chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Feeling abnormal, Hyperhidrosis, Nausea, Pallor
Clinical narrative: After patient had received the vaccines: FLUZONE, MENACTRA in (L) deltoid & GARDASIL in (R) deltoid, he put his hand to his forehead & reported feeling funny/nauseous & looked pale; mom & RN assisted him to lie down on exam table & RN asked mom to get MD & RN lifted up patient's legs on her shoulder; No LOC; MD came & saw that pt. was diaphoretic & alert; BP Rt. arm supine was 106/64 with AP 42; after 2 small bags of juice (Capri Suns) he looked pinker & HR was 55. He sat up & within 1 minute stood up & was able to walk out to car after waiting 10 minutes - he continued to look pinker. He left to go out car with mom.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen & giving off heat from injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Tenderness
Clinical narrative: Within 48 hours after receiving DTaP/IPV in (R) deltoid pt developed redness / tenderness & multiple large fluid filled blisters.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pain, Pruritus, Tenderness
Clinical narrative: ADACEL: Given 1 wk ago in her (R) shoulder with persisting pain itch and ache. Exam with mild erythema and tenderness but good ROM of shoulder.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: (L) upper arm pain, numbness (L) hand especially around 4th and 5th fingers. Tx: Naproxen 500mg BID with food. F/U one week or sooner if sx worsen.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Urticaria
Clinical narrative: Hives on trunk - from umbilicus up.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Haemorrhage, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Redness, tenderness, pain, swelling & internal bleeding in upper arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Approximately 10 min. after administration, the patient complained of pain in the muscle at injection site as well as tingling sensation from shoulder to hand with some pain in elbow and wrist.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Breast swelling, Mobility decreased, Oedema peripheral, Skin warm
Clinical narrative: Pt developed swelling on right arm all the way little bit above elbow, all the way back and right breast. Very hot and unable to lift the arm. Pt taking BENADRYL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Red spot now spread to elbow and upper arm, swollen, redness, painful.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Nausea
Clinical narrative: ZOSTAVAX vaccine given around 1:00pm on 10/1/12 pt left and came back approximately 30-45 mins later complaining of injection site itching and she was feeling nauseated. Based on the timing and her complaint, I gave her liquid BENADRYL 50mg & had her sit so I could monitor her. Then we eventually called the ambulance upon patient wanting to go home and not feeling well.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site cellulitis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Cellulitis redness and swelling of right upper arm with warmth to touch around vaccine site. Possibly unrelated however of note patient also developed fever, fatigue and body aches,
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: Cellulitis redness and swelling of right upper arm with warmth to touch around vaccine site. Possibly unrelated however of note patient also developed fever, fatigue and body aches,
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: After 8 hr of vaccination pt. had chills, fever (100 degrees) for about 4-5 hours. When he took Advil he went to bed, Today (next day of vaccination) he is feeling ok.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Low grade fever, headache, body aches. Swollen arm.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: (L) axillary lymphadenopathy. Had Tdap and Flu shots given 9/28/12.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Disturbance in attention, Dizziness, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: 3-4 days following smallpox vaccine developed headache, neck pain, marked fatigue and body aches. These symptoms persisted over the next two weeks along with trouble concentrating and some dizziness.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Laboratory test normal, Lumbar puncture normal, Neck pain, Pain
Clinical narrative: 3-4 days following smallpox vaccine developed headache, neck pain, marked fatigue and body aches. These symptoms persisted over the next two weeks along with trouble concentrating and some dizziness.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, edema (L) upper arm at injection site - very tender. Afebrile.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Myalgia, Throat irritation
Clinical narrative: Shortness of breath, tickling in throat, radiating muscle pain, fatigue 4 hours - 24 hours after shot.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Paraesthesia, Peripheral coldness
Clinical narrative: Within 10 seconds lost consciousness for 10 seconds probable vasovagal reaction. Tongue & hands were cool, felt tingling. BENADRYL given at 10:05, pulse ox raised from 83 to 99% in 15 minutes. It took 1 hour to recover.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Swollen and red arm left arm. Upper arm warm.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site swelling
Clinical narrative: On 9/26/2012 6:45PM pt received the ZOSTAVAX shot. After injecting 0.1ml about 10-15 seconds I noticed pt's skin start swelling at the injection site. I immediately stop injecting. Pt was complaining about not feeling good. We gave her water and let her rest for 15 mins. She felt much better and walked out on her own.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling, Malaise, Underdose
Clinical narrative: On 9/26/2012 6:45PM pt received the ZOSTAVAX shot. After injecting 0.1ml about 10-15 seconds I noticed pt's skin start swelling at the injection site. I immediately stop injecting. Pt was complaining about not feeling good. We gave her water and let her rest for 15 mins. She felt much better and walked out on her own.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Injection site warmth, Paraesthesia, Rash macular, Swollen tongue
Clinical narrative: Red blotches on both arms. Hot injection site. Swollen tongue/numbness. Pins & needles in (L) gums & ear & throat. Signs after about 10 min BENADRYL after 20 minutes.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLUN3, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: .2ml FLUMIST inadvertently administered instead of .25ml FLUZONE IM. Mom with pt & aware. Health System incident report completed. No adverse events noted.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.4
Sex: F
Vaccine: UNK
Symptoms: Vomiting projectile
Clinical narrative: Pt had 2 episodes of forceful large volume emesis the day following administration of 2 month immunization. The episodes were about 12 hrs apart.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that GARDASIL had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392, 1210USA000959, 1210USA000960, 1210USA000961, 1210USA000962. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 years old male patient. Someone received on unknown date his first and second 0.5 ml IM doses of GARDASIL (Lot # not reported) at age 62. Additional information is not expected.
Sex: U
Vaccine: RV5
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. The pharmacist reported that he was notified by an unspecified physician's office that a patient was vaccinated with expired ROTATEQ on 25-SEP-2012 (dose and route not provided, lot # reported as 1477Z, exp. 23-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenia
Clinical narrative: This spontaneous report was received from a female consumer concerning her 1 year son, who on an unknown date in 2012, was vaccinated with a dose of MMR II (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that about month ago, in approximately August 2012, her son had developed thrombocytopenia shortly after turning 1 year old. The consumer could not verify if the patient had received the vaccine or not at 12 months old. The consumer stated that she was reading the product insert and noticed what it said about getting developing thrombocytopenia after getting the vaccination, and she realized that the patient might have received the vaccine shortly after developing thrombocytopenia. The patient was given unspecified IV infusion as treatment for the event. On an unknown date, the patient improved. Additional information is not expected.
Age: 1.6
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 month old patient, who on 25-JUN-2012 was vaccinated in error with a dose of RECOMBIVAX HB (Lot # not reported) IM. The patient had already received 3 doses of PEDIARIX on 25-JAN-2011, 21-MAR-2011 and on 23-MAY-2011. The patient had also received Hep B (manufacturer unknown) on 21-NOV-2010. Additional information received from medical assistant noted that on 25-JUN-2012, the 19 month old female patient had been vaccinated with RECOMBIVAX HB (lot # 669597/0294AA, expiration date 27-SEP-2013) in right thigh in error (4 previous doses: 21-NOV-2010, 25-JAN-2011, 21-MAR-2011, 23-MAY-2011), HAVRIX in left thigh (3 previous doses, dates not reported) and INFANRIX in right thigh (1 previous dose, date not reported). On 07-JUL-2012, the patient had been vaccinated with Hib (OMPC) in left thigh (lot # 668962/1744AA) (2 previous doses: 25-JAN-2011, 21-MAR-2011). No known adverse effects were reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Swelling
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacist refers to a female patient in her mid 50's. On an unknown date, the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX (Lot number was not provided) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacist reported that on an unknown date the patient who got the ZOSTAVAX experienced "swelling and a ring starting from the shoulder down to their elbow. The ring of redness was around the injection site and it lasted about 7 to 10 days". The doctor of pharmacist also mentioned that "other than it looking bad, the patient said it was not too uncomfortable and did not hurt too bad." The patient did check with her physician and the physician was not concerned about it. No treatment was given for the events. On an unknown date, the patient recovered from all the events. It was unknown if lab diagnostic studies were performed. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old male patient. It was reported that the patient was vaccinated with two doses of ZOSTAVAX, dose 1 on 30-APR-2012 and dose 2 on 25-SEP-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of nursing students. The patients were vaccinated with 3 dose of hepatitis B (manufacturer unspecified and RECOMBIVAX HB could not be ruled out (Lot number unspecified) (vaccination site unknown) on an unknown date and not seroconvert. The nursing students who had completed the 3 dose series and it had been less than 6 months since completion were given additional another 3 doses of hepatitis B vaccine (manufacturer unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. The patient had sought unspecified medication attention. This is one of three reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to unknown number of patients of unknown age. On an unknown date the unknown number of patients vaccinated the third dose later than recommended in the prescribing information for GARDASIL (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 16 weeks old male patient. "Last week" in September 2012, the patient was vaccinated with the first dose of ROTATEQ (Lot#, dose and route not reported) along with other unspecified vaccines that were normally given for a 4 month old well visit. The patient was not experiencing any known symptoms. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Rheumatoid arthritis
Clinical narrative: This spontaneous report was received from a consumer concerning her 65 year old husband with no pertinent medical history or drug allergies. On an unknown date in July 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number unspecified). Concomitant medications included metoprolol (reported as Netoprolol) and atorvastatin. Since July 2012 (since he received vaccination), the patient experienced rheumatoid arthritis and had major pain in all his joints. The patient sought medical attention (office visit). On an unknown date, unspecified blood test was performed and the result was unknown. No treatment was given for the adverse events. The outcome of rheumatoid arthritis and has major pain in all his joints was reported as not resolved. Additional information has been requested.
Age: 74.0
Sex: M
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. The patient was vaccinated with an expired 0.5 ml dose of PNEUMOVAX 23 (Lot # 666558/0449Z, expired on 08-OCT-2012, route not reported) on 24-SEP-2012. No adverse effect reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with diabetes, hypertension and asthma with no relevant medical history. Her relevant past drug history was unknown. The patient was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously in the deltoid area of her left arm (lot number reported as 0242AE, expiration date 01-APR-2013) on 29-AUG-2012. No other co-suspects were reported. Concomitant medications included several unknown medications (unspecified). On 30-AUG-2012, the patient developed a reddened rash in a circular pattern around her left arm at the injection site. No treatment information was reported. The patent had no laboratory testing performed. As of 30-AUG-2012, the patient would not receive another ZOSTAVAX and the outcome of reddened rash in a circular pattern around her left arm at the injection site was unknown. The relatedness for reddened rash in a circular pattern around her left arm at the injection site was not reported for ZOSTAVAX. This is one of two reports received from the same source.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse, concerning a 87 years old male patient, who on 28-AUG-2012 was vaccinated with a dose of improperly stored ZOSTAVAX (dose and route not reported) (lot # 0567AE, Exp: 04-APR-2013 - in validation process). The nurse reported that ZOSTAVAX that was administered to the patient had been delivered after being in transit from Company for 5 days; The nurse stated that it was stored in a truck over the weekend, and she does not know the temperature the ZOSTAVAX was exposed to during that time. No adverse effect had been observed or reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 16 years old male patient with no pertinent medical history or drug reaction and allergy. The patient was vaccinated with first dose of GARDASIL (lot number not reported) on 18-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-SEP-2012(reported as "five days after the vaccination") the patient experienced generalized hives. The patient had taken an office visit for medical attention and was treated with unspecified dose of BENADRYL. On an unspecified date, the patient was recovered. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that PNEUMOVAX23 had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392 1210USA000958 1210USA000959 1210USA000960 1210USA000962. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that (Merck) VARIVAX had been administered to an unspecified number of patients between 13-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392 1210USA000958 1210USA000959 1210USA000960 1210USA000961. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that ROTATEQ had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1210USA000958, 1210USA000959, 1210USA000960, 1210USA000961, 1210USA000962. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: FEVER, SEVERE Myalgias, SEVERE ARTHRALGIAS, SEVERE NAUSEA AND VOMITING, HEADACHE... TREATMENT OF FLUIDS, TYLENOL, MOTRIN, BED REST...lasting 36 hours...nausea continues.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER, SEVERE Myalgias, SEVERE ARTHRALGIAS, SEVERE NAUSEA AND VOMITING, HEADACHE... TREATMENT OF FLUIDS, TYLENOL, MOTRIN, BED REST...lasting 36 hours...nausea continues.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: FEVER, SEVERE Myalgias, SEVERE ARTHRALGIAS, SEVERE NAUSEA AND VOMITING, HEADACHE... TREATMENT OF FLUIDS, TYLENOL, MOTRIN, BED REST...lasting 36 hours...nausea continues.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: Fever, large swollen red welt on arm at injection site spreading down arm. Welt is raised, hard, and hot to the touch.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Malaise, Myocardial infarction, Nausea
Clinical narrative: Case number PHEH2012US019182 is an initial spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to a 49-years-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and nauseous. It was reported that he suffered a heart attack at his work site and expired before the ambulance arrived on 27 Sep 2012. No further information was available.
Age: 0.28
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Dizziness
Clinical narrative: Sudden onset of chills, temp of 102.5, generalized body ache, weakness, nauseous, loss of appetite, dizziness, headache.
Age: 0.28
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain
Clinical narrative: Sudden onset of chills, temp of 102.5, generalized body ache, weakness, nauseous, loss of appetite, dizziness, headache.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chest X-ray, Cough, Dyspnoea, Ocular hyperaemia
Clinical narrative: Difficulty breathing and coughing.  Blood shot eyes.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Lacrimation increased, Neck pain, Sinus operation, Throat irritation
Clinical narrative: WATERY EYES, SINUS DRAINAGE, SCRATCHY THROAT, NECK ACHE, MILD HEADACHE.
Age: 94.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, vomiting, nausea.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, itchiness, soreness. Benadryl 25 mg taken and ice applied.
Age: 12.0
Sex: F
Vaccine: FLUN3, TDAP, VARCEL
Symptoms: Cellulitis, Chills, Erythema, Headache, Induration
Clinical narrative: She has swelling around where the immunization was given and than has also had chills and a headache. On exam, patient has a 7.5 by 2.5 area on posterior left arm of erythema, well-circumscribed, with induration and mild tenderness. That area is warm to the touch. She is not febrile. No streaking
Age: 12.0
Sex: F
Vaccine: FLUN3, TDAP, VARCEL
Symptoms: Injection site swelling, Skin warm, Tenderness
Clinical narrative: She has swelling around where the immunization was given and than has also had chills and a headache. On exam, patient has a 7.5 by 2.5 area on posterior left arm of erythema, well-circumscribed, with induration and mild tenderness. That area is warm to the touch. She is not febrile. No streaking
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Noticed redness and swelling of his arm around area of vaccination.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary mass, Pyrexia
Clinical narrative: Approx 112 hours after receiving vaccination patient started feeling feverish.  Awoke with large tennis ball signs lump in R axillary.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Pain, Vaccination complication, White blood cell count increased
Clinical narrative: Arrived to ED stating achy all over and has developed a cough and mild headache.  States that current episode started 12 to 24 hours ago after getting flu shot.  Diagnosis Vaccine Reaction.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia oral, Nausea, Urticaria
Clinical narrative: Patient c/o of nausea and tongue feeling numb.  Hives noted across face and redness on chest.  Patient placed on side, gave Epinephrine .4cc IM.  Called 911. EMT's arrive at 3:25pm.  EMT's transferred patient to hospital at 3:40.  Follow Up Done 10/3/2012 and patient released from hospital approximately 6:00pm after observation according to RN.  Patient back to work today 10/3/2012.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram head normal, Feeling abnormal, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient received his third anthrax vaccine on 22 AUG 2012. It was the only vaccine he received that day. He was feeling fine prior to vaccine receipt and denies a history of recent infection or viral symptoms. He had been following a healthy diet and performing PT without problems. Patient denies any unusual or prolonged local symptoms at the vaccination site on his right upper arm. Within 24-48 hours of vaccine receipt, patient was driving and said he was feeling "weird". As he read license plates and signs, he knew the letters/numbers/words as he was reading, but could not "say" what he was reading. He saw some "spots" and then his right arm, followed by his right leg went numb and then his tongue went numb. He then experienced an extreme pain in his right temporal area. He reports his head felt like "someone was punching their way out of my brain from the inside". He rates the pain intensity as a 10/10 and says he honestly felt like he was going to die. He called his boss near the onset of the episode and within 1/2 hour, someone took him to the local clinic for evaluation. On his way there, he had one episode of emesis and began to experience altered mental status - "in and out of it". He does not recall exact details of treatment course, but describes "arm muscle spasms" on the way to get a head CT, which he reports was normal. He was taken by ambulance for admission at a hospital where his headaches were treated with Morphine, VICODIN and steroids. He was an inpatient for approximately 4-5 days where he reports he had a normal MRI. He was started on TOPAMAX and was discharged with a headache (2-3/10) and then transferred. He had a second severe episode similar to his initial presentation that awoke him from his sleep, but the symptoms affected the left side of his body, as well as his tongue. Other headaches that were occurring daily were associated with seeing white spots, blurring vision and tingling in his fingers. If he takes IMITREX at the onset of symptoms, his headaches have been aborted. Admits to taking IMITREX if he even thinks he is experiencing the onset of a migraine. Patient denies a history of similar pain or symptoms in the past. Although some of his records report migraines during his teens, he says he sometimes experienced headaches if he played video games for too long. He never was evaluated for headaches or took any medications for headaches as a teen. These headaches were not accompanied by other symptoms like increased sensitivity to light or sound or nausea or vomiting. Patient was evaluated in MAY 2012 for a significant headache accompanied by N/V, weakness, dizziness, decreased appetite and chest tightness; he was told he had a viral illness and felt better after receipt of fluids. Patient denies a history of seizures. He denies a history of head trauma except a concussion experienced during football about 2 years ago.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Mental status changes, Muscle spasms, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Vision blurred
Clinical narrative: Patient received his third anthrax vaccine on 22 AUG 2012. It was the only vaccine he received that day. He was feeling fine prior to vaccine receipt and denies a history of recent infection or viral symptoms. He had been following a healthy diet and performing PT without problems. Patient denies any unusual or prolonged local symptoms at the vaccination site on his right upper arm. Within 24-48 hours of vaccine receipt, patient was driving and said he was feeling "weird". As he read license plates and signs, he knew the letters/numbers/words as he was reading, but could not "say" what he was reading. He saw some "spots" and then his right arm, followed by his right leg went numb and then his tongue went numb. He then experienced an extreme pain in his right temporal area. He reports his head felt like "someone was punching their way out of my brain from the inside". He rates the pain intensity as a 10/10 and says he honestly felt like he was going to die. He called his boss near the onset of the episode and within 1/2 hour, someone took him to the local clinic for evaluation. On his way there, he had one episode of emesis and began to experience altered mental status - "in and out of it". He does not recall exact details of treatment course, but describes "arm muscle spasms" on the way to get a head CT, which he reports was normal. He was taken by ambulance for admission at a hospital where his headaches were treated with Morphine, VICODIN and steroids. He was an inpatient for approximately 4-5 days where he reports he had a normal MRI. He was started on TOPAMAX and was discharged with a headache (2-3/10) and then transferred. He had a second severe episode similar to his initial presentation that awoke him from his sleep, but the symptoms affected the left side of his body, as well as his tongue. Other headaches that were occurring daily were associated with seeing white spots, blurring vision and tingling in his fingers. If he takes IMITREX at the onset of symptoms, his headaches have been aborted. Admits to taking IMITREX if he even thinks he is experiencing the onset of a migraine. Patient denies a history of similar pain or symptoms in the past. Although some of his records report migraines during his teens, he says he sometimes experienced headaches if he played video games for too long. He never was evaluated for headaches or took any medications for headaches as a teen. These headaches were not accompanied by other symptoms like increased sensitivity to light or sound or nausea or vomiting. Patient was evaluated in MAY 2012 for a significant headache accompanied by N/V, weakness, dizziness, decreased appetite and chest tightness; he was told he had a viral illness and felt better after receipt of fluids. Patient denies a history of seizures. He denies a history of head trauma except a concussion experienced during football about 2 years ago.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Visual impairment, Vomiting
Clinical narrative: Patient received his third anthrax vaccine on 22 AUG 2012. It was the only vaccine he received that day. He was feeling fine prior to vaccine receipt and denies a history of recent infection or viral symptoms. He had been following a healthy diet and performing PT without problems. Patient denies any unusual or prolonged local symptoms at the vaccination site on his right upper arm. Within 24-48 hours of vaccine receipt, patient was driving and said he was feeling "weird". As he read license plates and signs, he knew the letters/numbers/words as he was reading, but could not "say" what he was reading. He saw some "spots" and then his right arm, followed by his right leg went numb and then his tongue went numb. He then experienced an extreme pain in his right temporal area. He reports his head felt like "someone was punching their way out of my brain from the inside". He rates the pain intensity as a 10/10 and says he honestly felt like he was going to die. He called his boss near the onset of the episode and within 1/2 hour, someone took him to the local clinic for evaluation. On his way there, he had one episode of emesis and began to experience altered mental status - "in and out of it". He does not recall exact details of treatment course, but describes "arm muscle spasms" on the way to get a head CT, which he reports was normal. He was taken by ambulance for admission at a hospital where his headaches were treated with Morphine, VICODIN and steroids. He was an inpatient for approximately 4-5 days where he reports he had a normal MRI. He was started on TOPAMAX and was discharged with a headache (2-3/10) and then transferred. He had a second severe episode similar to his initial presentation that awoke him from his sleep, but the symptoms affected the left side of his body, as well as his tongue. Other headaches that were occurring daily were associated with seeing white spots, blurring vision and tingling in his fingers. If he takes IMITREX at the onset of symptoms, his headaches have been aborted. Admits to taking IMITREX if he even thinks he is experiencing the onset of a migraine. Patient denies a history of similar pain or symptoms in the past. Although some of his records report migraines during his teens, he says he sometimes experienced headaches if he played video games for too long. He never was evaluated for headaches or took any medications for headaches as a teen. These headaches were not accompanied by other symptoms like increased sensitivity to light or sound or nausea or vomiting. Patient was evaluated in MAY 2012 for a significant headache accompanied by N/V, weakness, dizziness, decreased appetite and chest tightness; he was told he had a viral illness and felt better after receipt of fluids. Patient denies a history of seizures. He denies a history of head trauma except a concussion experienced during football about 2 years ago.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dyspnoea, Hypoaesthesia
Clinical narrative: 2 days later numbness in hands and feet and arm. Then 2 days also 102 temp. and then SOB. Put on steroids and inhalers. Same thing happened in Sept 2011.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pt. presented with a rash approx. 8 inches wide on and around injection site. It is warm to the touch. Counseled to use cool compresses and if anything worsens, contact MD. RPh will follow-up 9/28/12 in the AM. Pt. improved overnight.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat at site of injection. Largest area of redness is 105 mm width.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Dyspnoea, Pharyngeal disorder
Clinical narrative: PT COULDN'T BREATHE, WAS CRYING AND POINTING TO HIS THROAT. MOM GAVE BENADRYL AND TOOK HIM TO THE ER WHERE HE WAS FINE.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Flushing, Myalgia, Paraesthesia
Clinical narrative: Flushed, all over body rash with hives, burning sensation, all over itching, tingling of face, lips. Wheezing. Fever 101.5 all over joint and muscle pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus generalised, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Flushed, all over body rash with hives, burning sensation, all over itching, tingling of face, lips. Wheezing. Fever 101.5 all over joint and muscle pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Flushed, all over body rash with hives, burning sensation, all over itching, tingling of face, lips. Wheezing. Fever 101.5 all over joint and muscle pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face chest and back.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Erythema, Malaise, Oedema peripheral
Clinical narrative: Pain to left chest with shot administration, lasted for an hour. Three days later reports malaise, redness and edema to arm.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth, Joint effusion
Clinical narrative: (R) deltoid pain, fever, swelling and a knot at injection site. Parasthesia in (R) hand. Erythema extended down arm from deltoid to elbow with soft fluid sac at elbow.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: (R) deltoid pain, fever, swelling and a knot at injection site. Parasthesia in (R) hand. Erythema extended down arm from deltoid to elbow with soft fluid sac at elbow.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Rash
Clinical narrative: Patient reported red, painful welt at injection site and rash on arm and back.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site inflammation, Injection site streaking
Clinical narrative: Inflamed red area with streaking below & beside small pox vaccination area. Area noted 8/2/12, saw ER MD 8/2/12. C/O of fatigue and aching under axilla, on ABX.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Staphylococcal infection
Clinical narrative: Inflamed red area with streaking below & beside small pox vaccination area. Area noted 8/2/12, saw ER MD 8/2/12. C/O of fatigue and aching under axilla, on ABX.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt was treated at - please consult: ER Dept.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Computerised tomogram, Drooling, Dysgeusia, Hypoaesthesia, Laboratory test
Clinical narrative: Pt. have swollen lymph nodes on Rt. side of neck, Rt. facial swelling and drooping, with tingling, numbness and bad taste in mouth. Symptoms occurred 24 hours after FLUMIST vaccine.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Lymphadenopathy, Paraesthesia, Swelling face
Clinical narrative: Pt. have swollen lymph nodes on Rt. side of neck, Rt. facial swelling and drooping, with tingling, numbness and bad taste in mouth. Symptoms occurred 24 hours after FLUMIST vaccine.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Pyrexia, Wheezing
Clinical narrative: Fever 103, wheezing, local erythema at (L) arm, myalgia.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient claims she suffered cellulitis to left upper arm, from injection 2 days after FLUZONE HD & PNEUMOVAX.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Post-tussive vomiting
Clinical narrative: Child was given FLUMIST. No H/O egg allergy and asthma. After 5 mins., she started to touch. (-) Resp. distress. had few posttussive emesis. (-) wheezing. Gave her one Albuterol neb treatment. Observed her fro 30 mts. BP/Pulse were normal on D/C. Doing fine as per mother today (10/3/12).
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Case number PHEH2012US018706, is an initial spontaneous report received from a consumer on 21 Sep 2012 with a follow up information received on 24 Sep 2012: This report refers to a female patient whose age was not reported. She was vaccinated with influenza vaccine (unknown manufacturer and batch number) on an unknown date. On an unspecified date she died following a flu shot. Cause of death was not reported. Causality assessment was not reported. No further information was provided. Follow up information received on 24 Sep 2012: Gender of the patient was updated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: All over body itching almost immediately after intradermal flu vaccine. Rash on & off ever since - 5 days ago.
Age: 21.0
Sex: U
Vaccine: TDAP
Symptoms: Rash pruritic, Skin plaque
Clinical narrative: Given 9/21/12 @ 445 pm, employee reports that on about 1 hour 5:45 she developed 5-6 round raised rash, each area size of a dime. They itched. No SOB, no other symptoms 9/24/12 I observed 2 area that remained. Raised plaques approx. 2 cm/1 cm wide. 10/1/12 areas flat, fading away.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Palm size redness and tenderness (hot to touch) at shot site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Skin warm, Urticaria
Clinical narrative: 3 x 5 allergic reaction, huge welt (L) arm area warm to the touch.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pulsating pain at injection site greater than or equal to 6 days. (Ongoing).
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Paraesthesia, Vertigo
Clinical narrative: Arm soreness and was unable to lift arm (paresthesia) vertigo, chills.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Mouth and lip tingling, swollen lips.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Right side enlarged supraclavicular lymph node.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain at injection site, down right arm and into right shoulder. Difficulty sleeping that night due to the discomfort. Continued pain on 10/3/2012 though slightly less. IM injection given at one and on-half finger widths below acronium process.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Asthenia, Chills, Dyspnoea, Nervousness
Clinical narrative: Fever, chills, weakness, severe pain, swollen arm and under the arm, shortness of breath, nervousness, temporary loss of memory.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pyrexia
Clinical narrative: Fever, chills, weakness, severe pain, swollen arm and under the arm, shortness of breath, nervousness, temporary loss of memory.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Lump quarter size at injection site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain
Clinical narrative: Patient described extreme soreness under left arm, around back, down to waist area.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal chest pain, Pain, Renal pain
Clinical narrative: Headache, body ache, pain in kidneys, rib pain.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Crying, Electroencephalogram normal, Hypertonia, Pyrexia
Clinical narrative: Went to ER -> Pt experienced high fever, seizure & prolonged crying x 2 wks. Also with increased tone in lower extremities.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Administered FLUMIST to a pregnant woman. No adverse event noted.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Novartis FLUVIRIN received 10/1/12 to (L) deltoid Lot # 1205401 Exp 6/2013. 10/2/12 Noted increase burning and tenderness to site. On 10/3/12 awoke with positive redness/heat. On exam at 1205 P 10/3/12 2x2 very light pink area, tender to touch with very light erythema, (+) Pulses. No neurovascular changes. No other c/o.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Mother t/c this A.M. regarding rash that appeared on this child approximately 48 hrs. after IZS (9/18/12) given. Mother stated it lasted about 3 days. Treated with antihistamine, resolved. No M.D. visit.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Swelling
Clinical narrative: Rash and swelling, pain for 6 days. Given Depo-Medrol 80mg I.M. for treatment.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cold sweat, Feeling cold, Oedema peripheral
Clinical narrative: Approx midnight of 9/26/12 pts arm swollen she went to hospital at 4am 9/27. She received f/u and pneumonia in left arm- this was the swollen arm. Pt felt cold and clammy.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Formication, Paraesthesia oral, Pruritus, Pruritus generalised
Clinical narrative: Influenza vaccine administered 1500 (L) delt. 1510 Returned to clinic area stating "felt like bugs crawling over me. Lips tingle, eyes itch, hand itch and injection site: no redness, no swelling, no hives. Administer BENADRYL 25mg PO 1510. Instructed to return to clinic area after 30 min. Returned to work station. Follow up clinic area visit 1555; continues to state "itch all over", hives noted on clients back. Second dose BENADRYL 25mg PO adm. Client alert, oriented. No respiratory distress. Work day ends 1600 - instructed to see local primary care provider. Tele call 10-2-12 AM "all ok. Itching resolved.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Influenza vaccine administered 1500 (L) delt. 1510 Returned to clinic area stating "felt like bugs crawling over me. Lips tingle, eyes itch, hand itch and injection site: no redness, no swelling, no hives. Administer BENADRYL 25mg PO 1510. Instructed to return to clinic area after 30 min. Returned to work station. Follow up clinic area visit 1555; continues to state "itch all over", hives noted on clients back. Second dose BENADRYL 25mg PO adm. Client alert, oriented. No respiratory distress. Work day ends 1600 - instructed to see local primary care provider. Tele call 10-2-12 AM "all ok. Itching resolved.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Joint swelling, Lymphadenopathy, Pain, Pyrexia, Skin warm
Clinical narrative: Oral TYPHOID taken 8/22 - On 8/23 he felt "feverish and sore". Took another dose 8/28 - developed fever, swollen glands in neck, face. In the evening developed swelling in joints especially knees and fingers. It was very painful and warm to touch. Symptoms resolved within 72 hours.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: 4:00 PM on 10-2-12 Received vaccine. 930 - 1030 on 10-21-12 Had chills, no elevated temp. No respiratory distress. Was given TYLENOL by spouse. Symptoms reported by spouse on 10-3-12 to H.D.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Petechiae
Clinical narrative: Day after Influenza vaccine: diffuse petechiae to lower legs.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Red blotchy patches on arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Administered in left deltoid - unable to use arm 2 wks post vaccine. Has had flu vaccine previous years.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Began with slight fever (100) which resolved by next day. Then swelling, redness and pain at injection site began. Went to get it looked at on 10/03/2012. Placed on antibiotics for cellulitis.