chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7-1-15 TC to pt to give lab results-he stated he had cellulitis and got abx from ER-arm is better now-pt declines to report to VAERS-record requested from ER. 6-20-15 pt. presented to ER c/o site red, swollen and painful c/o feels run down. T=98.3 degrees F, BP 127/70 P103 R 20 wt 242.51 lbs. Dx-(L) arm cellulitis given abx (per ER note rec'd 7-6-15).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess, Injection site erythema, Injection site swelling
Clinical narrative: Pt received vaccination on 7/2/15 she states 7/4/15 in AM, injection site was pink and swollen.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2015057902). A currently 57-year-old female patient received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Cochlea implant
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Service Request Number# 1-13928173306), by a contactable physician. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on 27Mar2015. The patient medical history and concomitant medications were not reported. The patient received a cochlear implant on 07May2015 with outcome of unknown. No further information was provided.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Cold sweat, Fatigue, Formication, Heart rate increased
Clinical narrative: I had some extreme cold sweats and elevated heart rate. Symptoms progressed quickly and all of a sudden my whole body had some weird sensations like my skin was crawling. I took the afternoon off of work and went home took a luke warm bath and continued to experience pain throughout my shoulders, core, and arms. These symptoms subsided over night. The next day I noticed little muscle quivers throughout my body and mass exhaustion for about a week. They were never painful but quite concerning. These have slowly subsided over the past 3 weeks but still happen occasionaly. I went to my regular physician on June 19th and we decided that as long as it kept improving not to take any action. They continue to improve but still happen on occasion.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching, Musculoskeletal pain, Pain in extremity
Clinical narrative: I had some extreme cold sweats and elevated heart rate. Symptoms progressed quickly and all of a sudden my whole body had some weird sensations like my skin was crawling. I took the afternoon off of work and went home took a luke warm bath and continued to experience pain throughout my shoulders, core, and arms. These symptoms subsided over night. The next day I noticed little muscle quivers throughout my body and mass exhaustion for about a week. They were never painful but quite concerning. These have slowly subsided over the past 3 weeks but still happen occasionaly. I went to my regular physician on June 19th and we decided that as long as it kept improving not to take any action. They continue to improve but still happen on occasion.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Gastroenteritis viral, Nausea, Vomiting
Clinical narrative: nausea, vomiting, stomach pain, stomach flu
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PER FATHER STARTED SAT. SWELLING REDNESS ITCHING MILD PAIN AT INJECTION SITE WHICH WAS LEFT DELTOID.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Irritability
Clinical narrative: Became fussy 1 1/2 hours after vaccine and returned for re-eval. No fever mild swelling at PENTACEL injection site.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 6/24/15. Pt was given 0.5mL dose of KINRIX for DTAP and Polio vaccine. No adverse event noted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Rash, Scar
Clinical narrative: Shot given 3-2-15 at pharmacy didn't have AE and didn't hurt. About 3 days later had scarring/bruising rash down (R) arm and on (R) side stomach and breast (R). No pain but cosmetically disturbing. No previous rxns.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Pain
Clinical narrative: (L) UE redness, occurred 24 hours after vaccine. Persistent pain/edema as of Tues 6/30 (6 days later)-50% improvement. T= 97.1 F.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Headache, Laboratory test, Lethargy, Muscular weakness
Clinical narrative: Severe HA, muscle weakness, lethargy, no appetite, achy, pain, fever.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Severe HA, muscle weakness, lethargy, no appetite, achy, pain, fever.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Balance disorder, Computerised tomogram head, Electroencephalogram, Gait disturbance, Tremor
Clinical narrative: Tremors of upper arms. Regressive gait, abnormal gait. Loss of balance.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Influenza virus test negative, Nausea, Pyrexia, Streptococcus test negative
Clinical narrative: Fever. Arthralgia. Nausea. Seen at our office following day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient received vaccine on 6/11/15. On 6/14/15, came back to report severe redness/bumps/swelling and severe pain at injection site and extending to elbow.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chills, Injection site erythema, Injection site swelling
Clinical narrative: Day after imm. pt developed redness swelling (L) arm site of inj. Had chills and back pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Large area of swelling, burning, stinging, and redness with heat in the area. Injected on June 11 and, as of today, 7/1/15, still have a red mark, with a bump in it, at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: Large area of swelling, burning, stinging, and redness with heat in the area. Injected on June 11 and, as of today, 7/1/15, still have a red mark, with a bump in it, at injection site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Eye movement disorder, Loss of consciousness, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: I had the pleasure of seeing patient, an 18-year-old female, in the office today. Patient presents with a chief complaint of syncope. She was given the GARDASIL vaccine on May 29 2015. According to mother who was with her, eye rolled back and she passed out. Mom said her arms and jaw were jerking at that time. She woke up pretty quickly and did not have any tongue biting. The week afterwards, she had some fevers and did not feel well. Currently she is at baseline, denies any focal weakness or numbness, changes in speech, swallow, vision, bowel or bladder control. What her mom witnessed most likely is convulsive syncope and not a seizure. However as never occurred before, comprehensive workup will be performed with an MRI of the brain today as well as an EEG. If these are unremarkable, then I would be most comfortable with making the diagnosis of convulsive syncope. Certainly if there is another episode such as this, that conclusion would need to be reconsidered.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Syncope
Clinical narrative: I had the pleasure of seeing patient, an 18-year-old female, in the office today. Patient presents with a chief complaint of syncope. She was given the GARDASIL vaccine on May 29 2015. According to mother who was with her, eye rolled back and she passed out. Mom said her arms and jaw were jerking at that time. She woke up pretty quickly and did not have any tongue biting. The week afterwards, she had some fevers and did not feel well. Currently she is at baseline, denies any focal weakness or numbness, changes in speech, swallow, vision, bowel or bladder control. What her mom witnessed most likely is convulsive syncope and not a seizure. However as never occurred before, comprehensive workup will be performed with an MRI of the brain today as well as an EEG. If these are unremarkable, then I would be most comfortable with making the diagnosis of convulsive syncope. Certainly if there is another episode such as this, that conclusion would need to be reconsidered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 6-25-15-rash around site on arm, burning around injection site. 6-26-15 began with redness and swelling at inj. site. Area is itchy-the character is described as pruritic. Ineffective treatments include observation only-2 cm area of erythema. Advised ice and BENADRYL PO.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions and medical history were provided. The reporter stated that on 03-APR-2015, 17-APR-2015, 11-MAY-2015, 27-MAY-2015, 01-JUN-2015 and 02-JUN-2015 an unspecified number of patients were vaccinated with an improperly stored GARDASIL (dose, route of administration, lot number and expiration date were not reported). No concomitant medication therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Herpes virus infection, Vitreous floaters
Clinical narrative: Moderate dizziness. Made my herpes on the back of my leg breakout with sores. Floaters in my left eye.
Age: 1.06
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Seen in office for 1 year exam. Given Hib, PREVNAR, MMR and varicella. Presented to ER in pm w/fever and seizure activity x 30 seconds. Sent home after ER exam.
Age: 77.0
Sex: U
Vaccine: PNC13
Symptoms: Dysgeusia, Fatigue, Headache, Pain
Clinical narrative: Slept for 3 hours. Headache. Horrific body ache, metallic taste in mouth. Tired.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Vomiting, abdominal pain, loose stools. Resolved within 24 hrs.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Wide spread rash, swelling, and pain on left arm which all appeared on 3rd of June-15. June 4th saw Dr and treatment was to apply hot & cold compress.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Bradycardia, Loss of consciousness
Clinical narrative: 10:00 am 5 min 1p Hep A and HPV pt fell back on table loosing conscious-but responded immediately. B/P 110/64 HR 44-Highest HR 60 but returned to 44-45. After 10 min, B/P 98/60. Remained bradycardic-911 called for transport -pt left awake and alert w parents to ER.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: 4,5 x 4 inch red flat rash. Warm to touch at site of PREVNAR administered 6/29/15.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Developed fever, redness, swelling, pain at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Gastrooesophageal reflux disease, Injection site rash, Pyrexia
Clinical narrative: The day of vaccine devlp'd fever, chills, GERD sxm & next day devlpd rash at inj. site. Rash is now abating. Other sym resolved after 2 days. Still with faint erythema of left arm.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site haemorrhage, Injection site inflammation, Injection site pain
Clinical narrative: Localized redness, swelling, discomfort/pain, and itchiness at site of injection. Seen in office today. 1 cm diam ecchymosis at injection site 2 cm surrounding area of inflammation.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, swelling, discomfort/pain, and itchiness at site of injection. Seen in office today. 1 cm diam ecchymosis at injection site 2 cm surrounding area of inflammation.
Sex: U
Vaccine: VARZOS
Symptoms: Blepharochalasis, Eyelid oedema, Herpes zoster, Post herpetic neuralgia, Skin disorder
Clinical narrative: This spontaneous report was received from patient of unknown age and gender reporting on him/herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not provided). No concomitant therapies were reported. In 2012 the patient experienced shingles (herpes zoster). Then, on an unknown date the patient experienced post herpetic neuralgia - primary, blepharoedema, right (eyelid oedema), blepharochalases of right upper eyelid, limited to breakdown of skin (skin disorder) and skin ulceration. The patient had one consultation appointment with the clinic eye doctor already. He would have an upcoming appointment in July. The outcome of shingles, post herpetic neuralgia, skin disorder, eyelid oedema, blepharochalases and skin ulcer was unknown. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: This spontaneous report was received from patient of unknown age and gender reporting on him/herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not provided). No concomitant therapies were reported. In 2012 the patient experienced shingles (herpes zoster). Then, on an unknown date the patient experienced post herpetic neuralgia - primary, blepharoedema, right (eyelid oedema), blepharochalases of right upper eyelid, limited to breakdown of skin (skin disorder) and skin ulceration. The patient had one consultation appointment with the clinic eye doctor already. He would have an upcoming appointment in July. The outcome of shingles, post herpetic neuralgia, skin disorder, eyelid oedema, blepharochalases and skin ulcer was unknown. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 01-JUL-2015, the patient was inadvertently vaccinated with expired M-M-R II (lot # not reported, expiry date 17-APR-2015, dose not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K008874 (dose, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 74 year old female patient refers to herself. Pertinent medical history included osteoporosis, tremors and allergy to PAXIL. On 23-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 shot/once, subcutaneously). The reporter said she had "many" concomitant medications and declined to list them all. On 13-JUN-2015, the patient noticed a rash forming. She sought medical attention on an unspecified date and was given an unspecified antiviral by a physician for treatment. None lab diagnostics studies were performed. The outcome of rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous reprot as received from a certified medical assistant refers to unspecified patients. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (doses and lot numbers were not reported), oral. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patients. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (doses and lot numbers were not reported), oral. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an approximately 14 years-old patient of unknown gender. On 25-FEB-2015, GARDASIL (lot # K004205, expiration date 12-JAN-2017 and lot # K005881, with expiration date 14-JAN-2017) was improperly exposed to 21.72F for 40 minutes for 1 cycle (incorrect product storage) (dose and frequency were unknown). On unspecified date, in approximately 2015, the patient may have received this improperly stored GARDASIL. There were no known adverse effects. The vaccine was, however, given via the correct route, as per the prescribing information. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker (also reported as "practice administrator") referring to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-JUN-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J007349, expired date 13-JUN-2015; dose and route were not reported). Information regarding concomitant medications was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions or pertinent medical history were reported. On 02-AUG-1976, the patient was vaccinated with the first dose of M-M-R II (dose, lot number, expiration date and route were not reported). On 15-JUN-2015, the patient was vaccinated with an expired the second dose of M-M-R II (lot # J006954, expiration date 07-JUN-2015) (Inappropriate schedule of drug administration) dose and route were not reported). Concomitant medication was not reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product quality control issue, Wrong patient received medication
Clinical narrative: This spontaneous report as received from an office manager refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2015, the patient was accidentally vaccinated with a dose of VARIVAX (Merck) (subcutaneously; dose, lot # and expiration date were not reported). No adverse effects were reported. The office manager also stated that a vial of VARIVAX (Merck) with the flip cap dislodged and was found inside carton. The outcome of the adverse event was unknown. The relatedness between the adverse event and the vaccination with VARIVAX (Merck) was not reported. A product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from an administrator referring to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-JUN-2015 the patient was vaccinated with an expired dose of VAQTA (0.5 ml, lot # 0532AE, expiration date 25-JAN-2015, intramuscular). Information regarding concomitant medications was not reported. No adverse reactions had been reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse regarding to a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-JUN-2015, the patient was vaccinated with the dose of improperly stored ZOSTAVAX, 0.65 ml, subcutaneous. No concomitant medication was reported. The patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a certified medical assistant (C.M.A.) referring to an unspecified number of patients. On unspecified dates since 02-JUN-2015, these patients were administered an unspecified number of improperly stored doses of PROQUAD (Merck) (lot # K025760) subcutaneously (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a pharmacist via field representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot# and dose were unknown). On an unknown date the patient experienced an unspecified adverse reaction. The outcome of adverse reaction was reported as recovered/resolved. The relationship of the adverse reaction and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates after 01-JUN-2015, these patients were vaccinated with doses of GARDASIL (dose, frequency and lot# were not reported) which was improperly stored (incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by 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 of unknown age and gender. On unspecified dates after 01-JUN-2015, the patients were vaccinated with doses of GARDASIL 9 (dose, frequency and lot# were not reported) which was improperly stored. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: I started to lose my vision while driving home (blurry) and became very sweaty.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Noticed bald spots on patient's scalp. I waited to see if they would go away. About two weeks after initial notice of bald spots I observed that the spots were actually growing in size. I made an appointment for patient to see her doctor. She was seen March 24 and was diagnosed with Alopecia AREATA. No tests were done. Treatment of steroid was offered but I declined. As of today (07/06/20015) patients hair appears to be growing back but still thin in the areas where the bald patches developed.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Alopecia
Clinical narrative: Noticed bald spots on patient's scalp. I waited to see if they would go away. About two weeks after initial notice of bald spots I observed that the spots were actually growing in size. I made an appointment for patient to see her doctor. She was seen March 24 and was diagnosed with Alopecia AREATA. No tests were done. Treatment of steroid was offered but I declined. As of today (07/06/20015) patients hair appears to be growing back but still thin in the areas where the bald patches developed.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, diarrhea, headache, muscle aches lasting 5 days. Symptomatic treatment.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age. Patient's drug reaction and medical history were not reported. On an unknown date unspecified patients received improperly stored RECOMBIVAX Hb (lot # K021444 exp 17-SEP-2016; lot # K017721 exp 27-AUG-2016). The nurse also reported RECOMBIVAX HB (lot # K021444 as reported) exposed to a maximum temperature of 52.28F for cumulative time of 7 hours and 50 minutes. There were totally 28 doses were administered. Concomitant medication was not reported. At the time of the report, no adverse effects were reported. Additional information has been requested.
Age: 1.12
Sex: F
Vaccine: HEPA, MMR, MNQHIB, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chicken pox.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Axillary pain, Injection site pain, Injection site rash, Pain in extremity, Rash pruritic
Clinical narrative: Left arm pain and rash. Mom reports that patient received PEDIARIX 6/29/15 and the following day significant arm pain armpit to fingers develop a 2 in x 1 in itchy rash and firm lump 2".
Age: 65.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Patient woke up next morning with large red area & very big blister. He went to emergency room and they hadn't seen this before. They drew marker around large area & advised BENADRYL. The area going down but still looks bad 5 days later.
Age: 65.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site scab, Injection site vesicles, Peripheral swelling
Clinical narrative: Patient woke up next morning with large red area & very big blister. He went to emergency room and they hadn't seen this before. They drew marker around large area & advised BENADRYL. The area going down but still looks bad 5 days later.
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin, Intensive care, Jaundice neonatal
Clinical narrative: Baby became serevely jaundiced requiring UV light therapy and a 5 day stay in the NICU.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Autonomic nervous system imbalance, Blood pressure abnormal, Dizziness, Headache, Heart rate abnormal
Clinical narrative: About 1 hr after vaccine sudden dizziness. Later nausea & headaches. Since then has been diagnosed with POTS (postural orthostatic tachycardia syndrome, orthostatic intolerance, dysautonomia. Still trying to treat symptoms with medication.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nausea, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: About 1 hr after vaccine sudden dizziness. Later nausea & headaches. Since then has been diagnosed with POTS (postural orthostatic tachycardia syndrome, orthostatic intolerance, dysautonomia. Still trying to treat symptoms with medication.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Autonomic nervous system imbalance, Blood pressure orthostatic abnormal, Dizziness, Headache, Heart rate abnormal
Clinical narrative: About 1 hr after vaccine sudden dizziness. Later nausea & headaches. Since then has been diagnosed with POTS (postural orthostatic tachycardia syndrome, orthostatic intolerance, dysautonomia. Still trying to treat symptoms with medication.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a mild shingles type rash on right side.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye movement disorder, Immediate post-injection reaction, Muscle twitching, Seizure, Unresponsive to stimuli
Clinical narrative: Tdap given in left deltoid.  Then Gardasil was given in right deltoid.  Then Menactra was given in right deltoid.  Immediately after Menactra given in right deltoid, pt became unresponsive to vaccine administrator. Patient's eyes were rolled back in his head and arms were twitching bilaterally.  After 30 seconds, the patient stopped twitching and his eye focused.  The examiner was called into the room approximately 1 minute after the seizure activity began and the patient was responsive.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, redness and tender nodule under vaccination site.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUC3
Symptoms: Injection site pain
Clinical narrative: Soreness in arm where injection was given.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUC3
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm where injection was given.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pustular, Skin lesion
Clinical narrative: Extensive rash spreading over entire abdomen and sides of body.  Rash also on face.  Rash consisting of large red lesions as well as individual pox.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Cold sweat, Excessive eye blinking, Hyperacusis, Insomnia, Muscle contractions involuntary
Clinical narrative: 6/26/15 daytime....our son was "balling his fists"  and simultaneously saying "eeee" many times that first day.  6/26/15 8:00pm.  Woke up after 1 hour of sleep, in a cold sweat.  Awake from 8:00pm to 2:00am.  Our son was very hyper, acting as if someone gave him adrenaline.   Day 1 result per my wife, "psycho motor agitation".  Wife is a Child Psychologist. 6/27/15, various times and days until 7/2/15. Our son started "blinking repetitively" while watching television.  We stopped playing television and the Iphone as we realized this was causing the excessive blinking. 7/1/15 (approximate) Repeteadly asking "what is that noise" and became fixated on Sound.  He is perseverating on the noises. 7/3/15-7/5/15, had fever of 100-103.7 degrees. 7/6/15.  Has become fearful of some sounds and still perseverates on them.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Psychomotor hyperactivity, Pyrexia
Clinical narrative: 6/26/15 daytime....our son was "balling his fists"  and simultaneously saying "eeee" many times that first day.  6/26/15 8:00pm.  Woke up after 1 hour of sleep, in a cold sweat.  Awake from 8:00pm to 2:00am.  Our son was very hyper, acting as if someone gave him adrenaline.   Day 1 result per my wife, "psycho motor agitation".  Wife is a Child Psychologist. 6/27/15, various times and days until 7/2/15. Our son started "blinking repetitively" while watching television.  We stopped playing television and the Iphone as we realized this was causing the excessive blinking. 7/1/15 (approximate) Repeteadly asking "what is that noise" and became fixated on Sound.  He is perseverating on the noises. 7/3/15-7/5/15, had fever of 100-103.7 degrees. 7/6/15.  Has become fearful of some sounds and still perseverates on them.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Agitation, Psychomotor hyperactivity, Tic
Clinical narrative: 6/26/15 daytime....our son was "balling his fists"  and simultaneously saying "eeee" many times that first day.  6/26/15 8:00pm.  Woke up after 1 hour of sleep, in a cold sweat.  Awake from 8:00pm to 2:00am.  Our son was very hyper, acting as if someone gave him adrenaline.   Day 1 result per my wife, "psycho motor agitation".  Wife is a Child Psychologist. 6/27/15, various times and days until 7/2/15. Our son started "blinking repetitively" while watching television.  We stopped playing television and the Iphone as we realized this was causing the excessive blinking. 7/1/15 (approximate) Repeteadly asking "what is that noise" and became fixated on Sound.  He is perseverating on the noises. 7/3/15-7/5/15, had fever of 100-103.7 degrees. 7/6/15.  Has become fearful of some sounds and still perseverates on them.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: SORENESS, REDNESS ON ARM.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Incorrect route of drug administration
Clinical narrative: PPD test given on (L) deltoid (partial) (wrong route) instead of intradermal. Patient was very nervous about getting vaccine after the vaccine was a bit dizzy-recovered in approx 10 min.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema around injection site after 1 week of administration.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Blood/mucus in stool.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Meningococcal Liquid Conjugate Component only and not the mixture.
Age: 1.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Cough, Erythema, Full blood count normal, Pyrexia
Clinical narrative: Pt received PEDIARIX, PREVNAR, for on 7-1-15. Went to ER that night with 105 fever, wheezing and cough. Seen in office on 7-2-15 at 2:00 pm with c/o fever and cough. Cxr normal in ER. Temp 99.3 in office. CBC normal. (L) ear red & dull put on abx.
Age: 1.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Wheezing
Clinical narrative: Pt received PEDIARIX, PREVNAR, for on 7-1-15. Went to ER that night with 105 fever, wheezing and cough. Seen in office on 7-2-15 at 2:00 pm with c/o fever and cough. Cxr normal in ER. Temp 99.3 in office. CBC normal. (L) ear red & dull put on abx.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Urticaria
Clinical narrative: Severe hives-prednisone taper, hydrocortisone cream, persistent eczema.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain
Clinical narrative: Pt reports today that within a few hours of receiving PREVNAR her whole body ached cold chills, not sure if she had a fever, and scratchy throat. No local reaction noted by nurse.
Age: 36.0
Sex: F
Vaccine: TTOX
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Left arm pain and decreased range of motion in all directions. Shooting pain from neck down to fingers (left side).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender/age unknown). The patients' concurrent/historical conditions or concomitant therapies were not reported. On an unspecified date, since 20-APR-2015 the patients were vaccinated with PNEUMOVAX 23 (lot # K008410, exp. date 26-FEB-2016) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Rash. Diphenhydramine 25 mg prn, ibuprofen 300 mg prn.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus. Diphenhydramine 50 mg prn.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored M-M-R II (therapy type, lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the unspecified number of the patients were vaccinated with the dose of improperly stored VARIVAX (Merck), (dose strength, route and lot number was unknown). No concomitant medication was reported. The patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. 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 unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored PEDVAXHIB (lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that 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 as received from a registered nurse refers to an unspecified number of patients (gender/age unknown). The patients' concurrent/historical conditions or concomitant therapies were not reported. On unknown dates, since 20-APR-2015 the patients were vaccinated with GARDASIL (lot # K009482, exp. date 06-MAR-2017) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a Registered Nurse referring to a 4 year old male patient with immunodeficiency. In June 2013 (reported as 2 years ago) the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, rout, lot# and expiration date were unkonwn). Concomitant therapies were unspecified by the reporter. In 2015 (reported as recently) the patient was determined to have low antibody titers. The patient had an office visit for medical attention. No treatment was given for the event. The patient had not recovered from the event. Additional information is not expected as the reporter refused to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Heathcare worker reported that unspecified doses of improperly stored GARDASIL (lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a currently 18 year old female patient. The patient had no pertinent medical history or drug allergies. The patient's last menstrual period was in December 2014 and the due date was calculated as approximate September 2015 based on the patient's last menstrual period. On 24-JUN-2015 the pregnant patient was vaccinated with GARDASIL (lot # K007828, expiration date 2-MAR-2017, dose 1, concentration was unknown, 0.5 ml/once) intramuscularly (drug exposure during pregnancy). The patient had no concomitant medication. No adverse effect was reported. The pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored RECOMBIVAX HB (therapy type, lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema
Clinical narrative: Patient received PNEUMOVAX in his right upper arm area on April 23. The next day, he noticed significant redness near the area of the injection. The redness has extended downward an additional several centimeters. No associated fever or chills. No difficulty breathing. No swelling or rash elsewhere on the body. Of note, patient received PNEUMOVAX in 2007 without complication.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 2 days ago, no redness, yesterday arm became red, and redness increased over the day and arm became hot, today arm less red and less hot and is pruritic. Redness fading. Triamcinolone.
Age: 1.27
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008874, expiration date, dose and route were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 36 year old pregnant female patient and refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck), subcutaneous (dose, lot # and expiration date were not provided). It was unknown how many doses of VARIVAX (Merck) the patient had received and if she was pregnant before or after receiving VARIVAX (Merck). The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Additional information is not expected as the reporter did not provide any contact details.
Age: 36.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a 36 year old pregnant female patient and refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck), subcutaneous (dose, lot # and expiration date were not provided). It was unknown how many doses of VARIVAX (Merck) the patient had received and if she was pregnant before or after receiving VARIVAX (Merck). The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Additional information is not expected as the reporter did not provide any contact details.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 23-JUN-2015, the patient was vaccinated with both VARIVAX (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported). No product confusion was specified. No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been information.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female pregnant patient, with no drug reactions or allergies. On 27-APR-2015, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# and expiration date were not reported). No concomitant medication was administered. At the time of vaccination the patient was in the first week of gestation. It was the first trimester of exposure. The Last Menstrual Period (LMP) was calculated based on gestational age as 20-APR-2015, the Estimated Date of Delivery (EDD) was 25-JAN-2016. At the time of report the pregnancy outcome was pending. The patient sought medical attention during office visit. No treatment was given. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 23-JUN-2015, the patient was vaccinated with both VARIVAX (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported) and PROQUAD (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported). No product confusion was specified. No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, frequency, lot # and expiration date were unknown) orally. No concomitant therapy was reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.