chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report has been received from a nurse referring to a 21 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with a complete 3-doses series of RECOMBIVAX HB (strength, doses, routes, lot#, expiration dates and anatomical locations were not reported), as routine vaccination. The patient was seen in the medical office on 16-MAY-2017 and had "Hepatitis B titers drawn" (for an unspecified reason) which showed that her titers were low (hepatitis b surface antibody negative); no further clarifying information was provided. The outcome of hepatitis b surface antibody negative was unknown. The causal assessment between the event and the suspect therapy was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001140.
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a medical assistant concerning herself, a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, lot# and expiration date were unknown), which was administered with a properly stored sterile diluent (lot# and expiration date were unknown) subcutaneously for prophylaxis. It was reported that the VARIVAX had a temperature excursion, which was detected by a data logger, of -9°C to 8°C for 1 hour and 14 minutes, and -14°C to -10°C for 7 days. On 20-MAY-2017, the patient experienced general body aches (pain). On approximately 21-MAY-2017, the recovered from the event of pain (reported as "which lasted about 24 hours). The causality between the event of pain and VARIVAX and sterile diluent was not assessed. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015757: US-009507513-1706USA000283:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report has been received from a nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with a complete 3-doses series of RECOMBIVAX HB (strength, doses, routes, lot#, expiration dates and anatomical locations were not reported), as routine vaccination. The patient was seen in the medical office on 16-MAY-2017 and had "Hepatitis B titers drawn" (for an unspecified reason) which showed that her titers were low (hepatitis b surface antibody negative); no further clarifying information was provided. The outcome of hepatitis b surface antibody negative was unknown. The causal assessment between the event and the suspect therapy was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013186.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Pain, Pigmentation disorder, Skin warm
Clinical narrative: Pigmentation changes (redness, pain, warm to touch), diagnosed as cellulitis, rx'd cephalexin course.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Extreme itching, redness, heat, swelling.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Underdose
Clinical narrative: Patient was given pediatric dose of Hep A instead of adult dose of Hep A.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Laboratory test, Loss of personal independence in daily activities, Muscular weakness, Neurological examination normal
Clinical narrative: One day after MCV administration, muscular weakness developped starting in legs and progressing to arms. No resp symptoms. Clinically normal neuro exam, normal reflexes and sensation. Missed 2 days of school due to weakness and then went to emergency department on 5/31 because he was too weak to get out of bed. Weakness resolved, no further symptoms as of 2 weeks later, reviewed by PCP, no further testing or diagnostics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Erythema, Headache, Mass, Pain in extremity
Clinical narrative: Had DTaP-IPV and MMRV 6/1/2017. 6/2/2017 all day with c/o sore arms, headache, stomachache and tactile fever. Has been taking fluids, and acetaminophen and ice seem to help temporarily. Mom also notes that on DTaP side, there is a "softball sized brown lump" with a pink ring around it.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Had DTaP-IPV and MMRV 6/1/2017. 6/2/2017 all day with c/o sore arms, headache, stomachache and tactile fever. Has been taking fluids, and acetaminophen and ice seem to help temporarily. Mom also notes that on DTaP side, there is a "softball sized brown lump" with a pink ring around it.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Arm was soar/red/swollen at injection site and extended all the way below elbow. Could not lift arm above head for 3 days. Took ibuprofen for 4 days following administration to help with symptoms and sleep.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm was soar/red/swollen at injection site and extended all the way below elbow. Could not lift arm above head for 3 days. Took ibuprofen for 4 days following administration to help with symptoms and sleep.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: LEFT THIGH RED, SWOLLEN AT INJECTION SITE, TEMP. 101.3 RECTALLY.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient received a dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). Then, on an unknown date, the patient received a dose of GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported). No adverse experience was reported. There was no product quality complaint involved in this case. 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 medical assistant and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in May 2017 (reported as last week), single dose of improperly stored VARIVAX lot # L034369, expiration date 08-SEP-2017 (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (MRK) was administrated to the patient. No adverse effects were reported. The vaccine was stored in temperature 8 degrees Fahrenheit for 10 minutes (supported). There was no previous excursion reported. The digital data logger was involved. Product quality complaint was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient's concurrent conditions included diabetes mellitus, hypertension and hypercholesterolaemia. The patient's concomitant therapies included metformin, unspecified medication for hypertension and hypercholesterolaemia. There were no drug reactions or allergies. The patient's medical history was not reported. On 06-MAY-2017, the patient was vaccinated with a single dose of ZOSTAVAX subcutaneously in the right arm, which had a lot # of M040146, expiration date of 26-DEC-2017 (concentration and dose were not provided), for prophylaxis, which was reconstituted with sterile diluent with a lot # of M046369 and an expiration date of 07-JUN-2019. On the same day, the patient also was vaccinated with PNEUMOVAX 23 in the left arm (dose, route and concentration were not provided), which had a lot# of N004564 and an expiration date of 22-OCT-2018, for prophylaxis. Approximately in May 2017, the patient experienced a red rash at the injection site of the right arm and the right side of her back. Therefore, on 09-MAY-2017, the patient came into the pharmacy and the pharmacist gave the patient diphenhydramine hydrochloride (BENADRYL) and an unspecified hydrocortisone cream to apply to the rash. At the time of reporting, the patient did not recover from injection site rash, injection site erythema and rash erythematous. The reporter did not provide a causality assessment between ZOSTAVAX, PNEUMOVAX 23, sterile diluent, injection site rash, injection site erythema and rash erythematous. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date in 2017, the patient was vaccinated with an expired dose of VAQTA (expiry date 28-APR-2017, dose, lot #, site and route of administration were not provided). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's concurrent conditions included diabetes and blood pressure high. The patient had no drug reactions nor allergies. On 10-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M035693 with expiration date on 07-NOV-2017 (dose and route of administration were not reported). Concomitant therapies included sitagliptin phosphate (JANUVIA), glipizide (reported as glypizide) and metformin. On an unknown date in MAY 2017,, the patient experienced redness, a lump itchiness and bruising at the injection site. The patient sought medical attention by calling the pharmacy, however she did not receive any treatment for the events. No laboratory test diagnostic was performed. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 15-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, once, subcutaneously (lot # L004656 and expiry date 11-FEB-2017) reconstituted with sterile diluent (STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as a nurse prescriber) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 12-MAY-2017, the patient was inadvertently administered a single dose of M-M-R II (rHA, recombinant human albumin) lot # K012472, subcutaneously (dose was not provided), that had expired on 11-JUN-2016. The vaccine was reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. Since 04-MAR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035692 with an expiration date 07-NOV-2017 for prophylaxis (doses, routes of administration and anatomical location were not reported). There was no adverse experience reported.  Administered doses of ZOSTAVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 40 minutes. There was no previous temperature excursion, A digital data logger was was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015675:
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 16-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot# L029073, expiry date 19-APR-2017; exact dose and route of administration were not reported). The vaccine was not involved in any temperature excursion. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Dyspnoea, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a reporter (role unspecified) via a company representative refers to a 16-year-old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was intramuscularly vaccinated with a dose of GARDASIL 9 injection (exact dose, lot# and expiry date were not reported). Concomitant therapies included unspecified antibiotics. On an unknown date, reported as "several days later", the patient experienced itchiness, joint pain and hives. The patient then went to an emergency room due to breathing issues. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not provided. Additional information is not expected as there was no consent to contact the patient's physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047661 with an expiration date 02-DEC-2018, subcutaneously for prophylaxis (dose, and anatomical location were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot#L025375 with an expiration date 14-MAR-2018). There was no adverse effect reported. Administered doses of VARIVAX experienced the temperature excursion of - 13 degrees Celsius for 34 minutes. There was no previous temperature excursion. A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to 4 non-pregnant patients of unknown age and gender that the physician had within the last several months. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, lot # and expiry date were not reported). On unknown dates, about one hour after receipt of PNEUMOVAX 23, the patients experienced extreme arm and shoulder pain. The arm pain gradually increased over a few days, then decreased - total time to resolution was about 3-4 days. The reporter noted that a few of the patients (unspecified number) had such severe pain, they could not move their arm, and that they went to emergency rooms (hospital unspecified) in which they had blood work drawn, which showed elevated white blood cell counts. The patients received unspecified treatment for the events. The reporter also stated that one of the patients had such severe shoulder pain, that he went to an orthopaedic physician and was determined to have a torn ligament. This patient's pain was treated with hydrocodone. The patients recovered from arm pain on an unspecified date. The outcome of the events of shoulder pain, patients not being able to move their arm, white blood cell count elevated and torn ligament was not reported. Causal relationship between the events and PNEUMOVAX 23 was not provided. The orthopaedic physician considered the event of torn ligament to be not related to PNEUMOVAX 23, however the reporting physician did not provide his own assessment. Product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a medical assistant via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot# and expiration date were not reported). It was not specified was this the patient's first dose of GARDASIL 9. In approximately May 2017, the patient experienced unspecified rash (rash located on patient's body). The patient treated herself with a cetirizine dihydrochloridum (ZYRTEC), on an unknown date. At the reporting time, (reported as "today"), the patient's status was described as  "to be better". The relatedness between the event of rash and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was accidentally administered a dose of PROQUAD (lot # M031943, expiration date 27-DEC-2017; dose and route of administration were not reported) reconstituted with sterile diluent (dose, route of administration, lot # and expiration date were not reported) instead of intended doses of M-M-R II and VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II (for prophylaxis; dose, route of administration, lot # and expiration date were not reported) reconstituted with sterile diluent (dose, route of administration, lot # and expiration date were not reported) which could undergo temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, subcutaneously, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015683: US-009507513-1705USA015682:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since February 2017, the patients were vaccinated with the improperly stored (-14 degrees Celsius to -10 degrees Celsius for 153 hours and 39 minutes) doses of VARIVAX (lot # M047662, for prophylaxis; dose, route of administration and expiration date were not reported) reconstituted with the properly stored sterile diluent (dose, route of administration and expiration date were not reported). No adverse effects and previous excursion were reported. The call was made because of data logger. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001227:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M047661, expiration date 02-DEC-2018 (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccines were exposed to a temperature in the range 15 Fahrenheit degrees to 46 Fahrenheit degrees for an undetermined amount of time and then stored at "room temperature" for 1 week. It was unknown if there were previous temperature excursions. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since February 2017, the patients were vaccinated with the improperly stored (-14 degrees Celsius to -10 degrees Celsius for 153 hours and 39 minutes) doses of PROQUAD (lot # M044718, for prophylaxis; dose, route of administration and expiration date were not reported) reconstituted with the properly stored sterile diluent (dose, route of administration and expiration date were not reported). No adverse effects and previous excursion were reported. The call was made because of data logger. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA000851.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. It was reported that RECOMBIVAX HB lot # K010535 (expiration date 27-AUG-2016), lot # K021444 (expiration date 17-SEP-2017) and lot # K020216 (expiration date 17-SEP-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L045117 (expiration date reported as 06-OCT-2017, but auto generated as 06-OCT-2018) and M010212 (expiration date 21-JAN-2019) underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no RECOMBIVAX HB lot number reported in 2017 temperature excursions. It was unknown if unknown number of patients were vaccinated with RECOMBIVAX HB (dose, route, site of administration unknown) for prophylaxis. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001291: US-009507513-1706USA001292:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of M-M-R II (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that M-M-R II lot # K014833 (expiration date 14-SEP-2016), K021151 (expiration date 02-NOV-2016), K024824 (expiration date 02-DEC-2016), L001336 (expiration date13-JAN-2017), L009213 (expiration date 17-MAR-2017), L012480 (expiration date 10-APR-2017) and L015279 (expiration date 30-APR-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L015279 (expiration date 30-APR-2017), L024266 (expiration date 01-JUL-2017), L026553 (expiration date 16-JUL-2017), L030162 (expiration date 11-AUG-2017), L036851 (expiration date 23-SEP-2017), L039551 (expiration date 07-OCT-2017), M008589 (expiration date 16-FEB-2018), M015931 (expiration date 30-MAR-2018) and M020073 (expiration date 19-APR-2018)  underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no M-M-R II lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case: 1705USA004287 US-009507513-1706USA001288: US-009507513-1706USA001287: US-009507513-1706USA001290: US-009507513-1706USA001291: US-009507513-1706USA001292.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of VARIVAX (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that VARIVAX lot # K016129 (expiration date 23-SEP-2016), K021484 (expiration date 03-NOV-2016), K026385 (expiration date 15-DEC-2016), L002868 (expiration date 27-JAN-2017), L012036 (expiration date 17-APR-2017), lot # L023593 (expiration date 26-JUN-2017) and L029466 (expiration date 06-AUG-2017) underwent a temperature excursion in 2015. In October, November and December of 2015, the minimal/maximal temperature of the freezer was -2/6, -2/6 and -2/6 (units not provided) respectively.  The lot number L029466 (expiration date 06-AUG-2017), L035126 (expiration date 14-SEP-2017), L040419 (expiration date 14-OCT-2017), L049532 (expiration date 08-DEC-2017), M005974 (expiration date 02-FEB-2018), M009765 (expiration date 23-FEB-2018), M025864 (expiration date 24-MAY-2018), lot # reported as M0228553 (expiration date 07-JUN-2018), lot # reported as M03138 (expiration date not provided), and M034586 (expiration date 28-JUL-2018) underwent a temperature excursion in 2016. In January to March, May, July to October, and December of 2016, the minimal/maximal temperature of the freezer was -2/10, -7/15, -7/ 9, -4/8, -15/19, -6/7, -5/12, -5/10 and -10/10 (units not provided) respectively. There was no VARIVAX lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Lot number M0228553 and M03138 are invalid lot numbers for VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001292:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II (lot and expiry date: not reported) (incorrect product storage). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported.  There was no prior temperature excursions.  This is one of the four reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in 2012, the patient was vaccinated with M-M-R II (dose, route, anatomical location, lot# and expiration date unspecified), then received a dose of VARIVAX (dose, route, anatomical location, lot# and expiration date unspecified) "about 2 weeks later" for prophylaxis (Inappropriate schedule of drug administration). The administrator was unable to specify the lot and expiration date for the sterile diluent(DILUENT MRK INJ) used to reconstitute the vaccines. No adverse effects were reported. No additional information is available. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001721: Original Case : 1706USA001714 US-009507513-1706USA001722: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001724: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001720: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: 706USA001720: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714 US-009507513-1706USA001722: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001719: Original Case : 1706USA001714 US-009507513-1706USA001724: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case : 1706USA001714 US-009507513-1706USA001721: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001719: Original Case : 1706USA001714 US-009507513-1706USA001724: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)) (lot and expiry date: not reported) (incorrect product storage). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported.  There was no prior temperature excursions.  This is one of the four 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 received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot and expiry date: not reported). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported.  There was no prior temperature excursions. This is one of the four 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 received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ (lot and expiry date: not reported). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported. There was no prior temperature excursions. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Chills, Laboratory test normal, Tremor
Clinical narrative: I that noticed my son shaking like he was shivering but he wasn't cold.(tremors) I overlooked it at first and convinced myself that he was doing it on purpose until I noticed him, doing it while he slept. I reported it to his pediatrician and went in for blood work. I also brought him to a naturopathic doctor who treated him. The tremors have stopped since he has been on a detox regimen.
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Aphonia, Asthenia, Chest X-ray normal, Chills, Cough
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.