chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also an office manager) refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ (lot # L029615 with expiry date 15-MAY-2017 and lot # L035510 with expiry date 13-MAY-2017; dose was not reported). These doses were exposed to 56 F for 798 hours and 33 F for 273 hours. There were no previous excursions. Data logger was not involved. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of ROTATEQ per oral route, lots # L033548 and L013206 with expiration dates 14-MAY-2017 and 29-JAN-2017 respectively, (concentrations and dosages were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010369, 1608USA010370, 1608USA010372). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patient and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of VAQTA lots # L041676 and M011116 with expiration date 15-APR-2017 and 17-JUN-2017 respectively, (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS# 1608USA009575, 1608USA010369, 1608USA010370, 1608USA010371). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22 year old female patient. The patient's medical history and concurrent conditions were not reported. On 17-AUG-2016, the patient was vaccinated with the third dose of M-M-R II Lot # K011317, expiration date: 13-AUG-2016 (route of administration not reported). The patient stated that she received two doses of M-M-R II as a child (on unspecified dates). There were no concomitant medications reported. On an unknown date, the patient had serologic testing and it result in negative titers for measles, mumps and rubella. At the time of the report, the outcome of measles, mumps and rubella test was reported as recovering. The reporter did not assess the causality between of M-M-R II and the events. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Pt was given flu shot- The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis staphylococcal, Erythema, Peripheral swelling
Clinical narrative: Pt was given flu shot- The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling
Clinical narrative: Pt was given flu shot- The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Pt was given flu shot - The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling
Clinical narrative: Pt was given flu shot - The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Drooling, Staring, Tremor
Clinical narrative: Pt in middle of night started shaking, drooling with blank stare in eyes lasting approx. 2-3 min. Mother took in to ER, ERMD thinks symptoms may R/T Immunizations side effects - he took PEDIARIX, HIB, PCV13.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Hyperhidrosis, Hyperventilation, Laboratory test normal, Tetany
Clinical narrative: Father informed Dr. that shortly after MENACTRA and BEXSERO were given in the office 8/19/2016, Pt. experienced some very bad abd. pain which lasted 10-15 mins. Followed by diaphoresis, hyperventilation, and then carpopedal spasm - Received IV flds in ER and then sent home - Symptoms had resolved when arrived in ER.  8/20/16
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Erythema of eyelid, Eyelid oedema, Tenderness
Clinical narrative: Progressive increased erythema. Edema to (R) peri-orbital (R) eyelid area with slight tenderness (10/3/10) on palpation. Sent to workers comp-> CONCENTRA.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Pt state right "achy" arm down to elbow sight of FLUZONE high dose.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches, headaches, swollen lymph nodes and high body temperature the day after receiving the vaccine. The patient went to the doctor and was diagnosed with having cellulitis.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm pain and fever.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Patient complains of bruise and arm swelling two days after vaccination received AFLURIA 2016-14/PNEUMOVAX 23.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient complains of bruise and arm swelling two days after vaccination received AFLURIA 2016-14/PNEUMOVAX 23.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: R arm pain and stiffness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At the site of MMRV injection on (R) thigh developed about 1.5" oval redness, mild swelling, local warmth and tenderness. These symptoms developed this am. No itching, no systemic symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Diarrhoea, Injection site nodule, Injection site pain
Clinical narrative: 2 days later knot to Rt. deltoid/tenderness/diarrhea and Rt. knee pain.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in to show the arm that she had gotten ZOSTAVAX injection in. It was swollen, red and hot at injection site - Also slightly painful to touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: 8/10/16 - Pt. Received MMR, Varicella, HepA, PVC 13. 8/11/16 - Pt. Developed 101 fever and rash, all over body. 8/16/16 - No fever, Rash still Presenting. 8/18/16 No rash present.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: Had chills and shakes and threw up. Went to ER approximately 2 hr after shot. Gave fluids and recovered.
Age: 51.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Eye swelling, Lacrimation increased, Ocular hyperaemia, Paraesthesia
Clinical narrative: 8-16-16-Dose #1 TWINRIX and Typhoid VI. 8-171-6 red swollen tingling watery eyes.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: Pt. awoke with redness and swelling around injection site and also facial swelling, eyes puffy.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Red rash welts over all of body. MD prescribed BENADRYL, lactate ringers.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Pallor
Clinical narrative: Patient had came in for vaccines, and after receiving the following 2 vaccines became pale. Pt. stated "I feel funny" and his eye rolled back in his head. Pt. was immediately layed down and felt fine within seconds to 1 minute of incident. Pt. was given a cold cloth and water to drink. Blood pressure 96/62.
Age: 71.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Cellulitis, Erythema, Pain, Pruritus
Clinical narrative: Several days after injection pt noticed increased soreness, itching, significant redness, was over the weekend when provider office closed. Pt's dgtr outlined red area with marker; on Monday 8/22/16 pt seen by MD, redness spread to pt's elbow, treated w/2 injections of 1 gram each of ceftriaxone (1 gram on 8/22/16 and 1 gram on 8/23/16) for cellulitis.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Headache, Insomnia, Oropharyngeal pain, Pain
Clinical narrative: Fever 101.4, bodyaches, insomnia, sore throat, dizziness, headache. Treating with TYLENOL and drinking alot of fluids.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 101.4, bodyaches, insomnia, sore throat, dizziness, headache. Treating with TYLENOL and drinking alot of fluids.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (L) arm red swollen - warm to touch.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Rash
Clinical narrative: Rash to cheeks, arms and legs after immunizations given 08/22/16 at night and running a temperature 101.9 ax per mother. Mother gave child TYLENOL q 8 hrs on 08/22/16 and then MOTRIN on 08/23/16 at 10:00 am and then 5:00 pm.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Hallucination, Headache, Malaise, Nightmare
Clinical narrative: Vaccine administered in the afternoon. That night, pt started with headache, vomiting, body aches, malaise, nightmares, hallucinating and uncontrollable sobbing. No fever. Husband reports symptoms have lessened since the night time.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Vomiting
Clinical narrative: Vaccine administered in the afternoon. That night, pt started with headache, vomiting, body aches, malaise, nightmares, hallucinating and uncontrollable sobbing. No fever. Husband reports symptoms have lessened since the night time.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Headache, Injection site pain
Clinical narrative: Sat evening started w/fever 100-101.7, headache, sore throat, swollen neck, low back pain, vomiting, diarrhea, stomach cramps, severe pain at injection site. IV fluids, doxycycline, prednisone.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Sat evening started w/fever 100-101.7, headache, sore throat, swollen neck, low back pain, vomiting, diarrhea, stomach cramps, severe pain at injection site. IV fluids, doxycycline, prednisone.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash began 8/19/16. Received MM2 8/2/16.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Incisional drainage, Peripheral swelling
Clinical narrative: Pt said after getting the vaccine on 6/14, her arm swelled up after a couple of days. The doctor had to drain 2 cups of fluids from her arm. She was diagnosed with cellulitis.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain at vaccination site for 2 weeks. Fatigue for 2 weeks.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients' of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients received unspecified doses of improperly stored ROTATEQ (lot # L039141, expiry date 16-AUG-2017), concentration, dose, route of administration were not provided, orally. It was reported that the temperature excursion was for cumulative 95 hours 24 minutes at -1.1C, according to the data logger. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist referring to a 62 years old female patient. The patient's medical history included shingles (resolved on approximately 21-MAY-2016, reported as 30 days prior to receiving ZOSTAVAX). The patient was allergic to penicillin, sulfa medications, iodine, morphine, cephalosporins  and methadone. On 20-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml/1 vial (lot # L032402, expiration date 26-NOV-2016) subcutaneously. Concomitant therapies included amlodipine and metoprolol. On 21-JUN-2016, the patient experienced "a lump" at the  injection site (left deltoid) that had been getting worse. Pharmacist instructed the patient to use hydrocortisone cream and cold compresses on the affected area. No lab diagnostics test was performed. On 01-JUL-2016,  the  patient called pharmacist and stated "I found 4 blistery bumps under the left breast, they looked like previous shingles rash I had before." The patient was advised to see a physician and the physician prescribed acyclovir and triamcinolone cream. The outcome of the injection site mass was reported as not recovered; the outcome of blistery bumps was unknown. Reporter's causality was not reported. Follow up information has been received from the pharmacist on 23-AUG-2016 and refers to a female patient. The patient's concurrent conditions also included high blood pressure, food allergies to strawberries, watermelon, tomatoes and kiwi and allergy to propoxyphene. On 20-JUN-2016 at 12:00, the patient was vaccinated with her first dose of ZOSTAVAX. The vaccine was purchased with private funds. On 29-JUN-2016, the patient experienced 3-4 bumps  /  cluster  under left breast on stomach. Flair  ups  happened when the patient got too hot or sweaty. The patient was prescribed acyclovir 800 mg and triamcinolone 0.1% cream. The outcome of 3-4 bumps  /  cluster  under left breast on stomach was reported as not recovered (previously reported as unknown). The reporter considered 3-4 bumps  /  cluster  under left breast on stomach to be medically significant as it required medical or surgical intervention. Additional information is not expected as all information was obtained. Patient, product, event and analysis tab were updated.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash vesicular
Clinical narrative: Information has been received from a pharmacist referring to a 62 years old female patient. The patient's medical history included shingles (resolved on approximately 21-MAY-2016, reported as 30 days prior to receiving ZOSTAVAX). The patient was allergic to penicillin, sulfa medications, iodine, morphine, cephalosporins  and methadone. On 20-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml/1 vial (lot # L032402, expiration date 26-NOV-2016) subcutaneously. Concomitant therapies included amlodipine and metoprolol. On 21-JUN-2016, the patient experienced "a lump" at the  injection site (left deltoid) that had been getting worse. Pharmacist instructed the patient to use hydrocortisone cream and cold compresses on the affected area. No lab diagnostics test was performed. On 01-JUL-2016,  the  patient called pharmacist and stated "I found 4 blistery bumps under the left breast, they looked like previous shingles rash I had before." The patient was advised to see a physician and the physician prescribed acyclovir and triamcinolone cream. The outcome of the injection site mass was reported as not recovered; the outcome of blistery bumps was unknown. Reporter's causality was not reported. Follow up information has been received from the pharmacist on 23-AUG-2016 and refers to a female patient. The patient's concurrent conditions also included high blood pressure, food allergies to strawberries, watermelon, tomatoes and kiwi and allergy to propoxyphene. On 20-JUN-2016 at 12:00, the patient was vaccinated with her first dose of ZOSTAVAX. The vaccine was purchased with private funds. On 29-JUN-2016, the patient experienced 3-4 bumps  /  cluster  under left breast on stomach. Flair  ups  happened when the patient got too hot or sweaty. The patient was prescribed acyclovir 800 mg and triamcinolone 0.1% cream. The outcome of 3-4 bumps  /  cluster  under left breast on stomach was reported as not recovered (previously reported as unknown). The reporter considered 3-4 bumps  /  cluster  under left breast on stomach to be medically significant as it required medical or surgical intervention. Additional information is not expected as all information was obtained. Patient, product, event and analysis tab were updated.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Dizziness, Head discomfort
Clinical narrative: This spontaneous report was received from a 72 year old female consumer. She had allergies to aspirin, penicillin and sulfa. Concomitant medications included ZETIA and levothyroxine. On 16-JUN-2016, the female received ZOSTAVAX at a pharmacy. Right after getting it, she felt dizzy. The pharmacist took her blood pressure which was high. An ambulance was called and she was taken to the Emergency Room. An electrocardiogram was performed which was "fine". She was released. The next couple of weeks, her blood pressure would go up every couple of days. The outcome of the event was unknown. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Hypertension, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a 72 year old female consumer. She had allergies to aspirin, penicillin and sulfa. Concomitant medications included ZETIA and levothyroxine. On 16-JUN-2016, the female received ZOSTAVAX at a pharmacy. Right after getting it, she felt dizzy. The pharmacist took her blood pressure which was high. An ambulance was called and she was taken to the Emergency Room. An electrocardiogram was performed which was "fine". She was released. The next couple of weeks, her blood pressure would go up every couple of days. The outcome of the event was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of paralysis in a 17-year-old female patient who received HAVRIX pediatric. Concomitant products included MENACTRA. On 3rd August 2016, the patient received the 1st dose of HAVRIX pediatric. On 3rd August 2016, several hours after receiving HAVRIX pediatric, the patient experienced paralysis (serious criteria GSK medically significant and other: serious as per reporter), leg pain and numbness in leg. On 8th August 2016, the outcome of the paralysis, leg pain and numbness in leg were recovered/resolved. The reporter considered the paralysis, leg pain and numbness in leg to be possibly related to HAVRIX pediatric. Additional details were provided as follows: The patient experienced paralysis of toes. The patient had visited emergency room (ER).  The other healthcare professional had no product information.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Hypoaesthesia, Pain in extremity, Paralysis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of paralysis in a 17-year-old female patient who received HAVRIX pediatric. Concomitant products included MENACTRA. On 3rd August 2016, the patient received the 1st dose of HAVRIX pediatric. On 3rd August 2016, several hours after receiving HAVRIX pediatric, the patient experienced paralysis (serious criteria GSK medically significant and other: serious as per reporter), leg pain and numbness in leg. On 8th August 2016, the outcome of the paralysis, leg pain and numbness in leg were recovered/resolved. The reporter considered the paralysis, leg pain and numbness in leg to be possibly related to HAVRIX pediatric. Additional details were provided as follows: The patient experienced paralysis of toes. The patient had visited emergency room (ER).  The other healthcare professional had no product information.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abasia, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Laboratory test normal
Clinical narrative: Leg numbness.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Red blood cell sedimentation rate normal, X-ray of pelvis and hip normal
Clinical narrative: Leg numbness.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site hypoaesthesia
Clinical narrative: Leg numbness.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Staff states hives appeared in evening after receiving vaccine in the afternoon. Next day itching/hive continues reported to work but itching was bad went for treatment to ER. Course of treatment unknown, discharge paperwork states: allergies.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUL-2016, the patient was vaccinated with a first dose PNEUMOVAX 23, 0.5 ml, subcutaneously. Then, on 01-AUG-2016, the patient again administered with second dose of PNEUMOVAX 23, 0.5 ml, subcutaneously. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with 1 dose of improperly stored dose ZOSTAVAX (incorrect product storage). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. On an unknown dates the patient was vaccinated with 1st, 2nd and 3rd dose of GARDASIL 9, intramuscular (lot # was not reported). On an unknown date, an additional dose of GARDASIL 9 (lot # was not reported) was intramuscularly administered to the patient after the series of three GARDASIL 9 vaccinations was already completed. The physician stated that there were no adverse effects or side effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Edema of arm; injection site pain.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiry date: 07-DEC-2017) (incorrect product storage). Medical assistant stated that the vaccine was possibly stored at 0.1 F for a maximum of 14 hours, 15 minutes. No adverse events were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883 with expiration date 02-OCT-2017), orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms was 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 pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L021214, expiry date: 10-JUN-2017 and lot # L019127, expiry date: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883, expiration date on 02-OCT-2017), oral, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/allergies were reported. On an unknown date these patients were vaccinated with improperly stored dose of ROTATEQ (lot # L042215, expiration date 02-JUN-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. The pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored ZOSTAVAX lot number M015925, expiration date 15-JUN-2017 and lot number M009773, expiration date unknown, (dose, route and frequency not reported). No adverse effects were reported. The pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M015925 and M009773 were confirmed to be valid lot numbers for ZOSTAVAX. This is one of several reports 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 certified medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication was provided. On unknown dates, multiple unspecified patients received doses of improperly stored GARDASIL 9 lot# M003659 with expiration date: 20-SEP-2017 and lot# L025737 with expiration date: 28-JUL-2017 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent temperature excursions at 31 Fahrenheit degrees, for 189 hours (7 days and 21 hours) (2 cycles). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 lot# L035882 with expiration date: 19-APR-2017 (dose and route of administration were not reported). Administered doses of PNEUMOVAX 23 underwent temperature excursions at 31 Fahrenheit degrees, for 189 hours (7 days and 21 hours) (2 cycles). Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Meningitis
Clinical narrative: This spontaneous report as received from a consumer (who was the patients' mother and grandmother) refers to 2 male patients of unknown age. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of an unspecified human papillomavirus vaccine (manufacturer unknown) injection (dose and route of administration were not reported). There were no concomitant therapies reported. On unknown dates, the patients were both diagnosed with meningitis. The outcome of the event was not reported. The relatedness between the unspecified human papillomavirus vaccine (manufacturer unknown) and the event was not provided. Upon internal review, the event of meningitis was considered to be medically significant. Additional information is not expected as the reporter refused to provide any contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored RECOMBIVAX HB lot# L023387 with expiry date: 22-JUN-2017, lot# M010212 with expiry date: 21-JAN-2019 and Lot# M001579 with expiry date: 05-OCT-2018 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Decreased appetite, Dermatitis diaper, Injection site erythema, Injection site inflammation
Clinical narrative: On 8/15 pt vomited one time. Then, on 8/17 at 02:00 AM pt developed a fever, which lasted almost 24 hours and went up to 102 degrees. When fever broke, mother noticed a rash which first developed on child's face and torso, and then spread to her back, diaper area and legs. At the same time, the injection site where the pt had received her MMR injection became red and inflamed. Mother describes child acting as though she was in pain with decreased appetite and increased whining. Mother states the rash lasted until 8/21/16, and child's behavior was back to normal on 8/23/2016. Only treatment provided was Tylenol, which did relieve the fever and provided relief from pain as well. Mother researched measles online and said rash appeared similar to what she saw in online images, however she did not seek medical attention.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Irritability, Pain, Pyrexia, Rash
Clinical narrative: On 8/15 pt vomited one time. Then, on 8/17 at 02:00 AM pt developed a fever, which lasted almost 24 hours and went up to 102 degrees. When fever broke, mother noticed a rash which first developed on child's face and torso, and then spread to her back, diaper area and legs. At the same time, the injection site where the pt had received her MMR injection became red and inflamed. Mother describes child acting as though she was in pain with decreased appetite and increased whining. Mother states the rash lasted until 8/21/16, and child's behavior was back to normal on 8/23/2016. Only treatment provided was Tylenol, which did relieve the fever and provided relief from pain as well. Mother researched measles online and said rash appeared similar to what she saw in online images, however she did not seek medical attention.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform, Vomiting
Clinical narrative: On 8/15 pt vomited one time. Then, on 8/17 at 02:00 AM pt developed a fever, which lasted almost 24 hours and went up to 102 degrees. When fever broke, mother noticed a rash which first developed on child's face and torso, and then spread to her back, diaper area and legs. At the same time, the injection site where the pt had received her MMR injection became red and inflamed. Mother describes child acting as though she was in pain with decreased appetite and increased whining. Mother states the rash lasted until 8/21/16, and child's behavior was back to normal on 8/23/2016. Only treatment provided was Tylenol, which did relieve the fever and provided relief from pain as well. Mother researched measles online and said rash appeared similar to what she saw in online images, however she did not seek medical attention.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patients were vaccinated with doses of improperly stored Gardasil 9 injection (lot # M005714, expired on 30-OCT-2017) once, intramuscularly (dose and frequency unknown). Therapy with GARDASIL 9 was continued. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot#, expiration date, strength, dose, route and indication were unknown). No adverse effect was reported. It was unspecified if the patients sought medical attention. This is one of three reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a pediatric dose of HEPATITIS A.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Chills, Cough, Headache, Lung consolidation
Clinical narrative: Chills, Headache, cough, body aches, nightmares.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Nightmare, Pain
Clinical narrative: Chills, Headache, cough, body aches, nightmares.
Sex: M
Vaccine: TDAP
Symptoms: Formication, Hypersomnia, Migraine, Narcolepsy, Sudden onset of sleep
Clinical narrative: This case was reported by a consumer and described the occurrence of narcolepsy in a adult male patient who received BOOSTRIX. Concurrent medical conditions included foot infection (coral infection on foot). Concomitant products included antibiotics nos.  On 13th April 2016, the patient received BOOSTRIX. On 15th April 2016, 2 days after receiving BOOSTRIX, the patient experienced migraine headache. In April 2016, the patient experienced tremor limb. In 2016, the patient experienced narcolepsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sleep excessive. On an unknown date, the outcome of the narcolepsy, migraine headache and tremor limb were not recovered/not resolved and the outcome of the sleep excessive was unknown. The reporter considered the narcolepsy, migraine headache, tremor limb and sleep excessive to be possibly  related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in his late 50s. This case was not previously reported to anyone. The patient visited the hospital emergency room due to a coral infection on foot and was given BOOSTRIX along with IV antibiotics. The vaccination was administered sometime before noon that day. The patient did not experienced migraine headaches in 30 years. The leg tremors began about a week after receiving the vaccination and the patient described them as feeling like gremlins crawling around in legs. The patient stated that it is harder to pinpoint when the narcolepsy began but described it as sleeping for more than 12 hours, needing to nap (which never had in the past) and just falling asleep randomly. The patient did not want to provide further details for this report.
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of narcolepsy in a adult male patient who received BOOSTRIX. Concurrent medical conditions included foot infection (coral infection on foot). Concomitant products included antibiotics nos.  On 13th April 2016, the patient received BOOSTRIX. On 15th April 2016, 2 days after receiving BOOSTRIX, the patient experienced migraine headache. In April 2016, the patient experienced tremor limb. In 2016, the patient experienced narcolepsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sleep excessive. On an unknown date, the outcome of the narcolepsy, migraine headache and tremor limb were not recovered/not resolved and the outcome of the sleep excessive was unknown. The reporter considered the narcolepsy, migraine headache, tremor limb and sleep excessive to be possibly  related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in his late 50s. This case was not previously reported to anyone. The patient visited the hospital emergency room due to a coral infection on foot and was given BOOSTRIX along with IV antibiotics. The vaccination was administered sometime before noon that day. The patient did not experienced migraine headaches in 30 years. The leg tremors began about a week after receiving the vaccination and the patient described them as feeling like gremlins crawling around in legs. The patient stated that it is harder to pinpoint when the narcolepsy began but described it as sleeping for more than 12 hours, needing to nap (which never had in the past) and just falling asleep randomly. The patient did not want to provide further details for this report.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, (lot# M006102, expiration date 01-AUG-2017; lot # L024497, expiration date was unknown; lot # M012986, expiration date 12-SEP-2017) (strength, dose, route and indication were unknown). No adverse effect was reported. It was unspecified if the patients sought medical attention. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to  7 unspecified patient of unknown age and gender. On 09-AUG-2016, the patients were vaccinated with improperly stored doses of VARIVAX, lot#: l046887, expiry date: 23-NOV-2017. No adverse reactions reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. She had no known drug reactions or allergies. On 10-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, subcutaneously (exact dose, lot #, expiration date and anatomical location were not provided). On 11-AUG-2016, the patient experienced redness around the injection site. The site was circular, warm, raised and the size of a half dollar. It was also reported, that there were pustules around the border of the site. Treatment was not given for the events. Laboratory diagnostic studies were not performed. The outcome of the events was reported as not recovered/not resolved (reported as "still ongoing"). Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified patients of unknown demography. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # M000757 (expiry: 06-JAN-2018). It was reported that the vaccine reached -14.1 C for 20 minutes. They also had a prior excursion reaching 9 F for 10 hours. There details were captured by a data logger and the vaccine was back in range. No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to the case 1608USA012594 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified patients of unknown demography. On an unknown date, the patients were vaccinated with improperly stored PROQUAD lot # M006104 (expiry: 01-AUG-2017) (incorrect product storage). It was reported that the vaccine reached -14.1 C for 20 minutes. They also had a prior excursion reaching 9 F for 10 hours. These details were captured by a data logger and the vaccine was back in range. No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to case 1608USA009123 (same reporter link). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient presented with a swollen red arm (area larger than a softball). Patient complained of it being painful, warm and itchy.  It presented later that day after the vaccination was given and has slowly been getting smaller. I advised patient to monitor and continue to ice area as needed. I recommended an oral antihistamine to help with the itching.  She said she would follow up with me to let me know if there is any change.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Depressed level of consciousness, Dizziness, Hypotonia, Muscle twitching, Nausea
Clinical narrative: Patient was given shots with no problem. She was a little nervous but did not cry after injections. She sat up and mom noticed she was not alert, she asked her what was wrong and she didn't respond. Patient was limp and was laid down. Immediately she starting urinating. Eyes were open but fixed. Patient was not responding. Her rt leg was twitching during the event. Event lasted less than 1 minute. After regaining consciousness she responded to basic questions but remained pale. She laid down for 10-15 minutes then someone carried her to the bathroom. After coming back patient looked drowsy and felt like she had to vomit. She again turned very pale. Mom held her over the garbage can but did not vomit. Patient complained of just wanting to go to sleep. Also said she felt dizzy after the shots but was not dizzy anymore. EMS called.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Nervousness, Pallor, Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: Patient was given shots with no problem. She was a little nervous but did not cry after injections. She sat up and mom noticed she was not alert, she asked her what was wrong and she didn't respond. Patient was limp and was laid down. Immediately she starting urinating. Eyes were open but fixed. Patient was not responding. Her rt leg was twitching during the event. Event lasted less than 1 minute. After regaining consciousness she responded to basic questions but remained pale. She laid down for 10-15 minutes then someone carried her to the bathroom. After coming back patient looked drowsy and felt like she had to vomit. She again turned very pale. Mom held her over the garbage can but did not vomit. Patient complained of just wanting to go to sleep. Also said she felt dizzy after the shots but was not dizzy anymore. EMS called.