chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Neuralgia, Paraesthesia
Clinical narrative: This spontaneous report received from a pharmacist, via a company representative, concerning to a 52 year old male patient. Medical history and concurrent conditions were not reported. On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K000327, expiration date 05-MAR-2015, 0.65 ml, subcutaneous. Concomitant therapies included PROAIR, Meloxicam and Omeprazole (manufacturer unknown. The pharmacist reported to the representative that "the patient experienced joint, muscular and nerve pain in the arm that the vaccine was administered, and a feeling of numbness and tingling in the opposite leg of the vaccine administered arm, after receiving ZOSTAVAX, on 08-AUG-2014. At the time of the report the outcome was reported as not recovered. Patient received treatment with TYLENOL and MOTRIN. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The reporter stated that the patient inadvertently received a third dose of (Oka/Merck) VARIVAX. Does 1 of (Oka/Merck) VARIVAX was administered 15-APR-2011, dose 2 was administered sometime in February 2014 and dose 3 of (Oka/Merck) VARIVAX subcutaneous, 0.5 ml was administered on 13-AUG-2014. No symptoms reported. The outcome of the patient inadvertently received a third dose of (Oka/Merck VARIVAX was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: VARIVAX vaccine was given 8/13/14 right arm sc pt returned to office today for PPD read and showed us her arm. 4 cm raised reddened area warm to touch saw provider for evaluation of area.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Dry skin, Erythema, Pain, Rash, Rash erythematous
Clinical narrative: Large swollen area size of half a baseball. Red and  hot to touch, sore, then got a red small pin point rash on chest, shoulder, upper back. Rash raised and rough.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Large swollen area size of half a baseball. Red and  hot to touch, sore, then got a red small pin point rash on chest, shoulder, upper back. Rash raised and rough.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at the injection site; redness, swelling, and warmth.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Father states about 24 hours after receiving vaccines, developed pain and swelling at site, rt. deltoid. Provided no relief in interventions and today noticed swelling increased. On 8-15-14 returned to clinic. Ice applied to rt deltoid area 10 cm in diam. red, swollen and warm to touch. Child left with father in gd spirits, ambulatory.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at local site of injection 6 cm in diameter resolving on examination at 48 hrs.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Immediate post-injection reaction
Clinical narrative: Patient complains of dizziness for days after injection and diarrhea right after shot for 2 days.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 1 year old male patient with an unspecified genetic glycogen storage condition. No pertinent medical history was provided. About 2 weeks ago, approximately on 28-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX vial 1350U, 0.5 ml, subcutaneously (lot number not reported). No co-suspect or concomitant therapies were reported. On an unspecified date in 2014, the patient was diagnosed with varicella after receiving (Oka/Merck) VARIVAX. The patient sought medical attention by visiting an unspecified dermatologist. The adverse event was treated with BACTROBAN cream and an unspecified type of steroid treatment. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered from the adverse event. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Prolonged rash (Currently at 19 days) - treated with antibiotic, BENADRYL, oral steroids.
Age: 1.79
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Crying, Glassy eyes, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Fever over 104 intermittent for over 2 weeks; bloody nose; grapefruit size lump that persisted for weeks; lethargy; highpitch screaming; still in speech and OT over 3 years later: regression post vaccination.
Age: 1.79
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Malaise, Pyrexia, Speech disorder
Clinical narrative: Fever over 104 intermittent for over 2 weeks; bloody nose; grapefruit size lump that persisted for weeks; lethargy; highpitch screaming; still in speech and OT over 3 years later: regression post vaccination.
Age: 1.79
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Developmental delay, Encephalopathy, Epistaxis, Lethargy, Mass
Clinical narrative: Fever over 104 intermittent for over 2 weeks; bloody nose; grapefruit size lump that persisted for weeks; lethargy; highpitch screaming; still in speech and OT over 3 years later: regression post vaccination.
Age: 1.79
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Pyrexia, Screaming, Speech disorder developmental
Clinical narrative: Fever over 104 intermittent for over 2 weeks; bloody nose; grapefruit size lump that persisted for weeks; lethargy; highpitch screaming; still in speech and OT over 3 years later: regression post vaccination.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Recieved Td vaccine on 8/7/14.  On Saturday  8/9 I noticed an inflamed lump at injection site with another similar lesion next to it (about the diameter of a dime). On 8/10 the following began: vertigo, fever (101.2), sweats, chills, malaise, nausea, anorexia, prostration, headache, all began approx 2PM  on Sunday.  By Monday I was prostrate.  This continued all week.  As of today (8/16)  I am improved but still fatigued, with headache, chills and sweats. Fever resolved.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site inflammation, Injection site mass, Injection site reaction, Malaise, Nausea
Clinical narrative: Recieved Td vaccine on 8/7/14.  On Saturday  8/9 I noticed an inflamed lump at injection site with another similar lesion next to it (about the diameter of a dime). On 8/10 the following began: vertigo, fever (101.2), sweats, chills, malaise, nausea, anorexia, prostration, headache, all began approx 2PM  on Sunday.  By Monday I was prostrate.  This continued all week.  As of today (8/16)  I am improved but still fatigued, with headache, chills and sweats. Fever resolved.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Skin lesion, Vertigo
Clinical narrative: Recieved Td vaccine on 8/7/14.  On Saturday  8/9 I noticed an inflamed lump at injection site with another similar lesion next to it (about the diameter of a dime). On 8/10 the following began: vertigo, fever (101.2), sweats, chills, malaise, nausea, anorexia, prostration, headache, all began approx 2PM  on Sunday.  By Monday I was prostrate.  This continued all week.  As of today (8/16)  I am improved but still fatigued, with headache, chills and sweats. Fever resolved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Pt returned to pharmacy with swollen/red injection site reaction. It was hot and hard to the touch. She returned two days later (8/15/2014) and it wasn't as red, but the area was wider. The pt also indicated that her arm and side were both swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt returned to pharmacy with swollen/red injection site reaction. It was hot and hard to the touch. She returned two days later (8/15/2014) and it wasn't as red, but the area was wider. The pt also indicated that her arm and side were both swollen.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Localized, pyramid shaped rash around injection site. Tender to touch.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Large painful edematous areas of erythema at injection sites; treated with oral steroids.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Pt stated that she experienced a rash on her breast that slowly went away but then started to feel a tingle at her breast area. Pt consulted to get evaluated by MD to get a second opinion since this may due to another reason.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX (subcutaneous, dose reported as single dose). On an unknown date the patients experienced brief discomfort at the injection site after administration of ZOSTAVAX. The reporter states that discomfort resolved quickly without requiring medical attention. No lab tests were performed. The outcome of brief discomfort at the injection site was reported as recovered/resolved. The causality was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient. The reporter stated that on 08-AUG-2014 PROQUAD (route of administration and dose unknown) was inadvertently administered to an unspecified 17 year old female patient. Pertinent medical history and concomitant medications were unspecified by the reporter. No adverse effect reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with unspecified cancer. ON 10-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot # J013453, Expiry: 24-JAN-2015, 0.65 ml, subcutaneous). Pertinent medical history and concomitant medications were unspecified by the reporter. On 11-AUG-2014, 2 days after onset of therapy the patient experienced red bump on the back of an unspecified arm. The reporter also states that the patient had an unspecified cancer in the past and was in remission when she received the ZOSTAVAX. On 12-AUG-2014, the patient visited pharmacy and spoke to the pharmacist. IT was reported that no treatment was given for the event. No lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-AUG-2014 the patient was received expired PNEUMOVAX23 (25/0.5 Y) (lot # H022280, expiry: 16-JUL-2014, dose and route of administration was unknown). Pertinent medical history and concomitant medications were unspecified by the reporter. The reporter stated that PNEUMOVAX23 did not have any temperature excursions. The reporter also stated PNEUMOVAX23 supported with in-house stability data. No adverse symptoms reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 1.17
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 14 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 05-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot #K000328, 0.65ml/once, subcutaneous). Pertinent medical history was not reported. Concomitant therapies included ABILIFY, REMERON (dose and frequency unknown), CYMBALTA, LAMICTAL and SEROQUEL. On 09-AUG-2014, the patient was seen at the pharmacy and stated that she has had short-term memory loss "since she got the shot". The outcome of short term memory loss is unknown. The causality was unknown. No further information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pruritus generalised, Rash generalised, Syncope
Clinical narrative: Patient calls to the pharmacy and indicates that is suffering from dizziness, rash and itching in the whole body and fainting.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Large local reaction noted on 8/15/14. 4 x 4 cm erythematous wheal noted on the (L) deltoid at the injection site. Warm. Non tender normal ROM, sensation of arm.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 6 year old patient. On 10-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # reported as J014229, EXP 08-NOV-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: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 12 month old patient. On 09-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.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 12-AUG-2014 the patient was inadvertently administered with PNEUMOVAX23 (dose strength not reported) lot# J009827, expiration date 10-AUG-2014, route intramuscular which had expired on 10-AUG-2014 and this was supported. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Her entire left thigh swelled to twice its normal size. It was painful to the touch. The swelling and pain lasted for several days.
Age: 1.34
Sex: F
Vaccine: HIBV
Symptoms: Discomfort, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Swelling at the injection site, extending approximately 2" diameter around the site. Area was hot to the touch. She was uncomfortable and fussy. Swelling and fussiness went away after several days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant redness, swelling pain at injection site.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Shaking, chills, fever, joint pain, dizziness, extreme fatigue, injection site redness with warmth and swelling in one inch radius.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Tremor
Clinical narrative: Shaking, chills, fever, joint pain, dizziness, extreme fatigue, injection site redness with warmth and swelling in one inch radius.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash generalised
Clinical narrative: Rash on entire body no respiratory distress. Pulse ox 99% at room air  distress. Patient was prescribe Hydroxyzine 10mg/5ml.
Age: 1.02
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: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Vaccine recommended by MD. Pt reported no KNDA, no health conditions at the time of getting the shot. Pt saw "small dots around one side of her body, mainly breast area, it itches and she feels slight pain in the rib area. Rash is not open, she did not report this to her MD. I spoke with her on 8/17/14 and referred her to MD. Filled out this form and faxed. Pt not sure rash is due to shot , therefore, I referred her to MD.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Hypersomnia, Lethargy, Oropharyngeal pain, Rash vesicular
Clinical narrative: Rash similar to chx pox, onset lethargy, sore throat, canker sores covering all aspects of throat, mouth, gums, slept for 18 hours; TX: Acyclovir.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. In approximately June 2014, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route and lot number were not reported). A month after receiving ZOSTAVAX, in approximately July 2014, the patient had an eruption of varicella-like vesicles after receiving ZOSTAVAX. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a healthcare worker refers to unspecified patients of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date unknown number of unspecified patients at office had occasionally been administered with GARDASIL (therapy start dates, dose strength, frequency, route was not reported) at schedules other than what is in the prescribing information. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1408USA009648 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date unknown number of unspecified patients at office had occasionally been administered with RECOMBIVAX HB (therapy start dates, dose strength, frequency, route was not reported) at schedules other than what is in the prescribing information for vaccination. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1408USA008513 via same reporter link. Additional information ha been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a his 17 year old daughter with no pertinent medical history and no drug reactions or allergies. On 28-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose and route of administration were not reported). On 28-JUL-2014, the patient was diagnosed with being pregnant, the same day that she received her second dose of GARDASIL. The patient became pregnant with Last Menstrual Period (LMP) of 07-JUL-2014 and Estimated Date of Delivery of 13-APR-2015. Estimated Date of Conception of 21-JUL-2014. Initial exposure to GARDASIL was at 3 week(s). The pregnancy outcome was pending (also reported as not recovered). Gestation was provided as 3 weeks. On 28-JUL-2014, the patient was diagnosed with being pregnant, the same day that she received her second dose of GARDASIL. No treatment was given. None lab diagnostic studies were performed. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a his 17 year old daughter with no pertinent medical history and no drug reactions or allergies. On 28-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose and route of administration were not reported). On 28-JUL-2014, the patient was diagnosed with being pregnant, the same day that she received her second dose of GARDASIL. The patient became pregnant with Last Menstrual Period (LMP) of 07-JUL-2014 and Estimated Date of Delivery of 13-APR-2015. Estimated Date of Conception of 21-JUL-2014. Initial exposure to GARDASIL was at 3 week(s). The pregnancy outcome was pending (also reported as not recovered). Gestation was provided as 3 weeks. On 28-JUL-2014, the patient was diagnosed with being pregnant, the same day that she received her second dose of GARDASIL. No treatment was given. None lab diagnostic studies were performed. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Heart rate increased, Pharyngeal oedema
Clinical narrative: Anaphylactic reaction including swelling of the throat, skin irritation, shortness of breath, increased heart rate & blood pressure.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Skin irritation
Clinical narrative: Anaphylactic reaction including swelling of the throat, skin irritation, shortness of breath, increased heart rate & blood pressure.
Age: 43.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Activities of daily living impaired, Chills, Headache, Muscle spasms, Nausea
Clinical narrative: Woke with TDAP vaccinated arm too sore to use for regular activities. By 3PM, severe thirst and medium grade headache. By 3:30PM, severe body aches, cramps in feet, and mild fever onset. By 5PM, nausea set in and had to rest. At 5PM took 500mg Tylenol. By 5:45PM headache and body aches lessened to allow for walking and standing. At 9:45PM chills, body aches, and queasy stomach. 11PM took 220mg naproxen sodium.  Sunday at 10:30AM queasy stomach, no body aches, but arm still to sore to lift. Sunday 1PM some soreness in arm, but other symptoms gone.
Age: 43.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Pain, Pain in extremity, Pyrexia, Thirst
Clinical narrative: Woke with TDAP vaccinated arm too sore to use for regular activities. By 3PM, severe thirst and medium grade headache. By 3:30PM, severe body aches, cramps in feet, and mild fever onset. By 5PM, nausea set in and had to rest. At 5PM took 500mg Tylenol. By 5:45PM headache and body aches lessened to allow for walking and standing. At 9:45PM chills, body aches, and queasy stomach. 11PM took 220mg naproxen sodium.  Sunday at 10:30AM queasy stomach, no body aches, but arm still to sore to lift. Sunday 1PM some soreness in arm, but other symptoms gone.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Headache, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Optic neuritis
Clinical narrative: Pt is a 25 yo male who denied any previous problems with immunizations. On 04 Oct 2013 he was vaccinated with inactivated influenza vaccine. He denied any immediate problems. Ten days after vaccination he reported the onset of intermittent headaches and sought medical evaluation on 21 Oct. Headaches persisted and he began to note increasing vision loss. Ophthalmology exam on 24 Oct noted bilateral disc edema concerning for optic neuritis. He was admitted and received IV steroids and was discharged on a tapering dose of oral steroids. MS and Infection was ruled out. DX: bilateral optic papillitis.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Papilloedema
Clinical narrative: Pt is a 25 yo male who denied any previous problems with immunizations. On 04 Oct 2013 he was vaccinated with inactivated influenza vaccine. He denied any immediate problems. Ten days after vaccination he reported the onset of intermittent headaches and sought medical evaluation on 21 Oct. Headaches persisted and he began to note increasing vision loss. Ophthalmology exam on 24 Oct noted bilateral disc edema concerning for optic neuritis. He was admitted and received IV steroids and was discharged on a tapering dose of oral steroids. MS and Infection was ruled out. DX: bilateral optic papillitis.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Temperature up to 102, swollen left upper arm, next day pain at axilla with enlarged lymph node, body aches.  Was seen by PCP on 8/13/14 and prescribed Levoquin 500mg QDx7.  Symptoms relieved slowly.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Oral mucosal blistering, Rash
Clinical narrative: Client c/o bumps on cheeks of face on both sides of nose and a blister in the mouth.
Age: 1.51
Sex: M
Vaccine: DTAPH
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 231 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 07 August 2014. These 231 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 07 August 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3588AA received on 11 June2010, dose two lot number C3615AA received on 10 August 2010 and dose three lot number C3713AA received on 14 October 2010 and one dose of TRIHIBIT, lot number U3497CA (ACTHIB reconstituted with TRIPEDIA) on 11 October 2011 (routes and sites of administration for all doses not reported). The subject developed a cough on 20 July 2014, approximately 33 months after the last dose. On 22 July 2014, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR on 23 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2014 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pain in extremity, Visual impairment, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. Medical history and drug reactions or allergies were not specified. On 13-MAY-2014, the patient was vaccinated with a first dose of GARDASIL intramuscular injection, in the left arm, dose and frequency reported as "as directed per the prescribing information", (lot number was not reported). Concomitant medications were not specified. On 13-MAY-2014, also reported as after receiving the initial dose of GARDASIL, the patient experienced light-headedness, severe pain in the injection (left) arm, working, severe headache and visual disturbances. The patient sought medical attention via office visit on 13-MAY-2014. The patient was treated with MOTRIN (unspecified dose and frequency). The outcome of visual disturbances, vomiting, severe headache, light-headedness and severe pain in the injection (left) arm 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 nurse refers to an unspecified number of patients. On an unknown dare unspecified number of improperly stored doses of GARDASIL have been administered to patients. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown demographics. No concurrent conditions or medical history was provided. On 05-AUG-2014 (reported as "today").the patient was vaccinated with an expired dose of PNEUMOVAX23 injection (lot # H013847; expiry date: 15-MAR-2014: dose, route of administration and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as it was no consent to contact with reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions or allergies. On 06-AUG-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (0.65 ml, lot # K000995, expiration date 16-MAR-2015). Approximately in August 2014 (the pharmacist was not certain when the symptoms began), the patient was experiencing swelling, bruising, a hard lump, and a red rash at her injection site, she was also experiencing headache after receiving ZOSTAVAX. The reporter did not know, if the symptoms were improving at the time of the report. The reporter did not know, if the patient had notified her primary healthcare provider, and the pharmacist reported that the patient's daughter was a physician. The relatedness between the events and ZOSTAVAX was not reported. The PQC (product quality complaint) was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions or allergies. On 06-AUG-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (0.65 ml, lot # K000995, expiration date 16-MAR-2015). Approximately in August 2014 (the pharmacist was not certain when the symptoms began), the patient was experiencing swelling, bruising, a hard lump, and a red rash at her injection site, she was also experiencing headache after receiving ZOSTAVAX. The reporter did not know, if the symptoms were improving at the time of the report. The reporter did not know, if the patient had notified her primary healthcare provider, and the pharmacist reported that the patient's daughter was a physician. The relatedness between the events and ZOSTAVAX was not reported. The PQC (product quality complaint) was not involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient with diabetes and mushroom allergy On 24-JUL-2014 the patient was vaccinated with 0.65 ml of ZOSTAVAX (lot # J014812, expiration date: 20-FEB-2015) subcutaneously in the right arm. On 25-JUL-2014, the patient developed redness and swelling of his right arm at the injection site after receiving ZOSTAVAX. That area also itchy, "hot" and tender to touch. The affected area was about 3 inches in diameter. No treatment ws given for adverse event. None of lab diagnostics studies was performed. On 28-JUL-2014 the patient come back to the pharmacy for seeking medical attention. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Induration, Local swelling, Pain
Clinical narrative: Per 7/27/2014 ED note: the day after TDap vaccine, patient's right arm "felt hard" and the next day swelled to size of a softball. In ED noted erythema, pain, swelling, warm to touch - diagnosed as cellulitis and prescribed KEFLEX. Returned to ED 7/28 due to growth in margin beyond what was outlined in ink the day before. Prescriber then added BACTRIM to KEFLEX regimen to cover MRSA.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Per 7/27/2014 ED note: the day after TDap vaccine, patient's right arm "felt hard" and the next day swelled to size of a softball. In ED noted erythema, pain, swelling, warm to touch - diagnosed as cellulitis and prescribed KEFLEX. Returned to ED 7/28 due to growth in margin beyond what was outlined in ink the day before. Prescriber then added BACTRIM to KEFLEX regimen to cover MRSA.
Age: 18.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient's mom called and stated she woke up with rash on neck, some on legs and up into her scalp. States it does itch. She went to pediatrician (appt was already in place to check her for mono). Rash was diagnosed as definitely urticaria per RN at pediatric office. No treatment was given for rash. Recommended Benadryl, but pt did not want to "get sleepy".
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's medical history and current conditions were not specified. The nurse reported that the patient received 8 doses of M-M-R II on unspecified dates. No concomitant medications were reported. It was reported that, the patient titers still came back negative and reporter stated that some people does not respond to M-M-R II. The outcome of the event was unknown. The relatedness of the event with the therapy M-M-R II was not reported. 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 nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in June 2014, a dose of (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (lot # and expiry date unspecified), that underwent a temperature excursion, was administered to a patient. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. 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 nurse refers to three unspecified patients of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in July 2014, the doses of (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (lot # and expiry date unspecified), that underwent a temperature excursion were administered to those patients. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to 15 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs were provided. On an unknown dates in 2014, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with RECOMBIVAX HB 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: 0.6
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified 6 months old patient of unknown gender. The nurse reported that the unspecified patient received the 1st dose of LIQUID PEDVAXHIB (dose, route not reported) at "2 months old", the 2nd dose of LIQUID PEDVAXHIB at "4 months old" and the 3rd or "booster dose" at "6 months old" instead of the recommended age of 12 to 15 months old (for the booster dose). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to 10 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (doses, administrations sites and routes, lot# and expiration dates were not reported). This is one of several reports from then same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient in her 50's. On an unknown date in approximately 2011 (reported as "two or three   years ago") the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 shot, lot#, expiration date and route were unknown). On an unknown date the patient had three spots on her back, these spots were described has itchy, red and pimple like. Acyclovir was given for the events. The patient sought for medical attention. On an unknown date, the patient was reported as recovered/resolved.  The casual relation between the therapy and the events was unknown. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17 year old patient of unknown gender. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (Dose Frequency: unspecified, Therapy Route: unspecified). Concomitant medications were not reported. On an unknown date the patient received second dose of (Oka/Merck) VARIVAX less than 4 weeks later and no adverse effect reported. No product quality complaint (PQC) was reported for VARIVAX. Additional information has been requested.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 83 year old patient of unknown gender. On 07-AUG-2014 the patient was vaccinated with 0.65 ml expired ZOSTAVAX, lot # J003805, expiry date: 03-JUL-2014, subcutaneously. No adverse effects reported. The outcome of events was unknown. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse refers to a 45 year old male patient. The patient's current conditions included Type 2 diabetes, hyperlipidemia, hypertension and major depressive disorder. The patient had no drug reactions/allergies.  On 07-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX23, injection (lot # K004930, expired date: 06-MAR-2015) 0.5ml, intramuscularly in his right deltoid for immunocompromised patient. Concomitant therapies included alprazolam, CRESTOR, INVOKANA, LANTUS, losartan potassium (manufacturer unknown), LUNESTA, metformin, metoprolol, niacin, omeprazole, trazodone hydrochloride, VIIBRYD and "LAVASA". On 08-AUG-2014, the patient experienced redness around the injection site that had spread to two thirds of his upper arm. The patient came to office on 11-AUG-2014 to seek medical attention. The patient was diagnosed with cellulitis on 11-AUG-2014. The outcome of adverse event was reported as not recovered/not resolved. The relationship between adverse event and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot # not reported) which was improperly stored. The outcome of clients vaccinated with improperly stored (Oka/Merck) VARIVAX was unknown. Additional information is not expected because there is no possibility to contact physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant via a company representative, refers to an unspecified number of patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates the patients was vaccinated with ROTATEQ 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: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular
Clinical narrative: MACULAR RASH ON BOTH ARMS, NECK; DENIES RESPIRATORY SYMPTOMS.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Eight (8) inflamed, itchy, painful blisters at / near vaccine injection site with single lesions /blisters breaking out between 8/14/2014 & 8/18/2014 on back, buttocks, lower leg, breast, & labia majora. As of 8/18/2014, these lesions have not resolved, but they are less itchy with each passing day. No treatment was used.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Eight (8) inflamed, itchy, painful blisters at / near vaccine injection site with single lesions /blisters breaking out between 8/14/2014 & 8/18/2014 on back, buttocks, lower leg, breast, & labia majora. As of 8/18/2014, these lesions have not resolved, but they are less itchy with each passing day. No treatment was used.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Feeling tired redness and swelling at site some pain at site, chills headache feeling need to lie down...
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Feeling tired redness and swelling at site some pain at site, chills headache feeling need to lie down...
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Erythema, Lethargy, Nodule
Clinical narrative: Feeling tired redness and swelling at site some pain at site, chills headache feeling need to lie down...
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills, redness, knot, lethargy.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Chills, redness, knot, lethargy.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Erythema, Lethargy, Nodule
Clinical narrative: Chills, redness, knot, lethargy.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Varicella given on 7/30/14, the next day had an area of erythema 1 1/2 X 1 1/2 inches and fever of 99.4.  Area of redness enlarged to 3 inches overnight on 8/1/2014.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Mydriasis, Paraesthesia
Clinical narrative: Phone call from mother the afternoon after receiving shots to say that her daughter had a reaction follow vaccines that morning.  States she walked to the car and complained of feeling tingly, her eyes dilated and her arm jerked for about 30 seconds.  States her daughter "came to" and is doing fine since then.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a approximately 71 year old female patient. The patient was allergic to penicillin and codeine. The patients current condition included Lyme disease and high blood pressure. Approximately in 2012 (reported as about 2 years ago) the patient was vaccinated with PNEUMOVAX23 after being diagnosed with Lyme disease. Concomitant therapies included DIOVAN HCT (reported as DIOVAN HCTZ). The patient's whole upper arm swelled up, was red and inflamed after receiving the PNEUMOVAX23 (reported as unspecified pneumonia vaccine). The patient sought medical attention and was treated with ibuprofen. The outcome of whole upper arm swelled up was red and inflamed was reported as recovered after a week. The causality of the events was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was inadvertently vaccinated with a dose of M-M-R II (0.5 ml, subcutaneously) (lot # H012140, expired date 29-JUN-2014). No adverse effects reported. It was unknown if the patient had sought any  medical attention. Additional information is not expected because the pharmacist can not to be contacted.