chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test normal, Dizziness, Loss of consciousness
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and lightheadedness. In June 2016, the outcome of the passed out and lightheadedness were recovered/resolved. It was unknown if the reporter considered the passed out and lightheadedness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116035, reported by the same reporter.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 16cm x 16cm hard raised red, hot area (L) deltoid region encompassing site of hep A and MENACTRA-that were given more than an inch apart, developed within 24hrs of immunization, rapidly changing in size and in hr-red w/in 24 hours.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Received BEXSERO vaccine at 3pm. At 6pm he developed a fever of 102.5 and started to vomit. Vomited for 1 hour. Mother states symptoms resolved after 3 hours.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: About 10 minutes after receiving Tdap, the patient c/o itchy rashes all over both under arms spreading to upper arms.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: Neon green loose stools 5-6x/day for 13 days following Rotavirus vaccine.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain in arm, swelling at injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unknown number of unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K012457, expiry date: 04-JUN-2017). No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On 14-AUG-2016 ((two days too soon from the first dose), the patient was vaccinated with dose 2 of RECOMBIVAX HB) (dosing details not provided). Pharmacist reported that the patient received their first dose on 19-JUL-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX, 0.5 ml, subcutaneously, lot # K021936, expiration date 10-NOV-2016 (dose number, and anatomical location were unspecified). No adverse  effects reported. The reporter stated that he vaccine experienced previous unspecified defrost cycles with unspecified temperature and duration. The temperature excursion of this case was a defrost cycle exposed to a temperature of 13 F degrees for 30 minutes to 1 hour. Also, data logger in use was unspecified.  Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-year-old male patient. No concurrent conditions or medical history were provided. On 08-AUG-2016, the patient was vaccinated with a dose of PROQUAD, subcutaneously (strength, does, lot# and expiry date were unspecified). No concomitant medications were reported. No adverse effects were reported. Additional has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Patient's pertinent medical history drug reactions and allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provide). There were no concomitant medications reported. It was reported that "within the last month" approximately in July 2016, after receiving ZOSTAVAX the patient experienced an unusual rash in the hip area on unspecified date. It was reported that the patient sought medical attention with an unspecified healthcare provider and was prescribed an unspecified steroid for treatment. At the reporting time the outcome of the rash was unknown. The causal relationship between the rash and vaccination with ZOSTAVAX was not given by the reporting pharmacist. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Confusional state, Eye movement disorder, Fatigue, Hyperhidrosis, Muscle contractions involuntary
Clinical narrative: Fainted about 1 min. after vaccine, muscles contract, arms towards chest area with hands clenched. Eyes rolled up, unresponsive, lasted about 20 sec. then pt confused, not aware of what happened, felt tired and sweaty, vomiting. TX: rest, sponge towel and sips fluids.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Fainted about 1 min. after vaccine, muscles contract, arms towards chest area with hands clenched. Eyes rolled up, unresponsive, lasted about 20 sec. then pt confused, not aware of what happened, felt tired and sweaty, vomiting. TX: rest, sponge towel and sips fluids.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist referring to herself a currently 67 years old  non pregnant female patient. Patient's concurrent conditions and medical history included hypertension, hypothyroidism, arthritis and allergy to nitrofurantoin. On an unknown date in 2013 (reported as at least 3 years ago) the patient was administered a dose of ZOSTAVAX (concentration, dose, lot # and expiry date were not provided) intramuscularly, rather than recommended subcutaneous. Concentration, dose, lot # and expiry date were not provided. Concomitant medications were reported as none. The patient reported that on 14-AUG-2016 she was "been diagnosed with a zoster like rash". She received an unspecified treatment. At the reporting time the outcome regarding of the "zoster like rash" was not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse reporting on herself a 62 year old female patient with previous case of shingles and drug reactions and allergies to TALWIN, BENTYL and Vancomycin. In approximately june 2016 ("reported as about 2 months ago" (prior to 5-AUG-2016)) the patient was vaccinated with ZOSTAVAX 19400 PFU(dose, lot number, expiration date not reported) subcutaneously. Patient'sconcomitant medications included Atenolol, LEXAPRO, zolpidem(manufacturer unknown), Lisinopril(manufacturer unknown) and BONIVA. Subsequently on unspecific date in June 2016(reported as "within 24 hours") after administration of ZOSTAVAX 19400 PFU she developed a red, raised area 3 inches in diameter around the injection site in her left arm which was warmth to the touch and "hurt like hell. The patient also developed a rash around the injection site. The patient sough medical attention by visiting the physician on unspecified date in 2016, but none labs diagnostic studies were performed nor treatment was given. It was reported that the red raised area, warmth and pain at the injection site resolved "after about a week" (recovered unspecified date in 2016). The rash persisted for "several weeks" until it began "fading" (recovered unspecified date in 2016). The patient also reported that the skin where the rash was, is now discolored, described as lavender in color and "very noticeable"(not recovered). The nurse did not think the discoloration was due to the scarring.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse reporting on herself a 62 year old female patient with previous case of shingles and drug reactions and allergies to TALWIN, BENTYL and Vancomycin. In approximately june 2016 ("reported as about 2 months ago" (prior to 5-AUG-2016)) the patient was vaccinated with ZOSTAVAX 19400 PFU(dose, lot number, expiration date not reported) subcutaneously. Patient'sconcomitant medications included Atenolol, LEXAPRO, zolpidem(manufacturer unknown), Lisinopril(manufacturer unknown) and BONIVA. Subsequently on unspecific date in June 2016(reported as "within 24 hours") after administration of ZOSTAVAX 19400 PFU she developed a red, raised area 3 inches in diameter around the injection site in her left arm which was warmth to the touch and "hurt like hell. The patient also developed a rash around the injection site. The patient sough medical attention by visiting the physician on unspecified date in 2016, but none labs diagnostic studies were performed nor treatment was given. It was reported that the red raised area, warmth and pain at the injection site resolved "after about a week" (recovered unspecified date in 2016). The rash persisted for "several weeks" until it began "fading" (recovered unspecified date in 2016). The patient also reported that the skin where the rash was, is now discolored, described as lavender in color and "very noticeable"(not recovered). The nurse did not think the discoloration was due to the scarring.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 15-AUG-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # K011188, expiration date 12-AUG-2016, (dose, route and anatomical location were unspecified). 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 registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies as provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX injection, subcutaneously, lot # L050560 with expiry date 14-DEC-2017 and lot # L010146 with expiry date 24-MAR-2016 (dose and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Viral rash
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient. The patient's medical history and concurrent conditions were not reported. On 06-JUL-2016, ,the patient was vaccinated subcutaneous in the right with a first dose of VARIVAX (lot # reported as M001662, expiry date was not reported). On 15-JUL-2016 (also reported as 4-5 days after vaccination), the patient experienced bumpy rash to thigh, which spread to full body and viral exanthema. On 22-JUL-2016, the patient recovered from the adverse events. The causal relationship between the adverse events and the vaccination with VARIVAX was not reported. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. Medical assistant reported that on unknown dates, the patients received improperly stored VARIVAX (lot # M000998, expiry date: 07-JAN-2018; lot # M020899, expiry date: 27-APR-2018; l0t # L029466, expiry date: 06-AUG-2017; lot # M006724, expiry date: 08-FEB-2018; lot # K021930, expiry date: 10-NOV-2016; lot # M004330, expiry date: 26-JAN-2018. No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Shaking and pains at the points of injection.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Tremor
Clinical narrative: Shaking and pains at the points of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Father reported seeing a red rash at the injection site. He noticed it for the first time during the patients bath on the night of 08/16/2016. The patient was evaluated at the urgent care and diagnosed with an adverse reaction to vaccine. He was advised to use ZYRTEC and Ibuprofen for redness, swelling and any pain. The patient came back on 08/17/2016 to urgent care for continued redness and no improvement. Was again diagnosed with adverse reaction to vaccine, with possible cellulitis. Patient encouraged to continue use of ZYRTEC, ibuprofen. They were given a new rx for prednisolone and hydrocortisone topical. Patient was seen for a follow up on 08/20/2016. The rash improved significantly with the steroid and hydrocortisone. Some redness remained on 08/20/2016. The patient was encouraged to finish the steroid and use hydrocortisone until the redness has resolved completely. There were no signs of infection at the visit on 08/20/2016. He was referred for a consult with Allergy for evaluation of possible allergic response to vaccinations as pt will need a Tdap in the future.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Vaccination complication
Clinical narrative: Father reported seeing a red rash at the injection site. He noticed it for the first time during the patients bath on the night of 08/16/2016. The patient was evaluated at the urgent care and diagnosed with an adverse reaction to vaccine. He was advised to use ZYRTEC and Ibuprofen for redness, swelling and any pain. The patient came back on 08/17/2016 to urgent care for continued redness and no improvement. Was again diagnosed with adverse reaction to vaccine, with possible cellulitis. Patient encouraged to continue use of ZYRTEC, ibuprofen. They were given a new rx for prednisolone and hydrocortisone topical. Patient was seen for a follow up on 08/20/2016. The rash improved significantly with the steroid and hydrocortisone. Some redness remained on 08/20/2016. The patient was encouraged to finish the steroid and use hydrocortisone until the redness has resolved completely. There were no signs of infection at the visit on 08/20/2016. He was referred for a consult with Allergy for evaluation of possible allergic response to vaccinations as pt will need a Tdap in the future.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Itching, redness, heat, radiating outwards from injection site at left deltoid, reaching arm and face. Administered 50 mg diphenhydramine IM, reaction subsided. Patient was observed until 6 pm then cleared to return home.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Skin warm
Clinical narrative: Itching, redness, heat, radiating outwards from injection site at left deltoid, reaching arm and face. Administered 50 mg diphenhydramine IM, reaction subsided. Patient was observed until 6 pm then cleared to return home.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy site unspecified abnormal, Blood test abnormal, Coeliac disease
Clinical narrative: My daughter developed celiac disease symptoms about 4 months after her 3rd dose of HPV vaccine. She never had ANY symptoms before that.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Face injury, Lip injury, Loss of consciousness, Syncope
Clinical narrative: Vasovagal syncope fainting. Patient had stood up, despite being instructed to sit, passed out and hit face on carpeted floor. Although he did slightly bust his lip, no other injuries were noted, and patient was immediately alert and responsive. He lied on the floor, then slowly rose a bit later. He was observed for 20 more minutes, then allowed to leave with his mother.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Vasovagal syncope fainting. Patient was still sitting in immunization chair. Immunization had been completed. Approximately 10 seconds following vaccination, patient fainted and his head fell back against the wall behind his chair. He was moved down to the floor, where he slowly regained consciousness. He lied on the floor approximately 10 minutes, then slowly sat up on the floor, then was moved to a chair, where he relaxed with a cool, wet towel and drink. He was observed for 20 more minutes, then allowed to leave with his mother. His mother did note that he had done this same thing (syncope) after a Rocephin injection as a young child.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient presented to MD office with redness at site of injection. MD diagnosed cellulitis and prescribed cephalexin.
Age: 25.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient reports soreness of the arm that he received two immunizations on the day prior. No other symptoms reported. Told patient to move arm and to take ADVIL/ALEVE/acetaminophen to help with pain if needed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Conjunctivitis, Cough, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Sore arm starting day of vaccination, was given ibuprofen. One week after vaccination, severe conjunctivitis, fever 103, runny nose, cough. Sought treatment from Naturopath.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Cough, Decreased appetite, Pyrexia, Rhinorrhoea
Clinical narrative: First noted conjunctivitis then the following day it became severe. Then fever, anorexia, runny nose, cough developed. After 4-5 days I took her to pediatrician who recommended treating the conjunctivitis. I sought advice of a colleague who is a naturopath and with her help, my daughter fully recovered within about 3 days.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Asthenia, Guillain-Barre syndrome, Tremor
Clinical narrative: Total body weakness and shaking, couldn't speak was taken to the hospital.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash, Seizure
Clinical narrative: High fever, seizure, rash, loss of appetite, diarrhea.
Age: 11.0
Sex: F
Vaccine: HPV4, TD
Symptoms: Oropharyngeal pain, Pain, Streptococcal infection, Vomiting
Clinical narrative: Throwing up and pain all over and sore throat.
Age: 30.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Generalised erythema, Pain, Swollen tongue, Urticaria
Clinical narrative: Pain, slight swelling of tongue, whole body redness, small hives.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Swelling in sire of injection radiating towards elbow. Redness and hot.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Disorientation, Dysarthria, Feeling abnormal, Hyporesponsive to stimuli
Clinical narrative: Patient became disoriented 10 minutes after vaccine was administered and he had a difficult time focusing with his eyes and fell asleep the car. Slurred speech and slow response when asked questions. Then he began to feel sick that night. Woke up and could not walk due to pain and nausea which continued throughout day and night. Face rash. pale skin. feels like he ingested gluten.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Nausea, Pain, Pallor, Rash
Clinical narrative: Patient became disoriented 10 minutes after vaccine was administered and he had a difficult time focusing with his eyes and fell asleep the car. Slurred speech and slow response when asked questions. Then he began to feel sick that night. Woke up and could not walk due to pain and nausea which continued throughout day and night. Face rash. pale skin. feels like he ingested gluten.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Somnolence, Vision blurred
Clinical narrative: Patient became disoriented 10 minutes after vaccine was administered and he had a difficult time focusing with his eyes and fell asleep the car. Slurred speech and slow response when asked questions. Then he began to feel sick that night. Woke up and could not walk due to pain and nausea which continued throughout day and night. Face rash. pale skin. feels like he ingested gluten.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Ultrasound scan normal
Clinical narrative: On date of vaccination pt's birth control pill was increased from Junel 1.5 to Sprintec due to GYN concerns of dyspareunia/dysmenorrhea/menorrhagia. She was also give the vaccine uncomplicated administration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea haemorrhagic, Pain in extremity, Pyrexia, Rash generalised, Vomiting
Clinical narrative: My daugther got a rash all over her body, fever, red/bloody looking diarrhea, and vomiting. Vomiting was only one or twice. I think that she is also experiencing arm pain because something she walks around holding her arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: X-ray
Clinical narrative: My daugther got a rash all over her body, fever, red/bloody looking diarrhea, and vomiting. Vomiting was only one or twice. I think that she is also experiencing arm pain because something she walks around holding her arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L043624, 3-NOV-2017, lot # M000761, 06-JAN-2018; lot # L005299, 17-FEB-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Administered ZOSTAVAX/shingles vaccine and realized after the fact that patient is on immunosuppressants. Patient had checked off "no" for having been on any. No side effects occurred as far as we know 8/19/16.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from licensed vocational nurse practitioner via company representative regarding 5 patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in July 2016, the patients received unspecified doses of VARIVAX immunization series that were improperly stored (Lot # M006731, expiry date: 09-FEB-2018). Temperature time frame: 14.5 F, 6 hours and 24 minutes cumulatively. There was previous temperature excursion. The call was because of data logger. The nurse stated that the vaccinations occurred between 15-JUL-2016 to 22-JUL-2016. No adverse effects were reported. No product quality  complaint (PQC) was involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP
Symptoms: Blood glucose normal, Clonus, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: At 10:18am patient felt dizzy and became clonic for 15 seconds as we were about to slide patient to floor he reacted. Alert and oriented X3 but SOB, diaphoretic, pulse 30, respiration 12. As per MD orders oxygen 2L p/min via nasal cannula and Epi-pen was administered 0.15mg to right thigh at 10:20am, blood sugar 93mg/dL. Patient left in ambulance at 10:29am O2 99 and pulse 63.
Sex: U
Vaccine: RV5
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. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients' were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067, expiration date 06-APR-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 0.0 degree Celsius for 9 hours. Previous excursions were 1.4 degree Celsius for 14 minutes, 0.0 C for 11 hours and 43 minutes,0.7 degree Celsius for 12 hours and 53 minutes 0.0 C for 10 hours and 36 minutes 0.6 degree Celsius for 46 minutes and 32 degree Fahrenheit for 4 hour and 20 minutes. The temperature excursions were detected by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of three reports received 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 was received from a nurse regarding unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients' were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L033690, expiration date 14-JUN-2018 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 0.0 degree Celsius for 9 hours. Previous excursions were 1.4 degree Celsius for 14 minutes, 0.0 C for 11 hours and 43 minutes,0.7 degree Celsius for 12 hours and 53 minutes 0.0 degree Celsius for 10 hours and 36 minutes, 0.6 degree Celsius for 46 minutes and 32 degree Fahrenheit for 4 hour and 20 minutes. The temperature excursions were detected by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of three 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. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients' were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #L019297, expiration date 15-AUG-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 0.0 degree Celsius for 9 hours. Previous excursions were 1.4 degree Celsius for 14 minutes, 0.0 C for 11 hours and 43 minutes,0.7 degree Celsius for 12 hours and 53 minutes 0.0 degree Celsius for 10 hours and 36 minutes, 0.6 degree Celsius for 46 minutes and 32 degree Fahrenheit for 4 hour and 20 minutes. The temperature excursions were detected by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one three reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from the patient's husband referring to his wife, a 75 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (batch # reported as MJ1356, expiration date 15-OCT-2017, dose not reported) intramuscularly in left arm near the shoulder. On 29-JUL-2016 (reported as "the next morning"), the patient could not move her left arm, had chills, fever and was shaking. Therefore, the husband took the patient to an unspecified emergency room. The patient vomited violently on the way to the emergency room. The patient was given unspecified intravenous (IV) fluids in the emergency room and kept for several hours. The patient still had soreness in the left arm and the left hand was swollen. The outcome of the events was reported as not resolved. The causality between PNEUMOVAX 23 and the events was not provided. Lot number MJ1356 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting
Clinical narrative: Information has been received from the patient's husband referring to his wife, a 75 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (batch # reported as MJ1356, expiration date 15-OCT-2017, dose not reported) intramuscularly in left arm near the shoulder. On 29-JUL-2016 (reported as "the next morning"), the patient could not move her left arm, had chills, fever and was shaking. Therefore, the husband took the patient to an unspecified emergency room. The patient vomited violently on the way to the emergency room. The patient was given unspecified intravenous (IV) fluids in the emergency room and kept for several hours. The patient still had soreness in the left arm and the left hand was swollen. The outcome of the events was reported as not resolved. The causality between PNEUMOVAX 23 and the events was not provided. Lot number MJ1356 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, 17-AUG-2018; lot # L051123, 13-OCT-2018, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site reaction, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Red Rash 2 inches by 1 inch around injection site. Slightly itchy, hard to touch and warm.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient developed shooting pains in body along with chills and 101 degree fever.  (no pain at injection site).
Age: 0.28
Sex: M
Vaccine: PNC13
Symptoms: Communication disorder, Fatigue, Immediate post-injection reaction, Irritability, Lethargy
Clinical narrative: Immediate Lethargy. Low Grade Fever 101 for Three Hours. Increased Tiredness. Fussiness. Protruding Tongue. Second day and still remaining symptoms: Fussiness. Protruding Tongue. Trouble Bearing Weight. Loss of cooing and vocalizing. Child was extremely vocal and interactive at 3 months. Tongue protruding and very little communication. Still maintaining eye contact, but definitely a difference.
Age: 0.28
Sex: M
Vaccine: PNC13
Symptoms: Protrusion tongue, Pyrexia, Speech disorder, Weight bearing difficulty
Clinical narrative: Immediate Lethargy. Low Grade Fever 101 for Three Hours. Increased Tiredness. Fussiness. Protruding Tongue. Second day and still remaining symptoms: Fussiness. Protruding Tongue. Trouble Bearing Weight. Loss of cooing and vocalizing. Child was extremely vocal and interactive at 3 months. Tongue protruding and very little communication. Still maintaining eye contact, but definitely a difference.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient said there was some itching after the injection. The site was not red at the site 15 minutes after injection. She said there is a small red bump that is warm to the touch at the injection site and is still present 2 days later.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe arm pain at injection site and inability to lift arm. Still having significant pain when attempting to raise arm over head 14 days post injection.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient describe as having fever all day the next day. Area of injection swollen and red, body ache all day.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient called the day after she had received a PNEUMOVAX vaccine stating that her arm was red, swollen, and it hurt to move it. I instructed her to take an antihistamine, ibuprofen and put some ice on it. I called back about 2 hours later to check on her and she stated that the medication did help but her arm was still painful. I asked her to come to the pharmacy so that I could look at it. The patient's arm was red, swollen, and warm to the touch around the injection site so I instructed her to go to urgent care. She was seen by a nurse practitioner who diagnosed her with cellulitis due to the vaccine and gave her an antibiotic. Upon follow up today around 5:00 PM she stated that her arm was still red, swollen, and painful. She is to see her family care physician tomorrow (8/22/16). I instructed the patient to continue with her antibiotic as well as ibuprofen, antihistamine, ice, and to elevate her arm until seen by her physician.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Vaccination complication
Clinical narrative: The patient called the day after she had received a PNEUMOVAX vaccine stating that her arm was red, swollen, and it hurt to move it. I instructed her to take an antihistamine, ibuprofen and put some ice on it. I called back about 2 hours later to check on her and she stated that the medication did help but her arm was still painful. I asked her to come to the pharmacy so that I could look at it. The patient's arm was red, swollen, and warm to the touch around the injection site so I instructed her to go to urgent care. She was seen by a nurse practitioner who diagnosed her with cellulitis due to the vaccine and gave her an antibiotic. Upon follow up today around 5:00 PM she stated that her arm was still red, swollen, and painful. She is to see her family care physician tomorrow (8/22/16). I instructed the patient to continue with her antibiotic as well as ibuprofen, antihistamine, ice, and to elevate her arm until seen by her physician.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: Patient called while in his car stating that his face is all red 1 hr after receiving FLUCELVAX.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling redness and itching at injection site. Back of left arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Severe fatigue within 2 hours of receiving injection, body aches and headache within 4 hours of injection, diarrhea within 24 hours which continued for at least 36 hours; accompanied by severe stomach cramps and nausea. 48 hours later, the injection site was itchy, red, raised and swollen with a couple of red rashes. It is disappating but not completely gone and today is 8/21/2016.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Nausea, Pain
Clinical narrative: Severe fatigue within 2 hours of receiving injection, body aches and headache within 4 hours of injection, diarrhea within 24 hours which continued for at least 36 hours; accompanied by severe stomach cramps and nausea. 48 hours later, the injection site was itchy, red, raised and swollen with a couple of red rashes. It is disappating but not completely gone and today is 8/21/2016.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Severe fatigue within 2 hours of receiving injection, body aches and headache within 4 hours of injection, diarrhea within 24 hours which continued for at least 36 hours; accompanied by severe stomach cramps and nausea. 48 hours later, the injection site was itchy, red, raised and swollen with a couple of red rashes. It is disappating but not completely gone and today is 8/21/2016.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Pyrexia, Rash, Vomiting
Clinical narrative: Low grade fever on 8th and 9th day. Treated with TYLENOL and MOTRIN. Rash (mainly on chest, belly, and back) some on face and legs. Cough on 10th day and vomited at night.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event, Cervix carcinoma, Death
Clinical narrative: This spontaneous report as received from a health professional via a company representative refers to a patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date in May of 2015, the reporter discussed in an unknown article that she is now pressing "red alert button on the devastating consequences and irrelevancy of the vaccine". The reporter stated in the article that the HPV vaccine is "more dangerous that the HPV Virus". The reporter also stated "there were many unknown severe adverse events that occurred and multiple unknown deaths as there are cervical cancer cases developing each year after vaccination with HPV vaccine". The HPV vaccine discussed in the article could not be verified as GARDASIL, GARDASIL 9 or product from another company. The outcome of cervix carcinoma and death was reported as fatal. The outcome of adverse event was unknown. The reporter considered the events to be related to the suspect therapies. Upon internal review, the events of cervix carcinoma and death were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a 16 year old female patient. The patient was not pregnant. The patient had previous history of hives and irritable bowel syndrome. The patient's drug reactions/allergies and concomitant medication were unknown. On 11-AUG-2016, the patient was vaccinated with GARDASIL 9 (intramuscular; dose, lot # and expiration date were unknown). On 12-AUG-2016, the patient developed hives. The patient visited her doctor to seek medical attention. Unspecified treatments were given. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) (the third of three patients) who on 11-JUL-2016 was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. [Reference MARRS # WAES1607USA005542 for the first of 3 (unknown) patients who was vaccinated on 22-JUN-2016 with a dose of expired PNEUMOVAX 23 (lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). Reference MARRS # WAES1608USA010414 for the second of three (unknown) patients who was vaccinated on 07-JUL-2016 with a dose of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported)]. The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have ben no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site reaction, Pruritus
Clinical narrative: Injection local site reaction. Redness, itchy arm after vaccine for 2 days. Ice packs.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Shaking, fever of 102 F, chills, he went to hospital.
Age: 61.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: ZOSTAVAX subq shot given 8/19/16 in right upper arm. Patient has heat, redness and tenderness around injection site. The site appears swollen. Swelling has increased over past 24 hr. Swollen site appears to be about 4 inches in diameter.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: 8-17-16 AM, patient woke up with sore arm, difficulty moving arm and pain. 8-18-16 Patient slept half of day because of pain, pain subsided a little but still had difficulty moving. 8-19-16 AM Pain decrease, red color appeared from shoulder to elbow. 8-20-16 Redness, redness reducing, arm movement much better, still a little sore.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) who on 22-JUN-2016 (was the first of three patients) who was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. The second unknown patient (gender not specified) (Reference MARRS # WAES1607USA010414) was vaccinated on 06-JUL-2016 with a dose of expired PNEUMOVAX 23 (lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The third unknown patient (gender not specified) Reference MARRS # WAES1608USA010415) was vaccinated on 11-JUL-2016 with a dose of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have ben no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) who on 06-JUL-2016 (the second of three patients) was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. The second unknown patient (gender not specified) (Reference MARRS # WAES1607USA005542 for the first of 3 (unknown) patients who was vaccinated on 22-JUN-2016 with a dose of expired PNEUMOVAX 23 (Lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported).  Reference MARRS # WAES1608USA010415) for the third of three (unknown) patients who was vaccinated on 11-JUL-2016 with a dose of expired of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have been no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.