chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Case number PHHY2013US000787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469855) website on 02 Jan 2013 with a follow-up received from the Quality Assurance Department (reference number: 203375) on 09 Jan 2013 with a follow-up received from the Quality Assurance Department (reference number: 208982) on 15 Apr 2013. This case refers to a 62-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1206701) intramuscularly and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly on 30 Sep 2012. On the same day, she experienced itching, blotches, redness and severe pain immediately after vaccination. She also experienced fever with 102 degrees Celsius, which later diagnosed that the arm was infected, said by physician after emergency visit. The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1206701) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the Quality Assurance Department (reference number: 203375) on 09 Jan 2013: Update reference number. Follow-up received from the Quality Assurance Department on 15 Apr 2013: Updated batch review report.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: C-reactive protein increased, Erythema, Local swelling, Skin warm
Clinical narrative: Localized swelling, erythema and hot to touch.  Progressively spread down towards elbow over the next day.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, VARCEL, HIBV, MMR, MMRV, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None. No adverse event wrong vaccine given to child called spoke with educator.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, VARCEL, HIBV, MMR, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: None. No adverse event wrong vaccine given to child called spoke with educator.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Blood test abnormal, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no drug reactions or allergies. Pertinent medical history was none. Approximately on an unknown date in 1993(Reported as 20 years ago) the patient was vaccinated with a first dose of VARIVAX (Merck) (Lot number, expiry date, route and dose were not reported)as she never had chicken pox and wanted to get pregnant. No concomitant medications were taken. Approximately on an unknown date in April 2013 (reported as now) a blood test was performed and the patient has negative immunity titers to varicella. The patient sought medical attention(office visit) and no treatment was provided. The outcome of negative immunity titers to varicella was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Skin swelling
Clinical narrative: Skin redness/rash only on left side of body. Skin swelling, mildly itchy and hypersensitive. Started 4-18-13 pt had appt with Dr. on 4-18-13. Dr. prescribed Valacyclovir 1 gm: 1 every 8 hrs x 7 days.
Age: 41.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient received vaccine on 4/16/2013. Returned to clinic with redness at inj site and low grade temp on 4/22/13. Dr. prescribed prednisone for reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a approximately 70 year old female patient. No medical history or drug reactions were reported. On 08-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021711, expiry: 07-MAR-2014), 0.65 ml, subcutaneously. No concomitant medications were reported. On an unknown date in April 2013, the patient arm was red, sore, painful from shoulder to fingers. The patient had a hard time lifting anything, and stated that it feels like my arm is about to fall off. Pharmacist states according to patient there are no bumps or blisters present. Pharmacist stated that the patient initially felt feverish, but no currently. Patient sought medical attention(contacted the pharmacy). Pharmacist stated there has been no treatment given as yet but the pharmacist planned to contact the patient's physician today (18-APR-2013) for treatment options. The outcome of arm was red, sore, painful from shoulder to fingers and having a hard time lifting anything was unknown. The outcome of felt feverish was reported as recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from Novartis and was assigned manufacturer report number 11014746, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The patient reported that ZOSTAVAX caused her to be diagnosed with polymyalgia rheumatica. The outcome of polymyalgia rheumatica is unknown. The original reporting source was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash macular
Clinical narrative: This spontaneous report as received from a 60 year old female consumer refers to herself with penicillin allergy. On 09-APR-2013 the patient was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (1 time vaccine, lot number, expiry date unspecified). Concomitant therapies included CRESTOR and "amaprozol". On 09-APR-2013, the patient experienced 3 red blotches on her left arm (insertion arm). She described them as about 6 inches around, total. She said they were more like blisters, but they were not itchy. The patient did consult with a clinician. Antibiotic doxycycline-mono was given for treatment. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative refers to a 2-year-old (age estimated from date of birth is 6 months but narrative in the source document states 2 years) male patient. On 10-APR-2013 the patient was vaccinated with a 0.5 milliliter (ml) of GARDASIL (lot# H017898, expiration date July 2015)subcutaneously. Concomitant therapies included PEDIARIX, PREVNAR, ROTATEQ and TYLENOL. The GARDASIL dose was accidentally given to the patient who was supposed to get Hib which was due next week. The GARDASIL had been drawn up for a teenage patient who did receive GARDASIL due to an unrelated seizure condition. The 2 year-old patient did not experience any adverse event. The patient received TYLENOL in office for unknown reasons. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 16 year old female patient. The patient had no relevant medical history or drug allergy On 30-JAN-2013 the patient was vaccinated with first dose of GARDASIL (lot # 672834/0131AE, expiry date 26-OCT-2014) intramuscularly. No concomitant therapy reported. On 01-FEB-2013, 2 days after the vaccination, the patient developed red itchy rash over her whole body (head to toe). The patient contacted office for medical attention. She received over the counter antihistamines (manufacturer unspecified) as treatment. No lab tests were performed. On 02-FEB-2013, about 24 hours after starting, the patient recovered from the event. The reporter did not assess causality of the event. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 48-year-old patient, gender unspecified. On 03-APR-2013 the patient was vaccinated with a dose of M-M-R II (lot# 0404AA, expiration date 16-MAR-2013 and route was not reported). Additional information has been requested.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Movement disorder, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a health professional refers to a female patient of unknown age. Approximately on an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) and at the same time was vaccinated with a dose of flu shot-influenza virus vaccine (manufacturer unknown) (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in September 2012, the patient experienced fever of 100 plus, could not raise arm which was sore, redness and had nausea. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Uterine contractions during pregnancy
Clinical narrative: Information has been received from a 26 year old female consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself with no pertinent medical history and no drug reactions/allergies who received the vaccine (VARIVAX (Merck)) even though she had already had the chickenpox. On 15-APR-2013 the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # not reported) at her right arm while she was 20 weeks pregnant. Concomitant therapies included doxycycline succinate. The patient became pregnant with LMP of 26-NOV-2012 and EDD of 02-SEP-2013. Initial exposure to VARIVAX (Merck) was at 20 week(s). On 15-APR-2013, a few hours after receiving the vaccine she began to experience contractions. The patient had not sought medical attention. There was no treatment was given for the adverse event. There were not laboratory diagnostics studies performed. The outcome of contractions was reported as recovered/resolved on 16-APR-2013. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from the patient husband refers to his wife of unknown age. No medical history was reported. On 02-APR-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose, route not reported). No concomitant medications were reported. On 02-APR-2013, the patient experienced itching at the injection site for one day. The outcome of itching at the injection site was reported as recovered on 03-APR-2013. This is 1 of 2 assistant received from the same reporter. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 15-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date were not reported), 0.65 milliliter (reported as standard dose), subcutaneously. On 16-APR-2013, the patient experienced redness, inflammation and swelling at the injection site that was the back of the arm and severe headache. The patient stated that the swelling was the size of a walnut yesterday and the pharmacist stated that the swelling was the size of the tennis ball at the time of this report. The patient sought medical attention and visited the pharmacist. BENADRYL was taken last night and the pharmacist had recommended ibuprofen and the patient had applied cool compress. The patient would be stopping by the physician office today. The outcome of redness, inflammation at the injection site and severe headache was unknown. The outcome of inflammation at the injection site was not recovered/resolved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Blood glucose, Blood thyroid stimulating hormone, Cold sweat, Full blood count
Clinical narrative: Child had received Hep A shot (R) thigh. Developed weakness within 15 minutes. No SOB, no wheezing, clammy. Vitals stable but was lethargic.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test, Lethargy, Thyroxine
Clinical narrative: Child had received Hep A shot (R) thigh. Developed weakness within 15 minutes. No SOB, no wheezing, clammy. Vitals stable but was lethargic.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Red area over and surrounding injection site.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Parent describes via telephone red bump at injection site on LLE and 99.9 degrees F fever since 8 am (on TYLENOL). Gave parent parameters for calling PCP.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date, within 10 hours of receiving the vaccine the patient suffered severe abdominal pain. It was unspecified if the patient had sought medical attention. The outcome of severe abdominal pain was reported as recovered. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy, Laboratory test normal, Mass, Rash
Clinical narrative: This spontaneous report as received from a 59 year old male patient who recovered from an unspecified cancer in July 2012 and with no drug reactions/allergies. The consumer stated that he received ZOSTAVAX (0.65 ml/ 1 shot, injection, lot#, route were unspecified) in approximately October 2009, "about three and a half months ago". Concomitant therapies included atenolol, CRESTOR and fenofibrate. A couple of days later (unspecified in 2009), patient broke out with sores all over his arms, buttocks, head, and back and also developed a couple of unspecified lumps on his back. He was prescribed an unspecified medication administered as two weekly treatments of "6 pills" taken simultaneously a week apart on the same day of the week. He stated that these pills did eliminate the lumps but did not eliminate the sores. The consumer also stated that, as a result of his adverse experience, he saw dermatologists and had a diagnostic biopsy test to see if his reaction could have been caused by mite bites. The test for mites came back negative. The consumer also stated that he received a flu vaccine (unspecified dose and unspecified manufacturer) around the same time as receiving the ZOSTAVAX but not on the same day. The consumer also reported that he was prescribed triamcinolone acetonide cream USP 1% to treat his rash. The outcome was reported as recovering. Drug relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date, the patient experienced pain and tenderness at the injection site that appeared as a half moon mark, left visible on the upper arm. No treatment was received. No medical attention was sought by the patient. The outcome of pain and tenderness at the injection site was reported as recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 113 patients of demographics. Since an unknown date in August 2012, the patients were vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). It was unknown as to how many patients received just GARDASIL and how many received just PEDVAXHIB or how many patients had received both. Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit0 for a total of 135 hours. No adverse effects reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist to a patient of unknown age and gender. On 10-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date was not reported), 0.5 ml (milliliter), subcutaneously. On 17-APR-2013 (reported as today), the patient experienced varicella like rash. The patient sought medical attention (details unspecified) and the pharmacist stated that no treatment was provided. The outcome of varicella like rash was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no pertinent medical history or drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018799, expired date 14-JAN-2015). On 17-APR-2013 the patient experienced swelling redness and tenderness at the injection site 24 hours after she was given ZOSTAVAX. The patient also stated she had body chills, dizziness and "chill bumps" all over her body. The patient came to pharmacist for medical attention. There was no treatment given for the events. No lab diagnostics studies performed. At the time of the report, the patient was not recovered from the events. The causality was not provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Piloerection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no pertinent medical history or drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018799, expired date 14-JAN-2015). On 17-APR-2013 the patient experienced swelling redness and tenderness at the injection site 24 hours after she was given ZOSTAVAX. The patient also stated she had body chills, dizziness and "chill bumps" all over her body. The patient came to pharmacist for medical attention. There was no treatment given for the events. No lab diagnostics studies performed. At the time of the report, the patient was not recovered from the events. The causality was not provided. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: HEP, MMR
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 months old patient. The patient was vaccinated accidentally with a 0.5 ml dose of AFLURIA (Lot # was not reported) IM on 12-JAN-2013. The patient was not experiencing any known symptoms. Follow up information was received from the medical assistant who reported that the 16 month old (also reported as 26 months previously) patient was vaccinated the fourth dose of RECOMBIVAX HB (lot # 0958AA is an invalid lot number for RECOMBIVAX HB) on thigh intramuscularly on 05-APR-2012 06:35 PM, the second dose of AFLURIA (lot # 07149211 is an invalid lot number for AFLURIA but lot 07149221A is valid) on thigh intramuscularly on 12-JAN-2013 01:06 PM, the first dose of MMR II (lot # 1023AA) on thigh Intramuscularly on 05-APR-2012 06:36 PM. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. Relevant medical history and concomitant medication were not provided. On 09-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. Lot number was not provided. On 10-APR-2013, the patient experienced redness at site of injection diagnosed as cellulitis. The outcome of redness at site of injection diagnosed as cellulitis was unknown. The action taken regarding ZOSTAVAX was unknown. The reporter causality was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Vaccination site induration
Clinical narrative: Next day after vaccinations on left upper thigh pt redness, some pain and itching at site overlying erythema 3.5 cm x 2.25 cm, induration 1" x 3/4" at site of vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Swelling
Clinical narrative: Pt. had a swollen an puffy arm for 2-3 weeks. A 3" diameter red rash for 4-5 days. Went to MD and received antibiotics (unknown type).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Patient presented to pharmacy with unilateral shingles rash on left back and injection site. Dr. at clinic had given her a prescription for Acyclovir, NEURONTIN and LIDODERM. Rash had no blisters.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Patient presents today post VARIVAX 4/12/13. Right arm with 8x11 cm induration and redness. Afebrile without itching and pain at site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Within 24 hours of second dose of GARDASIL - noted significant hives all over - mom gave PEPCID and BENADRYL to treat symptoms - after appearance of hives.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Rash erythematous, Skin exfoliation, Skin hypopigmentation, Skin lesion
Clinical narrative: 1.5 cm diameter lesion, erythematous, scaly with clearing in center. There is also a hypopigmental patch.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Rash papular
Clinical narrative: Erythematous papules on neck. Began 3-4 hours after vaccination. Denied change of skin products, laundry det. etc. Triamcinolone acetonide 0.1% cream. Hydroxyzine hydrochloride 25 mg p.o. Q 4-6 hr. ordered.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired healing, Injection site reaction, Injection site scab
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to himself. The pharmacist reported that he was administered ZOSTAVAX (dose and lot# not reported) intramuscular 3-4 years ago. No adverse effects reported. At the time of reporting, the patient outcome was unknown. Additional information is not expected. Update (16-APR-2013): Additional information received from a pharmacist who is also the patient. On an unspecified date in 2009 the patient received vaccine ZOSTAVAX (0.65 ml, intramuscular). He also reported that after receiving the ZOSTAVAX the injection site never healed properly. He continually gets a scabby area on the arm where the ZOSTAVAX was administered. He stated that the area gets crustier and then sloughs off and leaves a very bright pink area of skin. This had occurred multiple times. He has not discussed it with his physician. The outcome of injection site never healed properly and continually gets a scabby area on the arm where the ZOSTAVAX was administered was reported as not recovered/not resolved. The relatedness of injection site never healed properly and continually gets a scabby area on the arm where the ZOSTAVAX was administered is unknown for ZOSTAVAX. No further information available. Additional information has been requested.
Age: 0.48
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 104 degrees the day after vaccines were administered.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Autism spectrum disorder, Cytogenetic analysis normal, Decreased eye contact, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report was received from a physician refers to his 1 year old son. Physician stated that his son was born healthy. Patient had no known allergies. On 17-JUN-2006, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # 650890/0144R, expiry: 31-AUG-2007, dose and route unknown). On 20-JUL-2007, the patient was vaccinated with a dose of MMR II (lot # reported as 01834, expiry: January 2009) and VARIVAX (Merck) (Lot # reported as 07804, expiry: May 2009). Approximately since an unknown date in 2007, the patient demonstrated symptoms within the autistic spectrum between the age of 1-4 years. The symptoms the child displayed include tip-toeing, withdrawn, lack of eye contact and speech delay. Physician states many therapies were used for treatment such as speech therapy, occupational therapy but no prescription medications were used for treatment. The physician states his son does maintain a gluten-free diet. Patient had sought medical attention. electroencephalography (EEG), Magnetic Resonance Imaging (MRI) of head and genetic testing were all negative. Physician states it was unknown what could have caused these symptoms of autism spectrum and questions whether it could be any of three vaccines. The outcome of autism spectrum symptom was reported as recovered completely by 4 years of age (unknown date in 2010). Physician states there is still no known reason for his son's autism spectrum symptoms. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Social avoidant behaviour, Speech disorder developmental, Toe walking
Clinical narrative: This spontaneous report was received from a physician refers to his 1 year old son. Physician stated that his son was born healthy. Patient had no known allergies. On 17-JUN-2006, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # 650890/0144R, expiry: 31-AUG-2007, dose and route unknown). On 20-JUL-2007, the patient was vaccinated with a dose of MMR II (lot # reported as 01834, expiry: January 2009) and VARIVAX (Merck) (Lot # reported as 07804, expiry: May 2009). Approximately since an unknown date in 2007, the patient demonstrated symptoms within the autistic spectrum between the age of 1-4 years. The symptoms the child displayed include tip-toeing, withdrawn, lack of eye contact and speech delay. Physician states many therapies were used for treatment such as speech therapy, occupational therapy but no prescription medications were used for treatment. The physician states his son does maintain a gluten-free diet. Patient had sought medical attention. electroencephalography (EEG), Magnetic Resonance Imaging (MRI) of head and genetic testing were all negative. Physician states it was unknown what could have caused these symptoms of autism spectrum and questions whether it could be any of three vaccines. The outcome of autism spectrum symptom was reported as recovered completely by 4 years of age (unknown date in 2010). Physician states there is still no known reason for his son's autism spectrum symptoms. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC
Symptoms: Febrile convulsion, Pyrexia, Streptococcus test, Urine analysis, Urine analysis normal
Clinical narrative: Patient received KINRIX and PROQUAD and PREVNAR on 4/12/2013. No symptoms until next afternoon when developed fever and developed a febrile seizure lasting 5-7 minutes. Seen in ER.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed 2-3cm raised red area at site with ring, less bright 2cm beyond that.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Gaze palsy, Malaise, Muscle rigidity
Clinical narrative: Per mom, pt had shots hadn't ate a lot today. When left office, didn't feel well, sat on steps outside office. Still wasn't feeling well. Went to car, then he got "stiff, eyes rolled back, and jerking for a few seconds" Mom brought pt back in office.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bacterial test negative, Diarrhoea, Faeces discoloured, Rotavirus test negative, White blood cells stool positive
Clinical narrative: Ongoing diarrhea with small amounts, noted to have green stools also.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Influenza like illness, Oedema peripheral, Pain in extremity
Clinical narrative: Severe pain and swelling in hands.  Weakness. Falling. Flu like feeling.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Headache (increasing in severity over next 2 days), swelling of injection site, redness around injection site, fever, vomiting, lethargic. Lasted for 3 days.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Headache (increasing in severity over next 2 days), swelling of injection site, redness around injection site, fever, vomiting, lethargic. Lasted for 3 days.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Rash erythematous, Rash maculo-papular
Clinical narrative: Pain with redness at injection site, followed hours later by erythematic macular papular rash to LE and UE.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: L lateral thigh 2 cm area of redness and slight tenderness @ sight of Kinrix; just a bit inferior at sight of the Proquad 1 cm local reaction. The Proquad reaction is just erythema and nontender. MD instructed to observe no treatment given.
Age: 1.16
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Irritability
Clinical narrative: Fussiness, irritability.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Myalgia, Pain, Sleep disorder, Tenderness
Clinical narrative: Extremely muscle soreness that prevents me from fully using my right arm to reach, or sleep on this side.
Age: 1.69
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Computerised tomogram head abnormal, Ischaemic stroke, Mobility decreased, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Stopped using right leg and right arm- found to have a stroke.
Age: 1.42
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chicken pox started on face and belly. Spread to whole body. Doctor said she has chicken pox from getting the vaccine.
Age: 1.42
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Chicken pox started on face and belly. Spread to whole body. Doctor said she has chicken pox from getting the vaccine.
Age: 1.42
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 4/20 - Vomiting. 4/21 - Rash started - spreading and itchy. 4/22 seen in our office.
Age: 1.42
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: 4/20 - Vomiting. 4/21 - Rash started - spreading and itchy. 4/22 seen in our office.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Local reaction, Pruritus, Rash, Scab, Thermal burn
Clinical narrative: The patient sustained a small burn to the left arm 3/26, and was seen in burn clinic 4/15.  There was a local reaction to tape on the left arm around the burn site.  She was treated with a silver impregnated foam dressing, and given TDap immunization, uncertain of her immunization status.  She noticed a rash and itch the next day.  The rash maximized about 4/18, on face, neck, left peri auricular, chest, with scattered on arms and legs, not at the injection site.  A crusty rash formed on the burn site.  Today the rash has not subsided.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling abnormal, Throat irritation, Vision blurred
Clinical narrative: C/o throat itchy/scratchy, blurry visiton, "not feeling right".
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Swelling
Clinical narrative: MOM NOTICED SWELLING IN THE ARM THAT VARICELLA VACCINE WAS GIVEN. THE SWELLING WAS THE SIZE OF A DONUT WITH A QUARTER SIZED AREA WHITHIN THE SWELLING THAT LOOKED "BLISTERY AND BUBBLY". MOM TOOK PATIENT TO ER FRIDAY MORNING ON 4/19/2013. ER PHYSICIAN SAID TO GIVE MOTRIN AND TO APPLY HEAT TO THE AREA.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Left arm examined with evidence of erythema and few small vesicles scattered on inside of forearm. Prescribed Valtrex and hydrocodone with follow up next week with Dr.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Injection site erythema, Injection site rash, Myalgia
Clinical narrative: Extremely sore arm, muscles, weakness.  Fever by evening 101.9, development of red spots on injection site traveling down arm.  Warm to touch.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Skin warm
Clinical narrative: Extremely sore arm, muscles, weakness.  Fever by evening 101.9, development of red spots on injection site traveling down arm.  Warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth (R) upper arm "14 cm diam area erythema" w/ central vaccine mark per Dr.
Age: 13.0
Sex: F
Vaccine: SMALL
Symptoms: Immunology test abnormal, Infection transmission via personal contact, Polymerase chain reaction, Rash papular, Viral test positive
Clinical narrative: Contact transmission. 21yo female who had intimate contact with a person, primary vaccinee on 4/1/13 (vaccination date 3/18/13). According to the pt there was no dressing on the "scabbed lesion". According to the patient the lesion was covered with a band-aid. On 4/2/13 the pt applied the other person's Permethrin cream to her body for self diagnosed scabies (the primary vaccinee was treated for scabies on March 19, 2013). On 4/6/13 the pt noted a papular lesion one her right wrist; on 4/7/13 she noted a lesion on her left hip and on 4/9/13 she noted a lesions in her right groin and several (about 10 lesions) in her suprapubic area. On 4/9/13 she went to the ER and the physician notified the CDC of the possibility of a contact transmission. On 4/11/13 the pt noted 4 lesions on her gluteal cleft. The pt was treated with VIG at ER on 4/14/13. Lesions from the right wrist, left hip and suprapubic area were positive for vaccinia by DFA and PCR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: 7cm area of erythema, non-tender progressing since vaccine 4/17/13. Pt is afebrile. Treatment KEFLEX (200/5) 4.5ml PO TID x 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Limb discomfort, Oedema peripheral
Clinical narrative: Pt appt was 11 AM - prepped left shoulder using alcohol. Used sterile syringe with sterile needle and administered DTaP. Mom states child c/o discomfort to arm. Later Friday night arm swelled. Mom applied cold packs to (L) shoulder, returned to office on 4/22/13 due to swollen arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2013US001217 is an initial spontaneous report received from a consumer on 11 Jan 2013, and with a follow up received from physician on 16 Apr 2013: This report refers to a 40-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Nov 2012. Three hours after vaccination, she experienced anaphylaxis. The outcome of the event was reported as subsided at the date of reporting. The seriousness and causality of the events were not reported. When the physician was contacted for follow up, he mentioned that he did not administer the vaccine and asked to contact the correct physician. No other information was provided. Follow up report received from a physician on 16 Apr 2013. When the physician was contacted for follow up, he mentioned that he did not administer the vaccine and asked to contact the correct physician.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Joint warmth, Musculoskeletal pain
Clinical narrative: Left shoulder - sore, hot, swollen, red. Tx was with ice, TYLENOL and heat. 4/22/13 - full recovery.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Throat irritation
Clinical narrative: Irritated throat after 1st pill. Suspended because also taking doxycycline.
Age: 20.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Gaze palsy, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient collapsed onto ground, whole body, was in tremors, eyes rolling in the back of his head. Patient was out for 1 minute and came to and was fine.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms: injection site is red warm and had evidence of swelling. Treatment: physician prescribed KEFLEX 500mg T.I.D.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Rash
Clinical narrative: This spontaneous report was received from a female consumer referring on herself with sulfides allergy and codeine allergy. The patient's medical history included breast cancer. On 06-NOV-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). No concomitant medications were reported. There was not lab diagnostics studies performed. The patient stated that approximately every 4 months she experienced left side neuropathy with numbness of hip. She has been experienced this ever since she received her ZOSTAVAX injection (onset date reported as March-2010). The patient also stated she broke out of rash. The patient had a healthcare professional visit and was treated with ZOVIRAX ointment. At the time of this report the patient's outcome was recovering. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Body temperature increased, Dizziness, Headache
Clinical narrative: Pt reported about 10 PM she began shaking, spiked 104 degrees F Temp, had headache, pain and swelling at site, joint pain weakness, dizziness and insomnia. Temp went down to 99 04/19/13 in the AM. Returned to normal 04/19/13 about 10 PM. Patient continues to have pain and mild swelling at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Insomnia, Tremor
Clinical narrative: Pt reported about 10 PM she began shaking, spiked 104 degrees F Temp, had headache, pain and swelling at site, joint pain weakness, dizziness and insomnia. Temp went down to 99 04/19/13 in the AM. Returned to normal 04/19/13 about 10 PM. Patient continues to have pain and mild swelling at injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying, Diarrhoea
Clinical narrative: The child developed inconsolable crying for 2 hrs the day after administration of vaccines (PEDIARIX, Hib, PCV, ROTARIX). He also had loose stools 2 to 3 times but no blood in stools. The symptoms resolved within 24 hrs with no intervention.
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Accidental exposure to product, Condition aggravated, Dry eye, Foreign body sensation in eyes
Clinical narrative: This spontaneous report as received from a female registered pharmacist of an unknown age with dry eyes reporting on herself. On 12-APR-2013, the pharmacist was administering a dose of ZOSTAVAX (Lot # not reported) to a patient and she splashed the ZOSTAVAX in her right eye. The pharmacist immediately flushed her eye with saline but continued to experience dry eye, eye pressure and felt like something was in her eye. The pharmacist used tobramycin eye drops for a couple days and was now using artificial tears. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-JAN-2010, the patient was vaccinated with first dose of GARDASIL. On 03-AUG-2010, the patient was vaccinated with the second dose of GARDASIL. On 10-APR-2013, at the time of reporting, the patient was in the office to get the third dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a LVN (licensed vocational nurse) and a health worker refers to a 4 month old male patient. The patient was vaccinated with the first dose of ROTATEQ on 23-JAN-2013, the second dose on 01-MAR-2013 and the third dose on 08-MAR-2013 (route orally, dose and lot# for all doses were not reported). No adverse event was reported. It was also reported the therapy of ROTATEQ was not discontinued. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site joint pain, Monarthritis, Ultrasound scan, X-ray limb abnormal
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 73 year old female patient with fibromyalgia and osteoarthritis. Height of the patient was 65 inches and weight of the patient was 208. On 05-APR-2013, at 09:00 am, the patient was vaccinated with dose 1 PNEUMOVAX23 (lot number reported as H022062, expiry date unspecified), intramuscularly in the right deltoid. There was no illness at the time of vaccination. No concomitant medications were reported. On 05-APR-2013, at 09:00 am, the patient experienced gradual increasing pain in the right shoulder. There was not erythema or induration. The patient visited a doctor. The patient was treated with ADVIL. On an unknown date, X-ray of right shoulder was performed which revealed arthritis of acromioclavicular (AC) joint and the patient was treated with calcium (ca) supplements tablets. On an unknown date, ultrasound scan (USS) was performed and the result was unknown. The patient was recovering from the pain as the pain decreased with ADVIL. The relatedness for the event was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Lymphoedema, Pyrexia, Tonsillitis
Clinical narrative: This spontaneous report as received from a Nurse Practitioner concerning a 2 year old male patient with snoring and no drug allergies or reactions who on 08-APR-2013 was vaccinated with a dose of M-M-R II (dose and route not provided) (lot # H014680). Concomitant therapies included VERAMYST. On 14-APR-2013, the patient developed fever as high as 103 degrees F. The nurse described that when he was seen in the office he had lymphadenopathy on the right side and a temperature of 102.2, the right tonsil was more swollen than the left tonsil. When seen in the office on 16-APR-2013, the right tonsil had improved but he had left side edema in his lymph nodes. AUGMENTIN was given as a treatment for the events. The outcome of lymphadenopathy on the right site was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site reaction, Skin papilloma
Clinical narrative: Wart like eruption at injection site (L) thigh: DTaP, Varicella site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot # and exp date unspecified) injection, dose 2 (dosage unspecified). The registered nurse stated that the patient received 2 doses of GARDASIL in one day. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a physician refers to an over 60 years old female patient. The patient's medical history included sensitivity to previous vaccinations. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot# was J000492, exp. 19-JAN-2014) single standard dose subcutaneous injection for routine vaccination. No other vaccines was taken on the same day. On 03-APR-2013, 1 week after vaccination the patient experienced fluid filled spots on her lower arm in the same arm that had been vaccinated. No treatment was given. No lab was done. Patient was recovering from the event. The patient did not seek medical attention. This patient had had a prior reaction to an unspecified Flu vaccination (reported in 1304USA008859). Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 84 year old female patient with shingles. The patient reported no allergies or previous drug reactions. The patient's medical history included orthopedic issues, flu and horse fly bites. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot number were not specified) while she had shingles already and her immunity was compromised because she had the flu and "horse fly bites" in February. Other concomitant medications included unspecified blood pressure medication, ADVIL, unspecified circulation medication, and PRILOSEC. The patient stated that after having ZOSTAVAX, in 2013, she has started to have dry skin and started to use cocoa butter to help soothe this. The patient spoke with her physician. The outcome of dry skin was reported as not recovered/not resolved. No labs were perform. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Amnesia, Anxiety, Arthralgia, Condition aggravated, Depression
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.