chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route of administration, lot # and expiration date were not reported). On the same day, the patient passed out and had seizure like symptoms for a few minutes after receiving the GARDASIL 9. The patient received unspecified medical attention because she was in the office at the time of the events. The outcome of the events was reported as recovered (date unspecified). The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of passing out and seizure like symptoms were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB injection (lot # N003536 with expiration date at 02-NOV-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 35.4 degrees Fahrenheit (F) for 12 minutes. There was no previous temperature excursion. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003902:
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Migraine, Myalgia, Pyrexia, Spinal pain
Clinical narrative: Fever, muscle pain, migraine-like headache, spine pain. Treated with Imitrex for headache and Advil for other pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Back pain, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever, muscle pain, migraine-like headache, spine pain. Treated with Imitrex for headache and Advil for other pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Loss of consciousness, Pain, Pyrexia, Sleep disorder, Spinal pain
Clinical narrative: Fever, muscle pain, migraine-like headache, spine pain. Treated with Imitrex for headache and Advil for other pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Patient complained of severe pain in left upper arm approximately 24 hours of administration of PNEUMOVAX. Arm was red, swollen, and warm to the touch. Patient was afebrile with temperature of 96.7 and devoid of chills or sweats. Treated with PRN APAP and cool compress QID for 30 min PRN. Followed up with nursing home on 8/4/2017 and administrator reported that symptoms of pain and swelling had subsided.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Small red bumps to forearm, abdomen and legs. No other signs or symptoms.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, warmth, pain entire upper extremity.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Adult dose was pulled for a pediatric patient in error.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Full blood count, Headache
Clinical narrative: Patient received the PREVNAR 13 vaccine on 7/26/17 at our office. That night, she did have pain to her Right upper arm and the next day she didn't feel well. She has contacted our office several times earlier in the week stating she had a really bad headache, chills, stiffness, and no appetite, as well as feeling really nauseated and fatigued. She was concerned it was all in relation to the vaccine. She was instructed to continue with supportive measures. Patient states that she took a shower the morning of 8/3/17 and noticed a rash to her trunk.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Malaise, Metabolic function test, Musculoskeletal stiffness, Nausea
Clinical narrative: Patient received the PREVNAR 13 vaccine on 7/26/17 at our office. That night, she did have pain to her Right upper arm and the next day she didn't feel well. She has contacted our office several times earlier in the week stating she had a really bad headache, chills, stiffness, and no appetite, as well as feeling really nauseated and fatigued. She was concerned it was all in relation to the vaccine. She was instructed to continue with supportive measures. Patient states that she took a shower the morning of 8/3/17 and noticed a rash to her trunk.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Vitamin D
Clinical narrative: Patient received the PREVNAR 13 vaccine on 7/26/17 at our office. That night, she did have pain to her Right upper arm and the next day she didn't feel well. She has contacted our office several times earlier in the week stating she had a really bad headache, chills, stiffness, and no appetite, as well as feeling really nauseated and fatigued. She was concerned it was all in relation to the vaccine. She was instructed to continue with supportive measures. Patient states that she took a shower the morning of 8/3/17 and noticed a rash to her trunk.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Biopsy skin, Biopsy skin abnormal, Lichenoid keratosis, Rash generalised
Clinical narrative: One month after vaccines patient got a rash that started in the groin and has spread to his torso, front, back, arms, feet, neck. Rash has been treated with oral prednisone for 3 days and topical triamcinolone cream, which did not effect the rash. On 07/28/2017 a shave biopsy was done on two of the rash bumps. The biopsy result is a lichenoid infiltration of lymphocytes in the dermal-epidermal junction with damage of basal keratinocytes.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient reported symptoms of slightly swollen and red upper left arm, Pt had shortness of breath and body aches yesterday but that subsided.
Age: 10.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Provider ordered a KINRIX (DTaP/IPV) for a 10 year old and staff gave vaccine without realizing KINRIX is only indicated to ages up to 7 years.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information was received from a pharmacist regarding a 67 year old female patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # N010494, expiration date 16-MAR-2018, 0.65 ml once to prevent  herpes zoster. STERILE DILUENT lot number was MO26304 and expiration date 13-MAR-2019. It was reported that the patient experienced redness at the injection site and that the injection site "hurts on contact with anything" on 12-JUL-2017. The patient saw the pharmacist and also her physician. The pharmacist contacted the patient on 12-JUL-2017 and the patient replied that she was okay. The pharmacist planned to contact the patient on 14-JUL-2017. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient did not received a complete dose of ZOSTAVAX lot # N009777, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). Some ran down to the patient arm. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a health department administrator refers to a 18 year old patient. On 2015 the patient was vaccinated with GARDASIL dose 1 for prophylaxis. On 08-JUL-2017, the patient returned to the health department for the second dose of their HPV vaccination series with GARDASIL 9. The outcome of inappropriate schedule of drug administration and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration to be not related to GARDASIL 9 and GARDASIL. The reporter considered interchange of vaccine products to be not related to GARDASIL and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 07-AUG-2017 the patient was vaccinated with an expired dose of GARDASIL lot # L042837 for prophylaxis. No adverse event was reported. The outcome of expired product administered is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information had been received on 07-AUG-2017 from a female patient (age unknown) who reported that she was participating in the class action lawsuit against Merck. On 07-APR-2007, patient was administered ZOSTAVAX (dose, lot#/expiration not reported) by an anonymous physician to prevent shingles. In 2015 (exact date unspecified), the patient developed shingles which seriously affected her eye and cornea. Patient's present status was not recovered. No further information available.  Upon internal review, shingles which seriously affected her eye and cornea was considered to be a medically significant event. Additional information is not expected as patient refused to provide contact details.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL 9 lot # N002720 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA004079: US-009507513-1708USA004080: US-009507513-1708USA004081.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 14-AUG-2014, the patient was vaccinated with GARDASIL lot # J006850 for prophylaxis. Other suspect therapies included GARDASIL 9. It was considered interchange of vaccine products, no adverse event and inappropriate schedule of drug administration. The outcome of interchange of vaccine products, no adverse event and inappropriate schedule of drug administration was unknown.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 70 year old female patient with diabetes mellitus, hypertension and hyperlipidaemia. Concomitantly, the patient was taking many unspecified medications. On 03-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 Lot # N010109 with an expiration date on 20-NOV-2018, Single dose, 0.5 ml for prophylaxis. In August 2017, the patient experienced injection site erythema, injection site warmth and injection site swelling. She visited the physician and it was  prescribed her cephalexin (KEFLEX) for the treatment of the adverse events. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovering/resolving.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 07-AUG-2017 the patient was vaccinated with M-M-R II lot # L027431 (rHA) for prophylaxis. On 07-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II injection (lot # M036544 (also reported as M023895), expiration date: 15-AUG-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK) (also reported as STERILE WATER DILUENT) injection. The reporter stated that the administered dose of M-M-R II was stored at temperature 10.2 degrees Celsius for 39 hours 45 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003879.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 15 year old patient of unknown gender. On 08-AUG-2017, the 15 year-old patient was inadvertently vaccinated with a dose of PROQUAD, for prophylaxis (strength, route, lot # and expiration date were not reported). Concomitant therapies included sterile diluent. On 08-AUG-2017, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 08-AUG-2017, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # L048265, expiration date 10-JUN-2017, single dose, intramuscular for prophylaxis (expired product administered). No adverse events reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 08-AUG-2017, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis (strength, route, Lot # and expiration date were not reported). On an unknown date the patient experienced product use issue and no adverse event.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 27-Jul-2017. This case involves a female patient of unknown age who was vaccinated with a dose of DAPTACEL (batch number: C5157AA, expiry date: 23-Feb-2019), IPV (VERO) (IPOL) (batch number: N1A451M, expiry date: 05-Feb-2019) and MEASLES, MUMPS AND RUBELLA VACCINE (MMR), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient passed out. No further symptoms reported. The patient required ER/ doctor visit. The patient's laboratory data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review the case was considered as serious because of important medical event: passed out. List of documents held by sender: none.; Sender's Comments: The patient passed out post vaccination with DAPTACEL and IPOL. Time to onset was not reported and the event is also not listed with the products. The patient was also vaccinated with MMR vaccine. Loss of consciousness could occur due to multiple reasons. No history of loss of consciousness has been reported in the patient along with any other medical history. Also, vaccination with multiple products also makes the assessment of causality in this case difficult. Additional information regarding latency, medical history and condition of the patient at the time of vaccination would be required to assess the case. Based upon reported information the role of the vaccine can not be assessed.
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site paraesthesia, Nausea
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 28 Jul 2017. This case involves a male patient (age not reported) who was vaccinated with dose one of IMOVAX administered in arm, and dose one of IMOGAM administered in four places in hand (also reported as fingers) (Batch number, expiry date, dose, dose in series, route of administration were not reported for both vaccines) on an 24 Jul 2017. After kitten bite. The patient also receive Day 3 IMOVAX (Batch number, expiry date, dose, dose in series, route of administration were not reported), on an unspecified date. The patient medical history, and concomitant medications were not reported. On 24 Jul 2017, same day after the vaccination with IMOVAX, and IMOGAM (also reported as since Day 0 doses of both products), the patient had tingling in hand at injections sites in hand, had some nausea and headache. It was reported as the patient will see HCP for f/u and further doses of post exposure series. The patient relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Joint swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 12-year-old male patient who received MENVEO. On 24th July 2017, the patient received the 1st dose of MENVEO. On an unknown date, less than a month after receiving MENVEO, the patient experienced localized erythema (serious criteria clinically significant/intervention required) and swollen joints (serious criteria clinically significant/intervention required). The patient was treated with antibodies NOS and antihistamine. On an unknown date, the outcome of the localized erythema and swollen joints were not reported. It was unknown if the reporter considered the localized erythema and swollen joints to be related to MENVEO. Additional details were provided as follows: This case was reported by the office manager. In 2017, the patient developed a red and swollen area on the shoulder after receiving MENVEO vaccine. The swelling was severe enough that antibiotics and perhaps antihistamine were given. Other seriousness criteria (death, hospitalization, disabling, congenital anomaly, and life-threatening) were not associated with the reported events.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Entire upper arm developed a rash that was hot to touch a couple days after the injection was given was when it was noticed. It was there for at least one week.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Small erythema and warmth 1 inch x 3/4 inch posterior left arm.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Rash, Vertigo
Clinical narrative: Right arm pain, rash, vertigo.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Vaccination site swelling
Clinical narrative: Swelling and redness at vaccination site.
Sex: F
Vaccine: DTAP
Symptoms: Condition aggravated, Crying, Discomfort, Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergy in a infant female patient who received DTaP vaccine. Co-suspect products included DTaP vaccine. On an unknown date, the patient received the 1st dose of DTaP vaccine and the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine and DTaP vaccine, the patient experienced allergy, discomfort, crying, discomfort, crying and condition aggravated. Rechallenge with DTaP vaccine was positive. On an unknown date, the outcome of the allergy was unknown and the outcome of the discomfort and crying were not recovered/not resolved and the outcome of the discomfort, crying and condition aggravated were recovered/resolved. It was unknown if the reporter considered the allergy, discomfort and crying to be related to DTaP vaccine. It was unknown if the reporter considered the allergy, discomfort, crying and condition aggravated to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was 12 years old at the time of reporting. The pharmacist reported that, one of her infant patients had a bad reaction to a pertussis containing vaccine. The pharmacist thought it was probably at DTaP vaccine, but was not certain. After he 1st DTaP injection, the patient exhibited extreme discomfort and inconsolable crying. After the 2nd DTaP injection, the reaction (unknown which reaction of the two) was worse and the physician dedcided the patient must had an allergy to the pertussis of part of the vaccine. The reporter knew that the mother contacted the physician, but did not know if the patient was actually seen by the physician of the reaction.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site paraesthesia, Injection site reaction, Rash macular
Clinical narrative: Red spots at injection site, tingling and numbness and splotchy rash. Pt. was told to use ice in area at HS.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dysgeusia, Dyspnoea, Nausea, Paralysis
Clinical narrative: Approximately 30 minutes after receiving the Tdap injection, the donor was sitting outside the facility. The donor states that she began to feel nauseated and felt paralyzed. She also stated that she was having trouble breathing and having chest pain. She alerted her husband and he alerted the RN staff. When the first RN arrived, the donor had already vomited a copious amount of emesis and was complaining of difficulty breathing and chest pain. Donor also stated that when she vomited it was a strange taste that tasted like "poison". The donor was given 3 liters of O2 via nasal cannula. The donor began to have rapid breathing and appeared to have trouble keeping her eyes open. Donor was laid flat on a bench and ice packs were applied to the nape of her neck and chest. The donor begain to slowly recover and was sat upright. At 10:44 am an apical pulse of 80 bpm was obtained via stethoscope. At 10:46 am a manual b/p of 92/62 was obtained. The donor stated that she no longer felt nauseated and was given 8 oz of water. At that time, 10:55 am through 11:00 am) multiple attempts were made to obtain the donor's b/p, which was unattainable. Donor was transported into the building and we made an additional attempt to get the donor's b/p. At 11:05 am, the donor's b/p was 82/56 and pulse was 72 bpm. Donor was given another 8 oz of water. Donor's b/p was retaken at 11:12 and b/p was 76/51 and pulse was 75 bpm. Donor was then transferred to an exam table and at 11:20 am, given a bolus of 500 ml of NS. Donor's b/p was 110/72 and pulse was 68 bpm at 11:49 am and donor stated no complaints and was released to her husband in satisfactory condition.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Approximately 30 minutes after receiving the Tdap injection, the donor was sitting outside the facility. The donor states that she began to feel nauseated and felt paralyzed. She also stated that she was having trouble breathing and having chest pain. She alerted her husband and he alerted the RN staff. When the first RN arrived, the donor had already vomited a copious amount of emesis and was complaining of difficulty breathing and chest pain. Donor also stated that when she vomited it was a strange taste that tasted like "poison". The donor was given 3 liters of O2 via nasal cannula. The donor began to have rapid breathing and appeared to have trouble keeping her eyes open. Donor was laid flat on a bench and ice packs were applied to the nape of her neck and chest. The donor begain to slowly recover and was sat upright. At 10:44 am an apical pulse of 80 bpm was obtained via stethoscope. At 10:46 am a manual b/p of 92/62 was obtained. The donor stated that she no longer felt nauseated and was given 8 oz of water. At that time, 10:55 am through 11:00 am) multiple attempts were made to obtain the donor's b/p, which was unattainable. Donor was transported into the building and we made an additional attempt to get the donor's b/p. At 11:05 am, the donor's b/p was 82/56 and pulse was 72 bpm. Donor was given another 8 oz of water. Donor's b/p was retaken at 11:12 and b/p was 76/51 and pulse was 75 bpm. Donor was then transferred to an exam table and at 11:20 am, given a bolus of 500 ml of NS. Donor's b/p was 110/72 and pulse was 68 bpm at 11:49 am and donor stated no complaints and was released to her husband in satisfactory condition.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain, cannot move arm.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain, cannot move arm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information was received from a pharmacist regarding a 83 year old male patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-JUL-2017 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M038351 expiration date 06-DEC-2017 (dosage and route unknown). The STERILE DILUENT used had lot # M034763 and expiration date 22-APR-2019. It was reported that "one or two days" later the injection site was red and warm to the touch. There was no rash. The outcome of the events was not recovered. Causality assessment was not provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Night sweats, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 27-OCT-2016 the patient was vaccinated with GARDASIL (lot number L040054, expiration date 26-DEC-2017) dose 2 for prophylaxis. On an unknown date the patient experienced night sweats and vomiting. The outcome of night sweats and vomiting was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring to three of her sisters of unknown age. On unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (reported as "shingles vaccine") for prophylaxis. On unknown dates, the patients experienced herpes zoster. The outcome of herpes zoster was unknown. This is one of two reports received from the same source. Sender's Comments: US-009507513-1708USA002224.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Appendicitis, Dizziness, Paraesthesia
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning a 12 year old male patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. On 04-AUG-2017, the patient experienced lightheaded-ness, tingling in his arm and abdominal pain. He was diagnosed with appendicitis. The outcome of appendicitis, paraesthesia and dizziness was unknown. The relatedness between the therapy with GARDASIL 9 and the events was not reported. Upon internal review, appendicitis was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age. On 08-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M035146 that expired on 26-JUL-2017. No adverse effects reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a 12 month old patient. On 18-JUL-2017, the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included sterile diluent. On 20-JUL-2017, 2 days after onset of therapy the patient experienced varicella. The outcome of varicella was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from office manager and refers to unspecified patients of unknown demographics. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were not provided. It was reported that, on an unknown dates, an unspecified amount of patients were administered improperly stored VARIVAX (lot#N000683, expiration 06-JAN-2019; lot N007930, expiration 08-MAR-2019) reconstituted with properly stored STERILE WATER DILUENT (unknown lot, unknown expiration). Concomitant medication included sterile diluent. Administered vaccine experienced the temperature excursion of 9°C to 8°C for 1 Hour; -14°C to -10°C for 1 Hour 30 Minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of incorrect product storage and no adverse event were unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA003049.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown.   The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA004081: US-009507513-1708USA003517: US-009507513-1708USA004080.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ lot # M040271, orally, for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA003517: US-009507513-1708USA004079: US-009507513-1708USA004081.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA lot # N003194 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA003517: US-009507513-1708USA004079: US-009507513-1708USA004080.
Sex: U
Vaccine: MEN
Symptoms: Optic neuritis
Clinical narrative: This case was reported in a literature article and described the occurrence of optic neuritis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 5 days after receiving Meningococcal ACWY-CRM vaccine, the subject developed optic neuritis. Serious criteria included GSK medically significant. The outcome of optic neuritis was unknown. The investigator considered that there was a reasonable possibility that the optic neuritis may have been caused by Meningococcal ACWY-CRM vaccine. Relevant Tests: In this study, the diagnosis (Optic Neuritis) was made by either an ophthalmologist or a neurologist. Additional information was provided. This case was reported in a literature article and described the occurrence of optic neuritis (ON) in a patient of unspecified age and gender who was vaccinated with unspecified meningococcal conjugate vaccine (MCV4) (manufacturer unknown). The patient was a part of the case-centered analysis that aimed to determine whether the observed rate of vaccination before onset of optic neuritis (ON) is higher than expected, by comparing vaccination rates in patients with ON to those in the matched general population during 1 January 2007 through 31 December 2012. The study estimated both the multiplicative effects (relative risk) and the additive effects (risk difference) of ON after vaccines in persons of all ages. The patient had no medical history of multiple sclerosis and ON. The study was conducted at healthcare system. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified MCV4 (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 2007 and 2013, between 5 and 28 days (exposure interval) following vaccination, the patient was diagnosed with ON. Treatment was unknown. The outcome of the event was not reported. The author commented "Our study found no evidence that vaccines are associated with development of ON in the 4 or 6 weeks after immunisation". The authors concluded, "We found no increased risk of ON after immunization. We had power to detect a small excess risk, and it is reassuring that we found no evidence of excess risk for ON after any vaccine". This is 1 of the 2 valid cases reported in the same literature article.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hypoaesthesia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Severe headache, nausea and vomiting. Arm numbness, severe pain radiating down arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Almost immediately, my left arm (injection site) became very sore; hard to lift and somewhat swollen. I also experienced an upset stomach and difficulty sleeping. After being awake until 2:30 a.m., I finally slept until 9:30 a.m. Very unusual for me. Arm is better today (08-09) and stomach is calmer. I have never experienced such a sore arm/shot site from other injections. The stomach issues was new too.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pain, Throat irritation
Clinical narrative: Patient had adverse reaction to HPV 9 she had the injection at 1:15 pm started having body aches, dizziness, faint feeling approximately 15 to 20 minutes later, throat felt scratchy.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Slight fever, body aches, headache, injection site swelling/redness/pain.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Slight fever, body aches, headache, injection site swelling/redness/pain.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Gaze palsy, Loss of consciousness, Seizure
Clinical narrative: Pt. said the vaccination when injecting felt funny, eyes rolled back into his head, slight convulsing, and passed out. Came back in a few seconds.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, and pain. Patient was prescribed cephalexin and medrol dose pack.
Age: 0.92
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Wrong drug administered
Clinical narrative: DAPTACEL was given early. Last dose of DAPTACEL was third dose on 5/24/17. Was supposed to get PREVNAR this visit, and received #4 DAPTACEL instead.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Dreamy state, Hyperhidrosis, Hypotonia, Syncope
Clinical narrative: Approximately 1 minute after receiving HPV vaccine patient had a syncopal episode and went limp onto exam table for approximately 10 seconds. Patient was diaphoretic and responded to gentle stimulation. Assisted patient to sitting position and provided juice. Pt. stated he felt dizzy and like he was dreaming. Observed for 20 minutes without further problems. Dad and patient reassured about event. Instructed Dad to take him to the ER for further syncopal episodes or other complications.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site pruritus
Clinical narrative: The morning after the vaccine mom noticed a red area approximately three inches by 1.5 inches and in the center were 4-5 blisters. Pt was seen by PCP and antibiotic was prescribed in case erythema became worse. Mom was instructed to administer Benadryl on morning of the 9th as site became itchy. When seen in office to 8/9/17 area was much smaller and blisters were drying up.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching, rash, swelling on right arm below injection site.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: No adverse events took place.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a technician via nurse regarding to a 38 year old male patient. The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent. On 21-JUL-2017, the patient was inadvertently vaccinated with VARIVAX (lot # M033214, expiry date 13-JUL-2018) reconstituted with a diluent for prophylaxis (dosing details unspecified) instead of ZOSTAVAX. No dose of ZOSTAVAX was administered. It was unspecified why the error occurred. It was unspecified whether product was documented incorrectly as ZOSTAVAX as a result of any product confusion. No adverse effects were reported. No further information provided. Product quality complaint (PQC) was not reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # L044694; expiration date 04-FEB-2018), (Lot # M000442; expiration date 31-MAR-2018), (Lot # M003658; expiration date 02-JUN-2018), (Lot # M029233; expiration date 09-AUG-2018), (Lot # M045653; expiration date 03-JUL-2019) for prophylaxis (dose and route not reported). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source. Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA011937: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-JUL-2017 the patient was vaccinated with incorrect storage RECOMBIVAX HB lot # M044032 and expiration date of 03-JUL-2019 for prophylaxis. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002800.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Tremor
Clinical narrative: Patient complained of dizziness, light headedness, double vision, and feeling very shaky approximately 30-45 minutes after receiving vaccine.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Electroencephalogram normal, Pyrexia, Seizure
Clinical narrative: Patient had received the vaccine on Thursday 7/20/17 and the fever began at about 10:30 p.m with the highest being 100.4 rectally per mother who also noticed that she was having a seizure at that time.  She was then taken to facility where she continued to seize for about a hour and a half, where they could not control the seizure and then transferred her to Hospital.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Culture throat, Dyskinesia, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: FEVER, GENERALIZED FATIGUE, JERK LIKE MOVEMENT, SORE THROAT.
Age: 31.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: FLUAD given to patient, he is 31. No symptoms reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema
Clinical narrative: RED SPREADING, WARM DX CELLULITIS.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Rash, Swelling, Throat irritation
Clinical narrative: 11 year old presents for follow up from urgent care center seen 8/2/17 at 21:43 for concern of allergic reaction potentially to vaccines which were given one day earlier. According to documentation from visit and report from patient and his father, they noted new onset swelling are erythema on face, cheeks, below eyes. There was no rash/swelling at injection sites on arm. There was no chest pain, SOB, nausea, vomiting, nor fevers, however throat was reported to feel "a little scratchy". As for potential exposures there is the potential for outdoor contact dermatitis for such as poison ivy, there was no other recent changes in soap/detergent/shampoo. There was no significant changes in food but he did attend a fair and ate some "junk food" there such at cotton candy. The urgent care administered Epinephrine x 2, prednisone and discharged on MEDROL DOSEPAK. Since that time the rash around face has improved. There was subsequently rash noted on right forearm/anecubital region and upper medial thighs. There has been no prior history of allergic reaction.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Immediately following the vaccine administration on 8/7/17 pt developed pain in R deltoid (site of the MENACTRA). Pain gradually worsened. Today pain is severe in the arm. Mother reports onset today of the following: sore throat, fatigue, lightheadedness, nausea with vomiting (one episode at 11AM today), and chills. Temp of 100. R deltoid is mildly swollen but no redness.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site swelling, Nausea, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Immediately following the vaccine administration on 8/7/17 pt developed pain in R deltoid (site of the MENACTRA). Pain gradually worsened. Today pain is severe in the arm. Mother reports onset today of the following: sore throat, fatigue, lightheadedness, nausea with vomiting (one episode at 11AM today), and chills. Temp of 100. R deltoid is mildly swollen but no redness.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Chest pain, Dizziness, Injection site bruising, Injection site vesicles
Clinical narrative: Severe blister at site, then dark bruising, weakness, dizziness, pain at the shoulder, chest and neck.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Severe blister at site, then dark bruising, weakness, dizziness, pain at the shoulder, chest and neck.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site reaction, Peripheral swelling
Clinical narrative: PATIENT PRESENTED TO PHARMACY TODAY WITH A REACTION AT THE SITE OF INJECTION. HER ARM WAS INFLAMED. SHE MENTIONED TO ME THAT SHE HAD DENTAL IMPLANTS DONE ON 08/07/2017 AND HER ARM SWELLED UP AFTER THE IMPLANTS. SHE FOLLOWED UP WITH PCP AND THE PCP PLACED THE PATIENT ON ORAL ANTIBIOTIC AND PATIENT WILL BE FOLLOWING UP WITHIN 1 WEEK.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt got shots on Thursday evening on 8/3/17. She stopped by at the pharmacy today on Wednesday 8/9/2017. She informed me she has redness on her left arm that appeared on Thursday evening and still present. Not itching/ not spreading just moved down a little. Her main concern however was itching and rash all over torso and chest that started on Monday and still continued. I advised her to try BENADRYL oral tab and Hydrocortisone spray for management of symptoms tonight and address this issue with her doctor tomorrow, 8/10/2017 to see if she needs further assessment - she stated she will be seeing him anyway and therefore I advised her to bring this issue to him as well.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Per patient's report, she experiences pain that radiates from injection site toward her armpit and chest, not radiates downward her arm and no sign of chest pain. Possible heart attack was ruled out. Patient was adamant that the pain is resulted from the vaccination since the onset of pain is after the vaccine administration. The pain has not subsided since day one and still occurring on second day. Rph recommended patient to take Tylenol since she is already on diclofenac so another NSAID is not recommended. Rph tried to call to follow up with patient several hours later; however, she did not answer the phone.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles after receiving the VAR vaccine.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Cough, Injection site erythema, Injection site rash, Mouth swelling
Clinical narrative: 7 days after vaccines fever 100-101. Mouth and throat red and swollen per mom. C/o pain knees and ankles. Red rash on legs on 8-6-17. Developed cough.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Oral mucosal erythema, Pharyngeal erythema, Pharyngeal oedema, Pyrexia, Rash erythematous
Clinical narrative: 7 days after vaccines fever 100-101. Mouth and throat red and swollen per mom. C/o pain knees and ankles. Red rash on legs on 8-6-17. Developed cough.