chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to an infant male patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose 1, 1 DF, oral, strength, lot # and expiration date not reported). Concomitant medications were not reported. The reporter stated that on an unspecified date in June 2014 (also reported as within this past month), the patient tested positive for rotavirus after receiving a single dose of ROTATEQ. The patient had unspecified laboratory tests performed. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right thigh raised painful puncture.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Received vaccine L deltoid 1040 hours. At 1041 pt c/o dif swallowing and throat tightness. Negative tongue swelling, positive smiling; stroke signs neg., grips hands, bilat LS ck ar. Neg c/o chest tightness, dif. breathing, shortness of breath. TX: BENADRYL 3 3/4 BP at 1046 hrs. Monitored 30 min's fully resolved.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Headache, Injection site erythema
Clinical narrative: Baseball size redness to (R) deltoid - headache - no fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse, refers to two patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patients were vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, Lot # J005726 and expiration date on 08-MAY-2014 (also reported as 08-APR-2014). Co-suspect therapy and concomitant medications were not provided. It was reported that two unspecified patients were administered doses of VARIVAX that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall
Clinical narrative: During administration of VAQTA, patient felt dizzy and lightheaded. Prior to vaccine patient had labs drawn. Patient slumped to the side and was assisted to lie down. I walled, called in, he was alert and stated he had not eaten. Gave him a popsicle. Left 30 min. later w/ guardian.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Dizziness, Pyrexia, Urticaria
Clinical narrative: 7/8/14 after vaccine - fever, hives, joint pain, dizziness.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, body aches. Patient state she woke up in the middle of the right with fever and body aches. Recommended alternating MOTRIN and TYLENOL, drink lots of fluids, get extra rest and if not better in 48 hours to call and be seen per doctors orders. Evidently fever is gone, arm is still sore.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Pt was given Tdap and PPSV 23 at 11:20 am office visit. At about 5:00 pm patient states she began having symptoms of headache, fever, nausea, vomiting, body aches, and chills. As of 7-11-14 patient still has headache, arm pain and warm spot on arm.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Pt was given Tdap and PPSV 23 at 11:20 am office visit. At about 5:00 pm patient states she began having symptoms of headache, fever, nausea, vomiting, body aches, and chills. As of 7-11-14 patient still has headache, arm pain and warm spot on arm.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No pertinent medical history and cocurrent condition reported. On 08-JUL-2014 the patient received an expired dose of PNEUMOVAX 23 (lot # H015749), intramuscular (dose not reported). No other concomitant therapies reported. No known adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: PPV
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: Projectile vomiting, vomit.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: Red, swollen @ injection site.  Swelling increased in size, site very red, warm to touch, arm sore and itchy by 7/12/2014 6:00 AM.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain in shoulder joint of arm where injected.  Pain increased during the day to the point of incapacitation.  Pain developed in opposite shoulder, both hips, both knees -- but not nearly so severe.  I have experienced bone breaks such as trimalleolar fracture; this was worse.  Pain peaked at 12 hours post-injection, then decreased over next 48 hours.  72 hours after injection, pain is substantially subsided.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Injected limb mobility decreased, Local swelling, Paraesthesia, Tenderness
Clinical narrative: Swelling, tenderness loss of motion in left arm, burning and slight tingling.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Full blood count, Increased tendency to bruise, Petechiae, Platelet disorder
Clinical narrative: Bruising very easily and petechiae all over body.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Anorectal discomfort, Burning sensation, Dysgeusia, Ear discomfort, Eye pain
Clinical narrative: Started with left ear burning, left arm burning.  Left side of face and behind left eye mild headache.  Burning down left arm/tingling. Hot flash, sweaty, nauseated, rectum felt hot.  Altered taste.  Went to medical clinic and was seen by Dr.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Hot flush, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Started with left ear burning, left arm burning.  Left side of face and behind left eye mild headache.  Burning down left arm/tingling. Hot flash, sweaty, nauseated, rectum felt hot.  Altered taste.  Went to medical clinic and was seen by Dr.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Allergy test positive, Allergy to vaccine, Anxiety, Asthenia, Feeling abnormal
Clinical narrative: PRESSURE AND SQUISHY FEELING IN THE HEAD, TINGLING, WEAKNESS AND STIFFNESS IN EXTREMITIES, ELEVATED FEELING LIKE GOING UP AN ELEVATOR, ANXIETY.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Headache, Muscular weakness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: PRESSURE AND SQUISHY FEELING IN THE HEAD, TINGLING, WEAKNESS AND STIFFNESS IN EXTREMITIES, ELEVATED FEELING LIKE GOING UP AN ELEVATOR, ANXIETY.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: I could lift my arm up. It was a sharp pain when I tried to lift anything. The pain is dull now but it still hurts occasionally since I recieved the vaccine.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13
Symptoms: Convulsion, Dyskinesia, Electroencephalogram normal, Pyrexia
Clinical narrative: Low grade fever around 6.30 PM, some arm jerking, then seizure around 8 pm.
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Balance disorder, Decreased appetite, Muscular weakness, Pyrexia, Rash
Clinical narrative: 3 days of fever, tmax 103.  The day following highest fever, broke out in rash to entire trunk and face.  Loss of appetite for the week following start of illness (1 week post vaccination).  Loss of balance and weakness in legs on day 11 post vaccination.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient received ADACEL vaccine in left deltoid on 7/7/14 and came into pharmacy with roughly 5 inch x 3 inch red/hot reaction. Patient came back on 7/12/14 and said it's been itchy with slight rash.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Red circle around area of administration. Itching.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: Large local reaction: Erythema and mild induration measuring 10cm x 7cm distal to the injection site. No warmth, tenderness. Moving extremity well. Weight-bearing, walking normally. Was here yesterday for her WCC, had her DTaP vaccine. This morning noticed a pink swollen area around where she had the shot. Seems to be firm and slightly bigger this afternoon. Doesn't seem to bother her otherwise. Was seen 7/8 for 18mo WCC. Received DTaP in (L) thigh. Returned the following day w/ a large erythematous wheal at the injection site. It was not felt to be infected. They have been giving patient BENADRYL q 6 hrs while awake. The area of erythema has gotten larger. It does not seem to bother patient at all. She is still moving the (L) leg without difficulty and walking fine. She has not been grabbing or itching the site. Has not been more irritable, no fever. Perhaps a little sleepy from the BENADRYL.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection and spreading was a red, raised area that was hot to touch. Also had a knot. Started day after vaccine ws given.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Blood lactic acid, Chest X-ray, Full blood count, Metabolic function test
Clinical narrative: Fever (103 degrees) treatment with TYLENOL and MOTRIN. No further treatment or fever.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever (103 degrees) treatment with TYLENOL and MOTRIN. No further treatment or fever.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. On 30-JUN-2014 the patient was vaccinated with GARDASIL (lot # J010668, 0.5 ml, intramuscular in the right arm). Other suspect therapies included VAQTA (lot # J014584, dose unknown, in the right arm). Concomitant therapies included PROZAC and amoxicillin for ear infection. No known allergies were reported. On 30-JUN-2014, the patient experienced headache and dizziness. No treatment was given for the events. The outcome of the event was reported as not recovered/not resolved. The patient was being monitored by the physician's office. The causality was unknown. No further details provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with (Oka/Merck) VARIVAX (dose, route of administration and anatomical location unknown) which underwent a supported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729. 1407USA005730, 1407USA005731, 1407USA005295. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 67 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 07-JUL-2014 the patient was vaccinated with ZOSTAVAX route subcutaneous (dose strength not reported) for vaccination. The patient reported to the pharmacist that on 09-JUL-2014, the patient experienced rash around the injection site. The outcome of rash around the injection site was reported as not recovered/not resolved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PROQUAD (merck) (lot number reported as K005648) Dose, route, and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patient was administered PROQUAD (merck) that was stored improperly (on an unknown date). No adverse effects reported. The outcome and causality of the event was not reported. This is one of four reports from the same source (other case # 1407USA000488 # 1406USA011997 and #1407USA005743). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with (Oka-Merck) PROQUAD, (lot number reported as J002932) Dose, route, and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patient was administered (Oka-Merck) PROQUAD that was stored improperly (on an unknown date). No adverse effects reported. The outcome and causality of the events was not reported. This is one of four reports from the same source (other cases # 1407USA000488, #1406USA011997 and #1407USA005742). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with GARDASIL (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005730, 1407USA005731 and 1407USA005736 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients were vaccinated with COMVAX (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005295, 1407USA005731, 1407USA005736. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with VAQTA (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA04195, 1407USA005730. 1407USA005731, 1407USA005736 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with PROQUAD (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005730, 1407USA005295, 1407USA005736 via same reporter link. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid irritation, Eyelids pruritus, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient with hypertension. The patient's medical history included being allergy  to LEVAQUIN, causes muscle pain. On 02-JUN-2014, the patient was vaccinated with ZOSTAVAX lot # J013453 expiry date 24-JAN-2015, 1 subcutaneous injection in the left arm, it was administered very low on the arm near her elbow, unknown indication recommended by doctor. Concomitant therapies included Metoprolol (manufacturer unknown). On 03-JUN-2014 (also reported as 02-JUL-2014), the patient developed a hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper cheek is swollen. Patient used ice for her eyes. As of 06-JUL-2014, it was unknown if the patient will continue to receive ZOSTAVAX. There has been some improvement of her left arm but she continues to have the hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper check is swollen and the outcome of the injection being administered too low was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Swelling face
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient with hypertension. The patient's medical history included being allergy  to LEVAQUIN, causes muscle pain. On 02-JUN-2014, the patient was vaccinated with ZOSTAVAX lot # J013453 expiry date 24-JAN-2015, 1 subcutaneous injection in the left arm, it was administered very low on the arm near her elbow, unknown indication recommended by doctor. Concomitant therapies included Metoprolol (manufacturer unknown). On 03-JUN-2014 (also reported as 02-JUL-2014), the patient developed a hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper cheek is swollen. Patient used ice for her eyes. As of 06-JUL-2014, it was unknown if the patient will continue to receive ZOSTAVAX. There has been some improvement of her left arm but she continues to have the hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper check is swollen and the outcome of the injection being administered too low was unknown. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Disturbance in attention, Headache, Muscular weakness
Clinical narrative: Severe headache, inability to concentrate, muscle weakness, abdominal pain.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Pt. experienced some difficulty breathing. At the injection site, severe erythema and swelling occurred.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: nausea, starting 7-3-2014 and on going, physician prescribed reglan to treat but was not helping and patient is going to make doctor appt.
Age: 0.52
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Listless, Moaning, Pyrexia
Clinical narrative: Fever of 103 F, lethargy, listless, moaning. Lasted 72 hours without any relief from regular Tylenol doses. Fever was not lowered by Tylenol. Returned to the doctor after 48 hours and we were told to "wait it out".
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Syncope
Clinical narrative: This spontaneous report was received from physician's assistant via field employee regarding an 17 years old male patient (age reported as 17 years at the time of vaccination). There was no information on patient's medical history and drug reactions or allergies. On 20-APR-2012, the patient was vaccinated with GARDASIL intramuscular injection single standard dose intramuscularly taken intramuscularly. There was no concomitant medications. On 20-APR-2012, the patient fainted after his first dose with GARDASIL (disability) (reported as significant disability or incapacity: "syncope"). The patient decided not to continue with the series with GARDASIL after having this reaction. The lab diagnostics studies performed was unknown. No treatment was given. The patient did not seek any medical attention. There was no product quality complaint involved. On an unknown date the patient recovered from the event. The causality of the event with GARDASIL was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker (also reported as clinic manager) refers to a 31 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated the patient was supposed to have received (Oka/Merck) VARIVAX but on 07-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque forming units (PFU)) (route, indication was not reported) in error and also mentioned that the error was not due to medication confusion. It was also reported that the facility does not routinely carry ZOSTAVAX, and one dose of ZOSTAVAX had been purchased for the physician's personal use. The reporter also stated that the patient was vaccinated with M-M-R II and hepatitis B vaccine (recombinant) (manufacturer unknown) (also reported as unspecified Hepatitis B vaccine) during the same visit. The reported mentioned that the patient had not demonstrated or reported any adverse experiences. The outcome of events reported was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age. The nurse reported that 3 unspecified patients were administered GARDASIL (strength, dosage, route and indication unknown) which were stored improperly on an unknown date. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 27-JUN-2014 the patient was inadvertently vaccinated with a does of expired (Oka/Merck) VARIVAX lot # H011232, expiration date: 06-JUN-2014, 0.5 ml, subcutaneous. No adverse reactions reported. The outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient. On 07-JUL-2014, the patient was vaccinated with first dose of VAQTA (dose, route and frequency were not reported). The nurse reported that on 07-JUL-2014, the patient received second dose of VAQTA at 19 years of age. No adverse symptoms reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received via social media regarding a female/girl- (age not reported) who was affected by GARDASIL. It was reported that the girl passed away two days after her third GARDASIL injection. No further information was provided. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Cough, Fatigue, Impaired work ability
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Blood test, Body temperature increased, Computerised tomogram, Malaise
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Obliterative bronchiolitis, Pneumonia, Pulmonary function test, Varicella, X-ray
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Computerised tomogram normal, Cough
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Full blood count normal, Pyrexia, Rash, Respiratory disorder
Clinical narrative: Sick x4 months. Temp greater than or equal to 101 x2 months. Temp greater than or equal to 99 x2 months. Chicken pox. Pneumonia. Bronchiolitis obliterans. Asthma. 2 mo. 100+ temp.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain where shot was given, Redness, Headache, Tiredness, Nausea, and aches.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain where shot was given, Redness, Headache, Tiredness, Nausea, and aches.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Pain where shot was given, Redness, Headache, Tiredness, Nausea, and aches.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain
Clinical narrative: Pain where shot was given, Redness, Headache, Tiredness, Nausea, and aches.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient. On 05-JUL-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015, 0.5 ml, dose number were unknown) intramuscular. The patient developed cellulitis on 06-JUL-2014 after being administered with PNEUMOVAX 23 and was admitted to hospital on an unspecified date in July 2014. IV (intravenous) vancomycin (dosage unspecified) was given for the adverse event. MRI (magnetic resonance imaging) was used to determine the cellulitis. The patient sought for medical attention through contacting the pharmacy. And no intervention to prevent serious criteria. The outcome of developed cellulitis was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient. On 05-JUL-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015, 0.5 ml, dose number were unknown) intramuscular. The patient developed cellulitis on 06-JUL-2014 after being administered with PNEUMOVAX 23 and was admitted to hospital on an unspecified date in July 2014. IV (intravenous) vancomycin (dosage unspecified) was given for the adverse event. MRI (magnetic resonance imaging) was used to determine the cellulitis. The patient sought for medical attention through contacting the pharmacy. And no intervention to prevent serious criteria. The outcome of developed cellulitis was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient. On 05-JUL-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015, 0.5 ml, dose number were unknown) intramuscular. The patient developed cellulitis on 06-JUL-2014 after being administered with PNEUMOVAX 23 and was admitted to hospital on an unspecified date in July 2014. IV (intravenous) vancomycin (dosage unspecified) was given for the adverse event. MRI (magnetic resonance imaging) was used to determine the cellulitis. The patient sought for medical attention through contacting the pharmacy. And no intervention to prevent serious criteria. The outcome of developed cellulitis was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Posture abnormal
Clinical narrative: This spontaneous report was received from a register nurse concerning a 17 year old male patient. The patient's medical history included asthma as child. On 09-JUL-2014, the patient was vaccinated with the first dose of GARDASIL lot # J009788, expiration date 17-MAR-2014, 0.5 ml, intramuscular in the right arm. Other suspect therapies included VAQTA (dose, frequency, strength, lot number, expiration date and route were not reported) in left arm. The registered nurse stated following administration, on 09-JUL-2014, "patient become dizzy, slumped in chair". Nurse stated she had office staff (unspecified) took patient's blood pressure which was "76/48", pulse was 64. Nurse stated they had patient lay down for 30 minutes. Nurse stated after 30 minutes, patient advised he had not eaten so patient was provided crackers and water. Nurse states patient was released, his "color improved and he was not dizzy, was doing better". At the tie of the report the outcome was recovering. Patient received crackers and water, and was lay down for 30 minutes as treatment for the adverse event. Patient's blood pressure was "76/48" (units not provided) and pulse was 64/units not provided).  Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a register nurse concerning a 17 year old male patient. The patient's medical history included asthma as child. On 09-JUL-2014, the patient was vaccinated with the first dose of GARDASIL lot # J009788, expiration date 17-MAR-2014, 0.5 ml, intramuscular in the right arm. Other suspect therapies included VAQTA (dose, frequency, strength, lot number, expiration date and route were not reported) in left arm. The registered nurse stated following administration, on 09-JUL-2014, "patient become dizzy, slumped in chair". Nurse stated she had office staff (unspecified) took patient's blood pressure which was "76/48", pulse was 64. Nurse stated they had patient lay down for 30 minutes. Nurse stated after 30 minutes, patient advised he had not eaten so patient was provided crackers and water. Nurse states patient was released, his "color improved and he was not dizzy, was doing better". At the tie of the report the outcome was recovering. Patient received crackers and water, and was lay down for 30 minutes as treatment for the adverse event. Patient's blood pressure was "76/48" (units not provided) and pulse was 64/units not provided).  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Headache, Nausea, Syncope, Vomiting
Clinical narrative: Syncope, nausea, vomiting for ~ 2 hours, kept pt for observation until vomiting subsided. Pt reported at next visit that after she got home continued vomiting until 8:00 PM that night.Pt reported she had H/A the next day, that lasted all day.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Loss of consciousness, Syncope
Clinical narrative: witnessed Syncopal Episode, patient walked from bedroom to bathroom, eyes rolled up, fell to the ground, had brief LOC for 3 seconds, no seizure like activity before or after
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: This spontaneous report as received from health care worker refers to a female patient of unknown age (reported as college age). Approximately on an unknown date in 2009 (reported as 4-5 years ago) the patient was vaccinated with GARDASIL (dosing regimen unspecified). Approximately on an unknown date in 2009 (reported as 4-5 years ago), patient experienced anaphylactic reaction (medically significant) and difficulty breathing (medically significant) about 45 minutes after vaccinated with GARDASIL. The patient came back to the clinic, reporting she was having difficulty breathing and was given an injection of epinephrine. The patient sought medical attention and was taken to an unspecified hospital emergency room. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Upon internal review the events anaphylactic reaction and difficulty breathing was considered as serious (medically significant). The case is linked to #1407USA005962 via same reporter link. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Infant developed rash and swollen on vaccine site (right thigh).
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Pallor
Clinical narrative: Patient stated she was weak, pale color. Did not faint, we had her lay down on exam table, patient advised that she had not eaten that morning. Kept for 1/2 symptoms resolved after drinking some water and resting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt reported having issues with the shot on the very first day after the injection of Zoster. She also noted that it got worse by Saturday with blistering and redness to the injection site.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: Pt reports back aches, headache, fever in ED upto 101.3
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain, Rash, Swelling
Clinical narrative: Achy joints  Pain  Rash  Stiffness  Swelling
Age: 59.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Abdominal pain, Cardiac enzymes normal, Electrocardiogram abnormal, Eosinophil percentage increased, Laboratory test normal
Clinical narrative: Abdominal pain. Myalgia. Sinus bradycardia. Symptoms began 48 to 72 hours after vaccine.
Age: 59.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Lipase normal, Myalgia, Sinus bradycardia, White blood cell count normal
Clinical narrative: Abdominal pain. Myalgia. Sinus bradycardia. Symptoms began 48 to 72 hours after vaccine.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Client reported discomfort at site of the injection. Upon observing area, noted that the skin was red, warm, and had about 30mm of hardened area underneath the skin. Client reports no s/s of anapylaxis.
Age: 12.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: No reaction, signs, or symptoms; I gave MMR vaccine instead of Varicella.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Crying, Eye movement disorder, Fall, Feeling abnormal, Hypotonia
Clinical narrative: Approx 15 minutes after vaccine given, pt while standing became limp and fell to ground. Father reports eyes rolling into back of head. Pt seemed dazed for about a minute then started crying. Vital signs were normal, pt responsive and able to answer to name
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Received Tdap (LD) on 6-16-14. Had small amount of redness starting on 6-18-14. On 6-22-14 redness and swelling increased. On 6-23-14 presented to clinic with area of redness, swelling 150 x 150 mm. On 6-24-14 client reports redness swelling subsiding.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Father called and reported (R) arm at site of injection. Red, swollen, painful to touch, size silver dollar - referred to MD.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 76 year old female patient with allergies, high cholesterol and penicillin unspecified reaction. On 02-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J014568, expiration date 18-FEB-2015) subcutaneously. The pharmacist reported that on 05-JUL-2014, the patient developed itchy, raised, red bumps on her forehead and both cheeks. The patient went into the pharmacy on 08-JUL-2014 and was advised to take CLARITIN and apply AVEENO lotion to the affected areas. There were no Lab diagnosis or studies performed. The outcome of itchy, raised, red bumps on her forehead and both cheeks was reported as recovering/resolving. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Pt. developed hives all over body within 1 hour of receiving 1st GARDASIL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Pt received vaccines 7/11/14. 7/12/14 mother reports rash on left thigh where pt was administered varicella et KINRIX. 7/14/14- rash still currently present. No other symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a register nurse via company representative refers to an unspecified group of patients of unknown age and gender. The reporter stated that on unspecified dates all patients received GARDASIL one injection annually or yearly for a series of three (dose number, dose, lot number and expiration date were not provided). Additional information is not expected, because reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H010515, expiration date: 13-FEB-2014), 25 mcg/0.5 ml 1 standard package vial of 2.5 0.4 ml, intramuscular, the vaccine which had expired on 13-FEB-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 8 unspecified patients of unknown age. The 8 unspecified patients received doses of GARDASIL (lot number, dose, route and indication were not reported) on unspecified dates, that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome and action taken were not provided. It was not specified if the patients sought any medical attention. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old adult patient (no patient information provided). The physician inadvertently administered to the patient with PNEUMOVAX 23 (lot#, dose, route, frequency and indication were unknown) instead of MENACTRA. No adverse effect was reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 24 year old female patient. Patient had no previous medical history. On 09-JUL-2014 the patient was vaccinated with VARIVAX 1 single shot subcutaneous injection lot # J012383 and expiry date 03-OCT-2015. No concomitant medications were reported. The nurse reported, before administration of (Oka/Merck) VARIVAX, the patient was asked if she was pregnant and said no. On the same day, a few hours after she receiving (Oka/Merck) VARIVAX, she took pregnancy test and was confirmed as pregnant. The patient became pregnant. The last menstrual date (LMP) and estimated delivery date (EDD) was unknown. The pregnancy outcome was outcome pending. No adverse effect was reported. Patient sought medical attention and no treatment was provided. The outcome of a few hours after receiving (Oka/Merck) VARIVAX, the patient called office stating she took a pregnancy test and she was pregnant and no adverse effect was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 24 year old female patient. Patient had no previous medical history. On 09-JUL-2014 the patient was vaccinated with VARIVAX 1 single shot subcutaneous injection lot # J012383 and expiry date 03-OCT-2015. No concomitant medications were reported. The nurse reported, before administration of (Oka/Merck) VARIVAX, the patient was asked if she was pregnant and said no. On the same day, a few hours after she receiving (Oka/Merck) VARIVAX, she took pregnancy test and was confirmed as pregnant. The patient became pregnant. The last menstrual date (LMP) and estimated delivery date (EDD) was unknown. The pregnancy outcome was outcome pending. No adverse effect was reported. Patient sought medical attention and no treatment was provided. The outcome of a few hours after receiving (Oka/Merck) VARIVAX, the patient called office stating she took a pregnancy test and she was pregnant and no adverse effect was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, No adverse event, No therapeutic response
Clinical narrative: This spontaneous report was received from a physician reports regarding himself, not demographics information was provided. On an unspecified date between 1968 and 1969, the patient received series of RECOMBIVAX HB (dose, Lot # and route were not reported). He stated that he was a non responder to series to vaccine. He never developed antibody. No adverse effects were noted. The outcome of he was a non-responder to series to RECOMBIVAX HB series in 1968 and He never developed antibody was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. On 16-AUG-2010 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route unspecified). On 08-APR-2014, the patient was diagnosed with shingles on 08-APR-2014. He reported that he developed a rash on the center of his chest that wrapped around his right side to his spine. He stated that he was seen by a dermatologist on 08-APR-2014 who took "scrapings" of his rash. He reported that the result of the "scrapings" showed tha the had shingles. He stated that he was placed on VALTREX for 7 days and was also prescribed ibuprofen 800mg 2 or 3 times per day for pain. He reported that after he finished the VALTREX, he still had "discomfott" and went to see his primary care physician "2-3 weeks later". He stated that his primary care physcian prescribed him an unspecified steroid. He reported that he was recovering and only got an itching sensation in his back "every so often". This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered  nurse refers to unspecified patients of unknown age. On an unknown dates the patients was vaccinated with improperly stored GARDASIL (dose and lot # not reported) intramuscular that were exposed to 50F for 55 hours and to 34F for 55 hours. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous, (Lot number and expiration date were not provided) that was stored outside the recommended temperature range noted in the product insert. Co-suspect therapy and concomitant medications were not reported. No adverse effects were reported. Additional information is not expected since no follow up can be obtained.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Day 14 developed fever 104 degrees and had febrile seizure. Seen at ER. R/o UTI and URI possibilities.