the patient had recovered from the events. No product quality complaint (PQC) was involved. The causality between the events and the GARDASIL was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 14 year old male patient (also reported as "around 14 years ago"). The patient's medical history, concurrent conditions and drug reactions or allergies were not reported. In approximately 2016, the patient was vaccinated with GARDASIL 9 dose number: 1, intramuscular (lot number, expiration date, concentration, dose and frequency were not reported). Concomitant therapies were not reported. Additionally it was also reported that around 2 weeks after taking the first dose of GARDASIL 9, the patient experienced periods of dizziness that lasted between 4 and 6 weeks. No laboratories or studies were performed and no product quality complaint was requested. At the time of the report, the outcome of dizziness was recovered. The causality between dizziness and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB with either lot number M022077 and expiration date of 10-MAR-2019 or L048849 with expiration date of 04-FEB-2018 (strength, route of administration and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 21-NOV-2016 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # L004601, expiration date 04-NOV-2016) rather than GARDASIL 9. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 21-SEP-2015, the patient was vaccinated with RECOMBIVAX HB (first dose) (route, lot # and expiration date were not reported). On 29-NOV-2015 and 23-JAN-2016 the patient received the second and the third dose of RECOMBIVAX HB respectively (inappropriate schedule of drug administration). No adverse effect reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has ben received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017, dose not provided) intramuscularly, which was exposed to 35 Fahrenheit (F) for 1 hour and 15 minutes as well as 47 Fahrenheit (F) for 15 minutes. No adverse effects were reported. The data logger was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 10-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route unknown, lot # L022262, expiration date: 05-NOV-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of VARIVAX (anatomical route of vaccination, lot number and expiration date were not provided). The patients' concomitant medications were not reported. The registered nurse reported, that VARIVAX was stored under a temperature of -14.4 degrees C for 54 minutes. Data logger was involved. The vaccine was not exposed to a previous temperature excursion. Additionally, no adverse events was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of PROQUAD (anatomical route of vaccination, lot number and expiration date were not provided). The patients' concomitant medications were not reported. The registered nurse reported, that PROQUAD was stored under a temperature of -14.4 C for 54 minutes. Data logger was involved. The vaccine was not exposed to a previous temperature excursion. Additionally, no adverse events was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (dose and route not reported; lot# and expiration date were unspecified) outside of the recommended dosing schedule. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (incorrect product storage) (lot #, expiry date unspecified) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 6 Fahrenheit (F) for 1 hour. Previous temperature excursion was reported on an unknown date, at a temperature of 22.6 F, for a duration of 13 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA005078 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Hyperhidrosis
Clinical narrative: This spontaneous report was received from a patient's mother regarding her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, a while ago, the patient was vaccinated with third dose of GARDASIL or GARDASIL 9 in series (exact vaccine not confirmed) (dose and lot # not reported). Within short time of being administered the vaccine, the patient experienced sweating and she did not feel good (date unspecified). She did not seek medical attention and no treatment was given. Later, she recovered from the event in a few hours. The reporter did not provided the causality. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 74 year old female patient. There was no concurrent condition, medical history or concomitant therapy. The patient had no drug reactions/allergies. On 18-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M000592, expiration date 12-OCT-2017) intramuscularly. On an unspecified time November 2016, the patient reported that the injection site being "hot, red and painful". The patient's husband, who was a retired physician stated that it was "cellulitis". The patient began to treat with oxycodone (lot#, expiration date and manufacturer were unknown) and CEFTIN (lot#, expiration date and manufacturer were unknown). The symptoms had not yet improved. No lab diagnostics studies were performed. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored VARIVAX (dose, route, lot# and expiration date unknown). The vaccines were stored in temperature 6-10 Fahrenheit degree (time frame: over 18 months but exact time frame not available at the time of call). There was no previous temperature excursion. The call was due to a "data logger". 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 referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 15-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVSX (dose and route unknown, lot # L025001, expiration date: 06-OCT-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 17-NOV-2016, the patient was vaccinated with an unspecified dose of PROQUAD via intramuscular route instead of the recommended subcutaneous route, (lot number M001152 with an expiration date of 05-JUL-2017) (dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an infant patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, intramuscularly (lot # and dose were not provided), on 08-JUL-2016 with the second dose and third dose on 08-SEP-2016. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified patients of an unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX injection (dose and route of administration were not reported; lot# L027287 and expiration date 21-JUL-2017). There were no concomitant therapies reported. The doses of (Oka/Merck) VARIVAX were stored at a temperature of -1.9 degrees Celsius for 7 hours and 30 minutes, on an unknown date. The doses of the vaccine were exposed to previous temperature excursion of -14 degrees Celsius for a time frame of 2 hours an -13.7 degrees Celsius for a time of 7 hours and 30 minutes (dates unspecified). A Digital data Logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot # M001578 with expiration date 21-NOV-2018; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of VAQTA (lot # L023232 with expiration date 25-FEB-2017; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot # L023866 with expiration date 24-MAR-2017; dose not reported) orally. The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (lot # L024993 with expiration date 17-OCT-2017; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning, multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot number: M027879, expiration date: 24-JAN-2018) (dose and route of administration were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning, multiple, unspecified patients' of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot number: M020926, expiration date: 11-AUG-2018) (dose and route of administration were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: Information has been received from a 43 year old female consumer, who was enrolled in a market research, referring to some female patient of unknown age. The patients' concurrent conditions, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (dose and route were unknown). Other suspect therapy included hpv rl1 6 11 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose and route were unknown). The consumer had heard from friends that some girls had fainted when they received vaccination. She spoke with her doctor about it and he said that it was because the girls were afraid of shots. The outcome of the events were unknown. The causality was not provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 15-NOV-2016, the patient was inadvertently administered a dose of PROQUAD (lot #, expiration date, dose and route were not reported) and a dose of VARIVAX (lot #, expiration date, dose and route were not reported), simultaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 22-NOV-2016 the patient was inadvertently vaccinated with expired third dose of RECOMBIVAX HB (lot # L008660 and expiry date 10-NOV-2016) (dosing regimen unknown). No adverse effects reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to a three unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the three patients were vaccinated with improperly stored doses of GARDASIL (lot, expiry date and dosing regimen were unknown). No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of the year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Inflammation, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of the year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of the year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of the year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.