chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 "PFU" (dose, frequency, and route of administration were not reported; lot number M041182 with expiration date 04-JAN-2018) for prophylaxis, that was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number M012717 with an expiration date 19-SEP-2018). The temperature data logger measured a vaccine dose stored temperature range of 6°F to 14°F for a period of 1 hour. There were no previous temperature excursions. There were no side effects reported.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number: M032141 with an expiration date of 02-OCT-2017; dose regimen details and anatomical location were not provided) reconstituted with sterile water diluent (unknown lot number and expiration date) for prophylaxis. The sterile water diluent did not undergo an excursion. The temperature was 6°F to 14°F for a time frame of  2.5 hours and 15°F to 46°F for 1.5 hours. No previous excursions were reported. The temperature excursions were detected by a data logger. There was no PQC involved. This is one of two cases from the same reporter. Additional information is not expected since consent to contact the patient's physician was not provided.; Sender's Comments: US-009507513-1705USA004671:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 17-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU), with expiry date in February 2016 (exact dose, site, route of administration and lot # were not reported). Concomitant medications included sterile diluent (DILUENT MRK INJ). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of consciousness, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist reporting on her grandmother, a female patient in her 80ties. The patient's relevant medical history and concomitant medications were unknown. On an unknown date approximately in 2007, reported as 10 years ago, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for shingles vaccination. The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (reason for use reported as diluent for powder; strength, dose, formulation, route of administration, lot# and expiration date were not reported). On an unknown date in May 2017, reported as last week, the patient passed out while out to dinner with her husband. The patient ended up in "ER" where, on an unknown date in May 2017, they found lesions on the right side of her torso which indicated the start of shingles. The patient was not admitted and, at the time of the report, was at home being treated with 2 oral medications, a pain medication and a cream that was drying up the shingles on her torso. Relevant lab data was unknown. The pharmacist reported that, at the time of the report, it was unknown whether the patient would be given ZOSTAVAX again. The patient was recovering from the shingles lesions and passing out. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to approximately two patients of unknown age and gender. No information was provided regarding the patients past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not  provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot number and expiration date were not provided). The physician stated that there are two patients "that he knows of" who have developed herpes zoster after being vaccinated with ZOSTAVAX reconstituted with sterile diluent (STERILE DILUENT) on two separate unspecified dates. The outcome of herpes zoster was unknown. Causality assessment was not  provided. A product quality complaint (PQC) was not involved. 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 nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA007715: US-009507513-1705USA011217:
Sex: U
Vaccine: HEP
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 regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA007715:
Sex: U
Vaccine: HEP
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 regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 ( dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA007715: US-009507513-1705USA011216: US-009507513-1705USA011217:
Sex: U
Vaccine: HPV9
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 regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # M041990 with expiration date 28-JUN-2019 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007715: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA011217.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a 14 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL lot number reported as "M009378" with expiration date on 23-APR-2018 (strength, anatomical location and administration route were not reported) for prophylaxis. Then, on 17-OCT-2016, the patient received the second dose of GARDASIL lot number reported as "M011840" with expiration date on 01-FEB-2018 (strength, anatomical location and administration route were not reported) for prophylaxis. At the reporting time, on 24-MAY-2017, the reporting medical assistant stated that the patient was at the office to receive a dose of GARDASIL 9 (strength, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. It was reported that no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX with  lot # M035696 and expiration date of 07-NOV-2017 (strength, dose and route of administration were unknown) for prophylaxis which was reconstituted with sterile diluent injection with lot number reported as M026304 and expiration date of 13-MAR-2019  (strength, dose and route of administration were unknown)  instead of VARIVAX (strength, dose, route of administration, lot number and expiration date were unknown) for the same indication. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 8 unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) (dose, route, lot# and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 F to 14 F (degrees Fahrenheit) for 135 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested. Sender's Comments: US-009507513-1705USA014052: US-009507513-1705USA014053.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve compression
Clinical narrative: This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On approximately May 2014, reported as "three years ago", the patient was vaccinated by a physician with a dose of ZOSTAVAX subcutaneously, for prevention of shingles (strength, dose, frequency, lot/batch # and expiration date were not reported). It was reported that, on an unknown date, the patient developed a pinched nerve (nerve compression). It was reported that the patient sought medical attention, she did receive physical therapy, and was also advised by a pharmacist to use lidocaine (manufacturer unknown), all on an unspecified date. At the time of reporting, the patient was not recovered from pinched nerve. The causality between pinched nerve and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 5 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis, lot # L046899 with expiration date of 23-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) (dose, route, lot# and expiration date were not reported).   No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 ËF to 14 ËF (degrees Fahrenheit) for 155 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014053: US-009507513-1705USA013888:
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 11 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX  for prophylaxis, lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) (dose, route, lot# and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 ËF to 14 ËF (degrees Fahrenheit) for 121 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013888: US-009507513-1705USA014052:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received regarding a case in litigation on 26-MAY-2017 from a lawyer and a consumer regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 08-DEC-2010 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-OCT-2011, the patient was treated by health care professionals at a health clinic for a vesicular outbreak that was diagnosed as herpes zoster (shingles.) As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 2013 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-JUL-2015, the patient was treated by a nurse practitioner at a hospital emergency room for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 provided. On 07-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 01-OCT-2012 as recommended for routine adult health maintenance for the prevention of shingles (lot number, expiration date, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 13-JUN-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-AUG-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or 15-SEP-2015, the patient was vaccinated with ZOSTAVAX by a physician for routine adult health maintenance for the prevention of shingles (route and lot number not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was further treated for continuing and worsening symptoms on or about 11-OCT-2016. She was prescribed famciclovir and mupirocin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. The outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 07-AUG-2013, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JAN-2014, the patient was treated by a physician at a office for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated for shingles and residual conditions of nerve pain at a clinic and dermatologist, and was prescribed acyclovir (manufacturer unknown) for management of painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Back pain, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received the first dose of TRUMENBA single dose, and influenza vaccine, both on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient experienced fever at 104 Fahrenheit and back pain. The patient went to the emergency room (ER). Clinical outcome of the events was unknown at time of this report.
Age: 47.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: A few hours after vaccination, pt developed erythema, pain to injection site. Area was erythematous a few hours after receiving injection. Pain described as tenderness with radiation down the arm.
Age: 36.0
Sex: M
Vaccine: DTP, MMR
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased, Myalgia, Toothache
Clinical narrative: Muscles Pain (whole body). Join Pain (whole body). Join restriction        (Hands, Arms, and Legs both sides). Dificulties to get up and down stairs. Teeth pain.
Age: 72.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Swelling at injection site with NO redness. Soreness at injection site. Weakness in injection arm (left).
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Loss of consciousness, Visual impairment
Clinical narrative: AFTER RECEIVING VACCINE PATIENT STATED THAT SHE FELT HOT AND I PROVIDED WATER TO HER. THEN SHE SAID SHE WAS HAVING TROUBLE SEEING AND THEN SHE PASSED OUT IN MY ARMS. PATIENT WAS IN THE SEATED POSITION AND DID NOT HIT THE FLOOR. I HELD PATIENT IN A BEAR HUG AND SHE WAS UNCONSCIOUS FOR 3 TO 4 MINUTES. AFTER REGAINING CONSCIOUSNESS, THE PATIENT STATED THAT SHE HAS A TENDENCY TO FAINT WHEN GIVING BLOOD ETC. PATIENT WAS ESCORTED FROM WALMART BY HER MOTHER AND DECLINED PARAMEDIC TRANSPORT.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Muscle oedema, Musculoskeletal pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt stated the area where the vaccine was administered became itchy, swollen and painful. The swelling started spreading to his whole upper arm and trapezius. Pt also began having bilateral shoulder pain. Pt reported to the urgent care and was examined by the provider working. Provider determined it was widespread intramuscular edema. Provider prescribed pt a MEDROL DOSE PAK and ATARAX and told to follow up in 24 hours or sooner if the area gets worse.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain at injection site began. By midnight pain had had spread to entire shoulder of injected arm and became unbearable. Took 2 Aleve and by morning pain had significantly decreased and was bearable.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: Feet, legs and hands started getting tingly and weak.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient noticed small rash around site, warm to touch itchy 3 days after injection. On 4th day rash spread wider diameter from deltoid to above elbow. Pharmacist called MD on 5/30 to report reaction. Dr saw patient and prescribed BACTRIM DS suspecting cellulitis.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal faeces, Crying, Diet refusal, Dyspnoea, Emotional distress
Clinical narrative: Stools turned black-green in color and lasted for about 36 hours after the vaccine was administered. Her stools continue to be small, hard, and pebble formed. She has always had large, peanut butter-like stools. Her attempts to suck from the bottle were painful until last night. She said that her tooth and chin hurt when she sucked, so much so that she refused to drink from it. We have never seen this before from her. She developed a continuous runny nose about 6 hours after our visit. Nasal passages completely blocked. Her sleep at night is sparse and erratic, presumably because of the breathing difficulty. Yesterday she became inconsolably upset out of the blue in the middle of the day. Usually, she wants one of us to hold and comfort her, and that calms her down. For the first time in her life she refused to be touched and writhed on the floor for a very long time as if she was in excruciating pain. We could never get her to tell us what she experienced, but it seemed like joint pain. She finally cried herself to sleep.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Facial pain, Faeces discoloured, Faeces hard, Insomnia, Nasal obstruction
Clinical narrative: Stools turned black-green in color and lasted for about 36 hours after the vaccine was administered. Her stools continue to be small, hard, and pebble formed. She has always had large, peanut butter-like stools. Her attempts to suck from the bottle were painful until last night. She said that her tooth and chin hurt when she sucked, so much so that she refused to drink from it. We have never seen this before from her. She developed a continuous runny nose about 6 hours after our visit. Nasal passages completely blocked. Her sleep at night is sparse and erratic, presumably because of the breathing difficulty. Yesterday she became inconsolably upset out of the blue in the middle of the day. Usually, she wants one of us to hold and comfort her, and that calms her down. For the first time in her life she refused to be touched and writhed on the floor for a very long time as if she was in excruciating pain. We could never get her to tell us what she experienced, but it seemed like joint pain. She finally cried herself to sleep.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Rhinorrhoea, Toothache
Clinical narrative: Stools turned black-green in color and lasted for about 36 hours after the vaccine was administered. Her stools continue to be small, hard, and pebble formed. She has always had large, peanut butter-like stools. Her attempts to suck from the bottle were painful until last night. She said that her tooth and chin hurt when she sucked, so much so that she refused to drink from it. We have never seen this before from her. She developed a continuous runny nose about 6 hours after our visit. Nasal passages completely blocked. Her sleep at night is sparse and erratic, presumably because of the breathing difficulty. Yesterday she became inconsolably upset out of the blue in the middle of the day. Usually, she wants one of us to hold and comfort her, and that calms her down. For the first time in her life she refused to be touched and writhed on the floor for a very long time as if she was in excruciating pain. We could never get her to tell us what she experienced, but it seemed like joint pain. She finally cried herself to sleep.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Donor described joint pain in upper body and muscle pain in shoulders, back, chest area, neck, general fatigue, mild headache for 4 days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Chills, Full blood count normal, Musculoskeletal pain, Pyrexia
Clinical narrative: Fever 104.1, severe chills. Severe shoulder pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Administration site swelling, Lip swelling
Clinical narrative: 24 hour after administering vaccine, patient went to help his friend move. His lips swelled and there was some swelling at the administration site.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: Bite on Left hand (Dorsal) by cat; inturned today by Vet that cat (+) rabies once occurred.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 5-19-17 - called clinic and states arm red and swollen. Also states more sore and symptoms more prominent than last CPX vaccine. Advised to ice, can see if needed. Declined. 5-22-17 call to patient - symptoms resolved.
Age: 2.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Pt received vaccine on 5/24/17 had large red patch with swelling on Rt arm. Mom reports high fevers. Mom was giving pt TYLENOL and MOTRIN for fever. Dr recommended BENADRYL.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature, Injection site erythema, Injection site induration
Clinical narrative: Vaccine give L upper arm - that evening it became red and hard. Entire upper outer arm involved. Temp up to 102 x one week.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Mobility decreased, Nausea, Pyrexia
Clinical narrative: Per patient report by phone: mild fever, erythema and warmth at and around injection site, nausea, and difficulty raising her arm.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain, Dizziness, Nausea, Paraesthesia, Syncope
Clinical narrative: Syncope, blurred vision, tingling in hands and feet. Patient was seen in office - 5/24/17 and Hosp. ED - 5/25/17. Documents attached. Pt. is here due to nausea and dizziness since Monday night. Mom says that pt. has had episodes of dizziness since January. The patient presents with chest pain and Per triage note patient with chest pain that started this morning when he woke up before school. Patient went to school came home early because of his chest pain. Denies shortness of breath he does have some dizziness which she notices more often when he gets up quickly bends over. The dizziness is been going on for several days. The patient does have an appointment with the cardiologist on 6 June which is approximately 2 weeks. The mother brought the patient in because of the concern of the chest pain in the dizziness. Patient denies fever chills nausea vomiting or diarrhea. The onset was gradual and chronic. The course/duration of symptoms is fluctuating in intensity. Location: Left anterior inferior chest. Radiating pain: none. The character of symptoms is dull and achy. The degree at onset was minimal. The degree at maximum was minimal. The degree at present is minimal. Exacerbating factors consist of exertion, movement breathing. The relieving factor is rest. Associated symptoms: none.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Syncope, blurred vision, tingling in hands and feet. Patient was seen in office - 5/24/17 and Hosp. ED - 5/25/17. Documents attached. Pt. is here due to nausea and dizziness since Monday night. Mom says that pt. has had episodes of dizziness since January. The patient presents with chest pain and Per triage note patient with chest pain that started this morning when he woke up before school. Patient went to school came home early because of his chest pain. Denies shortness of breath he does have some dizziness which she notices more often when he gets up quickly bends over. The dizziness is been going on for several days. The patient does have an appointment with the cardiologist on 6 June which is approximately 2 weeks. The mother brought the patient in because of the concern of the chest pain in the dizziness. Patient denies fever chills nausea vomiting or diarrhea. The onset was gradual and chronic. The course/duration of symptoms is fluctuating in intensity. Location: Left anterior inferior chest. Radiating pain: none. The character of symptoms is dull and achy. The degree at onset was minimal. The degree at maximum was minimal. The degree at present is minimal. Exacerbating factors consist of exertion, movement breathing. The relieving factor is rest. Associated symptoms: none.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Visual impairment
Clinical narrative: At 2100 on same day, noted stiff neck, increasing fatigue and vision changes. On 5/26/17 noted moderate headache, and fatigue. 5/30 f/u with Pt and she is doing much better ."It might have been from a cold".
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient brought in today by parents because child has his immunizations 2 days ago and developed on his left thigh some redness and tenderness. Increasing in size. No fevers or chills. No nitrates. Child is active and alert. States he's never had an issue with reactions like this in the past. Prescribed KEFLEX 250 mg/5ML oral liquid 6ML oral , Q12H, x10days. Discussed with parents if increasing redness or any other issues to please present to the E.R. over weekend. Return in 2 weeks.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction, swelling, redness, warmth of injection site R greater than L treated for cellulitis.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth, edema, pain extending from shoulder to Elbow (Left arm) Dx: Cellulitis; Treated with Clindamycin 300mg PO QID. Ice packs to site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pruritus, Rash, Skin warm
Clinical narrative: Patient noticed rash Sunday night (5/28/17) around 8pm - she came in to pharmacy and showed pharmacist who said rashes have been reported and instructed patient to contact MD if it worsened - this was on Mon 5/29 - patient called back on Tues (5/30) evening to let pharmacist know rash was much larger (despite taking BENADRYL), itchy, warm, and larger. Visited clinic at work where instructed compress and more BENADRYL. Patient also C/O headache.
Age: 56.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Patient reported redness to site 24 hours after administration. Also reported she felt feverish. Reported redness spread. Presented to clinic 72 hours after receiving vaccine for complaint of increased redness to arm surrounding injection site. Treated for cellulitis.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy and fainted after admin of TDaP and MCV vaccines.
Age: 58.0
Sex: U
Vaccine: HEPA
Symptoms: Injury associated with device
Clinical narrative: Needle stick to the pharmacist administering the vaccine. Patient is fine.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: No adverse event, Vaccination error
Clinical narrative: Pt. received BEXSERO in error. Gma reported no adverse events as a result,
Sex: U
Vaccine: HEPA, TDAP
Symptoms: Erythema, Injection site pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Redness, swelling (L) arm, Pain at site of ADACEL and hep A Fever and vomiting 2-4 d after.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a male patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 18-SEP-2015 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-OCT-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed valacyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641591) on 02-MAY-2017. This spontaneous report refers to a 5 month old patient of unknown gender. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 17-JUN-2016 at 12:10, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiration date: 30-JUL-2017) (dose and frequency were not reported), dose 1, intramuscularly in the right thigh (reported as right leg) for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # 54L57, dose 1, intramuscularly in the right thigh (reported as right leg) and MENACTRA batch/lot # U5185BA, dose 1, intramuscularly in the left thigh (reported as left leg) for prophylaxis. On 17-JUN-2016, drug administered to patient of inappropriate age and no adverse event were reported. On 18-JUN-2016, no signs or symptoms were seen in the patient. On 21-JUN-2016, the patient was stable. The outcome of drug administered to patient of inappropriate age and no adverse event was reported as recovered. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood thyroid stimulating hormone normal, Chest pain, Depression, Fatigue, Lipids normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641617) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 16-MAR-2015, the patient was vaccinated with GARDASIL 9 lot # K009482 (dose, frequency and lot expiration dates were not reported), dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5013AA, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5049AA, dose 1, intramuscularly in the left arm for prophylaxis. On 01-SEP-2015, the patient's mom brought her to office with concerns of fatigue, costochondral chest pain, not sleeping well, weight gain and underwent thyroxine free, lipids and blood thyroid stimulating hormone tests which were normal. The patient's mom believed that the patient had some depression and all these events were caused by GARDASIL 9 and hence reported. Counseling was recommended to the patient. The outcome of weight increased, thyroxine free, lipids, insomnia, fatigue, chest pain and blood thyroid stimulating hormone normal was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Poor quality sleep, Thyroxine free normal, Weight increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641617) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 16-MAR-2015, the patient was vaccinated with GARDASIL 9 lot # K009482 (dose, frequency and lot expiration dates were not reported), dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5013AA, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5049AA, dose 1, intramuscularly in the left arm for prophylaxis. On 01-SEP-2015, the patient's mom brought her to office with concerns of fatigue, costochondral chest pain, not sleeping well, weight gain and underwent thyroxine free, lipids and blood thyroid stimulating hormone tests which were normal. The patient's mom believed that the patient had some depression and all these events were caused by GARDASIL 9 and hence reported. Counseling was recommended to the patient. The outcome of weight increased, thyroxine free, lipids, insomnia, fatigue, chest pain and blood thyroid stimulating hormone normal was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641707) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's other medication included STRATTERA. The patient had no concurrent illnesses and medical history. On 13-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L038917 dose 2 (unspecified dosage), intramuscularly in an unspecified arm, for prophylaxis. On the same day, the patient experienced pain on moving the left arm, which indicated the area at deltoid. The patient's mother had been using ice packs daily. The outcome of pain was reported as unknown. The causality assessment for pain was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641710) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L038503 dose 1 (unspecified dosage) in the left arm and MENVEO lot # M15100 dose 2 (unspecified dosage) in the right arm via intramuscular route, for prophylaxis. On the same day, the patient experienced soreness and numbness on the left deltoid muscle, which continued till the day of the reporting. The patient went to the clinic to have the nurse look into her left deltoid muscle, after the patient's mother had called in the morning. The area of the left deltoid muscle was hard and sore to touch, but the patient said that it was not as bad as it had been. No inflammation was noted at the site and no treatment was given to the patient. The outcome of injection site hypoaesthesia, injection site pain and injection site induration was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.