chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Joint swelling, Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 4-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-DEC-2017, the patient was vaccinated with PROQUAD injection (dose, route of administration, lot# and expiration date were not provided) for prevention of measles, mumps, rubella and varicella. On 07-DEC-2017, the patient experienced severe allergic reaction all over his body. The reporter has not sought medical attention for the patient at the time of the report, but has alerted the office of the adverse reaction. The reporter was treating the patient with essential oils, "a natural approach". The caller has also filed an adverse event report with VAERS (131188). The outcome of severe allergic reaction was reported as not recovered/not resolved. The causality assessment was not provided.
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 4-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-DEC-2017, the patient was vaccinated with PROQUAD injection (dose, route of administration, lot# and expiration date were not provided) for prevention of measles, mumps, rubella and varicella. On 07-DEC-2017, the patient experienced severe allergic reaction all over his body. The reporter has not sought medical attention for the patient at the time of the report, but has alerted the office of the adverse reaction. The reporter was treating the patient with essential oils, "a natural approach". The caller has also filed an adverse event report with VAERS (131188). The outcome of severe allergic reaction was reported as not recovered/not resolved. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner (also reported as a "physician"), via a company representative, referring to a 19 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 dose (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unknown date in November 2017, the patient developed "a quarter sized red, hard, and warm area" at injection site (injection site unspecified). The outcome of a quarter sized red, hard, and warm area" at injection site was unknown. The causality between the vaccination with GARDASIL 9 and all the events was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 28-NOV-2017, the patient was vaccinated with the first dose of VAQTA lot # N019924 with an expiration date of 02-SEP-2018, intramuscular for prophylaxis (dose, and anatomical location were not reported). No adverse effects were reported.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 year old male patient. No pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant therapies  were provided. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 17-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9  (dosage schedule, route, anatomical location, lot number and expiration date were not reported) and influenza virus vaccine (unspecified) (dosage schedule, route, anatomical location, lot number and expiration date were not reported), both for prophylaxis. On 26-SEP-2017, the patient was diagnosed with alopecia.  The outcome of alopecia was unknown. The causality assessment between the adverse event and the suspect therapies was  not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 23-month-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD injection (dose and route of administration were not reported) lot # N015623 with expiration date 15-NOV-2018. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001322: US-009507513-1712USA001321: US-009507513-1712USA009066: US-009507513-1712USA009807: US-009507513-1712USA009808: US-009507513-1712USA009809: US-009507513-1712USA009810: US-009507513-1712USA009811: US-009507513-1712USA009812: US-009507513-1712USA009813: US-009507513-1712USA009814: US-009507513-1712USA009815: US-009507513-1712USA009816: US-009507513-1712USA009817: US-009507513-1712USA009818: US-009507513-1712USA009819: US-009507513-1712USA009820: US-009507513-1712USA009821.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 1-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose and route of administration were not reported) lot # N019127 with expiration date 22-JUN-2019. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 58-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (dose and route of administration were not reported) lot # N015627 with expiration date 04-JUL-2018. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 17 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 12-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On 09-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis(inappropriate schedule of drug administration). There was no adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 08-JUN-2017, the patient was vaccinated with the first dose of ZOSTAVAX lot# N020852 and expiry date 31-JUL-2018 (exact dose and route of administration were not reported) for prophylaxis. On 11-DEC-2017, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis (extra dose administered). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 67-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N010106 with expiration date 15-NOV-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac failure, Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericarditis
Clinical narrative: Initial solicited report received on 12DEC2017  from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the above mentioned trial. This is a 21 year old male who received immunization with ACAM2000 03JUN2017. The patient had no prior cardiac or other relevant medical history. Other vaccines received within 30 days included immunization with BIOTHRAX on 21MAY2017. On 16JUN2016 (13 days after smallpox vaccine) the patient had an abnormal electrocardiogram, echocardiogram and troponin I (1.5). On 16JUN2017, he was diagnosed with acute pericarditis and heart failure. On 19JUN2017 he was diagnosed with myocarditis. No further information was provided.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 12DEC2017  from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the above mentioned trial. This is a 21 year old male who received immunization with ACAM2000 03JUN2017. The patient had no prior cardiac or other relevant medical history. Other vaccines received within 30 days included immunization with BIOTHRAX on 21MAY2017. On 16JUN2016 (13 days after smallpox vaccine) the patient had an abnormal electrocardiogram, echocardiogram and troponin I (1.5). On 16JUN2017, he was diagnosed with acute pericarditis and heart failure. On 19JUN2017 he was diagnosed with myocarditis. No further information was provided.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial solicited report received on 12DEC2017 from an investigator in a trial. This is a 28 year old female who received immunization with ACAM2000 05SEP2017. The patient had no prior cardiac or other relevant medical history. Other vaccines received within 30 days included immunization with BIOTHRAX, Japanese encephalitis and Typhoid ViCPs on 10AUG2017. On 20SEP2017 (15 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (0.08), and a normal echocardiogram and was diagnosed with myocarditis, unspecified. On 22SEP2017, she was diagnosed with acute pericarditis. On 28SEP2017 she was diagnosed with acute myocarditis. At the time of the report the outcome was unknown. No further information was provided.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: (R) arm red, swollen, warm and tender to touch. Rash, itching. Started on KEFLEX 500mg TID x 7 days.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Tenderness
Clinical narrative: (R) arm red, swollen, warm and tender to touch. Rash, itching. Started on KEFLEX 500mg TID x 7 days.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Localized swelling warmth, pain.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood pressure increased, Chest pain, Laboratory test, Pain in extremity
Clinical narrative: PATIENT REPORTED THAT AFTER RETURNING TO HER CAR THAT SHE SUSPECTED AN ADVERSE REACTION. SHE EXPERIENCED CHEST PAIN, PAIN IN HER BACK NEAR COCCYX BONE, AND ALSO PAIN IN HER LEFT ARM. SHE FLAGGED DOWN ANOTHER PATIENT TO ALERT US. I WAS THE ONE WHO RESPONDED TO THE PATIENT AND CHECKED FOR AN ANAPHYLACTIC REACTION WHICH WAS NEGATIVE. I THEN INSTRUCTED STAFF TO CALL 911 AND FROM THERE SHE WAS TRANSPORTED TO THE HOSPITAL WHEN HER BLOOD PRESSURE WAS VERY ELEVATED, (SHE SAYS THIS IS TYPICAL IF SHE IS UP MOVING AROUND HOWEVER). AFTER BEING SEEN AT THE HOSPITAL AND HAVING NUMEROUS TESTS, THE PATIENT WAS RELEASED AND WAS TOLD BY THE PHYSICIAN THAT SHE MUST HAVE JUST HAD A "STRONG REACTION" AFTER HAVING THE VACCINE.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: PATIENT REPORTED THAT AFTER RETURNING TO HER CAR THAT SHE SUSPECTED AN ADVERSE REACTION. SHE EXPERIENCED CHEST PAIN, PAIN IN HER BACK NEAR COCCYX BONE, AND ALSO PAIN IN HER LEFT ARM. SHE FLAGGED DOWN ANOTHER PATIENT TO ALERT US. I WAS THE ONE WHO RESPONDED TO THE PATIENT AND CHECKED FOR AN ANAPHYLACTIC REACTION WHICH WAS NEGATIVE. I THEN INSTRUCTED STAFF TO CALL 911 AND FROM THERE SHE WAS TRANSPORTED TO THE HOSPITAL WHEN HER BLOOD PRESSURE WAS VERY ELEVATED, (SHE SAYS THIS IS TYPICAL IF SHE IS UP MOVING AROUND HOWEVER). AFTER BEING SEEN AT THE HOSPITAL AND HAVING NUMEROUS TESTS, THE PATIENT WAS RELEASED AND WAS TOLD BY THE PHYSICIAN THAT SHE MUST HAVE JUST HAD A "STRONG REACTION" AFTER HAVING THE VACCINE.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Right thigh red, swollen and painful; MD advised parent to try benadryl; patient evaluated in office - right lateral/posterior thigh with 2.5 cm x 4 cm area of firm induration, no tenderness, no erythema, no fluctuance.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: FEVER (99.4 TAKEN WITH TEMPORAL THERMOMETER WHICH IS USUALLY AN UNDERESTIMATE BY ONE DEGREE) WITHIN 12 HOURS OF THE VACCINE.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Deafness unilateral, Nausea, Vertigo, Vomiting
Clinical narrative: Patient reports left sided hearing loss, beginning hours after injection. He also reports vertigo, nausea and vomiting.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Gait disturbance, Gastric dilatation, Induration, Pain in extremity
Clinical narrative: Later that day patient was limping. The next day by the evening had area raised below the vaccination site, area warm to touch, significantly limping, stomach was swollen, hip to leg area very sore, patient had no fever. Size of raised area was like golf ball and half. Spoke to the doctor on Friday, advised just to watch progress and call if changes; no medication or treatment was given. Saturday, still limping, stomach still swollen, message to doctor and advised to give patient an extra dose of antibiotics. mentioned the swollen belly was related to the vaccine. By Saturday afternoon raised area was larger the size of a baseball. Sunday, little redness, still limping, stomach not as swollen. Monday, swelling was gone, limping and stomach back to normal
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: Later that day patient was limping. The next day by the evening had area raised below the vaccination site, area warm to touch, significantly limping, stomach was swollen, hip to leg area very sore, patient had no fever. Size of raised area was like golf ball and half. Spoke to the doctor on Friday, advised just to watch progress and call if changes; no medication or treatment was given. Saturday, still limping, stomach still swollen, message to doctor and advised to give patient an extra dose of antibiotics. mentioned the swollen belly was related to the vaccine. By Saturday afternoon raised area was larger the size of a baseball. Sunday, little redness, still limping, stomach not as swollen. Monday, swelling was gone, limping and stomach back to normal
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Erythema, Hypersensitivity, Swelling
Clinical narrative: 12-13-2017 @ 1137AM child received Flu vaccine. 12-15-2017 child was seen for allergic reaction redness, 7x8 cm, swelling, bruising. No fever. Treatment-Prednisolone x 3 days.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Limb injury, Musculoskeletal pain, Pain in extremity, Vaccination complication
Clinical narrative: Received quadrivalent flu shot Mon. 11/13/2017. Woke up the next AM with shoulder and arm pain. Felt like a rotator cuff injury but I had not injured or lifted anything. I started on prednisone and saw my doctor who said it was SIRVA.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, 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 concurrent conditions, pertinent medical history, drug reactions, allergies or concomitant medications was reported. On 16-MAY-2017, the patient was vaccinated with one pediatric dose of RECOMBIVAX HB injection (dose number, route, anatomical location, lot # and expiration date were not reported) instead of two doses. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-DEC-2017, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX injection, vial 19400 PFU (lot # M037653 with expiration date on 29-NOV-2017; dose, route of administration, indication were not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 67-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVA 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 74-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001322: US-009507513-1712USA001321: US-009507513-1712USA009066:
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP, HPV2
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported to be non viable due to temperature drop in refrigerator.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drip in refrigerator.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Rash and redness on chest and upper body.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Cyanosis, Hypotonia, Unresponsive to stimuli
Clinical narrative: PT HAD 20 SECONDS EPISODE WHERE PT WENT BLUE, ARMS WENT LIMP AND PT NON RESPONSIVE. PT THAN IMMEDIATELY BEGAN CRYING.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Pain, Pain in extremity
Clinical narrative: Complained of legs hurting and hurting to walk for about two days and was "not himself" as far as behavior, and then realized after getting the flu vaccine on 11/10/2017 noticed the behavior issues again.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection is red and puffy. It started to occur one week after the injection was given and continues to the present time.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported nonviable due to temperature drop in refrigerator.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported nonviable due to temperature drop in refrigerator.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported now viable due to temperature drop in refrigerator.
Age: 15.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was given after it was reported non viable due to temperature drop in refrigerator.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. Concomitant therapies included sterile diluent. On 29-NOV-2017, the patient was inadvertently vaccinated with a dose of VARIVAX 0.5 ml, lot # 1141AA, expiration date 14-JUL-2013 (route of administration was not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose and route of administration were not provided) lot # N011305, expiration date 20-JAN-2019; lot # N013541, expiration date 23-JAN-2019 for prophylaxis. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided).  Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse events were reported. The outcome of the events was unknown PNEUMOVAX 23 (lot number and expiration date not provided) was stored in temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 6 days. Pneumococcal vaccine, polyvalent (23-valent) PNEUMOVAX 23 lot # N013541, expiration date 23-JAN-2019 was stored in temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 days. PNEUMOVAX 23 lot # N011305, expiration date 20-JAN-2019 was stored in temperature from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 144 hours. There were no previous temperature excursions. Digital Data Logger was involved. ZOSTAVAX lot # and expiration date were not provided, was stored in temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 11 days There were no previous temperature excursions. Digital Data Logger was not involved.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report has been received from a consumer also the patient's mother, and refers to a 20 year old female. Amoxixillin allergy was reported as concurrent conditions and a "flu shot" was reported as concomitant medication. No information was provided regarding the patient's medical history. On an unknown date in December 2013, reported as "4 years ago", the patient was vaccinated in her arm with an only dose of GARDASIL to prevent cancer (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in December 2013, reported as "4 years ago",  after the administration of GARDASIL, the patient experienced being "Light headed" (dizziness) and recovered the same night without treatment. The patient did not sought medical attention and laboratory diagnostics or studies were not performed; besides, the reporter did not assess the causal relationship between vaccination with GARDASIL and the event of dizziness. There was not product quality complaint involved.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-DEC-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N019251, expiry date 20-DEC-2020 (exact dose and route of administration were not reported) for prophylaxis and a dose of M-M-R II (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The lot# of the sterile diluent used was N014365 with an expiry date of 11-OCT-2019. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain of skin, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 11-JAN-2007 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patent to contract a persistent strain of shingles. On or about 20-DEC-2015 through 24-DEC-2015, the patient sought medical attention at the emergency room for a painful skin condition. The patient was also treated at a family medicine clinic, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to zoster infections. The patient has been prescribed KEFLEX, VALTREX and acetaminophen and NORCO for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-DEC-2007 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patent to contract a persistent strain of shingles. On or about 13-FEB-2014, the patient was treated at a Rheumatology and Arthritis Center for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster (shingles).  The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Platelet count decreased, Red blood cell count decreased
Clinical narrative: PT'S WIFE CALLED ON MONDAY STATING THAT THEY WERE ON THE WAY TO THE ER THAT HE HAD A FEVER IN THE ARM AND REDNESS. THE ARM HAD A RED LINE RUNNING DOWN THE MUSCLE IN THE ARM AND SWELLING. PT DR SAID HE HAD CELLULITIS AND SENT HIM TO TH ER AT MEDICAL CENTER HE WAS ADMITTED WITH A STAPH INFECTION, GIVEN ANTIBIOTICS AND IS DUE TO BE REELEASED TODAY. PT WBC 2 PLATELET COUNT WAS 75 RED BLOOD CELL COUNT WAS ALSO LOW AS WELL.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Staphylococcal infection, White blood cell count decreased
Clinical narrative: PT'S WIFE CALLED ON MONDAY STATING THAT THEY WERE ON THE WAY TO THE ER THAT HE HAD A FEVER IN THE ARM AND REDNESS. THE ARM HAD A RED LINE RUNNING DOWN THE MUSCLE IN THE ARM AND SWELLING. PT DR SAID HE HAD CELLULITIS AND SENT HIM TO TH ER AT MEDICAL CENTER HE WAS ADMITTED WITH A STAPH INFECTION, GIVEN ANTIBIOTICS AND IS DUE TO BE REELEASED TODAY. PT WBC 2 PLATELET COUNT WAS 75 RED BLOOD CELL COUNT WAS ALSO LOW AS WELL.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoea, Condition aggravated, Constipation, Cough, Crying
Clinical narrative: Difficult to arouse for approx 13 hours immediately following 4 month vaccines. Persistent and inconsolable crying starting approx 15 hours following vaccines. New onset of colic like crying and fussiness, lasting approx 4 weeks. Development of rash on chest, stomach and back 24 hours following vaccines, later developing into eczema in same generalized locations. Loss head control and loss of skills such as lifting head and chest off of ground while on stomach, loss of ability to roll from belly to back. Diminished tone. First noticed approx 48 hours following vaccines. Loss of vocal skills, no longer cooing and babbling. Drastic increase in GERD/vomiting symptoms, with no relief from Zantac regimen. No bowel movement for 13 days. New onset of apnea, episodes ranging 15-30 seconds. During the episodes patient would take a large and audible gasp of air after being picked up for arousal. Cold and cough symptoms appeared 48 hours after administering vaccines. Symptoms persisted for approximately 6 weeks.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Depressed level of consciousness, Dyspnoea, Eczema, Gastrooesophageal reflux disease, Hypotonia
Clinical narrative: Difficult to arouse for approx 13 hours immediately following 4 month vaccines. Persistent and inconsolable crying starting approx 15 hours following vaccines. New onset of colic like crying and fussiness, lasting approx 4 weeks. Development of rash on chest, stomach and back 24 hours following vaccines, later developing into eczema in same generalized locations. Loss head control and loss of skills such as lifting head and chest off of ground while on stomach, loss of ability to roll from belly to back. Diminished tone. First noticed approx 48 hours following vaccines. Loss of vocal skills, no longer cooing and babbling. Drastic increase in GERD/vomiting symptoms, with no relief from Zantac regimen. No bowel movement for 13 days. New onset of apnea, episodes ranging 15-30 seconds. During the episodes patient would take a large and audible gasp of air after being picked up for arousal. Cold and cough symptoms appeared 48 hours after administering vaccines. Symptoms persisted for approximately 6 weeks.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Irritability, Motor dysfunction, Nasopharyngitis, Posture abnormal
Clinical narrative: Difficult to arouse for approx 13 hours immediately following 4 month vaccines. Persistent and inconsolable crying starting approx 15 hours following vaccines. New onset of colic like crying and fussiness, lasting approx 4 weeks. Development of rash on chest, stomach and back 24 hours following vaccines, later developing into eczema in same generalized locations. Loss head control and loss of skills such as lifting head and chest off of ground while on stomach, loss of ability to roll from belly to back. Diminished tone. First noticed approx 48 hours following vaccines. Loss of vocal skills, no longer cooing and babbling. Drastic increase in GERD/vomiting symptoms, with no relief from Zantac regimen. No bowel movement for 13 days. New onset of apnea, episodes ranging 15-30 seconds. During the episodes patient would take a large and audible gasp of air after being picked up for arousal. Cold and cough symptoms appeared 48 hours after administering vaccines. Symptoms persisted for approximately 6 weeks.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Regressive behaviour, Vomiting
Clinical narrative: Difficult to arouse for approx 13 hours immediately following 4 month vaccines. Persistent and inconsolable crying starting approx 15 hours following vaccines. New onset of colic like crying and fussiness, lasting approx 4 weeks. Development of rash on chest, stomach and back 24 hours following vaccines, later developing into eczema in same generalized locations. Loss head control and loss of skills such as lifting head and chest off of ground while on stomach, loss of ability to roll from belly to back. Diminished tone. First noticed approx 48 hours following vaccines. Loss of vocal skills, no longer cooing and babbling. Drastic increase in GERD/vomiting symptoms, with no relief from Zantac regimen. No bowel movement for 13 days. New onset of apnea, episodes ranging 15-30 seconds. During the episodes patient would take a large and audible gasp of air after being picked up for arousal. Cold and cough symptoms appeared 48 hours after administering vaccines. Symptoms persisted for approximately 6 weeks.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling and erythema around the injection site. She describes it as being somewhat painful but not itchy. She presented to her physician a few days later who was not terribly concerned and did not provide any treatment but recommended alerting the pharmacist to the reaction. She presented to the pharmacy on 12/6/17 and the swelling and erythema were still present, however the patient stated it was improved. Recommended she continue to monitor the injection site and inform her physician if it gets worse or if she develops rashes in other locations.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around injection site, pain for a few hours but gone now. Now redness is about 5 X 7 inch area. No itching, no pain. Advised patient to monitor size of redness and any changes in symptoms and contact dr if persists or worsens.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dysphonia
Clinical narrative: Patients parent reported dysphonia (hoarseness)  a few hours later.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Malaise, Pain, Pain in extremity, Vaccination site swelling
Clinical narrative: Patient states that 3 hours after receiving vaccine his arm hurt and pain radiated into fingers. The area of the vaccine also became swollen he did not feel well for a couple of days (achy and tired). Vaccine was given on a Friday and symptoms resolved on Sunday.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Tenderness
Clinical narrative: 1 day after receiving immunizations, patient noticed, redness, swelling, tenderness to touch, and difficulty moving her left arm. I recommended that she see her doctor for further examination.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Arm is bruised from midway on arm to shoulder.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hyposmia, Parosmia
Clinical narrative: While the olfactory sensations decreased, she reports an intermittent "burning plastic, burning rubber smell."
Age: 61.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Electromyogram abnormal, Injected limb mobility decreased, Injection site pain, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Pt developed pain and weakness from the left shoulder down the arm. Weakness progressed to the point of inability to lift arm. With physical therapy pain is resolved and weakness is improving.
Age: 61.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Radiculitis brachial
Clinical narrative: Pt developed pain and weakness from the left shoulder down the arm. Weakness progressed to the point of inability to lift arm. With physical therapy pain is resolved and weakness is improving.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain at injection site seemed to worsen 3 days post vaccination. Arm became stiff in certain positions, certain positions caused pain and stiffness. Sometimes hurts to sleep on this side. Sometimes just hurts (2 months later) while arm is at rest at side.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination site cellulitis, Vaccination site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 15-Nov-2017. This case involves a patient (age and gender was unknown) who was vaccinated with a dose of FLUZONE HIGH-DOSE (batch number, dose, site, route, dose in series and expiry date were not reported) on 16-Oct-2017. The medical history and concomitant medication were reported. On an unknown date, within a day or so after vaccination it became pretty painful. On an unknown date, following vaccination patient's injection site looks like a pimple and was not red or swollen but looks like if it is scratched there might be pus in it. Relevant lab tests and corrective treatment were not reported. Outcome of the events were not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from a Non Healthcare Professional (office staff) on 27-Oct-2017. This case is link with 2017SA211778, 2017SA244642, 2017SA244847, 2017SA244854, 2017SA244856 (same reporter). This case involves child patient (age also reported as 4-10 years old, gender not reported), who was vaccinated with a dose of FLUZONE (batch number: U1856AB, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had a severe, localized reaction, injection site swelled to baseball size, was very red and painful. Lab data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from a Non health care professional on 27-Oct-2017. This case was linked with cases 2017SA211778, 2017SA244642, 2017SA244729, 2017SA244854, 2017SA244856 (same reporter). This case involves a child patient (age also reported as 4-10 years of age, gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE (dosage form: injection) (batch number: U1856AB, expiration date, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination patient had a severe, localized reaction, injection site swelled to baseball size, was very red and painful. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came into store 12/19 complaining of arm pain/redness. She states swelling has gone down since the first night but very red still.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Staff gave patient High dose flu when a reg flu was needed-no reaction.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Lethargy, Myalgia, Pyrexia
Clinical narrative: Subjective: Pt describes overall aches in muscles and joints, a mild fever and general lethargy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Vaccines were administered at approx. 10:25, and at approx. 10:35 mother noticed rash on face and legs. Within a couple of minutes, rash became more profound and spreading to back. No respiratory distress. Patient was taken to treatment room by triage nurse at approx. 10:43 and vital signs taken, which were normal. At 10:55 administered IM BENADRYL 12.5mg per order of Dr. 11:05 hives resolving and patient was reassessed by Dr. 12:15 BENADRYL and PRELONE were ordered for home use as needed for rash. Patient was d/c'd home with mother in stable condition.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Had soreness/pain, swelling, redness. Went to Urgent Care on 12/18/2017 and received prescription for antibiotic.
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Feeling abnormal, Injection site swelling, Insomnia, Myalgia
Clinical narrative: The night of having the shot my arm was throbbing severely, couldn't even sleep it hurt so much. Very swollen around the injection site also. After a few days the pain was gone but I have not felt right since having it. Very foggy brained and not feeling all there. And so run down and exhausted I cannot wake up. It has been a week now since having it and still feeling the same. A lot of all body muscle pain also.
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: The night of having the shot my arm was throbbing severely, couldn't even sleep it hurt so much. Very swollen around the injection site also. After a few days the pain was gone but I have not felt right since having it. Very foggy brained and not feeling all there. And so run down and exhausted I cannot wake up. It has been a week now since having it and still feeling the same. A lot of all body muscle pain also.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Epistaxis
Clinical narrative: Dad states that they left the office after the vaccine, patient took a nap and then awoke with a nosebleed that lasted 2-3 minutes, he was able to stop it with slight pressure. Dad states that she has never had a nosebleed before. Denies other symptoms or treatments.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Heart rate increased, Swollen tongue
Clinical narrative: Patient received flu shot and experienced increase in heart rate and blood pressure. Her tongue started swelling and one dose of epinephrine was given. Emergency personnel was called and she was rushed to the emergency department. She was given further treatment and has recovered.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Heart rate increased, Lethargy, Myalgia
Clinical narrative: I do not know which TDAP vaccine I received. Adverse effects include: fever, chills, sore joints and muscles, lethargic, increased heart rate. The symptoms that I experienced were severe. The worst of the symptoms last for 24 hours.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: I do not know which TDAP vaccine I received. Adverse effects include: fever, chills, sore joints and muscles, lethargic, increased heart rate. The symptoms that I experienced were severe. The worst of the symptoms last for 24 hours.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Enterovirus test, Febrile convulsion, Human rhinovirus test, Pyrexia
Clinical narrative: High fever that resulted in a febrile seizure.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Hypoaesthesia, Loss of consciousness, Nausea
Clinical narrative: 11/20/17 at 1150, the patient was sitting when she felt numbness spreading from neck to the leg both on the left side, she felt nauseated then passed out, employee was caught by a co-worker. After few minutes she regained consciousness and nausea and numbness subsided. Vital signs were stable.  Finger-stick glucose level was 71 and was given orange juice and felt better after couple of minutes.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Drooling, Headache, Pyrexia
Clinical narrative: FEVER, HEADACHE, DIARRHEA, DROOLING.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Agitation, Autism spectrum disorder, Confusional state, Depression, Encephalitis
Clinical narrative: Within a couple hours after injections, symptoms of encephalitis. Confusion, agitated, irritable. Severe depression within days and became withdrawn. Continued to regress socially over the next 2 years. Diagnosed with Autism Spectrum Disorder in October 2017.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Irritability
Clinical narrative: Within a couple hours after injections, symptoms of encephalitis. Confusion, agitated, irritable. Severe depression within days and became withdrawn. Continued to regress socially over the next 2 years. Diagnosed with Autism Spectrum Disorder in October 2017.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Headache, Throat tightness
Clinical narrative: Started with headache at around 4:00 pm. Then, at around 6:45 pm when starting dinner felt throat like closing and started to cough and respiratory difficulties. Took a dose of ZYRTEC 10 mg (OTC) PO.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Full blood count, Metabolic function test, Unevaluable event
Clinical narrative: Pt received Tdap and pneumococcal vaccine yesterday.