chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a female patient who received BEXSEROL. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BVEXSERO .5 ml and the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site swelling, injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to BEXSERO. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was related via Merck National Service Center. This case was reported by a physician, who herself was the patient's mother. The reporter stated that the injection site reactions were worse with the 2nd dose of BEXSERO than with the 1st dose. The reporting physician agreed to follow up for information about the patient's injection site adverse events after the vaccination with BEXSERO. No additional information was provided. This case has been linked to case US2016GSK015758, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Movement disorder
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient with unspecified penicillin allergy. The patient's pertinent medical history was not reported. On 09-JAN-2015 at 14:35, the patient was vaccinated with ZOSTAVAX 0.65 ml, once, subcutaneously in left arm, lot # L028282, expiration date: 28-OCT-2016. Her concomitant therapy included multiple unspecified medications. On 09-JAN-2016, the patient developed bilateral numbness and was unable to move her fingers in both hands. On 09-JAN-2016 at 17:00, the patient sought medical attention- she visited unspecified emergency room, but she was not admitted. The patient received NEURONTIN as a treatment. On 12-JAN-2016, the patient was able to move her fingers and was improving. Laboratory diagnostic studies were not performed. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Child was seen at office today 2-11-16 and mother reported that child had a fever at 106 the night he got his vaccines  2-1-16. No other problems noted. Mother gave bath and gave TYLENOL and fever was gone. No other problem or reactions. Today was first report of this.
Sex: U
Vaccine: VARCEL
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. The patient's medical history and concurrent condition were not reported. On 04-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were 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 a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-JAN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.3 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: While patient was waiting in the office room after receiving GARDASIL and Hep A, patient loss consciousness for a few seconds. Patient woke up saying that it felt like a dream. Per mom's report. Pt was given juice and peanut butter with pretzels. Pt feeling back to normal.
Age: 0.9
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to an 11 months old male patient. No medical history or concurrent conditions were reported. On 06-JAN-2016, "7 days before his 1st birthday", the patient was vaccinated with VAQTA (dose, route and lot number were not provided). Concomitant medication was not reported. No adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt states she can not lift her arm in which she received the shot. She went to urgent care to be evaluated 2/16/16. No fever, no swelling.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Pyrexia, Tremor
Clinical narrative: Trembling 2 1/2 days. Fever 103.1 1 day and TYLENOL 102 degrees 1 day. 101 degrees 1 day. Loss of appetite - 4 days. Severe diarrhea 1-3 days after. Fatigue, tired - continuous.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: 02/03/2016 - PREVNAR 13 given IM left deltoid. VIS given. 2/5/2016 - Patient call back stating thinks has had side effect - states after she left clinic B.P 90s/50s - site of injection slightly swollen. 2/8/2016 - Patient comes to clinic arm swollen extending towards the elbow PCP informed patient seen. 2/11/16 - Called patient states arm swelling almost gone. PCP gave her BENADRYL she was on Amoxicillin given at time shot given and this continue as per PCP.
Sex: U
Vaccine: HEP, RV5
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. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
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. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ oral, lot # L008053 with expiration date on 30-NOV-2016 (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccine was exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report has been received from a 65 years old female healthcare worker concerning herself. The patient's medical history and concurrent conditions were not reported. The patient reported that she was allergic to ciprofloxacin and that she experienced hives following an administration of this medicine; she was also allergic to sulfa drugs and also reported ENBREL did not work for her. On 16-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX lot number L029484 and expiration date 10-JAN-2016 (dose and route of administration were not reported). Later, eight hours after administration of ZOSTAVAX, the patient experienced itching and redness at the injection site. The reporter noted that no rash had developed. The patient did not sought medical attention. On the same date, 8 hours after the onset of the symptoms, the patient recovered from her injection site pruritus and injection site redness. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
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. On 24-SEP-20155, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccine was exposed to temperature excursion of 34 F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chills, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative and refers to a female patient of 7 years old. Patient's pertinent medical history include sulfonamide allergy. The patient had no other pertinent medical history. On an unknown date in 2006, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, lot number and route were not reported). On 25-JAN-2016, the patient was vaccinated with a second dose PNEUMOVAX 23 intramuscular (dose, frequency, lot # and expiry date were unspecified by the reporter). Concomitant medication included ibuprofen. On an unspecified date in January 2016 (reported as 24 hours after vaccination) the patient experienced fever, chills, shaking and flu like symptoms. The reporter also stated that the patient sought medical attention on 28-JAN-2016, her body temperature was 103 F. It was reported that the patient had been sent to Doctor's office, for blood cultures to be drawn. In addition, on an unspecified date in January 2016, the patient experienced arm pain, swelling and redness at the injection site. At the time of this report, outcome of the events was not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative and refers to a female patient of 7 years old. Patient's pertinent medical history include sulfonamide allergy. The patient had no other pertinent medical history. On an unknown date in 2006, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, lot number and route were not reported). On 25-JAN-2016, the patient was vaccinated with a second dose PNEUMOVAX 23 intramuscular (dose, frequency, lot # and expiry date were unspecified by the reporter). Concomitant medication included ibuprofen. On an unspecified date in January 2016 (reported as 24 hours after vaccination) the patient experienced fever, chills, shaking and flu like symptoms. The reporter also stated that the patient sought medical attention on 28-JAN-2016, her body temperature was 103 F. It was reported that the patient had been sent to Doctor's office, for blood cultures to be drawn. In addition, on an unspecified date in January 2016, the patient experienced arm pain, swelling and redness at the injection site. At the time of this report, outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-FEB-2016 or 02-FEB-2016, the patient was vaccinated with a dose of PEDVAXHIB (lot # K026533 exp date 07-AUG-2017) (dose and route not reported) or a dose of GARDASIL (lot # K011562 exp date 08-APR-2017) (dose and route not reported) that were exposed to a minimum temperature of 328 degrees F and maximum of 84.3 degrees F for 8 hours. The current temperature was 48 degrees F in a time frame of 8 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
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. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 04-FEB-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K018173, expiration 10-JAN-2016, dose was not reported) subcutaneously (Expired vaccine used). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
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. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Swelling, itching, warm, redness at (L) vast lat site. Nausea/vomiting. Sx improving at time of visit. Advised OTC hydrocortisone, oral BENADRYL if itching prevents sleep.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Swelling, itching, warm, redness at (L) vast lat site. Nausea/vomiting. Sx improving at time of visit. Advised OTC hydrocortisone, oral BENADRYL if itching prevents sleep.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 18-JAN-2016, the patient received a dose of improperly stored VAQTA injection (lot # L017757 with expiration date 08-APR-2017; dose and route were not provided). No adverse effects were reported. The vaccination was exposed to temperature of 50.3F for 1 hour and 20 minutes. There was a previous temperature excursion of 48.9F for 2 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-DEC-2015 the patient was vaccinated with VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which improperly stored (Temperature: 9.5 F, time frame: 2 hours). No adverse events were 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, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-DEC-2015 the patient was vaccinated with VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This was one of several reports received from the same source. 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 a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-DEC-2015 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a patient's husband via Bayer HealthCare Pharmaceuticals (BUS-2016-US-008010) and refers to a 60 year old female patient who was not pregnant. The patient's medical history and current conditions were not provided. On 11-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX (manufacturer unknown) (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported, On an unknown date approximately in 2016, the patient's arm became swollen and red. After going to the urgent care, she was prescribed unspecified antibiotics but the redness continued all the way to her elbow. She went back to urgent care and was prescribed LEVAQUIN. The outcome of adverse events was reported as recovered on an unknown date approximately in 2016 (reported as "subsided"). The relatedness between adverse events and ZOSTAVAX (manufacturer unknown) was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with a first dose of GARDASIL lot # K007264, expiry date March 2017 (strength, route and site of administration were not reported). On 13-AUG-2015, also reported as seven weeks later, the patient was vaccinated with a second dose of GARDASIL lot # K010574, expiry date April 2017 (strength, route and site of administration were not reported). On 14-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L020015, expiry date August 2017 (strength, route and site of administration were not reported), third dose in her HPV vaccination series. The patient did not report any adverse experience. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. No concurrent conditions or medical history were provided. On 04-FEB-2016, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml injection, lot # K005415, 1 ml, intramuscularly (site of administration was unspecified), that had expired on 15-JAN-2016. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as there was no consent for further follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a 61 year old female patient. Concurrent condition and medical history was not reported. On 09-FEB-2016 the patient was vaccinated with a dose of expired ZOSTAVAX (0.65 ml, subcutaneous, lot # K012921, expired date: 29-NOV-2015) in the left arm (expired vaccine used). No adverse effects reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L009649, expiration date 29-NOV-2017 (dose and route of administration were not reported). No adverse effects 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, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 5 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the 4 patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030588, exp. 10-FEB-2017, dose and route of administration not provided) and 1 patient was vaccinated with PROQUAD (Merck) (lot # L031603, exp. 18-FEB-2017, dose and route of administration not provided). No concomitant therapy was reported, No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-FEB-2016 or 02-FEB-2016, the patient was vaccinated with a dose of PEDVAXHIB (lot # K02653 exp date 07-AUG-2017) (dose and route not reported) or a dose of GARDASIL (lot # K011562 exp date 08-APR-2017) (dose and route not reported) that were exposed to a minimum temperature of 32.8 degrees F and maximum of 84.3 degrees F for 8 hours. The current temperature was 48 degrees F in a time frame of 8 hours. No adverse effects were 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, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 5 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L032396, exp. 26-AUG-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an adult patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 28-JAN-2016 the patient inadvertently received an expired dose of PROQUAD (Merck) injection (dose, frequency and route unspecified, lot # K009892, Expiration Date 11-JAN-2016) (expired product administered). No adverse effects were reported. This was outside the labeled recommendations in the PROQUAD (Merck) prescribing information. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse referring to a teenager female patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patient was vaccinated with three series of RECOMBIVAX HB (lot#, dose, route and vaccination site unknown) for vaccination as a child (inappropriate schedule of drug administration). The patient recently (date unspecified) had titers drawn for Hepatitis B, and the results were negative. As treatment, the patient would begin a new three dose series of RECOMBIVAX HB beginning on 29-JAN-2016 (today) (Extra dose administered). The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Joint injury
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) and refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2008, the patient was vaccinated with GARDASIL (dose, lot #, expiry date, route of administration and anatomical location were not reported). On an unknown date, about a month after receiving GARDASIL, the patient experienced injury in her ankle. The reporter stated that, now she had medical bills related to unspecified type of medical problems that happened after receiving GARDASIL. Product quality complaint (PQC) was not involved. The outcome of the events and causality assessment were not provided. Additional information is not expected as no contact details were provided.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 16 year-old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 21-JAN-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (dose, lot #, expiry date, route of administration and anatomical location were not reported) instead of VARIVAX (Merck). No symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Night sweats, Pyrexia, Rash, Skin exfoliation
Clinical narrative: Patient received PREVNAR (PCV13) on 9/2, she subsequently developed initial onset of fever (oral 102 at home), night sweats. Then a rash began on her hands as pinpoint ulcerations, followed by superficial peeling of the epidermis which spread to entire body sparing face, neck, mucous membranes. Associated with loss of appetite and increase sensation of thirst. She was given an Rx for prednisone 20mg x 5 days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Skin ulcer, Thirst
Clinical narrative: Patient received PREVNAR (PCV13) on 9/2, she subsequently developed initial onset of fever (oral 102 at home), night sweats. Then a rash began on her hands as pinpoint ulcerations, followed by superficial peeling of the epidermis which spread to entire body sparing face, neck, mucous membranes. Associated with loss of appetite and increase sensation of thirst. She was given an Rx for prednisone 20mg x 5 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044707, expiration date 06-OCT-2018, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 with expiration date of 11-AUG-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # reported as L014419 with expiration date of 25-JUL-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L022447 with expiration date of 09-JUN-2018; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # L008034 with expiration date of 05-AUG-2016; lot# L022447 with expiration date of 26-FEB-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 5 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients inadvertently received doses of improperly stored ROTATEQ lot # L039297, expiry date 19-JUN-2017 orally. No adverse effects were reported. 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 a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.3 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-JAN-2016, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (dose not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with first dose of GARDASIL (dosing details were not reported) and then received a dose of GARDASIL 9 as second dose in the series. No adverse effects were reported. No concomitant medications were reported. There was no product complaint involved. Additional information is not expected, as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 18-JAN-2016, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (dose not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect 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 healthcare worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 08-JAN-2016, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (dose not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site cellulitis in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to BEXSERO. Additional details were provided as follows: This case was received via Merck National Service Center. Another physician reported to the reporting physician that the patient was diagnosed with cellulitis after receiving an unspecified number of doses of BEXSERO. No additional information was provided. This case has been reported to case US2016GSK015756, reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Product preparation error
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received MENVEO (batch number X15019, expiry date 30th October 2017). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, an unknown time after receiving MENVEO, the patient experienced injection site pain and inappropriate preparation of medication. On an unknown date, the outcome of the injection site pain and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the injection site pain to be related to MENVEO. Additional details were received as follows: The patient received only the diluent portion of the MENVEO vaccine in left thigh, which led to an inappropriate preparation of medication.
Sex: U
Vaccine: VARCEL
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. The patient's medical history and concurrent condition were not reported. On 07-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
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. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of VAQTA and RECOMBIVAX HB, (doses, lot numbers and expiration dates were not provided). The vaccines had been exposed to temperature excursion of 34 degrees F during that month. No adverse effects 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006124, expiration date 02-FEB-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K010577, expiration date 22-SEP-2016, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. 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 as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-FEB-2016, the patient was vaccinated with ROTATEQ lot # L039297, expiry date 19-JUN-2016, orally which was improperly stored, No adverse effects were reported. 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013192, expiration date 19-JUN-2016, exact doses were not reported, orally). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: L030865, expiration date on 07-JUN-2018 and lot #: L030867, expiration date on 09-JUN-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The medical assistant reported that the doses of PEDVAXHIB lot #: L030865 with expiration date on 07-JUN-2018, underwent a temperature of 32F during 2 hours and 15 minutes and that the doses of PEDVAXHIB lot #: L030867 with expiration date on 09-JUN-2018 underwent a temperature of 30.7F during 20 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The concurrent conditions and medical history were not provided. On 02-FEB-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot #: L030867, expiration date on 09-JUN-2018) route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issues was involved. This is one of several reports coming from the same source. Additional information has been requested;