chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 57 year old female patient who had unspecified reaction to penicillin. Medical history was reported as none. On 23-NOV-2014, the patient was vaccinated with ZOSTAVAX vial 19400 PFU for routine administration (dose, route and frequency were not reported). Lot number was reported as K014835 and expiry date as 14-DEC-2015. Concomitant therapies included losartan potassium (manufacturer unknown), ATIVAN, valacyclovir, lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On an unknown date approximately in 2014, the patient experienced small diffuse maculopapular rash down her arm. No lab diagnostics studies performed. No treatment was given for the event. Patient sought medical attention and saw physician. The outcome of small diffuse maculopapular rash down her arm was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported. Varicella zoster virus (VZV) packet accepted. No additional information to report. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Induration, Peripheral swelling
Clinical narrative: I received a shingles vaccination on Saturday. My arm got red, swollen & hard. An area about 6 inches by 4 inches. Then by Tuesday I had shingles on my neck and back. The pharmacist who gave me the shot said to put hydrocortisone cream on the areas. They said people don't get shingles from the vaccination but I sure did!
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to his/her friend who was a 75 year old female patient who enrolled in ZOSTAVAX Testing program (the reporter was also reported as the patient herself). On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route unknown). On unknown dates the patient developed shingles twice after receiving shingles vaccination (non-efficacy). The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be serious due to hospitalization/prolonged. Additional information is not expected as the reporter is not willing of follow up contact.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and soreness at injection site.
Age: 0.26
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Mom did not report Adverse Reaction.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash, Rash generalised
Clinical narrative: TC from pediatrician office (practice name unknown).  Spoke with RN (Name unknown), who reported that client had a rash at the Pentacel injection site (LAT) that spread over entire body.  Client was seen in an ER on 12-9-14 per RN.  RN stated that client was treated with Zyrtec and prednisone.  Plan per RN is to refer client to an allergist for follow-up.  RN stated she would call me back later 12-11-14 to complete VAERS report.  Have not heard from her.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Culture stool, Diarrhoea, Faeces discoloured
Clinical narrative: Started with extreme ache in stomach and head...chills, then aches all over. Fever ran between 101 and 103.3 for close to 12 hours. Had nausea. Had extreme diarrhea starting that morning and last a week which was yellowish in color. Had low grade fever for 3 days following.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Started with extreme ache in stomach and head...chills, then aches all over. Fever ran between 101 and 103.3 for close to 12 hours. Had nausea. Had extreme diarrhea starting that morning and last a week which was yellowish in color. Had low grade fever for 3 days following.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Asthma exercise induced, Blood test normal, Cold sweat, Condition aggravated
Clinical narrative: This spontaneous consumer report (initial receipt 02-Dec-2014) concerns a 15 year-old male patient who had a penicillin allergy and a medical history of asthma as a child. His concomitant medication included albuterol. In Nov-2013, approximately 1 to 2 weeks following FLUMIST (batch number not provided), the patient experienced breathing difficulty and was prescribed an albuterol inhaler by a paediatrician. He thought that he had exercise-induced asthma after the FLUMIST administration. It lasted until the summer of 2014. He had many blood tests at the paediatrician's office and with an allergist, but the tests were all negative and there were no reasons for the episodes identified. The paediatrician suggested the episodes may have come from anxiety. On 30-Nov-2014 at 12:00 hours, the patient intramuscular received AFLURIA (batch number not provided) 0.5mL. On 01-Dec-2014 at 21:30 hours, the patient experienced difficulty breathing, tachycardia, paleness, nausea, clamminess, feelings of fainting, decreased appetite and mood changes. They lasted for approximately one hour. He was a healthy, athletic, straight-A, funny person who felt debilitated with these episodes as they caused him to cry and appeared like a brick wall which was not typical to his mood and behaviour. His entire family received AFLURIA but only he experienced these adverse events. Outcome was not reported.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Decreased appetite, Dizziness, Dyspnoea, Mood altered
Clinical narrative: This spontaneous consumer report (initial receipt 02-Dec-2014) concerns a 15 year-old male patient who had a penicillin allergy and a medical history of asthma as a child. His concomitant medication included albuterol. In Nov-2013, approximately 1 to 2 weeks following FLUMIST (batch number not provided), the patient experienced breathing difficulty and was prescribed an albuterol inhaler by a paediatrician. He thought that he had exercise-induced asthma after the FLUMIST administration. It lasted until the summer of 2014. He had many blood tests at the paediatrician's office and with an allergist, but the tests were all negative and there were no reasons for the episodes identified. The paediatrician suggested the episodes may have come from anxiety. On 30-Nov-2014 at 12:00 hours, the patient intramuscular received AFLURIA (batch number not provided) 0.5mL. On 01-Dec-2014 at 21:30 hours, the patient experienced difficulty breathing, tachycardia, paleness, nausea, clamminess, feelings of fainting, decreased appetite and mood changes. They lasted for approximately one hour. He was a healthy, athletic, straight-A, funny person who felt debilitated with these episodes as they caused him to cry and appeared like a brick wall which was not typical to his mood and behaviour. His entire family received AFLURIA but only he experienced these adverse events. Outcome was not reported.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pallor, Tachycardia
Clinical narrative: This spontaneous consumer report (initial receipt 02-Dec-2014) concerns a 15 year-old male patient who had a penicillin allergy and a medical history of asthma as a child. His concomitant medication included albuterol. In Nov-2013, approximately 1 to 2 weeks following FLUMIST (batch number not provided), the patient experienced breathing difficulty and was prescribed an albuterol inhaler by a paediatrician. He thought that he had exercise-induced asthma after the FLUMIST administration. It lasted until the summer of 2014. He had many blood tests at the paediatrician's office and with an allergist, but the tests were all negative and there were no reasons for the episodes identified. The paediatrician suggested the episodes may have come from anxiety. On 30-Nov-2014 at 12:00 hours, the patient intramuscular received AFLURIA (batch number not provided) 0.5mL. On 01-Dec-2014 at 21:30 hours, the patient experienced difficulty breathing, tachycardia, paleness, nausea, clamminess, feelings of fainting, decreased appetite and mood changes. They lasted for approximately one hour. He was a healthy, athletic, straight-A, funny person who felt debilitated with these episodes as they caused him to cry and appeared like a brick wall which was not typical to his mood and behaviour. His entire family received AFLURIA but only he experienced these adverse events. Outcome was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Decreased appetite, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: 11/15/14 at 1130 Patient visited the facility to receive an influenza injection. Five minutes after the injection the patient complained of sweating, nausea, and a fast heart beat. The patient was seated with her head back and her feet elevated. Patient was alert, OX3, able to move all extremities. Skin warm and clammy, Resp even and unlabored. No wheezing noted, no rash noted on the body. Patient denied chest pain, SOB, Headache at this time. An icepack was applied to the back of her neck and offered sips of Gatorade and continued to monitor. Patient denied not eating today and yesterday. She verbalized just wanting to stay in the house all the time after losing her job. Patient denied homicidal/suicidal thoughts or depression. Patient say she just don't have a appetite. Encouraged patient to eat small frequent meals even if she is not feeling hungry. Patient denies a medical history of heart problems, HTN, diabetes or psychiatric problems at this time. Vitals at 1135 BP 91/55, HR 101, Resp 24, Temp 98.2 orally Fifteen minutes after interventions, patient denied Headache, SOB, chestpain, nausea, pain level was 0. Vitals 107/62 HR 60 Resp 16 Temp 98.2. Skin warm and dry, color pink, no rashes noted, no wheezing noted. Patient was dismissed home in stable condition ambulating without assistance. ER precautions given, go to the ER or call 911 with SOB, chest pain, call PCP with new symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: 11/15/14 at 1130 Patient visited the facility to receive an influenza injection. Five minutes after the injection the patient complained of sweating, nausea, and a fast heart beat. The patient was seated with her head back and her feet elevated. Patient was alert, OX3, able to move all extremities. Skin warm and clammy, Resp even and unlabored. No wheezing noted, no rash noted on the body. Patient denied chest pain, SOB, Headache at this time. An icepack was applied to the back of her neck and offered sips of Gatorade and continued to monitor. Patient denied not eating today and yesterday. She verbalized just wanting to stay in the house all the time after losing her job. Patient denied homicidal/suicidal thoughts or depression. Patient say she just don't have a appetite. Encouraged patient to eat small frequent meals even if she is not feeling hungry. Patient denies a medical history of heart problems, HTN, diabetes or psychiatric problems at this time. Vitals at 1135 BP 91/55, HR 101, Resp 24, Temp 98.2 orally Fifteen minutes after interventions, patient denied Headache, SOB, chestpain, nausea, pain level was 0. Vitals 107/62 HR 60 Resp 16 Temp 98.2. Skin warm and dry, color pink, no rashes noted, no wheezing noted. Patient was dismissed home in stable condition ambulating without assistance. ER precautions given, go to the ER or call 911 with SOB, chest pain, call PCP with new symptoms.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Flushing, Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: SWELLING OF EXTREMITIES - RIGHT THIGH FROM KNEE UP, LIMPING THE DAY OF AND DAY AFTER, BLISTER AT INJECTION SITE TWO DAYS AFTER, FLUSHED SKIN AND REDNESS, WARM TO THE TOUCH TWO DAYS AFTER, PAIN IN LEG FOR FOUR DAYS AFTER INJECTION.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site vesicles, Skin warm
Clinical narrative: SWELLING OF EXTREMITIES - RIGHT THIGH FROM KNEE UP, LIMPING THE DAY OF AND DAY AFTER, BLISTER AT INJECTION SITE TWO DAYS AFTER, FLUSHED SKIN AND REDNESS, WARM TO THE TOUCH TWO DAYS AFTER, PAIN IN LEG FOR FOUR DAYS AFTER INJECTION.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness/pain in left deltoid (site of injection), area approximately 3 inches in diameter per mother's report.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Abasia, Asthenia, Ataxia, Chest X-ray normal, Chills
Clinical narrative: Received flu, pneumococcal, zoster vaccines at 5 PM on 12/8/14. 12/9/14 - fever, chills, sweats, weakness, couldn't stand, walk, diarrhea. Presented to ER. Ataxia present WBC 27,000. Admitted to hospital. Also developed local rxn (L) upper arm. SIRS criteria met - cult (-). Improving and discharged from hosp. 12/11/14.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Computerised tomogram head normal, Culture negative, Diarrhoea, Dysstasia, Feeling cold
Clinical narrative: Received flu, pneumococcal, zoster vaccines at 5 PM on 12/8/14. 12/9/14 - fever, chills, sweats, weakness, couldn't stand, walk, diarrhea. Presented to ER. Ataxia present WBC 27,000. Admitted to hospital. Also developed local rxn (L) upper arm. SIRS criteria met - cult (-). Improving and discharged from hosp. 12/11/14.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Hyperhidrosis, Influenza virus test negative, Local reaction, Pyrexia, Systemic inflammatory response syndrome
Clinical narrative: Received flu, pneumococcal, zoster vaccines at 5 PM on 12/8/14. 12/9/14 - fever, chills, sweats, weakness, couldn't stand, walk, diarrhea. Presented to ER. Ataxia present WBC 27,000. Admitted to hospital. Also developed local rxn (L) upper arm. SIRS criteria met - cult (-). Improving and discharged from hosp. 12/11/14.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Received flu, pneumococcal, zoster vaccines at 5 PM on 12/8/14. 12/9/14 - fever, chills, sweats, weakness, couldn't stand, walk, diarrhea. Presented to ER. Ataxia present WBC 27,000. Admitted to hospital. Also developed local rxn (L) upper arm. SIRS criteria met - cult (-). Improving and discharged from hosp. 12/11/14.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Confusional state, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, confusion, headache, lack of appetite. I think they are macking shots too strong - bad effects lasted one week.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site pain, Malaise
Clinical narrative: Client received TDAP on 8-29-14, called clinic on 9-1-14 wanted to know if she should see her doctor as she just hadn't felt well after shot. Slept all weekend, had a knot under her arm, knot where she got shot and very sore. On 9-2-14 had redness, tenderness at injection site. No treatment given. Discussed normal side effects.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule
Clinical narrative: Client received TDAP on 8-29-14, called clinic on 9-1-14 wanted to know if she should see her doctor as she just hadn't felt well after shot. Slept all weekend, had a knot under her arm, knot where she got shot and very sore. On 9-2-14 had redness, tenderness at injection site. No treatment given. Discussed normal side effects.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Contusion, Feeling hot, Injection site bruising, Injection site discolouration
Clinical narrative: Patient reported bruising and purple color of vaccinated arm from wrist to shoulder day of vaccination, still has purple. Face on left side gets hot and burns approximately five times daily starting the morning after vaccination and continues today. Patient has seen multiple doctors.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Patient reported bruising and purple color of vaccinated arm from wrist to shoulder day of vaccination, still has purple. Face on left side gets hot and burns approximately five times daily starting the morning after vaccination and continues today. Patient has seen multiple doctors.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient had local swelling at the injection site.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Discomfort, Erythema, Palpitations, Swelling
Clinical narrative: Left deltoid erythema, swelling and discomfort with palpation larger than softball size.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Deafness unilateral, Dizziness, Facial pain, Headache
Clinical narrative: Oct 1, 2014, received flu shot, left arm at 12 noon. 11 days later, on Oct 12th - symptoms developed in (L) side (facial droop, couldn't hear (L) ear; no taste). 10/9, 10, 11 I had pain extending from (L) ear to top of head - along nerve roots. 10/8 - dizzy. 10/9 - dizzy, headaches, pain in (L) facial area.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Oct 1, 2014, received flu shot, left arm at 12 noon. 11 days later, on Oct 12th - symptoms developed in (L) side (facial droop, couldn't hear (L) ear; no taste). 10/9, 10, 11 I had pain extending from (L) ear to top of head - along nerve roots. 10/8 - dizzy. 10/9 - dizzy, headaches, pain in (L) facial area.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Developed vomiting intermittently beginning day after vaccine, lasting 3 days. Had diarrhea day 6 post for 1d and no fever. No specific Tx except diet changes recommended.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness
Clinical narrative: Felt dizzy.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swelling/Rash at injection site.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None reported. Patient was given her second ZOSTAVAX shot on 10/23/14 after having received her first ZOSTAVAX shot on 8/22/13. Patient reports no adverse effects. Duplication discovered upon routine review of patient profile on 12/13/14.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site macule, Injection site pruritus, Macule
Clinical narrative: All skin surfaces became covered in erythematous macules and patches. Some were raised and the worst is over cheeks and deltoids. BENADRYL was given due to itching at injection site.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a nurse manager refers to a 13 year old female patient. Patient's pertinent medical history and drug reactions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency, lot#, expiration date unspecified). Concomitant medications were not reported. On an unknown date after vaccination the patient experienced dizziness and numbness of the hands and feet (medically significant by the reporter). The patient sought medical attention. Patient went to the emergency room (ER) two days later, due to continuing symptoms, and then had a second trip back to the ER. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction
Clinical narrative: Initial unsolicited report was received on 04 December 2014 from another manufacturer (manufacturer report number 2014297065) who received it from an investigator. An 11 year-old female patient had received on 06 November 2013 the following vaccines: a 0.5 ml intramuscular right deltoid injection of DTP Absorbed Vaccine (manufacturer and lot number not reported) and a 0.5 ml intramuscular left deltoid injection of MCV4 (manufacturer and lot number not reported). The patient also received on 02 October 2013 a dose three 0.5 ml intramuscular left deltoid injection of Meningococcal Group B RLP2086 (other manufacturer lot number not reported) and on 26 November 2013 the patient had a positive PCR for Bordetella pertussis. The patient had no significant past medical history but had a cough without fever at time of Tdap vaccination. The patient received dose one and two of Meningococcal Group B RLP2086 on 07 May 2013 and 19 June 2013 respectively. Treatment included Azithromycin from 26 November to 30 November 2013. According to the report the initial aware date of the event was 27 October 2013. No further information was available at the time of the report. Outcome was recovered on 04 April 2014. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pruritus, Feeling abnormal, Hypertension, Laboratory test
Clinical narrative: Pt. reported approx 1 hr after adm of vaccine she woke up from nap with red itchy eyes, feeling bad, dilated pupils, heart racing and chills. Family member took pt to local ER. She was given BENADRYL, then she was admitted for observation alt persistent HTN. Labs obtained. Pt. discharged on 12-11-14. Pt. recovered.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mydriasis, Ocular hyperaemia, Palpitations
Clinical narrative: Pt. reported approx 1 hr after adm of vaccine she woke up from nap with red itchy eyes, feeling bad, dilated pupils, heart racing and chills. Family member took pt to local ER. She was given BENADRYL, then she was admitted for observation alt persistent HTN. Labs obtained. Pt. discharged on 12-11-14. Pt. recovered.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Activities of daily living impaired, Injection site pain, Injection site reaction, Pain
Clinical narrative: I have muscle pain where I received my vaccine. First I just thought it was painful from having the vaccine, but then it continued. I now have to watch how I use my arm, it feels at times as if my muscle is pulling/ripping. I have tried taking Ibuprofen and using muscle rub cream. I has been 2.5 months now and I still having problems. I have to watch how I use my arm, I can't prop myself with my arm, it hurts if I try to buckle my seat belt, or if I try to put my arm in my pocket. I also am limited to what I can do at the gym and it even hurts my arm when I run on the treadmill.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Fatigue, Irritability, Pyrexia
Clinical narrative: Fever of 100.5 before bed, Motrin given. Patient woke up with a 103.0 fever at 7am. Very fussy night before and fatigued night prior and morning of high fever onset.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Electroencephalogram normal, Grand mal convulsion
Clinical narrative: Child had tonic-clonic seizure a few hours after vaccination. Doctor was notified night of seizure and child was taken to doctor the following day. Seizure not relatd to fever. No diagnosed seizure disorder and no prior seizures or seizures since.
Sex: M
Vaccine: FLUX
Symptoms: Headache, Influenza like illness, Pain, Pneumonia, Pyrexia
Clinical narrative: Initial unsolicited report was received on 12 December 2014 from a consumer who is also the patient's spouse. A male patient had received on an unspecified date an Influenza vaccine (Sanofi Pasteur lot number and administration details not reported) and an unspecified amount of time later developed flu like symptoms including fever, headache and body aches. The patient was treated with antibiotics. The patient was being hospitalized for pneumonia at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified nurse assistance regarding a 13 year old female patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 30JUN2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Medical assistant reported that since 13-NOV-2014 patients have been administered ROTATEQ orally, (dose and lot numbers were not provided) that underwent a supported temperature excursion. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (healthcare worker) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. On 03-DEC-2014, the patients were vaccinated with (Oka/Merck) VARIVAX injection, lot number K003414, expiry date 06-MAR-2016 (dose,route and frequency were not reported). Concomitant medications were not reported. Starting on 24-NOV-2014, the doses of (Oka/Merck) VARIVAX were exposed to a supported temperature excursion of 17.8F for 93 hours. According to the Prescribing Information for (Oka/Merck) VARIVAX, the (Oka/Merck) VARIVAX should be frozen between-58F and +5 F (-50 C and -15 C). Use of dry ice may subject (Oka/Merck) VARIVAX to temperatures colder than -58 F and +5 F (-50 C and -15 C). Use of dry ice may subject (Oka/Merck) VARIVAX to temperatures colder than -58F (-50 C). Based on the information and assessment data, these (Oka/Merck) VARIVAX should be used within three months. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No additional information was provided. additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patient's medical history were not provided. In approximately 2014 also reported as "on an unspecified dates since 02-NOV-2014", the patients were vaccinated with doses of VAQTA(dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Concussion, Fall, Head injury, Neurological symptom, Psychiatric symptom
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 02-DEC-2014 the patient was vaccinated with GARDASIL (dose 1; route and dosage unknown; lot number reported as K0006124). Concomitant vaccine, administered on the same date included FLUMIST. The patient initially did not have any adverse reactions. However, four to five hours later, when the patient was at school, he fell to this knees and then fell backwards and hit his head "sustaining a concussion". The patient had psychiatric and neurologic issues that are ongoing. The patient was "being followed closely by a neurologist and a psychiatrist". The reporter believed the patient's parents were given a "consult" with a division for infectious diseases. The patient sought unspecified medical attention. The outcome of hit his head "sustaining concussion" and he fell to his knee and then fell backwards was unknown. The outcome of the patient had neurologic issues and the patient had psychiatric issues was reported as not recovered. Lot number K0006124 is an invalid lot number for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified. The patient had no drug allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015), for vaccination. On an unknown date the patient experienced lump and redness at the injection site within a few minutes of receiving ZOSTAVAX. She took  ZYRTEC to treat her symptoms. The patient sought medical attention by calling the pharmacist. The outcome of adverse event was unknown. This is one of 4 report received from the same reporter. Pharmacist said her pharmacy reported 2 of these 4 patients (unspecified which ones) to VAERS. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, Chest pain, Facial paresis, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain Barre Syndrome- Pain in Thoracic region, facial weakness, limb paresthesias and weakness, elevated CSF protein, abnormal nerve conduction studies.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Guillain Barre Syndrome- Pain in Thoracic region, facial weakness, limb paresthesias and weakness, elevated CSF protein, abnormal nerve conduction studies.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became sore, swollen, and red.  Warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Cardiac arrest, Cyanosis, Electrocardiogram ambulatory abnormal, Extracorporeal membrane oxygenation, Hypotonia
Clinical narrative: Suddenly went limp, pulseless and cyanotic.  Needed CPR then came to and was breathing spontaneously, had a HR of 60 and then after a few min went blue again and pulseless. CPR started again. Transferred to ED via EMS and needed CPR for about 3 hrs, ended up on ECMO with severe cardiac arrest and V tach.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Intensive care, Pulse absent, Renal failure, Resuscitation, Ventricular tachycardia
Clinical narrative: Suddenly went limp, pulseless and cyanotic.  Needed CPR then came to and was breathing spontaneously, had a HR of 60 and then after a few min went blue again and pulseless. CPR started again. Transferred to ED via EMS and needed CPR for about 3 hrs, ended up on ECMO with severe cardiac arrest and V tach.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope episode and dizziness.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Blood potassium decreased, Dehydration, Erythema, Fungal infection, Gastrointestinal haemorrhage
Clinical narrative: Soreness redness swelling pain fever aches all over headache.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Gastrointestinal infection, Gastrointestinal inflammation, Headache, Injection site infection, Pain
Clinical narrative: Soreness redness swelling pain fever aches all over headache.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Sepsis, Skin infection, Swelling, Urinary tract infection
Clinical narrative: Soreness redness swelling pain fever aches all over headache.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Had swelling and redness to right arm. Exmained by provider, patient has possible cellulitis to right arm, started on Keflex and Motrin.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Depressed level of consciousness, Dyskinesia, Eye movement disorder, Posture abnormal
Clinical narrative: Slumped backward in chair, jerky movements of arms (left, then right, not at same time). Eyes rolled back. non-arousable for approximately 15-20 seconds; then gradually woke up; aware of surroundings. Denied dizziness or feeling faint prior to vaccination. Reported some issues with recent blood draw but not with past vaccinations. Kept in clinic for 25 minutes past event. given water & juice.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Calcium ionised normal
Clinical narrative: Initially normal soreness after influenza shot but then instead of getting better it got worse and worse. I was unable to sleep because the pain was so bad when I moved my arm it would wake me up. My shoulder joint was extremely painful and started cracking everytime I moved it.  My deltoid was so painful I was unable to use it to move a chair or pick up kids or put my weight on my elbow.  I start naproxen scheduled for 6 days and pain went away but it came back after stopping the naproxen.  I went on/off Naproxen depending on how much pain there was.  Eventually about 3-4 weeks after the vaccine I went to the doctor to get a prednisone bolus and taper to help with the pain.  The pain was better after the prednisone bolus but it still hurts 1.5 months later. I am unable to sleep on the left side due to pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint crepitation, Metabolic function test normal, Middle insomnia, Myalgia
Clinical narrative: Initially normal soreness after influenza shot but then instead of getting better it got worse and worse. I was unable to sleep because the pain was so bad when I moved my arm it would wake me up. My shoulder joint was extremely painful and started cracking everytime I moved it.  My deltoid was so painful I was unable to use it to move a chair or pick up kids or put my weight on my elbow.  I start naproxen scheduled for 6 days and pain went away but it came back after stopping the naproxen.  I went on/off Naproxen depending on how much pain there was.  Eventually about 3-4 weeks after the vaccine I went to the doctor to get a prednisone bolus and taper to help with the pain.  The pain was better after the prednisone bolus but it still hurts 1.5 months later. I am unable to sleep on the left side due to pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Weight bearing difficulty
Clinical narrative: Initially normal soreness after influenza shot but then instead of getting better it got worse and worse. I was unable to sleep because the pain was so bad when I moved my arm it would wake me up. My shoulder joint was extremely painful and started cracking everytime I moved it.  My deltoid was so painful I was unable to use it to move a chair or pick up kids or put my weight on my elbow.  I start naproxen scheduled for 6 days and pain went away but it came back after stopping the naproxen.  I went on/off Naproxen depending on how much pain there was.  Eventually about 3-4 weeks after the vaccine I went to the doctor to get a prednisone bolus and taper to help with the pain.  The pain was better after the prednisone bolus but it still hurts 1.5 months later. I am unable to sleep on the left side due to pain.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Extremely sore arm with limited mobility.  Worsened over time.  Went to doctor and was diagnosed with Shoulder Impingement.  Then, prescribed physical therapy.   Pain still exists so had MRI which reveals tears in the at the base of the superior posterior labrum as well as a low-grade rotator cuff tear in the left shoulder.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in my right hand, arm, face.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Influenza virus test negative, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Fever 103, vomiting, chills, aches.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Fever 103, vomiting, chills, aches.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Shooting Pain in her right arm that was vaccinated.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Red, swollen, hard, warm circular welt surrounding injection site.  Nearly 4 inches in diameter.  Did not appear until nearly 24-26 hours AFTER injection.  Nearly a week later, still present, but looks more like a bruise.  Benadryl given.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth
Clinical narrative: Red, swollen, hard, warm circular welt surrounding injection site.  Nearly 4 inches in diameter.  Did not appear until nearly 24-26 hours AFTER injection.  Nearly a week later, still present, but looks more like a bruise.  Benadryl given.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initially appeared a hot round red spot around the area where the vaccine was applied and the child complained of pain. After a few hours, the affected area has expanded taking the hole region of the arm (biceps and triceps) becoming completely swollen (3 times normal size), red, hot and very, very, very hard. The child can not lift the arm. He is currently taking Tylenol and making compress with cold water.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased
Clinical narrative: Initially appeared a hot round red spot around the area where the vaccine was applied and the child complained of pain. After a few hours, the affected area has expanded taking the hole region of the arm (biceps and triceps) becoming completely swollen (3 times normal size), red, hot and very, very, very hard. The child can not lift the arm. He is currently taking Tylenol and making compress with cold water.
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red or just skin colored hives that itch are occurring nightly. I also received two TB skin tests a week apart, with the second being done on 11/18/2014.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a certified nurse assistant regarding a 14 year old male patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in right deltoid on 02JUL2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a certified nurse assistant regarding a 12 year old male patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 05AUG2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Additional information is not expected.
Age: 1.59
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 4 in. mild redness, mild swelling, warm to touch.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: Patient was administered FLU MIST vaccine the day after expiration.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Vaccination site swelling
Clinical narrative: Patient indicates (R) shoulder pain since vaccination. Pain increases upon movement. Patient feels slight bump where vaccine administered. No palpable swelling or warmth to touch.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized reaction, pain, redness, swelling at site.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction left upper arm. Red swollen tender to touch 7 x 3 cm.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction left upper arm. Red, swollen tender to touch.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pt states her arm is painful especially when reaching across chest or lifting arm above shoulder height. Shoulder area is sore but she has no other symptoms.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Paraesthesia, Sensory disturbance
Clinical narrative: Pt. c/o erythema of face with mild edema, tingling in hands and "funny" sensation in mouth and throat. Denies SOB, itching, hives. Redness in face noted prior to flu shot, slight anxiety noted. BP 120/80 at 10:30 AM. Given BENADRYL 50mg PO at 10:32 AM. at 11:00 AM pt. called friend to dive her home. Called RN 1 hour later to report improvement in symptoms. Advised to call PCP or go to ER if symptoms return.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient complained of nausea and "feeling hot" 1/2 hour after self-reported first time flu vaccine. Asked to be seated and remove coat. Slightly diaphoretic. VS - 97/2 - 124/86 - 80/20. No vomiting, SOB, c/o itching or hives. After 30 min. pt. insisted on return to work. No exacerbation s/s. Instructed to call Dr. or go to ER with increase signs and symptoms. Pt. verbalized an understanding.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dystonia
Clinical narrative: Dystonia
Age: 34.0
Sex: M
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, hot, painful to touch, raised bump where vaccine was given.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Unclear where vaccine was administered. Unclear if patient received at medical facility or pharmacy as there is no documentation of the patient receiving the immunization at medical facility. Skin rash; Rash; Urticaria pruritus. Treatment Diphenhydramine 25 mg BID PO
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness. Symptoms worsened on 12/13/14 prompting urgent care visit. Rx: ADVIL, DURICEF 250mg/5mL, 9 mL BID for 7 days.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Lip swelling, Throat tightness
Clinical narrative: Pt requested flu shot w/o any allergy. Shortly after administering FLUVIRIN, pt complained of dizziness. Pt's condition get worse w/swelling lips, shortness of breath, tightening her throat. Called 911. EPIPEN 0.3 mg was administered. Paramedic came and took pt to hospital.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers  to an unspecified patients of unknown age and gender. It was reported that since 03-FEB-2014, the patients was vaccinated with ROTATEQ (dose and route was unknown) which was improperly stored. No adverse effects were reported. No product quality complaint (PC) was involved. No additional information was provided by this reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot# K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, concerning an unknown number of patients  of an unknown gender and age. Medical history and concurrent conditions were  not reported. The register nurse reported that on unspecified dates between 22-AUG-2014 and 10-SEP-2014, up to 27 doses of vaccinated with (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot number K006137 expiration date 29-APR-2016, K002923 expiration date 26-FEB-2016 and J005253 expiration date 26-APR-2015 underwent an unsupported temperature excursion were received by unspecified patients. No adverse experiences reported. Co-suspect and concomitant therapies were  not reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patient s received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports 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 as received from a health care worker refers to an unspecified patients of unknown age and gender. It was reported that since 03-DEC-2014, the patients was vaccinated with RECOMBIVAX HB (dose and route was unknown) for prophylaxis which was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided by this reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effects reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.