chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 647514) and refers to a 20 year old female patient. Patient had no current illnesses. Medical history and lab data was reported as none. No details about prior vaccination was provided. Her other medication included Chinese supplement for hair and wellness(content unknown). On 19-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M009362, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapy included vaccination with M-M-R II. On 19-JUL-2016, after receiving injection patient had local pain and later noticed some redness and a lump at the site of injection. She presented to the health center 3 weeks later complaining that the site was still tender, there was still a lump and occasional redness overlying the site. The outcome of injection site erythema, pain, injection site pain and injection site mass was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 648831) and refers to a 17 year old male. No details about current illnesses, medical history, prior vaccination and other medications were provided. Lab data was reported as none. On 19-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II, VAQTA, RECOMBIVAX HB, IPOL, MENVEO and ADACEL. On 19-AUG-2016, patient was in the act of receiving seven vaccines when he fainted. He was supported to the floor where he quickly recovered. After the fact, he revealed that he had not eaten that day. The outcome of syncope was reported as recovered/resolved. Causality assessment was not provided.      Additional information is not expected as no follow up could be requested from Agency.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Joint stiffness, Joint swelling, Lip swelling, Paraesthesia oral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 651565) and refers to a 18 year old female patient. Other medications and current illnesses were reported as none. Medical history was reported as none disclosed and denied any known. No details about lab data and prior vaccination was provided. On 30-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L036301, dose 1, unknown route in the right arm for prophylaxis. Other suspect therapies included vaccination with IPOL (administered on 30-AUG-2016, lot # M1453, unknown route in the left arm for prophylaxis), VARIVAX (administered on 30-AUG-2016, lot # M019643, unknown route for prophylaxis), M-M-R II (administered on 30-AUG-2016, lot # L037356, unknown route in the right arm for prophylaxis), BOOSTRIX (administered on 30-AUG-2016, lot # M1453, unknown route in the left arm for prophylaxis), and ENGERIX-B (administered on 30-AUG-2016, lot # EG942, unknown route in the left arm for prophylaxis). On 30-AUG-2016, presented 48 hours after vaccination at office with complaint of red swollen ankle with stiffness for several hours. Rash also present on ankles. Occurred that evening along with swelling and tingling of the lips; which resolved and symptoms now subsided. MD advised BENADRYL that night. The patient events showed Improvement. The outcome of erythema, rash, paraesthesia oral, lip swelling, joint swelling and joint stiffness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 651565) and refers to a 18 year old female patient. Other medications and current illnesses were reported as none. Medical history was reported as none disclosed and denied any known. No details about lab data and prior vaccination was provided. On 30-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L036301, dose 1, unknown route in the right arm for prophylaxis. Other suspect therapies included vaccination with IPOL (administered on 30-AUG-2016, lot # M1453, unknown route in the left arm for prophylaxis), VARIVAX (administered on 30-AUG-2016, lot # M019643, unknown route for prophylaxis), M-M-R II (administered on 30-AUG-2016, lot # L037356, unknown route in the right arm for prophylaxis), BOOSTRIX (administered on 30-AUG-2016, lot # M1453, unknown route in the left arm for prophylaxis), and ENGERIX-B (administered on 30-AUG-2016, lot # EG942, unknown route in the left arm for prophylaxis). On 30-AUG-2016, presented 48 hours after vaccination at office with complaint of red swollen ankle with stiffness for several hours. Rash also present on ankles. Occurred that evening along with swelling and tingling of the lips; which resolved and symptoms now subsided. MD advised BENADRYL that night. The patient events showed Improvement. The outcome of erythema, rash, paraesthesia oral, lip swelling, joint swelling and joint stiffness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 660128) and refers to a 16 year old male patient. Patient's current illnesses, medical history, lab data and other medications were reported as none known. No details about prior vaccinations. On 16-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # M018810, intramuscular in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 16-SEP-2016, lot # M000768, subcutaneous in the right arm for prophylaxis), VARIVAX  (administered on 16-SEP-2016, lot # M000768, subcutaneous in the right arm for prophylaxis), IPOL (administered on 16-SEP-2016, lot # M14771, subcutaneous in the left arm for prophylaxis), BOOSTRIX (administered on 16-SEP-2016, lot # 324Z7, Intramuscular in the left arm for prophylaxis), ENGERIX-B (administered on 16-SEP-2016, lot # D344L, Intramuscular in the right arm for prophylaxis), HAVRIX (administered on 16-SEP-2016, lot # ED72D, Intramuscular in the right arm for prophylaxis), and FLUARIX QUADRIVALENT (administered on 16-SEP-2016, lot # TSSF3, Intramuscular in the left arm for prophylaxis). On 16-SEP-2016, the patient experienced rash to bilateral upper extremities, posterior neck within approximately 20 minutes of vaccination and the event lasted for approximately 2 hours with resolution. The patient denies respiratory symptoms/distress. The outcome of rash was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose, Full blood count, Panic attack, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 661352) on 02-MAY-2017. This spontaneous report was received from a regulatory authority which refers to a 19 year old female patient. The patient's medical history included asthma (mild) and anxiety. The patient's other medications included Albuterol and LEXAPRO. The patient stated that she came for a wellness visit. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # M024261 (dose number: 2, frequency and lot expiration date were not reported) and FLUARIX QUADRIVALENT (dose number: 2,  intramuscularly in the right arm, lot # UT5629LA; manufacturer: GlaxoSmithKline, frequency and lot expiration date were not reported) for prophylaxis. On the same day, finger stick complete blood count (CBC) test was also performed. On 21-OCT-2016, about 5 minutes after injections the patient fainted and proceeded to have questionable panic attack for approximately 45 minutes. 911 was called for transport but the event had resolved before reaching the Emergency Room (ER). The outcome for the events syncope and panic attack were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Pruritus generalised, Rash generalised, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 661408) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. The patient's concurrent illness and other medications were reported as none. Patient's medical history included allergic to amoxicillin. On 10-OCT-2016, the patient was vaccinated with GARDASIL 9, lot # M017983, dose 1, via intramuscular route, in the right arm for prophylaxis (dose, frequency and lot expiration date were not reported). On the same day, the patient was vaccinated with other suspect therapies included TRUMENBA (lot# N11903, dose 1, via intramuscular route, in the left arm) and MENACTRA (lot# U5464AA, dose 2, via intramuscular route, in the left arm) for prophylaxis. On 12-OCT-2016, patient woke up with rash, started on legs and spread to most of body and itching which was treated with BENADRYL. Office visit was provided on the same day. Patient visited office (office visit date was reported as 13-OCT-2013) with rash and itchy over most of the body. Shortness of breath (SOB), wheeze was treated with BENADRYL, orally and ALBUTEROL nebulizer. The outcome of dyspnoea, wheezing, rash generalised and pruritus generalised were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 661467) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 29 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 25-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M014929 (dose, frequency and lot expiration date were not reported), dose 2, via intramuscular route, in the left arm for prophylaxis. On 25-OCT-2016, patient experienced dizziness and was placed in a reclining patient chair and lost consciousness. Patient regained consciousness, Alert and Oriented x4, patient stated that nausea was continued. The outcome of dizziness, nausea and loss of consciousness were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dyspepsia, Oesophageal pain, Somnolence
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664148) on 02-MAY-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old female patient. The patient's historical conditions include allergy to penicillin. The patient's other medications included ZOLOFT and TYLENOL. The patient had no concurrent conditions. On 09-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site unknown), lot # L038917 (dose number 1; frequency and lot expiration date were not reported) and MENVEO (site unknown) intramuscularly, (dose number: 1, lot# A15124; manufacturer: Novartis, frequency and lot expiration date were not reported) for prophylaxis. On the same day post vaccination, the patient complained of drowsiness and experienced dyspepsia with heartburn, and esophageal pain. The patient's mother gave her TUMS to relieve the heartburn. The outcome for the events dyspepsia, somnolence and oesophageal pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD, VARCEL
Symptoms: Injection site cyst, Injection site erythema, Injection site pustule
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA # 667847) and refers to a 16 year old male patient. Patient's current illnesses, medical history and other medications were reported as none noted. No details about prior vaccination and lab data was provided. On 09-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M017983, dose 1, intramuscular in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II, VARIVAX, TENIVAC, IPOL, FLUZONE QUADRIVALENT, ENGERIX-B, and BEXSERO. On 11-NOV-2016, the patient developed 5 cm erythematous cyst to the upper deltoid region of the left arm and a 3 cm pustule to the left antecubital area. Both developed on day 2 and progressed until reported on 22-NOV-2016 (day 13). Patient's mother had taken child to see a physician, but reported condition has gotten worse each day. Advised to place hot compress on affected areas and seek medical attention. The outcome of injection site cyst, injection site pustule and injection site erythema was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 21-APR-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (dose, frequency and route were not reported), lot # L046897 with expiration date of 23-FEB-2017, for prophylaxis. The sterile diluent (lot # reported as M006117 with expiration date of 24-AUG-2018) used to reconstitute the ZOSTAVAX was properly stored. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 21-APR-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (dose, frequency and route were not reported), lot # L046897 with expiration date of 23-FEB-2017, for prophylaxis. The sterile diluent (lot # reported as M006117 with expiration date of 24-AUG-2018) used to reconstitute the ZOSTAVAX was properly stored. No adverse effects were reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse referring to a 38-year-old, non-pregnant female patient. The patient's current conditions included allergies to both penicillin and sulfamethoxazole (+) trimethoprim (BACTRIM), diabetes, hypertension and obesity. Concomitant therapies included unspecified stool softeners, ethinyl estradiol (+) levonorgestrel (KURVELO), fluticasone propionate (FLONASE), Vitamin B-12 (manufacturer unknown), unspecified multivitamins, iron tablets, terbinafine and cyclobenzaprine hydrochloride. On 02-MAY-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX23, subcutaneously, for prevention of pneumococcal disease (lot # M040804, expiration date 20-MAY-2018). That same day, the patient experienced swelling in her upper arm around the injection site and the swelling extended down into her forearm. The patient also experienced extreme skin irritation that was very painful. The patient went to her nurse practitioner for medical attention and received treatment with ice and "benegril". No lab diagnostic studies were performed. The patient recovered from the events injection site swelling, pain of skin, skin irritation and extensive swelling of vaccinated limb on an unspecified date in May 2017. The causal relationship between the events and therapy with PNEUMOVAX23 were not reported. The patient's nurse practitioner requested a lot check for the product because another patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS case No. 1705USA004122).   No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004122:
Age: 38.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a nurse referring to a 38-year-old, non-pregnant female patient. The patient's current conditions included allergies to both penicillin and sulfamethoxazole (+) trimethoprim (BACTRIM), diabetes, hypertension and obesity. Concomitant therapies included unspecified stool softeners, ethinyl estradiol (+) levonorgestrel (KURVELO), fluticasone propionate (FLONASE), Vitamin B-12 (manufacturer unknown), unspecified multivitamins, iron tablets, terbinafine and cyclobenzaprine hydrochloride. On 02-MAY-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX23, subcutaneously, for prevention of pneumococcal disease (lot # M040804, expiration date 20-MAY-2018). That same day, the patient experienced swelling in her upper arm around the injection site and the swelling extended down into her forearm. The patient also experienced extreme skin irritation that was very painful. The patient went to her nurse practitioner for medical attention and received treatment with ice and "benegril". No lab diagnostic studies were performed. The patient recovered from the events injection site swelling, pain of skin, skin irritation and extensive swelling of vaccinated limb on an unspecified date in May 2017. The causal relationship between the events and therapy with PNEUMOVAX23 were not reported. The patient's nurse practitioner requested a lot check for the product because another patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS case No. 1705USA004122).   No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004122:
Age: 38.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Pain of skin, Skin irritation
Clinical narrative: This spontaneous report was received from a nurse referring to a 38-year-old, non-pregnant female patient. The patient's current conditions included allergies to both penicillin and sulfamethoxazole (+) trimethoprim (BACTRIM), diabetes, hypertension and obesity. Concomitant therapies included unspecified stool softeners, ethinyl estradiol (+) levonorgestrel (KURVELO), fluticasone propionate (FLONASE), Vitamin B-12 (manufacturer unknown), unspecified multivitamins, iron tablets, terbinafine and cyclobenzaprine hydrochloride. On 02-MAY-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX23, subcutaneously, for prevention of pneumococcal disease (lot # M040804, expiration date 20-MAY-2018). That same day, the patient experienced swelling in her upper arm around the injection site and the swelling extended down into her forearm. The patient also experienced extreme skin irritation that was very painful. The patient went to her nurse practitioner for medical attention and received treatment with ice and "benegril". No lab diagnostic studies were performed. The patient recovered from the events injection site swelling, pain of skin, skin irritation and extensive swelling of vaccinated limb on an unspecified date in May 2017. The causal relationship between the events and therapy with PNEUMOVAX23 were not reported. The patient's nurse practitioner requested a lot check for the product because another patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS case No. 1705USA004122).   No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004122:
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 multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M041514, expiration date: 11-OCT-2018) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.29 degrees Fahrenheit) for 44 hours and for 44 hours and 1 minute. Data logger was involved. There were no previous excursions reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005634:
Sex: F
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 65 or older age group female patient. The patient's concurrent condition and concomitant therapies were not provided. On 15-APR-2017, the patient was inadvertently provided an unknown dose of PREVNAR by an unknown route today. The pharmacist stated that the patient was supposed to receive PREVNAR (dose, frequency, route, lot# and expiration date were unknown), which was not provided. The pharmacist also reported that the patient had received PREVNAR previously within 2 years of the accidental administration today. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report has been received from a Nurse, concerning a 70 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date in 2016 (reported as "last year", the patient was vaccinated with a dose of PREVNAR 13 (dose, strength, route of administration were not provided) for prophylaxis. Then approximately in April 2017 (reported as within the last month), the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, lot # reported as N0039997 and expiration date of 20-OCT-2018 (dose and frequency were not provided) for prophylaxis. In April 2017, the patient experienced blood red areas around the arm (erythema), swollen, warm to touch, nothing at the injection site. The patient was treated with MEDROL dose pack and ATARAX as also experienced itching. It was unknown by the reporter if laboratories studies were performed. The patient was recovering from these events on an unknown date in April 2017. However, in April 2017, the patient died. It was unknown whether an autopsy was performed. The patient's cause of death was not provided. The causal relationship between the therapy with PNEUMOVAX23 and the events of blood red areas around the arm, swollen, warm to touch, itching and death was not reported. Upon internal review the patient's death was considered medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1705USA004706: US-009507513-1705USA004705.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-APR-2017, the patient was vaccinated with an expired GARDASIL with lot # L039066 and expiration date on 19-MAR-2017 (strength, dose, frequency, route of administration and anatomical location were not provided), for prophylaxis. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's concurrent conditions and concomitant medication were not reported. The patient's medical history included several past episodes of shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient stated that usually, she had an outbreak of shingles every time she had a surgical procedure, because when she had surgical procedures that situation stressed her out. On an unspecified date, after receiving the ZOSTAVAX, the patient experienced a case of shingles, but, she reported that it was much milder. Additionally, the patient stated that she was pleased because her case of shingles was milder than her previous cases. At the time of reporting, the outcome for the event shingles was not reported. The causal relationship between the event and the suspect vaccine was not reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX23 lot number M402785, expiration date 06-JUN-2018 (dose, route of administration and anatomical location were not reported) were administered to the patients. No adverse effects were reported. On unknown dates, the doses were stored in the temperature 33.6 degrees Fahrenheit (F) for 19.5 hours which was detected by a digital data logger. No previous temperature excursion was reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005227:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002920 with expiration date of 30-SEP-2018, lot # M018625 with expiration date of 11-AUG-2018, lot # M035487 with expiration date of 23-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (33F) for 3 hours. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided.        This is one of several reports received from the same reporter.      Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001232:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # M031696 with expiration date of 26-MAY-2017, lot# M034896 with expiration date of 26-MAY-2017, lot# M039202 with expiration date of 11-MAR-2018, and lot# N005274 with expiration date of 03-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001229: US-009507513-1705USA001009: US-009507513-1705USA001232: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001228:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Ophthalmological examination normal, Polymerase chain reaction positive, Rash
Clinical narrative: This literature marketed report was received from the authors of the published literature article and refers to a 15 month old male previously healthy patient. On an unknown date, at the age of 12 months, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose and route of administration were not reported). On an unknown date, the patient presented with a red vesicular rash on the right upper cheek of 3 days' duration. The patient was otherwise asymptomatic and had no constitutional symptoms. The patient's mother reported an uncomplicated pregnancy and delivery with no history of maternal varicella-zoster virus (VZV) infection. There was no known exposure to other individuals with VZV or a history of a similar rash. On an unknown date, physical examination revealed vesicles and pustules with an erythematous base on the right zygoma extending to the right lateral canthus and upper eyelid in a dermatomal distribution. No lesions were present on any other area of the body. One group of vesicles was ruptured with a polyester-tipped applicator and submitted for polymerase chain reaction (PCR) analysis for suspected VZV infection. An ophthalmology evaluation revealed no ocular involvement. A clinical diagnosis of Herpes Zoster (HZ) was made and the patient was started on acyclovir 200 mg 4 times daily for 1 week. At 1-week follow-up, the lesions had cleared and the patient was asymptomatic. The PCR analysis confirmed the presence of VZV. Although no complications were noted on the ophthalmologist's initial examination or at the follow-up visit, 1 month later the patient's father noted a "cloudy change" to the right eye. The patient had several subsequent evaluations with ophthalmologists, on unknown dates, and was treated for HZ ophthalmicus with acyclovir over the following 10 months. The patient's mother reported eventual clearance of the eye findings without permanent visual sequelae. The authors considered the event as related with varicella virus vaccine live (manufacturer unknown). Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pustular, Rash vesicular, Varicella virus test positive, Vision blurred
Clinical narrative: This literature marketed report was received from the authors of the published literature article and refers to a 15 month old male previously healthy patient. On an unknown date, at the age of 12 months, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose and route of administration were not reported). On an unknown date, the patient presented with a red vesicular rash on the right upper cheek of 3 days' duration. The patient was otherwise asymptomatic and had no constitutional symptoms. The patient's mother reported an uncomplicated pregnancy and delivery with no history of maternal varicella-zoster virus (VZV) infection. There was no known exposure to other individuals with VZV or a history of a similar rash. On an unknown date, physical examination revealed vesicles and pustules with an erythematous base on the right zygoma extending to the right lateral canthus and upper eyelid in a dermatomal distribution. No lesions were present on any other area of the body. One group of vesicles was ruptured with a polyester-tipped applicator and submitted for polymerase chain reaction (PCR) analysis for suspected VZV infection. An ophthalmology evaluation revealed no ocular involvement. A clinical diagnosis of Herpes Zoster (HZ) was made and the patient was started on acyclovir 200 mg 4 times daily for 1 week. At 1-week follow-up, the lesions had cleared and the patient was asymptomatic. The PCR analysis confirmed the presence of VZV. Although no complications were noted on the ophthalmologist's initial examination or at the follow-up visit, 1 month later the patient's father noted a "cloudy change" to the right eye. The patient had several subsequent evaluations with ophthalmologists, on unknown dates, and was treated for HZ ophthalmicus with acyclovir over the following 10 months. The patient's mother reported eventual clearance of the eye findings without permanent visual sequelae. The authors considered the event as related with varicella virus vaccine live (manufacturer unknown). Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant. 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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot# M032641 with expiration date of 07-MAY-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No other information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002242: US-009507513-1705USA002244:
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: muscle spasm at the injection site; This information has been received from a Licensed Practical Nurse and an administrator concerning a patients of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # M038359 and expiration date on 13-MAY-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. On an unknown date, the patient experienced muscle spasm at the injection site. The outcome of muscle spasm at the injection site and the causal relationship between the event and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine office coordinator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-MAY-2017, the patient received an unspecified dose of improperly stored VARIVAX in immunization series, lot # M040138 with an expiration date of 28-SEP-2018 (dose, anatomical location and route of administration were not reported). Diluent used to reconstitute VARIVAX was properly stored. The administered dose of vaccine underwent a temperature excursion of 8.2 degrees Fahrenheit for 6 hours and 12 minutes which was detected by a data logger. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 certified medical assistance referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M041513 with expiration date 11-OCT-2018 (dosage and route of administration were not reported) for prophylaxis which was reconsituyed with properly stored diluent. The vaccines which were exposed to temperature excursion from -14°C to -10°C for an unknown time frame because of data logger. The previous temperature excursion was -14°C to -10°C for 21 hours and 15 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005396:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Death, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report has been received from a Nurse, concerning a 66 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date in 2016 (reported as "last year", the patient was vaccinated with a dose of PREVNAR 13 (dose, strength, route of administration were not provided) for prophylaxis. Then approximately in April 2017 (reported as within the last month), the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, lot # reported as N0039997 and expiration date of 20-OCT-2018 (dose and frequency were not provided) for prophylaxis. In April 2017, the patient experienced blood red areas around the arm (erythema), swollen, warm to touch, nothing at the injection site. The patient was treated with MEDROL dose pack and ATARAX as also experienced itching. It was unknown by the reporter if laboratories studies were performed. The patient was recovering from these events on an unknown date in April 2017. However, in April 2017, the patient died. It was unknown whether an autopsy was performed. The patient's cause of death was not provided. The causal relationship between the therapy with PNEUMOVAX23 and the events of blood red areas around the arm, swollen, warm to touch, itching and death was not reported. Upon internal review the patient's death was considered medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004706: US-009507513-1704USA013548.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Death, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report has been received from a Nurse, concerning a 72 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date in 2016 (reported as "last year", the patient was vaccinated with a dose of PREVNAR 13 (dose, strength, route of administration were not provided) for prophylaxis. Then approximately in April 2017 (reported as within the last month), the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, lot # reported as N0039997 and expiration date of 20-OCT-2018 (dose and frequency were not provided) for prophylaxis. In April 2017, the patient experienced blood red areas around the arm (erythema), swollen, warm to touch, nothing at the injection site. The patient was treated with MEDROL dose pack and ATARAX as also experienced itching. It was unknown by the reporter if laboratories studies were performed. The patient was recovering from these events on an unknown date in April 2017. However, in April 2017, the patient died. It was unknown whether an autopsy was performed. The patient's cause of death was not provided. The causal relationship between the therapy with PNEUMOVAX23 and the events of blood red areas around the arm, swollen, warm to touch, itching and death was not reported. Upon internal review the patient's death was considered medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513 -1704USA013548: US-009507513 -1705USA004705.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035696, expiration date 07-NOV-2017 (dose and route of administration were not reported). There was no adverse effect reported. Vaccines were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005086.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored VARIVAX with lot # L029472 and L050956, expiration dates on 06-AUG-2017 and 17-DEC-2017, respectively (strength, dose, frequency, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature and the time frame were unspecified by the reporter, but it was reported that there was a previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390: US-009507513-1705USA005342.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of ROTATEQ (oral; dose, frequency, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390: