chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient. The patient had a prior history of seizures and non-compliance with his medications. the patient had no drug reactions/allergies. On 24-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX vial (lot # K016318, expired date 24-DEC-2015) subcutaneously. Concomitant therapies included lisinopril (manufactured by Qualitest), aspirin, atorvastatin, carvedilol, clopidogrel, unspecified multivitamin, NITROSTAT, omeprazole, VENTOLIN and vitamin B1. On 24-JUL-2015, that evening, the patient "felt like he was having a heart attack, felt totally weak and couldn't function, felt knocked out like he was in a car accident, and slept all day." No treatment was given for the events. The patient felt his symptoms were both life threatening and a significant disability, but he did not seek medical attention until he called the pharmacist on 27-JUL-2015, by which time all of his symptoms had resolved. On an unspecified date in 2015, after receiving ZOSTAVAX, the patient then had a nuclear magnetic resonance imaging (MRI) performed (result not provided) due to a prior history of seizures. On the same date, during the MRI, the patient used magnetic resonance imaging contrast dye (unspecified) (dose, frequency and route were not provided) which made the patient feel like he was hit on the forehead with a piece of steel. At the time of the report, the patient was still not feeling well. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient. The patient had a prior history of seizures and non-compliance with his medications. the patient had no drug reactions/allergies. On 24-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX vial (lot # K016318, expired date 24-DEC-2015) subcutaneously. Concomitant therapies included lisinopril (manufactured by Qualitest), aspirin, atorvastatin, carvedilol, clopidogrel, unspecified multivitamin, NITROSTAT, omeprazole, VENTOLIN and vitamin B1. On 24-JUL-2015, that evening, the patient "felt like he was having a heart attack, felt totally weak and couldn't function, felt knocked out like he was in a car accident, and slept all day." No treatment was given for the events. The patient felt his symptoms were both life threatening and a significant disability, but he did not seek medical attention until he called the pharmacist on 27-JUL-2015, by which time all of his symptoms had resolved. On an unspecified date in 2015, after receiving ZOSTAVAX, the patient then had a nuclear magnetic resonance imaging (MRI) performed (result not provided) due to a prior history of seizures. On the same date, during the MRI, the patient used magnetic resonance imaging contrast dye (unspecified) (dose, frequency and route were not provided) which made the patient feel like he was hit on the forehead with a piece of steel. At the time of the report, the patient was still not feeling well. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Burning sensation, Erythema, Rash, Swelling
Clinical narrative: Cool compresses applied and BENADRYL given at 10:00 PM on 8-12-15. Left eye started-size of dime rash-c/o burning. Pie shaped area red and slightly swollen progressed.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Headache, Poor quality sleep, Pyrexia
Clinical narrative: 15 yo m presented 1 d after HPV#3 and Hep A #1 with sx of HA, fever no nausea. No v/d. No appetite, poor sleep. Well appearing on exam. Tx: Acetaminophen as needed for pain/fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Haematocrit normal
Clinical narrative: Patient was given PROQUAD and KINRIX on 8/7/2015. Early morning 8/8/2015 he had an unwitnessed episode of syncope. He had what seems to be postictal period, and had ++polyps on diff, so was likely a seizure. Tmax 100.7 later in the day of 8/8/2015. 24 hours EEG nl; Echo/EKG nl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Haemoglobin normal, Lymphocyte percentage decreased, Monocyte percentage, Neutrophil percentage increased, Platelet count normal
Clinical narrative: Patient was given PROQUAD and KINRIX on 8/7/2015. Early morning 8/8/2015 he had an unwitnessed episode of syncope. He had what seems to be postictal period, and had ++polyps on diff, so was likely a seizure. Tmax 100.7 later in the day of 8/8/2015. 24 hours EEG nl; Echo/EKG nl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Postictal state, Seizure, Syncope, White blood cell count increased
Clinical narrative: Patient was given PROQUAD and KINRIX on 8/7/2015. Early morning 8/8/2015 he had an unwitnessed episode of syncope. He had what seems to be postictal period, and had ++polyps on diff, so was likely a seizure. Tmax 100.7 later in the day of 8/8/2015. 24 hours EEG nl; Echo/EKG nl.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Night of vaccination pt's arm slightly swollen, next day arm red, hot to touch and increased swelling. Pt was at the beach on this day also. 8/12/15 pt seen in clinic treated with clindamycin 300mg TID x 10 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, baseball size or bigger, warm on her arm where she received vaccine. Stated day after-called dr 8/5 and swelling down but still red.
Age: 1.47
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Induration, Swelling
Clinical narrative: Swelling, induration.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV, PNC13
Symptoms: Arthralgia, Arthritis reactive, C-reactive protein increased, Erythema, Full blood count normal
Clinical narrative: The day after these 5 vaccines she developed a fever, urticaria and then a reactive arthritis in the left knee. Tender, swollen, red but abnormal cbc and sed rate (but elevated CRP). Over 3 days the knee swelling and pain and fever to belly totally resolved on ibuprofen above. No other symptoms. ? vaccine reaction.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV, PNC13
Symptoms: Joint swelling, Pyrexia, Red blood cell sedimentation rate normal, Tenderness, Urticaria
Clinical narrative: The day after these 5 vaccines she developed a fever, urticaria and then a reactive arthritis in the left knee. Tender, swollen, red but abnormal cbc and sed rate (but elevated CRP). Over 3 days the knee swelling and pain and fever to belly totally resolved on ibuprofen above. No other symptoms. ? vaccine reaction.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Upper extremity mass
Clinical narrative: Received PREVNAR 13 on 5/20/15 and developed red, hot swollen lump on left arm. Came into office on 5/26/15 to have area evaluated. Dx with cellulitis and given doxycycline. for tx.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Red patch around injection area one week later. Saw MD diagnosed as infection-prescribed antibiotic.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Headache, Nausea
Clinical narrative: Headache. Tingling in hands. Weak. Nausea. Hip/back pain.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Headache. Tingling in hands. Weak. Nausea. Hip/back pain.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction, Pyrexia, Rash, Rash papular
Clinical narrative: The MOP states she received MMR, hep A and varicella at her 15 month checkup in 2012 and developed a generalized non pruritic papular exanthem approximately 6-8 hours after vaccine receipt. She also had fever of 101-102. The exanthem initially presented to her abdomen and back and lesions continued to evolve and spread to extremities, buttocks, and face. 'It was all over'. She did not believe it was pruretic or painful. There were no pustules or vesicles. Fever also increased to as high as 103 and resolved by the 4th day. She was not fussy, irritable and continue usual activity, eating and drinking. The exanthem started to fade by day 6 and resolved completely at approximately 1 week. She states the child was evaluated by provider who attributed it to the MMR and told her to have further evaluation prior to the second dose. She had no immediate symptoms after vaccine receipt of urticarial lesions, shortness of breath, oral/tongue or facial swelling or agitation or restlessness. The MOP also has a photo demonstrating a large local reaction at the injection site, which resolved without incident. She also denies any recent or concurrent illness symptoms prior to vaccine receipt, stating she would have delayed vaccination if there were any concerns. The MOP has photos of the exanthem which demonstrate popular erythematous lesions with diffuse distribution to her trunk. The MOP also states the younger sibling had a similar dermatoses after receipt of MMR but with a delay of onset of one day.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: The MOP states she received MMR, hep A and varicella at her 15 month checkup in 2012 and developed a generalized non pruritic papular exanthem approximately 6-8 hours after vaccine receipt. She also had fever of 101-102. The exanthem initially presented to her abdomen and back and lesions continued to evolve and spread to extremities, buttocks, and face. 'It was all over'. She did not believe it was pruretic or painful. There were no pustules or vesicles. Fever also increased to as high as 103 and resolved by the 4th day. She was not fussy, irritable and continue usual activity, eating and drinking. The exanthem started to fade by day 6 and resolved completely at approximately 1 week. She states the child was evaluated by provider who attributed it to the MMR and told her to have further evaluation prior to the second dose. She had no immediate symptoms after vaccine receipt of urticarial lesions, shortness of breath, oral/tongue or facial swelling or agitation or restlessness. The MOP also has a photo demonstrating a large local reaction at the injection site, which resolved without incident. She also denies any recent or concurrent illness symptoms prior to vaccine receipt, stating she would have delayed vaccination if there were any concerns. The MOP has photos of the exanthem which demonstrate popular erythematous lesions with diffuse distribution to her trunk. The MOP also states the younger sibling had a similar dermatoses after receipt of MMR but with a delay of onset of one day.
Age: 1.12
Sex: M
Vaccine: MMRV
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Developed fever, malaise & diffuse rash on day 3-4 after shot.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood pressure increased, Chest pain, Dyspnoea
Clinical narrative: Shortness of breathe, pain in chest that went to his lower back. 911 was called-they checked his blood pressure and said it was ok-only slightly elevated. Pt. did not go to ER-said he felt ok after all..
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Lethargy, Pyrexia, Vomiting
Clinical narrative: Dizzy, headache and vomiting after leaving the office within 20-30 min. Developed fever and dizziness and lethargy within 2-3 hrs. 6 hrs later felt better.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head abnormal, Dizziness, Fall, Head injury, Headache
Clinical narrative: Minutes after receiving GARDASIL 9 the patient followed her mother into the inner waiting room, area to receive a copy of her shot record. Without warning, she fell backwards hitting her head & losing consciousness. She was immediately placed in Trendelenburg became conscious pt 45-60 sec she remained pale c/o H/A and dizziness. Nystagmus noted. After 15 min she remained pale and not improving. ER strongly recommended. Follow up call to mom on 8-13-15 confirmed a skull fracture on CAT scan.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Nystagmus, Pallor
Clinical narrative: Minutes after receiving GARDASIL 9 the patient followed her mother into the inner waiting room, area to receive a copy of her shot record. Without warning, she fell backwards hitting her head & losing consciousness. She was immediately placed in Trendelenburg became conscious pt 45-60 sec she remained pale c/o H/A and dizziness. Nystagmus noted. After 15 min she remained pale and not improving. ER strongly recommended. Follow up call to mom on 8-13-15 confirmed a skull fracture on CAT scan.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: After receiving MENACTRA vaccine, patient left office. Once in parking lot, patient felt faint. Dizzy/lightheaded. Patient passed out. Patient came to quickly, and was then examined by Dr. Sxs resolved quickly.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Diplopia, Dizziness, Feeling cold, Hyperventilation
Clinical narrative: Mother phoned stating about 1 hr after receiving injection, daughter c/o lightheadedness and nausea within short time client c/o "seeing double", feeling icy cold, fingers and toes tingling and burning, "hyperventilating". Dr told mother combination of anxiety, nerves, fear of "shots". Given orange juice and sent home to rest. Client slept 3 hrs-at 6:00pm mom reports client doing well-no problems.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Paraesthesia
Clinical narrative: Mother phoned stating about 1 hr after receiving injection, daughter c/o lightheadedness and nausea within short time client c/o "seeing double", feeling icy cold, fingers and toes tingling and burning, "hyperventilating". Dr told mother combination of anxiety, nerves, fear of "shots". Given orange juice and sent home to rest. Client slept 3 hrs-at 6:00pm mom reports client doing well-no problems.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chest X-ray, Dyspnoea, Fatigue, Malaise, Musculoskeletal chest pain
Clinical narrative: Pt reports at 11pm on 8-10-15 she awoke with rib pain, leg pain and a  lump in throat she was having difficulty breathing and had one episode of vomiting her grandmother took her to ER where she received treatment. She was advised to follow up the next day but did not return to physician office until 8-12-15. Pt still having complaints of fatigue and malaise rx for BENADRYL 25mg and as needed for itching.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain in extremity, Sensation of foreign body, Vomiting
Clinical narrative: Pt reports at 11pm on 8-10-15 she awoke with rib pain, leg pain and a  lump in throat she was having difficulty breathing and had one episode of vomiting her grandmother took her to ER where she received treatment. She was advised to follow up the next day but did not return to physician office until 8-12-15. Pt still having complaints of fatigue and malaise rx for BENADRYL 25mg and as needed for itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt. developed a 4" x 4 1/2" annular raised, hot, hard rash around immunization site (left thigh). Also fever 99 degrees F.
Age: 23.0
Sex: F
Vaccine: HEP, HPV9, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fevers temperature is 38.5 degrees C and feel painful all through the body.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blood test, Muscle twitching
Clinical narrative: Involuntary muscle twitching noted in hands, feet and thighs 2 days after vaccine. (Had tick bites within the week preceding sx also).
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Fall, Heart rate decreased, Pallor
Clinical narrative: Administered vaccine. Pt looked pale and began to fall forward. Placed pt lying down on exam table with legs extended after 3-4 seconds. Received medical attention from Dr. after 2-3 seconds. HR dropped to 40-45 BPM after 5-7 seconds. HR normal and breathing normal after 10-15 seconds. Pt alert and responding the whole incident. Pt offered lollipop and PEDIALYTE with no problems. After 5 minutes pt sitting up. After 10 mins, pt left office.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Epstein-Barr virus antibody positive, Fatigue, Full blood count abnormal
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Infectious mononucleosis, Insomnia, Platelet count decreased, Pyrexia
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Band neutrophil count increased, Blood alkaline phosphatase normal, Blood calcium normal, Blood sodium increased
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chills, Dizziness, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Fatigue
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Hyperhidrosis, Insomnia, Lymphocyte count increased, Lymphocyte morphology abnormal
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Malaise, Nausea, Neutrophil count, Neutrophil count decreased, Platelet count decreased
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal, Vomiting
Clinical narrative: Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: She lost consciousness for aprox 30 seconds after HPV vaccine administered.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Mother of child phoned clinic stating "Pt has been throwing up for about 30 minutes now and she got Hep A, meningitis and Tetanus shots earlier today." Advised mother to consult child's PMD if vomiting not stopped within next 30 minutes.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medication were not reported. In 2012, the patient began the series of GARDASIL, (dose, frequency and route of administration not provided). On an unknown date in January 2013, the patient was vaccinated with dose two of GARDASIL, (dose, frequency and route of administration not provided). On 04-AUG-2015, the patient would be vaccinated with dose three of GARDASIL. No adverse effects reported. No further information provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improper stated VAQTA (lot # K005323, expiration date 10-FEB-2017) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improper stored RECOMBIVAX HB (lot # K024552, expiration date 22-OCt-2016) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K008931, expiration date 04-MAR-2017) (dose and route were not reported) by an unspecified physician. No adverse effects 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: Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improper stored oral, ROTATEQ (lot # K023532, expiration date 21-JUN-2016) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored PROQUAD (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 30-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. It was reported that five vials of ZOSTAVAX had black particles in the product, as well as one of the vials that were punctured did not have enough product inside after reconstitution. Product quality complaint was involved in this case. The reporter stated because of all these vials having a defect, the patient had missed a dose. The patient did not experience any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Crying, Grimacing, Myoclonus, Vomiting
Clinical narrative: Hush was bib mother this afternoon for inconsolable crying and grimacing since awakening after vaccinations. Began 2 hours ago. Grimacing has been every 30 seconds. No syncope, fever, vomiting, but will not nurse. Per literature, I think this is myoclonic reaction to Dtap, vs cramping pain from ROTATEQ. Soft abdomen. She did vomit with attempt at APAP for possible pain reaction. With this in mind, will allow home d/c, close observation and return to ED with any signs of emesis, hard stomach, cyanosis, prolonged clenching, or nursing refusal tonight. I suspect that this will abate over 24 hours. Mom and dad agree to this immediate POC.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a female adult patient of unknown age concerning herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported). On an unknown date the patient got bad cellulitis from injection site, down to elbow. The outcome of the event was unknown. Someone told the patient that she should get her blood level checked. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Patient presented at clinic with symptoms 48 hours after shot was administered, states reaction started 24 hours after the shot. Sedation, myalgia, rash and left arm pain, redness, swelling, hot to touch; overall fatigue, sweats, chills, muscle and joint pain. Diphenhydramine mg PRN.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Rash, Sedation, Skin warm
Clinical narrative: Patient presented at clinic with symptoms 48 hours after shot was administered, states reaction started 24 hours after the shot. Sedation, myalgia, rash and left arm pain, redness, swelling, hot to touch; overall fatigue, sweats, chills, muscle and joint pain. Diphenhydramine mg PRN.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient presented at clinic with symptoms 48 hours after shot was administered, states reaction started 24 hours after the shot. Sedation, myalgia, rash and left arm pain, redness, swelling, hot to touch; overall fatigue, sweats, chills, muscle and joint pain. Diphenhydramine mg PRN.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema, Skin warm, Swelling
Clinical narrative: Edema, warm to touch, swelling. Ibuprofen mg PRN.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis, Condition aggravated, Dyspnoea, Ear congestion, Headache
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 90 year old female patient with continuous positive airway pressure (CPAP) treatment and colitis. On 10-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not provided) subcutaneous in the arm. There was no concomitant medication reported. On 10-AUG-2015, the patient experienced a "hard and warm lump behind the arm" (injection site reaction and injection site induration). On an unknown date the reporter stated that the patient had congestion and trouble breathing while lying down. She also stated that her "ears were stopped up and she had headache". In addition, it was reported that the patient's colitis was "acting up", but it could be because she ate two pears. It was reported that on an unspecified date the patient sought medical attention and was treated with ZYRTEC. At the reporting time, the outcome of respiratory tract congestion, headache, injection site induration, injection site reaction, colitis, ear disorder and dyspnoea was unknown. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site warmth, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 90 year old female patient with continuous positive airway pressure (CPAP) treatment and colitis. On 10-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not provided) subcutaneous in the arm. There was no concomitant medication reported. On 10-AUG-2015, the patient experienced a "hard and warm lump behind the arm" (injection site reaction and injection site induration). On an unknown date the reporter stated that the patient had congestion and trouble breathing while lying down. She also stated that her "ears were stopped up and she had headache". In addition, it was reported that the patient's colitis was "acting up", but it could be because she ate two pears. It was reported that on an unspecified date the patient sought medical attention and was treated with ZYRTEC. At the reporting time, the outcome of respiratory tract congestion, headache, injection site induration, injection site reaction, colitis, ear disorder and dyspnoea was unknown. 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 licensed practical nurse referring to a patient of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant therapies were not reported. On 03-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot# reported as L019286, expiration date: 17-SEP-2017) (dose, route of administration and frequency were not reported), post temperature excursion. No adverse effects were reported. It was stated that the patient did not sought for medical attention. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (strength, dose, frequency and route of administration were not reported) lot # K009953, expiration date 03-APR-2016 and lot # L001456, expiration date 22-OCT-2016. No concomitant therapies were reported. No adverse effects were reported. This is one of three reports from the same source (MARRS linked cases 1508USA002613 and 1508USA004473). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood pressure decreased, Dizziness, Hypotension, Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 year old male patient with no pertinent medical history nor drug reaction/allergies. On 04-AUG-2015, the patient was vaccinated with GARDASIL lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). There was no concomitant therapy. On 04-AUG-2015, the patient experienced light-headedness and repositioned himself to the floor of the room. The patient was repositioned by nursing staff to a supine position. His blood pressure was measured and after he lost consciousness, was lower than it had been before he received the dose of GARDASIL. After an unspecified period of time, the patient was able to sit upright. He received some juice, and then he received one other unspecified vaccination. He did not experience any "light-headedness" after he received the second unspecified vaccination. The patient was released to home after this experience. The outcome of hypotension and dizziness was reported as recovered on 04-AUG-2015. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 year old male patient with no pertinent medical history nor drug reaction/allergies. On 04-AUG-2015, the patient was vaccinated with GARDASIL lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). There was no concomitant therapy. On 04-AUG-2015, the patient experienced light-headedness and repositioned himself to the floor of the room. The patient was repositioned by nursing staff to a supine position. His blood pressure was measured and after he lost consciousness, was lower than it had been before he received the dose of GARDASIL. After an unspecified period of time, the patient was able to sit upright. He received some juice, and then he received one other unspecified vaccination. He did not experience any "light-headedness" after he received the second unspecified vaccination. The patient was released to home after this experience. The outcome of hypotension and dizziness was reported as recovered on 04-AUG-2015. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 06-AUG-2015, the patient was subcutaneously vaccinated with ZOSTAVAX (0.65ml, lot # L003218, expiration date:30-APR-2016; once). Concomitant therapies were not reported. On 07-AUG-2015, the patient developed swelling at the injection site and a headache. The patient sought medical attention, she called the pharmacy on 08-AUG-2015 or 09-AUG-2015 asking if there was anything she could do to help reduce the persistent swelling and headache had lessened. The pharmacist stated that the patient used BENADRYL cream on the area as a home remedy. The patient did not recover from the adverse events. The relatedness between the injection site swelling and headache and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with VAQTA (lot # L008665, expiration date 10-FEB-2017; lot# K012457, expiration date 04-JUN-2017; lot# L004743, expiration date 01-JUN-2017); (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with GARDASIL, lot # k010574, expiration date 08-APR-2017 (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant refers to a 33 year old female patient with no relevant drug reactions or allergies and with no pertinent medical history. On 05-OCT-2011, the patient was vaccinated with a first dose of VARIVAX (Merck), IM, (lot # 670098/0331AA, expiration date: 07-MAR-2013, dose, frequency and route were unknown). On 09-NOV-2011, the patient received the second dose of VARIVAX (Merck), IM (lot # 670098/0331AA, expiration date: 07-MAR-2013, dose, frequency and route were unknown). Other concomitant therapies included vitamin D (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). It was stated that the patient had titers drawn during a physician's office visit on 30-JUN-2015, which were negative for immunity to varicella (PT:Antibody test negative). The outcome of the antibody test negative was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored ROTATEQ (lot # K023532, expiration date 24-JUN-2016) (dose and route were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently administered RECOMBIVAX HB, lot # L001456, expiration date 22-OCT-2016 (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored LIQUID PEDVAXHIB (lot # K025006, expiration date 22-JUL-2017) (dose and route were not reported). No adverse experiences 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 was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with ROTATEQ, lot # K016263, expiration date 26-JUN-2016, administered orally (dose and indication were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored GARDASIL 9 (lot # K011325, expiration date 08-APR-2017) (dose and route were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with GARDASIL 9 (lot# reported as L00610, expiration date 31-JAN-2017) (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Lot number l00610 is an invalid lot number for GARDASIL 9. 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: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K007785, expiration date: 28-MAY-2016, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with M-M-R II (lot # K022285, expiration date 12-NOV-2016; lot # K024038, expiration date 26-NOV-2016; lot #K018965, expiration date 15-OCT-2016; lot # L005291, expiration date 17-FEB-2017) (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored PROQUAD (lot # K011311, expiration date: 14-FEB-2016, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unspecified age and gender. No medical history and concurrent conditions of the patients were reported. Since 25-JUL-2015 (exact dates unspecified), the patients were vaccinated with doses of GARDASIL (lot number: K011562, expiry date: 08-Apr-2017) (dose, route and site of administration not reported) which were exposed to temperature outside of the recommended range. No concomitant medications were reported. No adverse experience was reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No additional information was provided. This is one of the two reports of 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 healthcare worker referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored M-M-R II (lot # J016234, expiration date: 19-APR-2016, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to currently 6 months old child as a female patient. No pertinent medical history was reported. Patient had no allergic reactions. On an unknown date, the patient was vaccinated with oral, ROTATEQ (dose and lot# were not reported). Concomitant therapies included PEDVAXHIB and PREVNAR. On an unknown date, within 24 hours the child had developed hives all over the body. Patient sought medical attention, contacted physician. The patient was given treatment with Antihistamines (unspecified name). On an unknown date, the same vaccines were administered again and within 24 hours on an unknown date approximately in July 2015 (also reported within the past month) the child developed hives all over the body. This had now occurred twice for the child. The patient was given treatment with Antihistamines (unspecified name). Physician stated he will perform skin test on the child. No Product Quality Complaint (PQC) was involved. Action taken was unknown. The outcome of event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. It was reported that on 03-AUG-2010, the patient received the first dose, on 04-OCT-2010, the second dose and on 10-FEB-2011, the third dose of GARDASIL. On 11-AUG-2015, the patient was vaccinated with the fourth dose of GARDASIL. It was confirmed that all four doses were not GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unspecified age and gender. Since 25-JUL-2015 (exact dates unspecified), the patients were vaccinated with doses of ROTATEQ suspension 2 (lot number: K011948, expiry date: 07-JUN-2016; lot number: K020181, expiry date: 24-JUN-2016) (dose, route and site of administration not reported) which were exposed to temperature outside of the recommended range. No adverse experience was reported. The outcome of incorrect storage was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.