chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via the field representative refers to a 71 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date in August 2012 (reported as two years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unspecified date (reported as recently), the patient came to the office and had developed a mild case of the "shingles". No further symptoms were provided. The patient sought medical attention via office visit. The outcome of the event was reported as recovering. The relationship between the event and ZOSTAVAX was unknown. Additional information is not expected because physician cannot be contacted.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 10-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, EXP 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient. The patient's medical history included anorexia. There were no known drug allergies. On 11-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose, frequency and route were unknown). Concomitant therapies included Fluoxetine. On 25-JUL-2014, two weeks after receiving the GARDASIL the patient developed blistery rash on her hands and feet. No treatment was given for the event. The outcome of blistery rash on her hands and feet was unknown. The patient has not been seen by a healthcare provider as of 01-AUG-2014. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Neuropathy peripheral, Pain
Clinical narrative: This spontaneous report as received from a male consumer refers to a female patient (his wife) of unknown age. The patient's medical history and current conditions are not reported. On an unknown date the patient was vaccinated with ZOSTAVAX of unknown strength and dose. Concomitant medications were not reported. On an unknown date, the patient's husband stated that ZOSTAVAX vaccine was not effective, and the patient was suffering from shingles and that the unspecified treatments for the conditions were ineffective in controlling her pain also reported that the patient was experiencing neuropathy in her head and stated that she cannot take the pain. The outcome of the events were unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Fatigue, Malaise, Wrong drug administered
Clinical narrative: Pt. rec Dtap instead of Tdap - Tdap also given when mistake was noted. Pt had malaise and fatigue x 2-3 days.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 37 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. Patient was not pregnant. On 24-MAR-2014 the patient was vaccinated with her first dose of M-M-R II (lot #, expiration date, dose, frequency were unknown) as it was mandatory requirement for employment. NO concomitant medication was reported. On 31-MAR-2014 (reported as "a week after vaccination") the patient experienced rash which was first appeared on her  back the size of a quarter. There were 2 of them. Once these rashes went away new rashes appeared on her legs, from her knees to her ankles, and then to her arms. Patient also reported that the rashes were red, burning and itching. Prior to receiving the M-M-R II, she reported that she had blood work done. The results showed an issue with unspecified mumps and antibodies (also reported as "no lab diagnostics studies performed"). Patient sought medical attention via doctor visit. An unspecified cortisone cream was given as treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Viral test
Clinical narrative: This spontaneous report as received from a consumer refers to a 37 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. Patient was not pregnant. On 24-MAR-2014 the patient was vaccinated with her first dose of M-M-R II (lot #, expiration date, dose, frequency were unknown) as it was mandatory requirement for employment. NO concomitant medication was reported. On 31-MAR-2014 (reported as "a week after vaccination") the patient experienced rash which was first appeared on her  back the size of a quarter. There were 2 of them. Once these rashes went away new rashes appeared on her legs, from her knees to her ankles, and then to her arms. Patient also reported that the rashes were red, burning and itching. Prior to receiving the M-M-R II, she reported that she had blood work done. The results showed an issue with unspecified mumps and antibodies (also reported as "no lab diagnostics studies performed"). Patient sought medical attention via doctor visit. An unspecified cortisone cream was given as treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Local swelling, Nausea, Pain in extremity
Clinical narrative: Pain down left arm and upper left chest area. Swelling in left armpit area. Upper back pain. Some nausea.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Induration
Clinical narrative: Induration.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Pt presented to pharmacy 7 day post-administration with injection site redness/inflammation approx 3 inch diameter complaint of itching.
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix normal
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On unknown dates the patient was vaccinated with three doses of GARDASIL (strength, dose, frequency and route unspecified). The result of a Papanicolaou smear (PAP smear) on an unspecified date was a negative PAP smear and Human papillomavirus (HPV) positive. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to 16 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates in 2014, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with VAQTA which was improperly stored (doses, administration sites and routes, lot # and expiration dates were not reported). This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Hepatitis B antibody negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown. The patient's medical history and current conditions were not specified. The patient had no drug allergies/reactions.  The nurse reported that the patient received the first dose of M-M-R II on 14-OCT-1997 and the second dose on 13-AUG-2001 (lot number not reported). On 08-AUG-2014 the patient was vaccinated with M-M-R II, dose 3. Other suspect therapies included 3 dose series of RECOMBIVAX HB (reported as "unspecified hepatitis B vaccine, manufacturer unspecified), but RECOMBIVAX could not be ruled out. Concomitant therapies included fluticasone, ethinyl estradiol, ferrous fumarate, GENERESS FE and clindamycin. On 05-AUG-2014 the patient had titers drawn and the rubella titer was negative. Reporter stated that the patient also showed negative for hepatitis titers. The reporter stated that she thought some "people just don't' respond". The outcome of the events was unknown. No intervention was provided-there was no hospitalization, no significant disability and no life threatening experiences. No product quality complaint was involved. Causality was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, the patients might have been administered doses of (Oka/Merck) VARIVAX (dose, route and lot number were not reported) that had been improperly stored. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, the patients might have been administered doses of M-M-R II (dose, route and lot number were not reported) that had been improperly stored. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent for  follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, the patients might have been administered doses of PROQUAD (merck) (dose, route and lot number were not reported) that had been improperly stored. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose and lot # not reported) which were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cyanosis, Fatigue, Feeling abnormal, Loss of consciousness, Posture abnormal
Clinical narrative: Approx 5 minutes after receiving vaccine pt stated "I don't feel good". Her head tilted forward and she lost consciousness while being supported by nurse. Became cyanotic O2 applied wake up with fatigue.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor, Peripheral coldness
Clinical narrative: Syncope - patient became pale, sweating, she felt dizzy, and weak; her hands were cold but she did not lose consciousness.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Syncope
Clinical narrative: Syncope - patient became pale, sweating, she felt dizzy, and weak; her hands were cold but she did not lose consciousness.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Ear discomfort, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain where shot was given (day after). Redness and swelling where shot was given (day after). Headache (for week and half). Tiredness (week and half). Nausea, vomiting, stomach cramps (2 weeks). Burning inside ears. Missed 3 days of school.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Pain where shot was given (day after). Redness and swelling where shot was given (day after). Headache (for week and half). Tiredness (week and half). Nausea, vomiting, stomach cramps (2 weeks). Burning inside ears. Missed 3 days of school.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came into clinic 2 days after receiving shingles vaccine. She had redness, swelling and heat at injection site.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: Malaise, weakness, dizziness.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt had T-DAP on 8-8-14 - She stated reaction started on 8-15-14. Area to (L) deltoid is red-hard-painful - warmth started on 8-5-14.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not reported). The patient missed her second dose of GARDASIL a year later. Additional information is not expected, because there were no contact details reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, induration, itching, redness, blisters at injection site. Initially 5 cm in size. This progressed over 2 days. Entire upper arm was swollen and red. Patient went to ER on 8/16/14. Was given prednisone and Benadryl. Swelling and induration are now resolving.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Swelling, induration, itching, redness, blisters at injection site. Initially 5 cm in size. This progressed over 2 days. Entire upper arm was swollen and red. Patient went to ER on 8/16/14. Was given prednisone and Benadryl. Swelling and induration are now resolving.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Aggression, Headache, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: C/O Pain to parent, she reported she looked at the site and it was red/purple/extremely swollen,down to elbow. Reported she remembered that he had C/O headache and that his are hurt on same day of shot. Also that he became very moody and impatient ("grouchy"), became violent with his sister for no good reason. Parent did not take his temperature at any time and could not verify that he had a fever. She reported he was pale. By 8/17/2014, swelling was less and there was continued redness and splotchy rash at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Irritability, Mood altered, Pain
Clinical narrative: C/O Pain to parent, she reported she looked at the site and it was red/purple/extremely swollen,down to elbow. Reported she remembered that he had C/O headache and that his are hurt on same day of shot. Also that he became very moody and impatient ("grouchy"), became violent with his sister for no good reason. Parent did not take his temperature at any time and could not verify that he had a fever. She reported he was pale. By 8/17/2014, swelling was less and there was continued redness and splotchy rash at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Rash macular
Clinical narrative: C/O Pain to parent, she reported she looked at the site and it was red/purple/extremely swollen,down to elbow. Reported she remembered that he had C/O headache and that his are hurt on same day of shot. Also that he became very moody and impatient ("grouchy"), became violent with his sister for no good reason. Parent did not take his temperature at any time and could not verify that he had a fever. She reported he was pale. By 8/17/2014, swelling was less and there was continued redness and splotchy rash at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: INJECTION SITE RASH AT SITE OF INJECTION ON RIGHT ARM APPROX 2.5 INCHES IN DIAMETER.
Age: 1.27
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: She has had a low-grade fever and been very irritable for a week now, having been in good spirits and fine before her shots.  Daily Tylenol and Ibuprofen.
Age: 0.18
Sex: F
Vaccine: DTAP, RV5
Symptoms: Diarrhoea, Infantile spitting up
Clinical narrative: Extreme diarrihea 10 to 12 a day for 7 days straight. Spitting up often, had never done this before Rotavirus vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Erythema/edema/warmth.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever, pain, redness and swelling of the arm that the injections were administered.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: A WELT DEVELOPED ON PT ARM WHERE VACCINE WAS ADMINISTERED.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Food allergy, Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: 4.5 x 2.5 area redness and induration (L) outer thigh. Reaction noted 8/15/14 after allergic reaction to walnut on 8/13/14. Immunization given 8/5/14.
Age: 61.0
Sex: M
Vaccine: HEPA, MMR, TYP, VARCEL
Symptoms: Herpes zoster, Musculoskeletal chest pain
Clinical narrative: Pt could not recall hx measles, chicken pox when being vaccinated to travel - received MMR, varicella, typhoid, HepA 8/12/14 - developed rib cage pain following day - diagnosed with shingles Monday 8-18-14.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age and gender with psoriasis. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced a flare up of psoriasis. The outcome and reported causality of the flare up of psoriasis is unknown. No information regarding treatment, if any, was reported. No information regarding the patient's medical history or concomitant medications was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy site unspecified abnormal, Human papilloma virus test positive, Laboratory test normal, Polymerase chain reaction, Psoriasis
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 19 year old male patient with allergy to iodine. There was a genetic component to the patient's psoriasis since patient's father had psoriasis. The patient's medical history included unspecified warts which he had as a child. The patient was not sexually active prior to receiving the GARDASIL. On 06-SEP-2012, the patient was vaccinated with the first dose of GARDASIL. On 20-FEB-2013, the patient received the second dose and on 12-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). On an unknown date, reported as after receiving GARDASIL, the patient developed psoriasis. The patient developed lesions from his neck down to his ankles due to the psoriasis. The patient sought medical attention. The patient had the lesions removed from an unspecified area on his body on an unspecified date but a psoriasis plaque developed on an unspecified date after the lesions were removed. The patient was placed on ENBREL (also reported as a concomitant medication) for the psoriasis on an unspecified date and did very well with the ENBREL. On 18-JUN-2014 and 05-AUG-2014, the patient tested positive through surgical biopsies for HPV types 6, 11, 16, 18, 30, and 32. On 22-JUL-2014, the patient had a polymerase chain reaction (PCR) DNA test done, but the results showed that there was no damage to oropharyngeal cells. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Skin lesion, Skin lesion excision
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 19 year old male patient with allergy to iodine. There was a genetic component to the patient's psoriasis since patient's father had psoriasis. The patient's medical history included unspecified warts which he had as a child. The patient was not sexually active prior to receiving the GARDASIL. On 06-SEP-2012, the patient was vaccinated with the first dose of GARDASIL. On 20-FEB-2013, the patient received the second dose and on 12-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). On an unknown date, reported as after receiving GARDASIL, the patient developed psoriasis. The patient developed lesions from his neck down to his ankles due to the psoriasis. The patient sought medical attention. The patient had the lesions removed from an unspecified area on his body on an unspecified date but a psoriasis plaque developed on an unspecified date after the lesions were removed. The patient was placed on ENBREL (also reported as a concomitant medication) for the psoriasis on an unspecified date and did very well with the ENBREL. On 18-JUN-2014 and 05-AUG-2014, the patient tested positive through surgical biopsies for HPV types 6, 11, 16, 18, 30, and 32. On 22-JUL-2014, the patient had a polymerase chain reaction (PCR) DNA test done, but the results showed that there was no damage to oropharyngeal cells. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was vaccinated intramuscularly with a dose of GARDASIL (once, 0.5ml, dose in series was unspecified, lot# was one of the following: J009243, expiration date 23-APR-2016 or J010668, expiration date 29-APR-2016) that was improperly stored at -0.5C for 1.5 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 30 year old female patient. On 28-MAR-2014, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. No adverse effect was reported. The outcome of the inappropriate schedule of vaccination is unknown. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an approximately 15 year old patient. No relevant medical history of the patient was reported. On 09-APR-2009, the patient was vaccinated with GARDASIL dose 1 (strength, route and lot number were not reported). No concomitant medications were reported. The patient received the second dose of GARDASIL on 26-APR-2010 and the third dose on 30-NOV-2010 (strength, route and lot number were not reported). It was reported that the patient did not experience any adverse effects. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23, lot # J006921 (expiry: 09-AUG-2014) (dose, route, and frequency were not reported). No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a local nurse refers to a patient of unknown age. The patient's medical condition and current conditions are not reported. On 13-AUG-2014 the patient was vaccinated with RECOMBIVAX HB of 1 ml strength via intramuscular route (lot #H010965 and expiry date 01-JUN-2014). Approximately on an unknown date in 2014 the patient received an expired dose of RECOMBIVAX HB. No adverse events are reported. The outcome of the events is unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient states both knees started to hurt some time after received vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Received ZOSTAVAX (varicella zoster vaccine by Merck) subcutaneously in right arm at 10pm 8/11/14. On 8/13/14 and 8/14/14 felt and observe significant erythema (redness, heat, mild itching) in injection area approximately 1 inch by 1.5 inches in size.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was due a DTAP vaccine on 8/2/2014 and TDAP was administered instead.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Pallor, Sluggishness
Clinical narrative: Within less than 5 mins after injection - extreme pallor, dizziness, responsive but sluggish, eyes tended to roll back in sockets - cold/clammy - on lying down/feet elevated B/P 80/0 P 50 R 16 at 1058 at 1110 B/P 108/72 P = 58 (snack/juice) [Note: Had not ate bkf] held 20 mins - alert lips pink/responsive B/P 110/70.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Mom states his left arm was red, swelling and blistered at the injection site after receiving vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Hypersomnia, Neuralgia, Pain in extremity
Clinical narrative: Felt tired, slept all day. Have a few blisters that look like shingles. Arm is sore. Nerve pain in arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Felt tired, slept all day. Have a few blisters that look like shingles. Arm is sore. Nerve pain in arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Induration, Rash erythematous
Clinical narrative: 3.5 cm x 3.5 cm red, indurated rash.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Reports headache a few hours after vaccine. Took TYLENOL. Then went to bed. Woke up at 2 am with severe headache pain 8/10. Took more TYLENOL. Reports headache lasted 24 hrs. Pt seen 7/28/14 H/A resolved.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Local redness at inj. site - was red, raised/swollen and sl warm - noted approx 24 hrs later (parents had not looked at area prior. Pt stated itchy. 24 hrs later still spreading - started on KEFLEX. Not improving 48 hrs later. Redness spreading seen at weekend access. Described as red 1.5 in pale border then serpiginous outer red ring. Abx stopped. Resolved on own. Also noted fine red rash facial/cheeks.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 40 year old female patient with no drug reactions or allergies. On an unknown date in 2013 (also reported as "about one year ago") the patient was vaccinated with the first dose of M-M-R II (route, dose and lot # not reported). On 17-JUL-2014 the patient was vaccinated subcutaneously with the second 0.5 ml dose of M-M-R II (lot # J000201, expiration date 09-JAN-2015). There was no concomitant medications reported. The registered nurse reported that on 12-AUG-2014 serologic testing was conducted (also reported as MMR II titers) and results showed that the patient's titer to measles was negative - less than 5 (units not provided). There was no treatment given for the event. The outcome of the event and relatedness between the event and M-M-R II was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Urticaria, Vomiting
Clinical narrative: Hives, dizziness, abd pain/vomiting. - BENADRYL.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: SWOLLEN RED HOT ARM -- STARTED 8/15/2014 STILL REACTING AS OF 8/18/14 PT USING BENADRYL AND ICE PACKS TO REDUCE SWELLING AND STOP ITCHING.
Age: 15.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Chills, Headache, Pyrexia, Skin warm, Urticaria
Clinical narrative: Patient developed fever and headache yesterday, approximately 6 hours after receiving Tdap, Menactra and IPV. Vaccines. Developed hive-like rash on forehead.  She was seen in the emergency room last evening.  Temperature was 99 degrees.  Treated with Tylenol and Benadryl.  Symptoms improved, but she awoke during the night complaining of headache again and chills.  Father went to work this morning.  Received a call from his wife stating that patient feels warm again and is complaining of a headache.  They do not have a thermometer in the home.  Father is unsure if hives have recurred.  Reports that patient has not complained of difficulty breathing or swallowing.  No nausea or vomiting.  No lethargy.  Recommend they monitor her and obtain a thermometer for home use.  Continue  Benadryl and Tylenol or ibuprofen for fever control, as well as increase fluids.  Explained that fever, headache and flulike symptoms can be a normal reaction following immunizations, especially Tdap.  Concern that possible hives a may be an allergic reaction.  If she should develop a fever over 101 or has increased lethargy, nausea, or vomiting, worsening headache or worsening hives,  difficulty breathing or swallowing. I recommended that she be reevaluated in the emergency room or urgent care.  Father agrees with this plan.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Patient experienced painful rash/hives all over body 2 days after receiving vaccine. Rash remained for 2 months after vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: Patient was given immunization and then stayed to be observed per office policy.  Five minutes later patient was pale and vomiting.  Doctor came in to exam room and observed patient. Water was given to patient and ice pack placed on back of neck.  Patient vomited one more time. Other nurse stayed with patient until the doctor and the patient and mother of patient felt it was ok for patient to leave office.  Left office by her own ability and color had returned to her face.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Local swelling
Clinical narrative: Cellulitis, localized swelling of right arm above elbow.
Age: 76.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Fever 24 hours later, resolved. Redness, heat, swelling, cellulitis, seen 6 days later, started on antibiotic.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2 days after vaccine 5 x 6 cm area of induration and erythema at site.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local rxn over (L) ant thigh.
Age: 56.0
Sex: M
Vaccine: MNQ
Symptoms: Antibody test positive, Blood test, Wrong drug administered
Clinical narrative: Patient called to inform me that he needed to get MMR for his job but was given MENACTRA. The titers showed no immunity until the nurse looked at the form given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, tenderness, swelling, "hot feeling" at injection site of ZOSTAVAX immunization.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Local swelling, Skin warm
Clinical narrative: Arm severely swollen, skin was hot and hard to the touch from shoulder almost to wrist. Heat had no effect, cold press had no effect, had to take max daily dose of BENADRYL to reduce swelling.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Lymph node pain, Lymphadenopathy
Clinical narrative: 4 cm induration/erythema at injection site and swollen painful lymph node in axilla. Differential includes cellulitis which was treated for.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Abdominal discomfort, Dyspnoea, Malaise, Palpitations, Pruritus generalised
Clinical narrative: Client came to clinic and received 4 vaccines. She spoke a foreign language and was accompanied by her brother who also spoke limited English. Per brother, client began to feel ill right after receiving the vaccines. He went into the TB clinic with her to report that she was not well. She was observed to be itching all over; head, neck, hands, arms. She was extremely restless, felt like her heart was pounding, had stomach discomfort and felt short of breath although respirations did not appear labored. Client was seen by a provider, adult EPIPEN was administered, and vitals monitored until arrival of EMS. She was taken to nearby emergency department for further treatment.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Restlessness
Clinical narrative: Client came to clinic and received 4 vaccines. She spoke a foreign language and was accompanied by her brother who also spoke limited English. Per brother, client began to feel ill right after receiving the vaccines. He went into the TB clinic with her to report that she was not well. She was observed to be itching all over; head, neck, hands, arms. She was extremely restless, felt like her heart was pounding, had stomach discomfort and felt short of breath although respirations did not appear labored. Client was seen by a provider, adult EPIPEN was administered, and vitals monitored until arrival of EMS. She was taken to nearby emergency department for further treatment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness and swelling started morning after, along with some tenderness. Taking ibuprofen and BENADRYL to help.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Within 4 hours of the injection patient developed a red, hot, circular rash measuring 10 cm x 13 cm lasting 48 hours and patient used ice packs and ibuprofen.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Dysgeusia, Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: Bell's Palsy occurred. Paralysis on left side of face. Unable to completely close left eye and metallic taste in mouth. Prescribed steroids and Acyclovir.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient came to pharmacy 8-12-14 to ask about ab OTC product for itching. He didn't think it was a shingles outbreak but after showing the Rph the rash I thought it certainly looks.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient went to ER approx 10-12 hrs after injection erythema/swelling/tenderness. ER diagnosed cellulitis.
Age: 1.38
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Seizure like activity with fever around 4:30 am on 8/16/14. Lasted for 2 minutes
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current conditions was reported. No historical drug was reported. On 12-AUG-2014 the patient was vaccinated with M-M-R II (SDV, MDV or addictive) lot # H012142, expiration date 29-JUN-2014, Albumin Status for H012142 was HSA, subcutaneous (dose  strength was not reported). No concomitant medication was reported. On 12-AUG-2014, the patient received an expired dose of M-M-R II. No known adverse effect was reported. No product quality complaint was reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Discomfort, Erythema
Clinical narrative: Left arm red and bruised to mid forearm. Symptoms started 6 hrs after vaccination. Pt. stated took TYLENOL for discomfort. Vaccine (pneumonia) admin 8/11/14 approx 9 am pt. states she feels arm is improving.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth starting 10-15 minutes after vaccine was given. Went away after about 14 hours.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain
Clinical narrative: Started with neck pain right side on 7/26. Shingles rash broke out 7/29/14.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to twin 4 year old female patients vaccinated with (Oka/Merck) VARIVAX. On 20-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous. This is the second dose in the series. On an 20-JUN-2014, the patient received VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours (supported). The outcome of receiving VARIVAVX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours is unknown. Additional information is not expected. This case is linked to 1407USA009865 due to twin patients who were vaccinated on the same date 20-JUN-2014.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to twin patients age unknown and gender unknown  which were vaccinated with (Oka/Merck) VARIVAX. On 20-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous. This is the second dose in the series. On 20-JUN-2014, the patient received VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours (supported). The outcome of receiving VARVIAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours is unknown. Additional information is not expected. This case is linked to 1407USA012109 due to twin patients who were vaccinated on the same date 20-JUN-2014.
Sex: M
Vaccine: MMR
Symptoms: Measles, Pyrexia, Rash, Viral test
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to an approximately 12 month old male patient. On an unknown date the patient was vaccinated with M-M-R II (dose, units, route of administration, anatomical location, lot number were not reported). The reporter state that on an unknown date, the patient appeared to have developed measles. Patient's mother contacted the physician's office and explained that the patient had a rash an fever (date unspecified). The mother made a second call the next day to stated the patient still had the fever and rash. On an unknown date diagnostic tests were conducted (mother took a patient into emergency room) to confirm the outbreak of measles. It was also unspecified whether the patient was admitted. The outcome of events was not reported. The relatedness between events and M-M-R II was not reported. Additional information has been requested
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 08-APR-2014, the patient was vaccinated with ROTATEQ  lot # H017721, expiration date 01-APR-2014, dose 1 (dose strength and route ws not reported). No concomitant medication was reported. On 08-APR-2014, the patient received his first dose of ROTATEQ with an expired dose of ROTATEQ. No adverse effect was reported. No product quality complaint involved. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's medical history included shingles (previous episode in February 2014). On 17-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001698, expiration date: 08-MAY-2014, dose: 0.65 ml, subcutaneously in the left deltoid). The patient started to experience symptoms of shingles on 10-AUG-2014. He sought medical attention by consulting his healthcare provider on an unspecified date (in August 2014). None laboratory diagnostic was performed. He was prescribed VALTREX 1000 mg, NEURONTIN 300 mg and MEDROL Dosepak for which he was in the pharmacy at the time of the report (15-AUG-2014). The patient informed the pharmacist that he has been applying an antiviral ointment to his lesions twice a day since 10-AUG-2014, but he has not applied any antiviral ointment to his lesions on 15-AUG-2014. At the time of the report the patient has not recovered from shingles. The relatedness between the ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant drugs was provided. On 14-AUG-2014 the patient was inadvertently administered a fourth dose of the GARDASIL 0.5 ml, intramuscularly; site of injection, lot# and expiration date not reported. The first dose of GARDASIL was administered on 28-MAR-2012, the second dose on 27-AUG-2012 and the third dose on 11-MAY-2013. No adverse effects were reported. Additional information is not expected, as there was no consent to contact the healthcare professional.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a 16 month old male patient. On 07-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot #, expiration date, dose unspecified), "injection". During the same clinic visit on 07-JUL-2041, the patient also received M-M-R II (lot #, expiration date, dose unspecified) and VAQTA (lot #, expiration date, dose unspecified). On 22-JUL-2014 (about 15 days later), developed a chickenpox-like rash "about 15 days later". The rash was described to be "all over the patient's body" including on the patient's tongue. The parents of the patient called the physician's office to seek medical attention. No treatment was given. The event outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with high blood pressure and none drug reactions/allergies. On 01-AUG-2014 the patient was vaccinated with ZOSTAVAX, (dose, lot# and expiration date not reported), subcutaneous. Concomitant medication included unspecified medication. The patient stated that on the night of 01-AUG-2014, after receipt of the injection, she experienced pain the left arm (in which she received the injection) which traveled down the side of her body to her left breast. She also stated that she did also experience swelling at the injection site. The patient said that this pain almost completely resolved itself by "Saturday morning" (on 02-AUG-2014). Patient did state that she did take an unspecified medication for the pain. None lab diagnostics studies were performed. The outcome of events was reported recovering. The patient had sought medical attention by calling the pharmacist on 04-AUG-2014. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site rash
Clinical narrative: Rash to R Lower extremity. Pap ulnar, no scabbing. Still present 1 month later. No response to steroid or antibiotic or anti fungal creams.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Body temperature increased, Computerised tomogram abnormal, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Fever, increased pain at injection site, general malaise in the evening on 08/15. Came back to hospital the evening of 08/16 with a temp of 40.1. He was given IV fluids, antibiotics (clindamycin and vancomycin) and received a CT scan of his right arm to rule out a necrotizing skin infection.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, increased pain at injection site, general malaise in the evening on 08/15. Came back to hospital the evening of 08/16 with a temp of 40.1. He was given IV fluids, antibiotics (clindamycin and vancomycin) and received a CT scan of his right arm to rule out a necrotizing skin infection.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Blood culture, Cellulitis, Full blood count, Laboratory test, Pruritus
Clinical narrative: Fever, increased pain at injection site, general malaise in the evening on 08/15. Came back to hospital the evening of 08/16 with a temp of 40.1. He was given IV fluids, antibiotics (clindamycin and vancomycin) and received a CT scan of his right arm to rule out a necrotizing skin infection.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Chills, Computerised tomogram, Dizziness, Headache, Injection site erythema
Clinical narrative: Pt was discharged and began to have a headached, fever to 103.4, chills and feel dizzy. The area where the injection was began to look red and raised. CT of the arm was completed. He was treated with clindamycin IV.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Pt was discharged and began to have a headached, fever to 103.4, chills and feel dizzy. The area where the injection was began to look red and raised. CT of the arm was completed. He was treated with clindamycin IV.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Cellulitis, Full blood count, Laboratory test
Clinical narrative: Pt was discharged and began to have a headached, fever to 103.4, chills and feel dizzy. The area where the injection was began to look red and raised. CT of the arm was completed. He was treated with clindamycin IV.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood culture negative, Erythema, Pyrexia, Vulvovaginal erythema
Clinical narrative: Received 2 mth vaccines. Fever that night started with redness of labia the next day. Spread to entire diaper area and above diaper line by 48 hrs later. No redness at injection site.