chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to at least 2 adult patients of unknown age and gender (however, there might have been as many as 48 adult patients who actually received a dose of PROQUAD. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-AUG-2016, the adult patients were vaccinated with a dose of PROQUAD subcutaneously. There was no known adverse effects. 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 other  source (office manager) refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #: M005972, expiry (exp): 02-FEB-2018, lot#: L024256 exp: 01-JUL-2017, lot# L034369 exp: 08-SEP-2017, lot# L037561 exp: 29-SEP-2017, lot#: L046884 exp: 23-NOV-2017 and lot#: L049533 exp: 08-DEC-2017. The temperature excursions were reported as -8.4 C for 11 hours, -9.7C for 16 hours and -11 C to 13.9 C for 59 hours. No previous excursion reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Glomerular filtration rate decreased
Clinical narrative: This spontaneous report as received from a consumer who refers to himself, a 69 year old male patient with chronic lymphocytic leukaemia, gastroesophageal reflux disease and allergy to contrast dye. On 26-JUL-2015, the patient was vaccinated with ZOSTAVAX dose 1 (Product circular #: USPI-V211-I-FRO-1602R019, lot number and expiration day unknown). Concomitant therapies included LIPITOR, extended release INDERAL and PRILOSEC. The patient reported that after receiving ZOSTAVAX, his glomerular filtration rate (GFR) levels have gone down. Before the ZOSTAVAX his levels were "73.2," however now it is "49.29" (conflicting information as the AE onset date was reported as 10-JUN-2015, which is prior to the start of therapy with ZOSTAVAX. The patient reported having routine blood work done very 6 months. The patient sought medical attention by presenting for an office visit and reported he received no treatment for his decreased GFR levels. The reporter did not assess the causal relationship between the adverse event and the therapy with ZOSTAVAX. The outcome of glomerular filtration rate decreased was reported as not recovered. No further information was provided. 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 other source (office manager) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050909, expiry date: 14-JUN-2016. The temperature excursion were reported as -8.4 degrees C for 11 hours, -9.7 degrees C for 16 hours and -11 degrees C to -13.9 degrees 59 hours. No previous excursion reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from office manager via company representative regarding 21 year old female patient. The patient's medical history and concurrent conditions. She had no concomitant medications. The patient was administered incorrectly with doses of GARDASIL in a series (dose, route and lot numbers not reported) (prophylaxis). The first dose was given on 18-OCT-2012, second dose on 30-MAY-2013 and the third dose on 08-JUL-2013 (Inappropriate schedule of drug administration). The patient did not seek medical attention and no treatment was given. No product quality complaint (PQC) was involved. No further information provided. 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 nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered ROTATEQ (Lot# L038536, expiration date: 19-AUG-2017, dose, frequency and route were not reported) that were improperly stored at 31.3 Fahrenheit for 124 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician via a company employee referring to a 15 year old male patient. The patient did not have any pertinent medical history. His drug reactions or allergies were unknown. Concomitant therapy included MENACTRA. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength and dose unknown, frequency was reported as 3 doses, intramuscular). The patient lay down to rest for about 10 -15 minutes and when he got up to leave he passed out. The patient did not seek medical attention or receive treatment for the event. No lab tests were performed. The outcome of the event was reported as resolved (unspecified date in August 2016). The reporter did not provide the causality assessment. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Activities of daily living impaired, Mobility decreased, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is the 1st of 2 reports (reporter's son). A male patient of an unspecified age and ethnicity received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swelling, extreme pain and limited arm movement, all on an unspecified date with unknown outcome. The events required a stay home from school on the next day. Follow-up (08JUL2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L040458 with expiry date 04-FEB-2018, lot # M000442 with expiry date 31-MAR-2018 and lot # M013639 with expiry date 15-SEP-2017 (dose, route of administration and anatomical location were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion of 31 Fahrenheit degrees for 189 hours (2 cycles). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported the patient was inadvertently administered the GARDASIL 9 series on the following dates: the first dose of GARDASIL 9 (lot number and expiration date unspecified) on 08-OCT-2015, the second dose of GARDASIL 9 (lot # L018351, exp. date 11-AUG-2017) on 09-MAR-2016 and the third dose of GARDASIL 9 (lot # L013429, exp. date 21-JUL-2017) on 12-MAY-2016. No adverse effect 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 a Medical assistant reporting to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The primary reporter stated that on unspecified dates, the patients received an improperly stored dose of (Oka/Merck) VARIVAX Injection (Concentration, dose, lot number, expiration dates were not provided). Concomitant therapy was not reported. No adverse events were reported and no product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-AUG-2016, reported as yesterday, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot# reported as M024698, expiry date 27-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the dose of ZOSTAVAX was exposed to a temperature excursion of 39 degrees Fahrenheit for a time frame of 14 hours. There was no previous temperature excursion involved. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions, pertinent drug allergies and medical history of the patient were not reported. On 01-AUG-2016, the patient was vaccinated with improperly stored PEDVAXHIB lot # L035878, expiry date 11-AUG-2018. Concomitant medication were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # L032044 with expiration date 24-AUG-2017, therapy type rHA; Lot # L036853 with expiration date 24-SEP-2017, therapy type rHA; dose and route were not reported). No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of school-aged children of unknown gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates (reported as "in the past"), the patients were vaccinated with unknown doses of VARIVAX (route and site of administration, lot # and expiry date were not reported). Concomitant medications were not reported). On unknown dates, the patients developed breakthrough varicella even though the patients had previously received VARIVAX. It was unspecified how many doses of VARIVAX the patients had received prior to developing breakthrough varicella. The outcome of the event was unknown. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 10-AUG-2016, the patient received M-M-R II, (rHA) (dose unknown), lot number L032182, expiration date 25-AUG-2017, intramuscularly (drug use via unapproved administration route). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not provided. On 18-JUL-2016 the patient was vaccinated with VARIVAX lot # M008171, expiration date: 16-FEB-2018), subcutaneous. There was no concomitant medication reported. The pharmacist reported that on 18-JUL-2016, the patient received an improperly stored dose of VARIVAX. No adverse effect reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018) (route: intramuscular) (incorrect product storage). The vaccine was store at a temperature of 32 F for 15 minutes and at 31 F for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. The outcome of the events was unknown. This is one on three reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Erythema, Mobility decreased, Night sweats, Nodule
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's pertinent medical history included fibromyalgia and muscular dystrophy. She had drug reactions or allergies to latex. On 03-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, subcutaneously (exact dose, lot #, expiration date and anatomical location were not provided). On 04-AUG-2016, 2 hours after receiving PNEUMOVAX 23, she could not move her right arm from pain. It was also reported, that inside of her elbows, right and left, there were tennis ball sized knots, that were raised about 1.5 inches, that were solid red and hot. It was also reported, that on the same date, the patient experienced cold sweats in the middle of the night. Treatment was given for the events. The patient sought medical attention (details were unspecified). Laboratory diagnostic studies were not performed. The outcome of the events was reported as not recovered/not resolved (reported as "still experiencing symptoms"). Causality assessment was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's pertinent medical history included fibromyalgia and muscular dystrophy. She had drug reactions or allergies to latex. On 03-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, subcutaneously (exact dose, lot #, expiration date and anatomical location were not provided). On 04-AUG-2016, 2 hours after receiving PNEUMOVAX 23, she could not move her right arm from pain. It was also reported, that inside of her elbows, right and left, there were tennis ball sized knots, that were raised about 1.5 inches, that were solid red and hot. It was also reported, that on the same date, the patient experienced cold sweats in the middle of the night. Treatment was given for the events. The patient sought medical attention (details were unspecified). Laboratory diagnostic studies were not performed. The outcome of the events was reported as not recovered/not resolved (reported as "still experiencing symptoms"). Causality assessment was not provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 75 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 08-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M018766 with expiration date: 15-OCT-2017; dose and route not reported), one time injection. On 09-AUG-2016, the patient experienced fever, red, hot, swollen and painful arm. The patient sought medical attention and unspecified treatments were given. At the time of reporting, the outcome of all events was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Nodule
Clinical narrative: Significant redness and swelling at injection site. Knot/swelling also below site.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated, in a series, with the doses of GARDASIL 9, 0.5 ml, via intramuscular route (also reported as "inter-muscular"). The patient received first dose on 23-OCT-2013 (lot# and expiry date not reported), second dose on 01-JUN-2016 (lot# and expiry date not reported) and third dose on 01-AUG-2016 (lot # M011117 with expiry date: 07-DEC-2017). No adverse effects and no product quality complainant (PQC) involved. No further information provided. 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, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with expired M-M-R II lot # K012472, expiry date 11-JUN-2016, .5 ml, subcutaneous. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. 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 pharmacist refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient were vaccinated with ZOSTAVAX 19400 PFU, (Lot#, expiry date, dose, frequency and route of administration were unknown). ZOSTAVAX "may" have been improperly stored. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, either lot number L037554 with expiration date of 25-DEC-2017 or lot number M009116 with expiration date of 13-JUN-2018 (strength, route of administration and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PEDVAXHIB, with lot number M001814 and expiration date of 15-OCT-2018 (strength, route of administration and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Burning sensation, Headache, Insomnia, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. No medical history or concurrent conditions were reported. Patient was not on any concomitant medication. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details and lot number not known). On 13-AUG-2016, the patient had a severe headache, a burning sensation in both of her legs, was not able to sleep and had missed one day of school due to leg pain. Patient sought medical attention by calling the physician on the phone and received treatment for the events. The outcome of the events of headache, pain in extremity, insomnia and burning sensation was reported as not recovered, while outcome of activities of daily living impaired was not known. Causality assessment was not provided. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, either lot number L033694 with expiration date of 16-JUN-2017 or lot number M019708 with expiration date of 25-OCT-2017 (strength and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. The consumer reported similar events for two patients. This is a second of two reports. A male patient of an unspecified age and ethnicity received on an unspecified date, TRUMENBA at single dose. Relevant medical history and concomitant medications were unknown. The patient experienced swelling, extreme pain and limited arm movement, all on an unspecified date with unknown outcome. The events required a stay home from school on the next day. Follow-up (08JUL2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On an unspecified date, the patient received an improperly stored dose of ROTATEQ (dose not provided; lot # L029615, expiration date: 15-MAY-2017) orally. The administered dose of vaccine was exposed to a temperature of 33.3 Fahrenheit for 24 hours. No previous temperature excursions were reported. The temperature excursion was detected by a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist reporting to a 74 years old female patient. The patient's medical history and concurrent conditions were not reported. On 17-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 19400 PFU (plaque-forming units)by subcutaneous route number: M015926, expiration date :28-JUN-2017. (Dose was not provided). There were no concomitant medications reported. On approximately AUG-2016, reported as 3-4 days after receiving ZOSTAVAX, the pharmacist reported that the patient developed red "patchy dots" that are itchy "throughout the patient's body(Rash pruritic), The reporter stated that no laboratory tests were performed to the patient, additionally no treatment was given for the event and no product quality complain was involved. The patient was seen on 23-AUG-2016 in the pharmacy. The outcome of the Rash pruritic was unknown. The relationship between the event and the vaccine ZOSTAVAX was unknown. Additional information is not expected as the reporter did not consent for new follow up attempts.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On unspecified dates the patient was vaccinated with the first and second doses of GARDASIL (dose, route, frequency, lot number and expiration date were not reported). On 18-AUG-2016 the patient was vaccinated with a dose of GARDASIL 9 (lot number M018810, expiration date 28-MAY-2016), intramuscular in the right arm (dose not reported) as the third dose administration in the series of three. On 18-AUG-2016, within one hour of the administration of GARDASIL 9, the patient experienced left arm pain that shot around to her back, around to her collar bone and down her left arm, that was a "five" out of "ten" on the pain scale. The reporter indicated that the pain was in the left arm, the opposite arm that the GARDASIL 9 injection was given in. The patient called to the pediatric office on 22-AUG-2016 to report the arm pain that developed on 18-AUG-2016 and a nurse practitioner advised her to take an unspecified dose of ibuprofen for the pain. The outcome of the above mentioned events was unknown at the time of the report. There was no product quality complaint. Additionally the reporter did not assess the causality between GARDASIL 9, GARDASIL and the above mentioned events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Impaired quality of life, Muscle disorder
Clinical narrative: This solicited report was received from a consumer and refers to a female patient of unknown age enrolled in a market research. the patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. It was stated that the patient was an extremely talented and dedicated dancer, who on an unknown date began to have major muscular issues and at the time of the report she was no longer able to dance. the outcome of the events was not reported. the relatedness between the events and GARDASIL was not reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: PNC, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified date in 2016 (reported as "within the last 2 weeks"), the patient was vaccinated with ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017), 1 injection, subcutaneously. At the same time the patient received PREVNAR. It was reported that the patient had excessive swelling and pain for ZOSTAVAX in injection site for longer than physician advised. The patient was advised to take TYLENOL and use warm compress. At the time of the reporting the outcome of excessive swelling and pain for ZOSTAVAX in injection site was unknown. This is one of two reports received from the same source. (Linked report MARRS # 1608USA006547). The linked report refers to a patient who received ZOSTAVAX with the same lot number reported and experienced same events. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A 17-year-old male patient received his first dose of TRUMENBA (NDC # 0005-0100-10, Lot # M13065, Expiry Date Sep2016), intramuscular in the left arm on 02May2016 at 0.5 ml, single. Medical history included ongoing acne (diagnosed a few years ago, probably in 2013 when EPIDUO was started), ongoing chronic allergies (multiple allergies since he was an infant), ongoing asthma (since he was an infant, he had asthma when he exercised), coeliac disease from 22MAY2008 and ongoing, food and environmental  allergies. Concomitant medications included EPIDUO gel from 07Oct2013 and ongoing PROAIR HFA from 30 Mar2009 and ongoing, ongoing EPIPEN. The patient experienced headaches, fever, malaise, body aches all over his body, it was generalized, swollen painful left upper arm/the left arm pain was at the injection site, myalgia, decreased range of motion in the left arm, all on 02May2016 with outcome of unknown. Since 02May2016, the patient had headaches, fever, malaise, myalgia and a swollen, painful left upper arm with decreased range of motion in the left arm. She further described the malaise as body aches all over his body; it was generalized. The left arm pain was at the injection site. The patient also had a fever for 48  hours. The temperature was not taken at home due to the mom did not have a thermometer but patient's mother reported he was hot. In the office, his temperature was normal, 97.4 degrees Fahrenheit on 04May2016. He had fever control medicine, MOTRIN 400 mg, before coming to the office. He did not receive treatment at the office. The patient was evaluated by physician and discharged home without being prescribed any medicine. Follow-up (29JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Myalgia, Pain, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A 17-year-old male patient received his first dose of TRUMENBA (NDC # 0005-0100-10, Lot # M13065, Expiry Date Sep2016), intramuscular in the left arm on 02May2016 at 0.5 ml, single. Medical history included ongoing acne (diagnosed a few years ago, probably in 2013 when EPIDUO was started), ongoing chronic allergies (multiple allergies since he was an infant), ongoing asthma (since he was an infant, he had asthma when he exercised), coeliac disease from 22MAY2008 and ongoing, food and environmental  allergies. Concomitant medications included EPIDUO gel from 07Oct2013 and ongoing PROAIR HFA from 30 Mar2009 and ongoing, ongoing EPIPEN. The patient experienced headaches, fever, malaise, body aches all over his body, it was generalized, swollen painful left upper arm/the left arm pain was at the injection site, myalgia, decreased range of motion in the left arm, all on 02May2016 with outcome of unknown. Since 02May2016, the patient had headaches, fever, malaise, myalgia and a swollen, painful left upper arm with decreased range of motion in the left arm. She further described the malaise as body aches all over his body; it was generalized. The left arm pain was at the injection site. The patient also had a fever for 48  hours. The temperature was not taken at home due to the mom did not have a thermometer but patient's mother reported he was hot. In the office, his temperature was normal, 97.4 degrees Fahrenheit on 04May2016. He had fever control medicine, MOTRIN 400 mg, before coming to the office. He did not receive treatment at the office. The patient was evaluated by physician and discharged home without being prescribed any medicine. Follow-up (29JUN2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from Physician via a company representative referring to patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified date in 2016 (reported as "within the last 2 weeks", the patient was vaccinated with ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017), 1 injection, subcutaneously. Concomitant therapies were not reported. It was reported that the patient had excessive swelling and pain for ZOSTAVAX in injection site for longer than physician advised. The patient was advised to take TYLENOL and use warm compress. At the time of the reporting the outcome of excessive swelling and pain in injection site was unknown. This is one of two reports received from the same source. (Linked report MARRS # 1608USA006626). The linked report refers to a patient who received ZOSTAVAX with the same lot number reported and experienced same events. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were unknown, lot # M004116, expiration date on 12-OCT-2017). No adverse event was 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 regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659, Expiration date 20-SEP-2017; batch # M009378, Expiration date 23-APR-2018; lot # L037554, Expiration date 25-DEC-2017) (exact dose and route of administration were not reported). The administered doses experienced a temperature excursion of 46.8 degree Fahrenheit for 6 hours and 53 minutes and 33.2 degree Fahrenheit for 27 minutes. There was no previous exposures and no data logger. No adverse effects were reported. This is one of the two 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 medical assistant to multiple unspecified patients. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose was unknown, lot # L013204, expiration date on 28-JAN-2017) orally. No adverse event was 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 medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was flied. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot# L035878, expiry date 11-AUG-2018, lot# M006710, expiry date 06-DEC-2018 and lot# reported as M025193, expiry date 21-MAR-2019; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# M016193, expiry date 24-APR-2018; lot# M011117, expiry date 07-DEC-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was administered with doses of GARDASIL in a series, via intramuscularly route (dose and lot numbers not reported). The first dose was given on 21-OCT-2014, a second dose on 12-MAR-2015 and the third dose too soon on 28-APR-2015 (Inappropriate schedule of drug administration). No adverse effects and no product quality complaint (PQC) reported. No further information provided. 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 multiple patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L045713 with expiry date 14-JAN-2017, lot # L009445 with expiry date 01-JUN-2017, lot # M022556 with expiry date 26-MAY-2016 (dose, route of administration and anatomical locations were not specified). Administered doses of VAQTA underwent temperature excursion of 31 Fahrenheit degrees for 189 hours (7 days and 21 hours, 2 cycles). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 15-AUG-2016, the patient was vaccinated with an expired dose of oral ROTATEQ (lot # L000434, expiry date: 10-JUL-2016 via oral route. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-AUG-2016, the patient was vaccinated with expired dose of ZOSTAVAX lot # L000461 /expiration date-08-MAR-2016, subcutaneous, (expired product administered). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not want to get connected.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 23-AUG-2016 the patient was vaccinated with expired dose of VAQTA 25/0.5 (units unknown), lot # K007791/expiration date-22-AUG-2016, 0.5 ml, intramuscular. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date: 02-FEB-2018) (route: intramuscular). The vaccine was stored at a temperature of 32 F for 15 minutes and at 31 F for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding a patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 23-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K022993, expiry date: 20-JUL-2016). No adverse effect was 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. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored dose of PROQUAD injection, lot # L050907, expiration date: 14-JUN-2017 and lot # L051102, expiration date: 17-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator refers to multiple patients of unknown ages and genders. On an unknown date in 2016, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD (lot # L017140, expiry date: 13-NOV-2016; lot # L051101, expiry date: 17-JAN-2017; lot #M0011660, expiry date: 08-SEP-2017; lot #M004889, expiry date: 25-JUL-2017, lot #L042817, expiry date-26-APR-2017, lot #M006107, expiry date:01-AUG-2017 (route: subcutaneous) throughout the temperature excursion beginning 06-JUL-2016 (incorrect product storage). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD which had lot # M001150, expiry date: 05-JUL-2017 and lot # M007961, expiry date: 15-AUG-2017 (route and dose not reported). The vaccines were exposed to temperature of -6.3 degree Celsius for 53 hours and 15 minutes. The vaccines had no previous temperature excursion, detected by data logger. No adverse effects and no product quality complaint (PQC) reported. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported similar events for two patients (two sisters). This is the first of two reports. A 16-year-old female patient of an unspecified ethnicity received her first dose of TRUMENBA (Lot # M37315, Expiration Date 01Apr2017), via an unspecified route of administration in left deltoid on 02May2016 16:35 at 0.5 ml single. Medical history included mild acne and mild scoliosis. Vaccines given on same date included GARDASIL, Merck and Company Incorporated) (Lot # L038503, Expiration Date 18Dec2017) in left deltoid. The patient experienced lemon size swelling at the injection site on 03May2016 with outcome of not recovered and pain on 02May2016 with outcome of not recovered. The events did not require an emergency room or doctor visit and the patient was not hospitalized. Follow-up (29JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Injection site warmth, Musculoskeletal disorder
Clinical narrative: This spontaneous report was received from a pharmacist via a consumers and refers to a 82-year-old female patient with arthritis, diabetes mellitus, asthma, hypertension, blood cholesterol increased and persistent headaches. On 30-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX one vial, once, subcutaneously in the left arm (lot# M014310; expiration date: 26-MAY-2017). Concomitant therapies included gabapentin, LIPITOR, metformin, omeprazole (manufacturer unknown), SINGULAIR, prednisone (manufacturer unknown), amlodipine, FIORICET. The patient called to the pharmacist, in approximately 2016 (reported as ten days after vaccination). She informed that she experienced pain and warmth at injection site on the left arm and numbness radiating down the arm, in approximately 2016. On 22-AUG-2016, the patient's daughter called to the pharmacist and reported that the patient's pain and numbness had not resolved and patient was not able to use the arm. The patient received a treatment (unspecified), for the events. The outcome of warmth at injection site on the left arm and not able to use the arm was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.