chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Scan with contrast
Clinical narrative: This spontaneous report was received from a consumer concerning his approximately 84 year old father in-law with no drug reactions/allergies. The medical history of the patient included 2 replacements of valves in his heart and a pacemaker. On 18-JUN-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were 672608/1715AA and 02-FEB-2013 respectively) (dose and route unspecified). Concomitant medication included COUMADIN. On 15-DEC-2012, the patient experienced transverse myelitis. Approximately on 26-DEC-2012 (for the last 2 weeks), he experienced extreme pain and is now paralyzed from the waist down. He was admitted to the Medical Center since 01-JAN-2013. He was treated with an unspecified medication to boost his blood pressure. On an unknown date, computerized tomography scans with dye and unspecified blood test were performed. The outcomes of all the events were reported as not resolved. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt received MENACTRA injection subcutaneously, developed some redness of the skin and warmth in area of injection later in the evening after receiving shot earlier in AM. Vaccine should have been given IM. Pt seen 1/14/13 and symptoms were resolving.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Heat, erythema circumferential (L) upper arm, including injection site.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Lethargy, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat by 4 am. Lethargic, slight fever (99 to 100), runny nose, and cough by 11am. Fever of 102 degrees by noon the next day on Sunday 01/13/13. Gave him water, ginger tea, orange juice, and about 2 or 3 doses total of kids liquid ibuprofen over the 2 day period. Fever was gone by Monday morning 1/14/13 with still slight cough and runny nose present.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Temp 101 degrees F for 2 days, localized redness and swelling at injection site, headache for 3 days. Treatment: alternated acetaminophen and ibuprofen.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Retching, Vomiting
Clinical narrative: Vomiting, nausea, dry heaving, general sense of not feeling well, heaviness in body.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Eyelid oedema, Hypersensitivity, Oedema peripheral
Clinical narrative: Very sleepy, then fever and chills, then pus-filled eyes, swollen eyelids and swollen under-eye area, swollen around left side of mouth. Swollen fingers both hands. Difficulty breathing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence
Clinical narrative: Very sleepy, then fever and chills, then pus-filled eyes, swollen eyelids and swollen under-eye area, swollen around left side of mouth. Swollen fingers both hands. Difficulty breathing.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Dyskinesia, Face injury, Fall
Clinical narrative: Blurry vision, fall from exam table hitting the floor on his face, jerking of legs for <10 sec., ~ 10 sec. Loss of consciousness per mother, faintness and weakness despite being laid down first on the floor, then carefully helped on to the exam table, nauseated, given water, HR- 80/min., pallor, was alert and oriented, complained of headache in the back of his head, PERL. Observed closely, since continued weak and slightly pale, begun Oxygen via mask and called Paramedics. Observed to be alert and with normal BP and hence helped to the car; Non-contrast head CT done around 3:30 PM, which was Negative. Sent home with parents and followed closely via telephone.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Headache, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: Blurry vision, fall from exam table hitting the floor on his face, jerking of legs for <10 sec., ~ 10 sec. Loss of consciousness per mother, faintness and weakness despite being laid down first on the floor, then carefully helped on to the exam table, nauseated, given water, HR- 80/min., pallor, was alert and oriented, complained of headache in the back of his head, PERL. Observed closely, since continued weak and slightly pale, begun Oxygen via mask and called Paramedics. Observed to be alert and with normal BP and hence helped to the car; Non-contrast head CT done around 3:30 PM, which was Negative. Sent home with parents and followed closely via telephone.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Vision blurred
Clinical narrative: Blurry vision, fall from exam table hitting the floor on his face, jerking of legs for <10 sec., ~ 10 sec. Loss of consciousness per mother, faintness and weakness despite being laid down first on the floor, then carefully helped on to the exam table, nauseated, given water, HR- 80/min., pallor, was alert and oriented, complained of headache in the back of his head, PERL. Observed closely, since continued weak and slightly pale, begun Oxygen via mask and called Paramedics. Observed to be alert and with normal BP and hence helped to the car; Non-contrast head CT done around 3:30 PM, which was Negative. Sent home with parents and followed closely via telephone.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hearing impaired, Heart rate increased, Mydriasis, Unresponsive to stimuli
Clinical narrative: Patient developed dialated pupils and rapid heart rate.  She became somewhat unresponsive, but remained upright. After becoming responsive the patient stated they were dizzy and have vision and hearing issues during the event.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Patient developed dialated pupils and rapid heart rate.  She became somewhat unresponsive, but remained upright. After becoming responsive the patient stated they were dizzy and have vision and hearing issues during the event.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Pyrexia
Clinical narrative: 103 F fever, sweats, large (15cm diam) localized erythematous skin reaction at point of injection.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Patient experienced trouble swallowing. Was given 2 tablets of diphenhydramine 25 mg and improved after approximately 15 minutes.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to some patient of unknown age. The reporter reported that sometimes, he does not get enough diluent volume to produce total volume of 0.65 ml for live ZOSTAVAX when reconstituted and some patients might have less than 0.65 ml live ZOSTAVAX. Specific number of patients unspecified. No adverse effects reported. PQC was filed. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referred to a 3 months old female patient. The medical assistant who administers the vaccine reported the patient was inadvertently "administered her only dose of M-M-R II on 28-JUN-2012 subcutaneously when she was three months old". No adverse effect reported. The outcome of AE was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: 1/11 "Blotchy, red" after shower 1/5/13 she states, was told by husband, 1/11 stated she had hives at hair line and were now receding, & itching decreased by 75%. Per phone call supervisor said chin & neck were "splotchy & red" on 1/7. 1/9 Hive on forehead & hand, very itchy.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 01-JUL-2010, the patient was vaccinated intramuscularly with the first dose of 0.5 ml GARDASIL 9lot # not reported). On 06-AUG-2012 the patient was vaccinated with the second dose of GARDASIL (lot # not reported). No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported "radiating pain" from the injection site to the fingers. Also reported a minor "tingling" sensation near fingers from approximately 600pm on 1/8/13 until the morning of 1/10/13. Also reported some redness and swelling at site which resolved by 1/10/13.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) on 16-JUN-2011 and second dose on 02-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker reported that PEDVAXHIB were exposed to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. AE term was amended. PT was changed to incorrect storage of drug.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient returned to pharmacy with report of lip numbness and concerned that it may be an allergic reaction. Patient reported back approximately 45 minutes after shot administered. Patient took 2 BENADRYL in pharmacy and waited to be observed. After 20 min patient was feeling fine called a ride to take her home.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia
Clinical narrative: This spontaneous report was received from a 70 year old female patient regarding herself with no drug reactions or allergies. The patient has no pertinent medical history. On 27-NOV-2012, the patient was vaccinated with a dose 1 injection live ZOSTAVAX(lot number, expiry date, route and dose were not reported). Concomitant medications included COUMADIN, unspecified drug CARTIZAM ,unspecified thyroid medication, metoprolol and ZOLEFT. The patient had shingles break out twice on her right arm after receiving ZOSTAVAX. Approximately on 04-DEC-2012 (reported as a week after injection), the patient experienced the first case of shingles. No treatment was given. It lasted about four weeks and then began to go away. Approximately on 01-JAN-2013, the first case of shingles had resolved. Approximately on an unknown date in January 2013, the patient had another break out of shingles. Since an unknown date, the patient had trouble sleeping. The patient sought medical attention (saw her physician) and no treatment was given. No laboratory test was performed. At the time of this report, the patient had not recovered from shingles. Outcome of the event trouble sleeping was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Urticaria
Clinical narrative: HIVES WITH SEVERE HEADACHE.
Age: 1.61
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Acoustic stimulation tests, Electroencephalogram, Sleep study, Tremor
Clinical narrative: Patient began to experience shakes lasting from 1-5 seconds.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Delirium, Headache, Hyperhidrosis
Clinical narrative: Violent shivering (chills), mid-grade fever, severe headache, mild delirium, chest pain, sweating, malaise, sweating.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Violent shivering (chills), mid-grade fever, severe headache, mild delirium, chest pain, sweating, malaise, sweating.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient's spouse reported that patient is having significant pain in her arm/shoulder.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt received yellow fever vaccine 15 Nov 2012 about 0804 am. Pt received VIS form, informed of adverse reactions, verified not possible pregnancy with disclaimer form. Pt waited read 30 min with no reaction. Pt states later she noticed red area at injection site the size of a small baseball and site was itching. Pt reported no other sx. Dr notified he said no intervention needed but to inform pt to watch for signs of anaphylaxis or other concerns and calling if needed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Lethargy
Clinical narrative: Lethargy for 2 days,
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Nerve conduction studies
Clinical narrative: Developed Guillain Barre Syndrome within few wks after flu vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Developed Guillain Barre Syndrome within few wks after flu vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a male patient of unknown age. On 11-DEC-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number reported as (671452/1124AA, expiry date: 12-OCT-2012, dose and route not reported). No concomitant medications were reported. No symptoms were reported. The patient had no complications and was not revaccinated. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling of body temperature change, Nausea, Pyrexia, Tremor
Clinical narrative: Reaction 3 hrs after injection vomiting, nausea, jaw locked fever spiked to 102 degrees shaking, shivering hot/cold. Shot rec 2:45 reaction 6:30-6:50.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Trismus, Vomiting
Clinical narrative: Reaction 3 hrs after injection vomiting, nausea, jaw locked fever spiked to 102 degrees shaking, shivering hot/cold. Shot rec 2:45 reaction 6:30-6:50.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician assistant, concerning an 18 year old female patient. The patient had no pertinent medical history and no known drug allergies or reactions. On 16-OCT-2008, 17-DEC-2008 and 12-APR-2009, the patient was vaccinated with the first, second and third dose of GARDASIL respectively, (doses, routes and frequencies were not reported) (Lot # and expiration dates were not reported). On 10-JAN-2013, the patient tested positive for Human papilloma virus (HPV) 16. The patient was referred to the OBGYN to seek medical attention. No treatment was given for the event. At the time of the report, the patient's outcome was unknown. The relatedness for tested positive for HPV16 was unknown for GARDASIL. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Erythema, Oedema peripheral
Clinical narrative: 2 month old that had vaccines on 1/14/13 (morning). Returned for recheck that afternoon. Was having high pitched crying for about 30 min then would go to sleep happened in cycle about 5-6 x. No fever. Legs were swollen and very red.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 13 years old male patient. On 08-JAN-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 0311Y; expiration date: 13-JUN-2010) (dose, route, indication and duration not reported). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed urticaria over face & anterior & posterior trunk. Diphenhydramine 18.75 mg given PO x1 immediately after hives developed. Hives resolved after 30 minutes.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash erythematous
Clinical narrative: This spontaneous report was received from a 60 years old female patient with high blood pressure, high cholesterol and sulfur hypersensitivity concerning her. The patient was vaccinated with ZOSTAVAX (dose, route, and lot not reported) on 09-JAN-2013. No other co-suspects were reported. Concomitant medications included enalapril maleate (manufacturer unknown), omeprazole, simvastatin (manufacturer unknown) and acyclovir. On 10-JAN-2013, the patient had a red silver dollar sized circle with bumps that hurts. No treatment information was reported. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: After receiving Flu shot within 20 minutes pain shot down my arm into my fingers woke up next morning w/ excruciating pain at injection site (deltoid not muscle).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a "60-61 years" old female patient with rheumatoid arthritis. "2-3 days ago", in approximately 07-JAN-2013, the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # not reported). The patient developed "mild erythema with itching" after getting ZOSTAVAX. It was unspecified if it was at the injection site. The patient sought for unspecified medical attention. CLARITIN was given for itching. The outcome of mild erythema with itching was unknown. The relatedness for mild erythema with itching was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare worker reported that M-M-R II were exposed to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. AE term was amended. PT was changed to Incorrect storage of drug.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated intramuscularly with 0.5 ml of first dose of GARDASIL (lot# and expiration unspecified) on 03-OCT-2012, second dose (lot# and expiration unspecified) on 05-DEC-2012 and the third dose (lot# reported as h01465, exp 27-MAR-2015) on 07-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 months old infant. On 11-JAN-2013, the patient was at the office to received the first dose of ROTATEQ single dose (Lot # and expiration date were not reported). There was no adverse effect. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Pt. became lightheaded, diaphoretic and sick feeling in stomach 5 min after flu vaccine. BP 82/58 HR = 60. Administered water, banana and head down between legs. Resolved after 5-10 mins with BP increased 94/60 HR = 68.
Age: 1.03
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of RECOMBIVAX HB (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. Follow up information as received from the medical assistant refers to a 12 months old patient. The patient was vaccinated IM with improperly stored VAQTA (lot # 672470/1697AA, Exp. Date: 22-SEP-2014) at right thigh on 17-SEP-2012. Concomitant medications administered on the same day included M-M-R II (lot # reported as 0233AE, Exp. Date: 24-JAN-2014, intramuscularly at left thigh), VARIVAX (Merck) (lot # reported as H007702, Exp. Date: 30-MAR-2014, subcutaneously at left thigh). This is one of several reports received from the same source. Additional information has been requested. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dyskinesia, Electrocardiogram normal, Injection site pain, Loss of consciousness
Clinical narrative: Had a seizure this morning, took her to the ER. Mother wants to know if the flu shot had anything to do with it. Had flu shot yesterday. 1-15-13 P.C - see above. Approx 20 hours after being given to flu shot developed LOC. Had been fine, but right before having LOC she complained of pain in the arm where the flu shot was given (no localized rxn noted). She fell to the ground and had LOC x 2 min. During this time she was staring and had some "rocking" movements. When she regained consciousness, she seemed normal. Ambulance squad came -> VS (no fever) and BS were normal. Seen in ER. EKG WNL. Pt scheduled for an EEG next wk. No treatment was given. Imp - LOC -> ? seizure vs vagal rxn. Rec - observation; get EEG. Would consider avoiding flu shot in the future. VAERS form submitted.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Had a seizure this morning, took her to the ER. Mother wants to know if the flu shot had anything to do with it. Had flu shot yesterday. 1-15-13 P.C - see above. Approx 20 hours after being given to flu shot developed LOC. Had been fine, but right before having LOC she complained of pain in the arm where the flu shot was given (no localized rxn noted). She fell to the ground and had LOC x 2 min. During this time she was staring and had some "rocking" movements. When she regained consciousness, she seemed normal. Ambulance squad came -> VS (no fever) and BS were normal. Seen in ER. EKG WNL. Pt scheduled for an EEG next wk. No treatment was given. Imp - LOC -> ? seizure vs vagal rxn. Rec - observation; get EEG. Would consider avoiding flu shot in the future. VAERS form submitted.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt states that 2 days after the tetanus shot that her arm swelled and was warm at the site. Five days later - it is still swollen and a little hardened. Ice packs applied periodically. She said this happened on her last tetanus shot - over 10 years ago.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Patient received a flu shot on 1/10/13. Came back and showed a lesion where shot was administered. Patient is taking COUMADIN.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age who was vaccinated with, 0.6 ml dose of PNEUMOVAX23 on 11-JAN-2013 (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, pain at the site of injection. Pain and itching subside within 72 hrs.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 43 year old female patient with hypothyroidism, polycystic ovary syndrome and no allergies or drug reactions. The patient may have had previous vaccinations with M-M-R II, however this is unknown. On 19-NOV-2012, the patient had M-M-R II titers drawn and the mumps titer was low. Subsequently, the patient was vaccinated with lot # (669943/0187AA), M-M-R II) on 20-NOV-2012 (subcutaneous administration). No other co-suspects were reported. Concomitant medications included: SYNTHROID. The M-M-R II titers were then repeated on 27-DEC-2012. The mumps titers were better on 27-DEC-2012, however, now the measles titers were low after being normal in the titers drawn on 19-NOV-2012. No treatment information was reported. It was reported that the patient situation was unchanged. She sought medical attention because of the event. The relatedness for M-M-R II. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site anaesthesia, Pain, Skin warm
Clinical narrative: Pain when moving the arm. Area really warm. When closing fist I feel pain, numbness in the upper part of left arm.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Hypoaesthesia, Hypokinesia, Migraine without aura, Panic attack
Clinical narrative: Numbness in lower half of body; inability to move legs. Panic attack; rapid heart beat. Debilitating migraines without aura occurring every day since vaccine administered.
Age: 1.44
Sex: M
Vaccine: FLUX, HEP, MMRV
Symptoms: Crying, Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever 103.5, Rash (small red) over entire body (torso, limbs, face, butt, very concentrated on neck), lethagy, poor appetite, very fussy, crying.
Age: 1.44
Sex: M
Vaccine: FLUX, HEP, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Fever 103.5, Rash (small red) over entire body (torso, limbs, face, butt, very concentrated on neck), lethagy, poor appetite, very fussy, crying.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Immediately following injection, on the way home in the car, the injection site began to itch.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported injection site swelling and pain as well as the site feeling warm to the touch. She says it has gotten worse as the day went on and she tried a warm compress. She is going to Dr.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic shock, Dyspnoea
Clinical narrative: Within an hour of getting the high dose flu vaccine vaccine my mother began to experience shortness of breath which continued to worsen until she went to ED about an hour later.  She was treated for anaphylactic shock, with IM epinephrine, IV steroids, Benadryl, and an H2 receptor antagonist.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity, Pruritus, Skin warm
Clinical narrative: First day, R arm hurt, then started to get hot - red, itchy, and hard in the area. No meds taken. Took about a week to go away completely.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Nausea, Tremor
Clinical narrative: Faintness, nausea & flushing about 30 minutes after vaccine administration. Refused diphenhydramine & stated feeling better (still shaky but not faint) an hour after administration.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt received intradermal flu shot at approx. 12:43pm soon after she felt lightheaded and almost fainted. Mom was with patient. We got her to sit down, gave her some water she started to feel better. Staff called ambulance as a precaution. Mom stayed w/daughter for about 10 min & stated her daughter was fine & refused ambulance she will follow-up w/MD if any other reactions are to occur.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Redness and swelling of the upper (L) arm at the injection site. The swelling was extended to the tissues on the chest/thorax muscles/frontal aspect.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza like illness, Pain, Pain in extremity, Periarthritis
Clinical narrative: Had flu-like symptoms for 18 hours after shot. Arm pain subsided after 2 days. Then approximately 8 days after shot, frozen shoulder symptoms started. Pain on raising arm. Some hand numbness.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Pt with a history of tongue swelling, numbness after immunization with Zoster vaccine 6 months prior. Pt requested flu vaccine, and AFLURIA was selected for him because he had received AFLURIA in the past and tolerated. Six to seven minutes post AFLURIA vaccine, pt again reported tongue swelling and numbness; no dyspnea. He was evaluated in the ED, given SOLUMEDROL, ranitidine and BENADRYL, after which symptoms resolved. Methylprednisolone 125 mg once, ranitidine 50 mg once, diphenhydramine 50 mg once.
Age: 57.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: Dev a very sore spot on arm that was still present 1/9/13, both wrists became extremely painful lasting 3-4 wks, (R) arm lost strength for several weeks, pain in wrists with grip or pressure.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Condition aggravated, Cough, Crying, Fatigue, Irritability
Clinical narrative: Fever greater than 103, dilated pupils, eyes glossy, extremely tired, fussy, rapid breathing, crying while sleeping throughout the night, coughing from previous illness was increased/worsened. These symptoms lasted until the morning of 01/13/11; however, the coughing persists. Treatment given was alternating Tylenol and Ibuprofen for the fever.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Mydriasis, Pyrexia, Respiratory rate increased, Staring
Clinical narrative: Fever greater than 103, dilated pupils, eyes glossy, extremely tired, fussy, rapid breathing, crying while sleeping throughout the night, coughing from previous illness was increased/worsened. These symptoms lasted until the morning of 01/13/11; however, the coughing persists. Treatment given was alternating Tylenol and Ibuprofen for the fever.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella vaccination - 1/2/2013. Onset rash - 1/9/2013. ER for clinical diagnosis 1/12/2013 - vesicular rash.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Injection site induration, Injection site rash, Vomiting
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age, reporting on himself, with rash, a line bumps from the top of his neck to the midpoint in his back and no drug reactions or allergies, who 3 1/2 weeks ago in approximately December 2012, was vaccinated underneath in his left arm with a dose of live ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that one week later after vaccination, in approximately December 2012, he developed a rash under his arm at the site of injection. Soon after the area around the injection site became hard, he experienced chills, shortness of breath and vomited. This lasted 24 to 48 hours. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the consumer reported that he felt better, but the injection site was still hardened. The consumer had scheduled a visit with his physician next week. The relatedness for rash under his arm at the injection site, patient experienced vomited, shortness of breath, chills and the area around the injection site became hard was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Today AM red dot on chest - increased # dots - 330p, slight fever last NOC.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling of body temperature change, Nausea
Clinical narrative: Inj. given at 11:30 AM, call received at 12:58. Patient states "I am having a reaction to the flu shot. I have been dizzy, nauseous, and having hot/cold flashes. Denies SOB, rash, or fever. Instructed to call 911 if symptoms worsen or with any change in breathing. (2:37) Patient denies nausea or dizziness. Still complains of hot/cold flashes continuing to follow.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, tenderness and itching noted on left upper arm on saturday.  Patient took ibuprofen and used cool compresses and applied hydrocortisone to area.  Was seen in Employee Health Office on Monday, 1/14/13.  1/15/13, writer had medical director examine arm again.  He noted that the swelling had subsided and the redness is decreasing.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large patch of redness surrounding injection site (4" x 3"); sub cu raised swelling at injection site 3" x 3"; pain and itching at injection site. Symptoms lasting through 01/15/2013.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Injected limb mobility decreased, Middle insomnia, Musculoskeletal pain
Clinical narrative: Severe pain in the left shoulder (where vaccine was administered).  Joint immobility left shoulder.  Awakened in middle of night from sleep by the pain. No fever, no redness at injection site.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal distension, Confusional state, Diarrhoea, Disorientation, Faeces discoloured
Clinical narrative: Black watery diarrhea, vomiting, bloating, cramping, muscle aches, fever, confusion, black outs, fainting, excessive sleeping, disorientation/confusion, and babbling.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersomnia, Loss of consciousness, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Black watery diarrhea, vomiting, bloating, cramping, muscle aches, fever, confusion, black outs, fainting, excessive sleeping, disorientation/confusion, and babbling.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Speech disorder, Syncope, Vomiting
Clinical narrative: Black watery diarrhea, vomiting, bloating, cramping, muscle aches, fever, confusion, black outs, fainting, excessive sleeping, disorientation/confusion, and babbling.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Cough, Dysphonia, Eyelid oedema, Eyelids pruritus
Clinical narrative: Fatigue, sore throat, coughing, hoarseness, itchy eyelids, extreme headache, congestion, inside of mouth felt like hives were breaking out, big puffy eyelids. Called pharmacy where shot was given to inquire about taking some Benadryl. They advised Tylenol and okay to take Benadryl. Symptoms were bad enough to consider going to Urgent Care, something I would need to be pretty sick to do. I was starting to get worried about being able to breathe. Severe symptoms lasted about 7 hours. Giant eyelids about 24 hrs.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Oropharyngeal pain, Respiratory tract congestion, Urticaria
Clinical narrative: Fatigue, sore throat, coughing, hoarseness, itchy eyelids, extreme headache, congestion, inside of mouth felt like hives were breaking out, big puffy eyelids. Called pharmacy where shot was given to inquire about taking some Benadryl. They advised Tylenol and okay to take Benadryl. Symptoms were bad enough to consider going to Urgent Care, something I would need to be pretty sick to do. I was starting to get worried about being able to breathe. Severe symptoms lasted about 7 hours. Giant eyelids about 24 hrs.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Got dizzy. Had to sit down on floor. I 'awoke' and was still sitting on the floor, but was making a kind of funny noise.  I sat their for a few seconds kinda dazed as I couldn't remember what I was doing on the floor. Then I remember and got up.  I was still a bit dizzy.  I am fine now. I hope it doesn't happen again.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test positive, Wrong drug administered
Clinical narrative: Patient given Zostavax (Shingles) vaccine instead of needed Varicella (Chickenpox) vaccine.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Convulsion, Pyrexia
Clinical narrative: Patient states shivering and "convulsions" along with high fever.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Rash
Clinical narrative: Periobital rash/redness.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Blood glucose decreased, Convulsion, Hypoglycaemia, Staring, Tremor
Clinical narrative: Hypoglycemia and seizure activity. For approximately 1 minute, patient stared off, non-responsive, both arms shaking.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Hypoglycemia and seizure activity. For approximately 1 minute, patient stared off, non-responsive, both arms shaking.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Difficulty breathing, shortness of breath. Fever, numbness and tingling in both left hand and left foot. Injection sight was left arm. Dizziness. Headache, change in vision. weakness, fast heart beat, numbness on left side of face, thought I was having a stroke.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Difficulty breathing, shortness of breath. Fever, numbness and tingling in both left hand and left foot. Injection sight was left arm. Dizziness. Headache, change in vision. weakness, fast heart beat, numbness on left side of face, thought I was having a stroke.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Difficulty breathing, shortness of breath. Fever, numbness and tingling in both left hand and left foot. Injection sight was left arm. Dizziness. Headache, change in vision. weakness, fast heart beat, numbness on left side of face, thought I was having a stroke.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pain, Pulmonary congestion, Pyrexia
Clinical narrative: Nasal and chest congestion cough and aches and pains starting about 2 days post vaccination, peaking at 4 days post vaccination with a fever of 101.5 degrees.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Loss of consciousness, Oropharyngeal pain, Pain, Vomiting
Clinical narrative: Sudden sore throat and some body aches.  I took 2 Advil, went to bed.  I woke at 2 a.m. to get some water.  Then I passed out on the floor and when I came to, I had vomiting.  This occurred 3 times throughout the night/early morning of January 15, 2013.  I also had a terrible headache, which I still have.  This was my first flu shot in 11 years.  I don't know if the sickness was because of the shot or coincidental. I felt excellent prior to the flu shot.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Injection site reaction, Myalgia
Clinical narrative: Extreme fatigue, chills, headache--duration=intermittent for 2 days.  Fever on 3rd day.  Muscle soreness at injection site x 7+ days.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, chills, headache--duration=intermittent for 2 days.  Fever on 3rd day.  Muscle soreness at injection site x 7+ days.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Became lethargic, no appetite, fever of 103.6. Fever continued for 30 hours. Highest recorded: 104.5.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Confusional state, Diarrhoea, Dizziness
Clinical narrative: 12:00 felt nauseous, weak 1:00 explosive diarrhea, 4:00 felt bad enough to leave work-home: dizzy, walk bent over, weak, confused, blurry vision-light and shadows bounce back and forth, saw movement in doorway when there was none, chills 5:00 nauseous, weak, blurred vision, runny nose, chills, sour taste in mouth, uncomfortable talking, slight sore throat.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia, Gait disturbance, Nausea, Oropharyngeal pain, Photophobia
Clinical narrative: 12:00 felt nauseous, weak 1:00 explosive diarrhea, 4:00 felt bad enough to leave work-home: dizzy, walk bent over, weak, confused, blurry vision-light and shadows bounce back and forth, saw movement in doorway when there was none, chills 5:00 nauseous, weak, blurred vision, runny nose, chills, sour taste in mouth, uncomfortable talking, slight sore throat.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Speech disorder, Vision blurred
Clinical narrative: 12:00 felt nauseous, weak 1:00 explosive diarrhea, 4:00 felt bad enough to leave work-home: dizzy, walk bent over, weak, confused, blurry vision-light and shadows bounce back and forth, saw movement in doorway when there was none, chills 5:00 nauseous, weak, blurred vision, runny nose, chills, sour taste in mouth, uncomfortable talking, slight sore throat.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, swollen at site....large egg like.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Dyskinesia, Eye movement disorder, Infantile spasms, Pyrexia
Clinical narrative: Crying fever and jerking movement with eyes crossing.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red burning hot splotch spreading out around injection site.  Diagnosed cellulitis.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Autonomic neuropathy, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea; fatigue; pale; weak x 2 weeks; then on 10/19/2012 sudden onset tachycardia; chest pain; after alot of testing, dx with autonomic neuropathy that can be triggered by a virus. Continues to have sx of tachycardia, orthostatic hypotension, nausea, wt loss; intermittent chest pain, shortness of breath.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram, Fatigue, Nausea, Orthostatic hypotension, Pallor
Clinical narrative: Diarrhea; fatigue; pale; weak x 2 weeks; then on 10/19/2012 sudden onset tachycardia; chest pain; after alot of testing, dx with autonomic neuropathy that can be triggered by a virus. Continues to have sx of tachycardia, orthostatic hypotension, nausea, wt loss; intermittent chest pain, shortness of breath.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Tachycardia, Tilt table test, Ultrasound scan, Viral infection, Weight decreased
Clinical narrative: Diarrhea; fatigue; pale; weak x 2 weeks; then on 10/19/2012 sudden onset tachycardia; chest pain; after alot of testing, dx with autonomic neuropathy that can be triggered by a virus. Continues to have sx of tachycardia, orthostatic hypotension, nausea, wt loss; intermittent chest pain, shortness of breath.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count decreased
Clinical narrative: Diarrhea; fatigue; pale; weak x 2 weeks; then on 10/19/2012 sudden onset tachycardia; chest pain; after alot of testing, dx with autonomic neuropathy that can be triggered by a virus. Continues to have sx of tachycardia, orthostatic hypotension, nausea, wt loss; intermittent chest pain, shortness of breath.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: An acute episode of vomiting lasting 30 minutes. Vomited 5-6 times in that span.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Burning sensation, Contusion, Pruritus, Rash
Clinical narrative: Itching, burning rash on hands, stomach, and back. As of 01/15/2013, rash has not cleared up. Still experiencing tenderness in armpits, bruising on arms and legs, and joint pain.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Itching, burning rash on hands, stomach, and back. As of 01/15/2013, rash has not cleared up. Still experiencing tenderness in armpits, bruising on arms and legs, and joint pain.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Severe vomiting one hour after injection. Vomited 7 times over the next 12 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Induration, Skin lesion, Skin warm
Clinical narrative: Temperature: 98.6 Palpable lesion found on thigh. Right, red in color, and 2 cm in size. Shape is round, indurated, and warm. Treated with cephalexin 250/5 2 tsp po q12. Cool compresses.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device
Clinical narrative: While administering FLUVIRIN, I felt the tip of needle swipe left index finger as I was inspecting the bevel. I examined my finger. It revealed no blemish and I administered vaccine. I noticed a finger stick after removing gloves.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: In lt arm: Fever, rash, swollen, whole lt side body in pain. Nausea, dizziness, flu like symptoms, fever extreme pain in whole arm. Took about 7 days for red rash to go away & pain to be totally gone.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Swelling
Clinical narrative: In lt arm: Fever, rash, swollen, whole lt side body in pain. Nausea, dizziness, flu like symptoms, fever extreme pain in whole arm. Took about 7 days for red rash to go away & pain to be totally gone.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Scar, Vaccination failure
Clinical narrative: This spontaneous report as received from a male patient (unknown age) refers to himself, with history of chickenpox (1947, when he had around 5 years old"). In December 2007, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On 02-DEC-2012, the patient was diagnosed with shingles. The location effected by blisters and scaring was his left waistline. Treatment consisted of only application of calamine lotion twice daily. To date, the patient still had a rash which seems to be fading. The patient inform the failure of the dose of vaccine he had by his internist MD. The patient studied the causes and prognosis of living with this virus the rest of his life. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.