chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial unsolicited report received from the literature on 06 September 2016. Abstract: BACKGROUND: Case reports have suggested that vaccines may trigger transverse myelitis (TM) or acute disseminated encephalomyelitis (ADEM), but the evidence for a causal association is inconclusive. We analyzed the association of immunization and subsequent development of TM or ADEM. METHODS: We identified all cases of TM and ADEM in the Vaccine Safety Datalink (VSD) population. Using a case centered method; we compared vaccination of each case to vaccination of all matched persons in the study population, who received the same type of vaccine, with respect to whether or not their vaccination occurred during a pre-determined exposure interval. We calculated a risk difference (excess risk) of TM and ADEM for each vaccine. RESULTS: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. Based on 2 exposed cases, the OR for Tdap exposure 5-28 days prior to ADEM onset was 15.8 (95 % CI 1.2-471.6, p=0.04) and the estimated excess risk was 0.385 (-0.04-1.16) cases per million doses. CONCLUSIONS: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered. This case involve a patient (age and gender was not reported) who was vaccinated with a dose of TDAP Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, 11 days post vaccination, patient developed Acute Disseminated Encephalomyelitis (ADEM). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event Acute Disseminated Encephalomyelitis (ADEM). List of documents held by sender: none. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis(ADEM), following TDAP VACCINE. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Secondary transmission
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as "at least 2 years ago"), the patient's mother was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided). The pharmacist reported that the patient's mother who received ZOSTAVAX never developed a rash or any other symptoms. No adverse effect was reported for the patient's mother. On an unknown date, the patient's mother transmitted the virus to the patient and he developed shingles. The patient was hospitalized on an unknown date for awhile after coming down with the shingles and he had severe pain. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. 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 medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-JUN-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2016 and on 19-MAY-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018 and lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided) respectively. The vaccines underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029617, expiration date 19-MAY-2017; lot # L033543, expiration date 30-MAY-2017 (exact dose was not reported, orally). There were no adverse effects reported. Administered doses of ROTATEQ experienced the temperature excursion of 9.5 degrees Celsius for 12 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-MAR-2016, the patient received improperly stored GARDASIL 9 (lot  number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-JUN-2016, the patient was vaccinated with an improperly stored PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.85
Sex: F
Vaccine: FLU4, HEP
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Two minutes after receiving flu vaccine and Hep B vaccine pt developed a diffuse, blanching, malar rash centered around site of flu shot injection, no joint swelling or difficulty breathing.
Age: 61.0
Sex: F
Vaccine: PNC
Symptoms: Asthenia, Injection site pain, Pain, Skin warm
Clinical narrative: Pt complaining of left arm pain (site of administration); arm warm to the touch; unable to lift arm without pain, generalized aching and weakness.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Swelling, redness, heat at injection site with extension of swelling into axilla.
Age: 47.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Right arm pain instantly after injection given very high on my right deltoid. Pain continued limiting the use of my right arm. Pain to shoulder/upper arm with lifting, getting dressed, raising arm up along with numbness extending down my right arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: ON DAY 2 POST PNEUMOVAX VACCINE, A SWOLLEN BULGE AND REDNESS IN AREA ERUPTED AT SITE OF INJECTION. PAIN THROUGH LARGE PART OF UPPER ARM AND UNDERARM. SWOLLEN BULGE CONTINUED TO SPREAD AND MOVE TOWARD INNER ARM WITH A CLEARLY DEFINED MARGIN THAT HAD A BRIGHT RED COLOR AROUND PERIMETER. ENTIRE AREA WARM AND TENDER TO TOUCH. STARTING TO LOOK BETTER ON DAY 3. A "KNOT" NOW APPEARS AND SWELLING NOT MOVING FAR BEYOND BORDER OF PREVIOUS EVENING (WHICH WAS MARKED WITH PEN BY PATIENT BEFORE GOING TO BED).AREA DOES NOT ITCH AND BODY DOES NOT ACHE.  PATIENT SELF TREATED WITH SALON PAS PATCHES TO SWOLLEN AREA AND ORAL IBUPROFEN ON DAYS 1 & 2.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: ON DAY 2 POST PNEUMOVAX VACCINE, A SWOLLEN BULGE AND REDNESS IN AREA ERUPTED AT SITE OF INJECTION. PAIN THROUGH LARGE PART OF UPPER ARM AND UNDERARM. SWOLLEN BULGE CONTINUED TO SPREAD AND MOVE TOWARD INNER ARM WITH A CLEARLY DEFINED MARGIN THAT HAD A BRIGHT RED COLOR AROUND PERIMETER. ENTIRE AREA WARM AND TENDER TO TOUCH. STARTING TO LOOK BETTER ON DAY 3. A "KNOT" NOW APPEARS AND SWELLING NOT MOVING FAR BEYOND BORDER OF PREVIOUS EVENING (WHICH WAS MARKED WITH PEN BY PATIENT BEFORE GOING TO BED).AREA DOES NOT ITCH AND BODY DOES NOT ACHE.  PATIENT SELF TREATED WITH SALON PAS PATCHES TO SWOLLEN AREA AND ORAL IBUPROFEN ON DAYS 1 & 2.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: Pt became sore immediately after injection, no redness or soreness at injection site while at pharmacy, nor development after. Worsened pain throughout the day of administration and worsens at night. Extreme muscle pain and discomfort in upper arm, shoulder, and radiating down arm. Pt took ibuprofen and applied ice with some improvement, but is still experiencing pain 72 hours out from vaccine administration.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-JAN-2016, the patient received improperly stored GARDASIL 9 (lot number L016429 and expiration date 09-AUG-2017, dose, anatomical location and route of administration were not provided). On 19-MAR-2016, the patient also received improperly stored GARDASIL 9 (lot number L037339 and expiration  date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 06-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041207 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M020103, expiry date 15-FEB-2018) or (lot # L038503, expiry date 18-DEC-2017) (dose and route not reported). The vaccine was exposed to temperature of 32 Fahrenheit for 9650 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This case was cross referenced with #1609USA007167 (same reporter link). Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 22 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-APR-2016, the patient received improperly stored GARDASIL 9 (lot number L026602 and expiration date 19-OCT-2017, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 15-JUL-2016, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose, dose number, strength, lot#, expiry date were not reported). No adverse reactions reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in hip in a 68-year-old male patient who received HAVRIX adult. On 18th July 2016, the patient received HAVRIX adult. On an unknown date, less than a year after receiving HAVRIX adult, the patient experienced pain in hip (serious criteria other: serious as per reporter), pain in thigh (serious criteria other: serious as per reporter), stiffness hip (serious criteria other: serious as per reporter) and limbs stiffness (serious criteria other: serious as per reporter). On an unknown date, the outcome of the pain in hip, pain in thigh, stiffness hip and limbs stiffness were not recovered/not resolved. It was unknown if the reporter considered the pain in hip, pain in thigh, stiffness hip and limbs stiffness to be related to HAVRIX adult. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in his deltoid and not in the hip or thigh, which was the area of complaint. In 2016, the patient went to the doctor a few weeks after the pain and stiffness began. No other vaccines were administered during the visit. The lot number and expiration date of the vaccine were unknown. The healthcare professional had no other information to offer. The healthcare professional does not want to receive any follow up about this event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041207 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# reported as M003027, expiry date 27-JUN-2017 (number of doses, doses, routes and sites of administration were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429 and expiration date 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L031601, expiration date: 18-FEB-2018 (exact dose, therapy type, anatomical location and route of administration were not provided). This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse effect reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 17-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot# L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 13-JUN-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L039092, expiry date 06-OCT-2017 or lot # L043622, expiry date 03-NOV-2017 or lot # M004326, expiry date 25-JAN-2018, VAQTA (lot#M011116 or K008333) and (Wistar RA 27-3) M-M-R II (lot#L003855 or L026553) (doses, routes and sites of administration were not reported). Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 14-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Appetite disorder, Chills, Headache, Malaise, Myalgia
Clinical narrative: S/S: chills, fever (tactile: fever undocumented), drowsiness, HA, malaise, change in appetite, myalgia.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Somnolence
Clinical narrative: S/S: chills, fever (tactile: fever undocumented), drowsiness, HA, malaise, change in appetite, myalgia.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noted 3"x3" area of redness, warmth, slight swelling and tenderness to left posterior arm at site where Varivax was administered.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Crying, Eye movement disorder, Muscle twitching, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Febrile in the evening of 9/14, 9/15 am crying, mother picked up and pt hot, fever reducer given, pt rolled eyes back, stiffened head and neck and body "twitching", episode lasting 15 to 20 min?, pt seen in office that am.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Throat irritation, Urticaria
Clinical narrative: At midnight (about 7 hours after flu shot given) developed hives, itchy throat, shortness of breath. Took 6 doses of oral BENADRYL at home, then went to ER because not improving.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 25-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Presyncope
Clinical narrative: This spontaneous report was received from a healthcare professional via Pfizer (manufacturer control # 2016343366) and refers to an 18 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown) (exact dose, route of administration, lot # and expiration date were not reported) and with a dose of TRUMENBA (0.5 ml, route of administration, lot # and expiration date were not reported). On an unknown date, after the use of the products, the patient almost passed out. His legs were elevated and he felt better. The outcome of the event was reported as recovering/resolving. The relatedness between the event and HPV (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unspecified dates in August 2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L032396, expiration date: 26-AUG-2017. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 6.9F for 30 min on 02-AUG-2016, 9.8F for 30 min on 04-AUG-2016, 7.8F for 30 min on 07-AUG-2016, 6.9F for 30 min on 09-AUG-2016, 6.9F for 30 min on 10-AUG-2016, 8.6F for 30 min on 15-AUG-2016, 6.8F for 30 min on 20-AUG-2016, 6.8F for 30 min on 22-AUG-2016, 5.9F for 30 min on 23-AUG-2016 and 6.0F for 30 min on 24-AUG-2016. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Impaired healing, Serum sickness, Urticaria
Clinical narrative: 4 hours after shot broke out with many hive and welts progressed thru next 4 mn with welts and hives on various parts of body. Slow to heal lasting > 1 wk. Saw UC, primary, and allergist. Dx serum sickness-like rx.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-07-28.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelled. bruised, red, and sore at injection site. Took awhile to heal. Major reaction.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: Patient is having pain in his left shoulder joint where vaccine was administered. There is also muscle weakness that has been there for 15 days now. Patient has an appointment with an orthopedist on 9/20/2016.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2016-08-18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-08-20.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-09-01.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-08-30.
Age: 26.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Patient is having severe nausea, and arm is swollen. Patient had a pneumonia vaccination in the same arm on the same day.
Age: 39.0
Sex: M
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Allergy status to serum and vaccine status on 2016-04-07.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC Unit on 2016-04-11.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, subs on 2016-04-20.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Diarrhoea, Paraesthesia, Vomiting
Clinical narrative: Vomiting, diarrhea, tingling sensation all over body.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Allergy status to serum and vaccine status on 2016-05-03.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site swollen-six inches in diameter read, very warm to touch starting 10 mins after injection. Treated w/ice, Ibuprofen.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Crying, Decreased activity, Decreased appetite, Pyrexia
Clinical narrative: 7 days after vaccination had fever, crying, decrease appetite and activity for 3 day. Fever to 101. No one in family was ill. No evaluation or office visit.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Blood albumin, Blood urine present, Chromaturia, Complement factor C3
Clinical narrative: Body aches developed after vaccination on 8/31/16. On 9/1/16 patient had some occasional brief, right sided back pains that had occurred a few times. Urine had a dark appearance. Dark appearing urine continued to 9/3/16 when she was evaluated in urgent care. Patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Complement factor C4, Full blood count, Metabolic function test, Pain, Ultrasound urinary system
Clinical narrative: Body aches developed after vaccination on 8/31/16. On 9/1/16 patient had some occasional brief, right sided back pains that had occurred a few times. Urine had a dark appearance. Dark appearing urine continued to 9/3/16 when she was evaluated in urgent care. Patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis
Clinical narrative: Body aches developed after vaccination on 8/31/16. On 9/1/16 patient had some occasional brief, right sided back pains that had occurred a few times. Urine had a dark appearance. Dark appearing urine continued to 9/3/16 when she was evaluated in urgent care. Patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Marked redness, swelling and tenderness, no history of previous flu shot reaction.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Feeling hot
Clinical narrative: Fever 102 degrees for 2 days 8th and 9th. Loss of appetite, redness, tenderness, chills, joint pain, hot from Wed 7th to Sat 10th.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Tenderness
Clinical narrative: Fever 102 degrees for 2 days 8th and 9th. Loss of appetite, redness, tenderness, chills, joint pain, hot from Wed 7th to Sat 10th.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L027282, expiration date: 21-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Pt came in Lt arm after (lt) arm with localize swelling min. redness, no c/o pain states itchy-Advise to start TYLENOL/BENADRYL.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pt. received PNEUMOVAX 23 on left deltoid 8/31 as part of routine preventive care. On 9/2 she presented c/o left arm swelling since 8/31, redness and pain that had improved from the day before. She was prescribed Ibuprofen 800 mg every 8 hrs and cool compress.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L010143, expiration date: 24-SEP-2016 (therapy type, exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (route and site of administration, dose and expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: M003659, expiration date: 02-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.