chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Grand mal convulsion
Clinical narrative: Case number PHEH2014US023180 is an initial spontaneous report received from a consumer on 16 Nov 2014. This report refers to an 18 years old male patient. His medical history included Cerebral Palsy, developmental disorder. His current condition included seizure and his last seizure was 9 months ago. He was healthy otherwise and his seizures were well controlled with zonisamide. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: not reported) until this year which were well tolerated. He was vaccinated with FLUVIRIN, (batch number: not reported) intramuscularly on 15 Nov 2014. It was reported that later that day he experienced grand mal seizure. The seizure occurred 3 hours after administration of FLUVIRIN. The event outcome was unknown. The seriousness of the event was not reported, but the event was upgraded based on information available on NVS-IME list. The causality of the event was not reported.
Age: 53.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Condition aggravated, Erythema, Erythema multiforme, Genital herpes, Oedema mouth
Clinical narrative: Case number PHEH2014US022756, is an initial spontaneous report received from a consumer (patient) on 10 Nov 2014. This report refers to a 53-year-old male patient. His medical history included multiple incidences of HSV (herpes simplex virus) and he took VALTREX as a treatment for it and at the time of the vaccination he was not taking the treatment. His vaccination history included 3 doses of RABAVERT (batch number: not reported) on unspecified dates and did not have any reaction to them. He was vaccinated with fourth dose of RABAVERT (batch number: not reported) intramuscularly on 29 Oct 2014. On 31 Oct 2014, he started getting erythema multiforme and exposed to HSV outbreak. He had the event HSV before but this time it was much more severe round. He also had lesions in his mouth and could not eat solid food. The dermatologist recommended prednisone. He started to take solid food from Saturday (on an unknown date). He almost stopped prednisone treatment and was kept on VALTREX treatment by the dermatologist. She was trying to get less susceptible to another outbreak after the last dose (28 day shot, which was due). The outcome of the events was unknown. Reporter did not assess the seriousness. Seriousness assessment of the events (herpes simplex virus and its symptoms) was upgraded based on information available in source document. The causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Scab
Clinical narrative: Case number PHEH2014US022756, is an initial spontaneous report received from a consumer (patient) on 10 Nov 2014. This report refers to a 53-year-old male patient. His medical history included multiple incidences of HSV (herpes simplex virus) and he took VALTREX as a treatment for it and at the time of the vaccination he was not taking the treatment. His vaccination history included 3 doses of RABAVERT (batch number: not reported) on unspecified dates and did not have any reaction to them. He was vaccinated with fourth dose of RABAVERT (batch number: not reported) intramuscularly on 29 Oct 2014. On 31 Oct 2014, he started getting erythema multiforme and exposed to HSV outbreak. He had the event HSV before but this time it was much more severe round. He also had lesions in his mouth and could not eat solid food. The dermatologist recommended prednisone. He started to take solid food from Saturday (on an unknown date). He almost stopped prednisone treatment and was kept on VALTREX treatment by the dermatologist. She was trying to get less susceptible to another outbreak after the last dose (28 day shot, which was due). The outcome of the events was unknown. Reporter did not assess the seriousness. Seriousness assessment of the events (herpes simplex virus and its symptoms) was upgraded based on information available in source document. The causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Aphagia, Condition aggravated, Erythema multiforme, Herpes simplex, Oral herpes
Clinical narrative: Case number PHEH2014US022756, is an initial spontaneous report received from a consumer (patient) on 10 Nov 2014. This report refers to a 53-year-old male patient. His medical history included multiple incidences of HSV (herpes simplex virus) and he took VALTREX as a treatment for it and at the time of the vaccination he was not taking the treatment. His vaccination history included 3 doses of RABAVERT (batch number: not reported) on unspecified dates and did not have any reaction to them. He was vaccinated with fourth dose of RABAVERT (batch number: not reported) intramuscularly on 29 Oct 2014. On 31 Oct 2014, he started getting erythema multiforme and exposed to HSV outbreak. He had the event HSV before but this time it was much more severe round. He also had lesions in his mouth and could not eat solid food. The dermatologist recommended prednisone. He started to take solid food from Saturday (on an unknown date). He almost stopped prednisone treatment and was kept on VALTREX treatment by the dermatologist. She was trying to get less susceptible to another outbreak after the last dose (28 day shot, which was due). The outcome of the events was unknown. Reporter did not assess the seriousness. Seriousness assessment of the events (herpes simplex virus and its symptoms) was upgraded based on information available in source document. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Hives, swelling, trouble breathing, an accelerated heartbeat, changes in behavior, dizziness, and weakness.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Hives, swelling, trouble breathing, an accelerated heartbeat, changes in behavior, dizziness, and weakness.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: When she got up, complained of "itchy feet" - presented with severe hives all over legs and feet. (We haven't contacted dr yet b/c too early).
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Given 2015 flu vaccine, within 5 minutes compaint of numbness and tingling down arm into fingers, and up into shoulder area and left side of neck, c/o headache. Treated w/ NSAID, ice, gentle ROM exercise/limited use-rest of left arm.  Has visit several times, report sx gradually decreasing.  Last contact 11/24, some pain in shoulder and slight headaches.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dry skin, Dyspnoea, Muscle rigidity, Nausea, Pallor
Clinical narrative: Employee complained of feeling nauseated, then became pale and fainted.  Fell out of chair onto floor, sustaining abrasion to R upper cheekbone.  Then arms turned inward and became rigid, unresponsive to verbal stimuli, stertorous breathing.  Turned onto L side, 911 called.  Employee then regained consciousness, but remained pale.  Placed in supine position with legs elevated, BP 120/84, P 80, A&O x 3, skin warm and dry.  EMS arrived who transported employee to ER where he was treated and released.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Syncope, Unresponsive to stimuli
Clinical narrative: Employee complained of feeling nauseated, then became pale and fainted.  Fell out of chair onto floor, sustaining abrasion to R upper cheekbone.  Then arms turned inward and became rigid, unresponsive to verbal stimuli, stertorous breathing.  Turned onto L side, 911 called.  Employee then regained consciousness, but remained pale.  Placed in supine position with legs elevated, BP 120/84, P 80, A&O x 3, skin warm and dry.  EMS arrived who transported employee to ER where he was treated and released.
Sex: U
Vaccine: TYP
Symptoms: Hepatitis C RNA increased
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer and concerns a subject of unspecified age and gender. The subject's height and weight was not reported. The subject's concurrent conditions included chronic hepatitis C. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) on an unspecified date as a prophylactic vaccination. Concomitant medications were not reported. On an unspecified date, the subject experienced increased RNA count. The reporter stated that last April (year unspecified) RNA count was 374, 000 and within 3 weeks of taking oral typhoid vaccine oral ty21a the subject's RNA count went up to 3,100,000. Action taken with typhoid vaccine oral ty21a was unknown. The subject outcome was unknown for increased RNA count. This report was serious (medically significant).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Feeling abnormal, Local swelling, Pyrexia
Clinical narrative: High fever, light headed beginning about 8-9 hrs after vaccine, 102 degrees for next 18 hrs, then 99 degrees for next 24 hrs, then normal but felt poorly for next 2 days.  Arm swollen, red and hot half way down to wrist for 5 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: High fever, light headed beginning about 8-9 hrs after vaccine, 102 degrees for next 18 hrs, then 99 degrees for next 24 hrs, then normal but felt poorly for next 2 days.  Arm swollen, red and hot half way down to wrist for 5 days.
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Feeling abnormal, Immediate post-injection reaction, Syncope
Clinical narrative: Pt had syncope in hallway. I was able to catch her and sit her down in a chair.  I gave her a Coke and wheeled her to a clinic table where she laid down with feet elevated. Symptom resolved in 15 minutes. Pt. stated that she felt the vaccine (HPV) go in and immediately a fog filled her head.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Irritability, Urticaria
Clinical narrative: Day 1: Irritable. Hives appeared on torso and thighs. Gave her Benadryl. Day 2: PM - Hives spread to lower legs and feet/ankles.  Gave her Benadryl. Day 3: AM - Hives appeared on arm near armpit.  Hives on torso and legs decreasing.  Gave her Claritin. Day 4: Hives gone.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: My son informed me that his arm was still hurting where he got the injection. There was an area below the injection site that was warm to touch, red and painful. He was diagnosed with cellulitis and prescribed antibiotics.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Abscess sterile, Culture negative, Erythema, Incisional drainage, Pain
Clinical narrative: Patient developed an abscess that was warm to the touch, red, and painful to the child, we did an I&D and cultured, culture came back as a sterile abscess, it accumulated again and we did another I&D with culture and it also came back as sterile.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: Patient developed an abscess that was warm to the touch, red, and painful to the child, we did an I&D and cultured, culture came back as a sterile abscess, it accumulated again and we did another I&D with culture and it also came back as sterile.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: Pain, tenderness, redness, warmth, swelling.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Confusional state, Headache, Influenza like illness
Clinical narrative: Severe Flu-like symptoms. Fever, Chills, Joint Pain, Vomiting, Headache and Mental Disorientation.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe Flu-like symptoms. Fever, Chills, Joint Pain, Vomiting, Headache and Mental Disorientation.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain, tingling, numbness, chest pain. Hospitalized to rule out cardiac cause; seen in office x 5. For same MRI of deltoid done; trial NSAIDS, prednisone, muscle relaxers, gabapentin. ? Nerve damage?
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Central nervous system inflammation, Injection site erythema, Injection site swelling, Local swelling, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received 13 November 2014 from a consumer, who is also the patient. A 72-year-old male patient, with a history of chronic urticaria and "hyperactive immune system", received an intramuscular left deltoid injection of FLUZONE HD, (lot number not reported) on an unspecified date in November 2014. Concomitant medications included an EPIPEN. One day after vaccination, the patient reported redness and swelling of the left deltoid. One to two days after that, he developed hives on his buttocks and swelling of the right side of his tongue. He was treated with BENADRYL. He also reported that since vaccination (date not specified), he had been experiencing a stiff neck with swelling at the back of his neck to the base of his skull. He was seen by a physician and sent for an MRI, which revealed inflammation/infection between T2 and T3. Further follow-up was scheduled. The patient had not recovered at the time of the report. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Spinal cord infection, Swollen tongue, Urticaria
Clinical narrative: Initial unsolicited report received 13 November 2014 from a consumer, who is also the patient. A 72-year-old male patient, with a history of chronic urticaria and "hyperactive immune system", received an intramuscular left deltoid injection of FLUZONE HD, (lot number not reported) on an unspecified date in November 2014. Concomitant medications included an EPIPEN. One day after vaccination, the patient reported redness and swelling of the left deltoid. One to two days after that, he developed hives on his buttocks and swelling of the right side of his tongue. He was treated with BENADRYL. He also reported that since vaccination (date not specified), he had been experiencing a stiff neck with swelling at the back of his neck to the base of his skull. He was seen by a physician and sent for an MRI, which revealed inflammation/infection between T2 and T3. Further follow-up was scheduled. The patient had not recovered at the time of the report. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: Initial unsolicited case received from a  nurse on 13 November 2014. The reporter stated that approximately 10 patients experienced "full blown" pneumonia within 24 to 48 hours after receiving FLUZONE HIGH DOSE or FLUZONE QIV; lot numbers, dates of administration, and other administration details were not reported. No identifying information was reported for the patients, and it was unknown how many patients received each vaccine. Treatment, diagnostic test results, and outcome were not reported. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Purulent discharge, Skin warm
Clinical narrative: Initial unsolicited case received from a physician, who is also the patient, on 17 November 2014. A 54-year-old female patient received an Influenza vaccine last year (manufacturer, lot number, date of vaccination and administration details not reported). The patient reported that she often experienced a site reaction after Influenza vaccination, but that last year her arm became swollen, red, and hot with pus draining from the back. She was treated with antibiotics and the events recovered within a week. Details regarding previous events following Influenza vaccination were not reported, and have been requested. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Area where pt received vaccine was red, hot, blotchy and itchy. Pt was put on oral antibiotics.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Swollen tongue
Clinical narrative: Tongue swelling, angioedema. EpiPen, Benadryl, Prednisone, Solumedrol, Pepcid.
Age: 46.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Breast pain, Diarrhoea, Renal pain
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a health professional and concerns a 46 year old female subject; Local case ID: 9414. The subject's weight and medical history were not reported. The subject received VIVOTIF (typhoid vaccine oral ty21a) (capsule, hard, oral, batch 132053B) administered on an unspecified date for prophylactic vaccination. Concomitant medications were not reported. On 24-SEP-1994 (interval period from vaccination to onset of reported event was 6-12 hours) the subject developed diarrhea. On 26-SEP-1994 (interval period from vaccination to onset of reported events was 6- 2 days) the subject experienced stomach cramps, breasts sore and kidney sore. The action taken with typhoid vaccine oral ty21a was unknown. The subject's outcome was unknown for kidney sore, diarrhea, stomach cramps and breasts sore. The reporter considered the events of diarrhea, stomach cramps to be definitely related and kidneys sore and breasts sore to be unrelated to typhoid vaccine oral ty21a. This report was serious (medically significant).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Rash, Swelling
Clinical narrative: Day after administration patient said she had a red, swollen, sore arm. Around 11/07/2014 she began to develop a rash on her trunk and legs. She called the office to notify us. Per Dr she was instructed verbally to use Benadryl and see if this helps. She then called back on 11/21/14 saying that it was not any better and spreading. We asked that she schedule an appointment but patient was unable to come in until 11/25/14. Therefore, Dr went ahead and called in Methylprednisolone. She came in for her appointment today and it is getting better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AT INJECTION SITE. MORE THAN THE USUAL AMOUNT OF REDNESS. 2 INCH ACROSS, RAISED AND RED.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable nurse on behalf of physician via a Pfizer sales representative. This nurse reported similar events for two patients. This is the first of two reports. A 92 years old female patient of unspecified ethnicity received PREVNAR 13 on unknown date at 0.5 ml single dose. Medical  history and concomitant medication were not reported. On unknown date after administration of PREVNAR 13 the patient experienced cellulitis with unknown outcome.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable nurse on behalf of physician via a Pfizer sales representative. This nurse reported similar events for two patients. This is the second of two reports. A 65 years old female patient of unspecified ethnicity received PREVNAR 13 on unknown date at 0.5 ml single dose. Medical history and concomitant medication were not reported. On unknown date after administration of PREVNAR 13 the patient experienced cellulitis with unknown outcome.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: SHE INSTANTLY COMPLAINED OF BURNING AND A RAISED LUMP/WELT APPEARED AT THE SITE WHERE THE VACCINE WAS INJECTED (ALMOST LOOKED LIKE A MOSQUITO BITE). THERE WAS SIGNIFICANT REDNESS AROUND THE AREA. HAD PT. REMAIN IN PHARMACY FOR 15 MINUTES. NO SHORTNESS OF BREATH OR ITCHINESS, JUST A RAISED BUMP WITH REDNESS. CALLED A FEW DAYS LATER AND PATIENT SAID THE AREA WAS STILL SWOLLEN AND THERE WAS SOME BRUISING, BUT NEVER HAD ITCHINESS OR SOB.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: SHE INSTANTLY COMPLAINED OF BURNING AND A RAISED LUMP/WELT APPEARED AT THE SITE WHERE THE VACCINE WAS INJECTED (ALMOST LOOKED LIKE A MOSQUITO BITE). THERE WAS SIGNIFICANT REDNESS AROUND THE AREA. HAD PT. REMAIN IN PHARMACY FOR 15 MINUTES. NO SHORTNESS OF BREATH OR ITCHINESS, JUST A RAISED BUMP WITH REDNESS. CALLED A FEW DAYS LATER AND PATIENT SAID THE AREA WAS STILL SWOLLEN AND THERE WAS SOME BRUISING, BUT NEVER HAD ITCHINESS OR SOB.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Chest discomfort, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer or other non health professional and concerns a 25 year old female local ID: VIV 9518. The subject's weight and medical history were unknown. On 10-JAN-1995 12:00, the subject received typhoid vaccine oral ty21a (capsule, hard) as prophylactic vaccination. Concomitant medications included unspecified hepatitis vaccine, polio booster and tetanus vaccine. On 11-JAN-1995 02:00, after receiving the first pill, subject experienced fast heart palpitations, numbness, tingling in arms and legs and chest cramping. She was taken to the hospital and given Benadryl and an unknown medication. One and a half hours later she felt better. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. The outcome of fast heart palpitations, numbness, tingling in arms and legs and chest cramping was resolved on 11-JAN-1995. This report was serious (medically significant).
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Myalgia
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report from a physician concerns a 27 year old female: US 9402. The subject's medical history was unknown, and the subject's weight was 51.5 kilograms. Other medical history included the subject was not pregnant, a non smoker, drinks 3oz beer/week, has no known medical problems, and has experienced no drug reactions in the past. Concomitant medications were not reported. The subject received TYPHOID VACCINE ORAL TY21A (capsule, hard, oral, batch 130611b, expiry DEC-1994) administered on 28-DEC-1993 and on 30-DEC-1993 for foreign travel. On 28-DEC-1993, the subject took first dose of TYPHOID VACCINE ORAL TY21A and 10-12 hours later experienced weakness and myalgia. 20 to 24 hours later the subject developed a temperature of 102.8 degrees, a severe left temporal headache and chills. On 30-DEC-1993, symptoms had subsided and the subject was advised to take the second dose of TYPHOID VACCINE ORAL TY21A. 3 hours after taking the second dose the patient experienced the same symptoms (weakness, myalgia, temperature of 102.8 degrees, a severe left temporal headache and chills). She was evaluated approximately 16 hours after her second dose. Her temperature was 99.8 and neuro examination was negative. The subject's outcome was unknown for weakness, myalgia, a temperature of 102.8 degrees, temporal headache and chills, although the physician reported that the events were 'mostly gone' by 48 hours after the second dose of TYPHOID VACCINE ORAL TY21A. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. This report was serious (permanent disability).
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Neurological examination normal
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report from a physician concerns a 27 year old female: US 9402. The subject's medical history was unknown, and the subject's weight was 51.5 kilograms. Other medical history included the subject was not pregnant, a non smoker, drinks 3oz beer/week, has no known medical problems, and has experienced no drug reactions in the past. Concomitant medications were not reported. The subject received TYPHOID VACCINE ORAL TY21A (capsule, hard, oral, batch 130611b, expiry DEC-1994) administered on 28-DEC-1993 and on 30-DEC-1993 for foreign travel. On 28-DEC-1993, the subject took first dose of TYPHOID VACCINE ORAL TY21A and 10-12 hours later experienced weakness and myalgia. 20 to 24 hours later the subject developed a temperature of 102.8 degrees, a severe left temporal headache and chills. On 30-DEC-1993, symptoms had subsided and the subject was advised to take the second dose of TYPHOID VACCINE ORAL TY21A. 3 hours after taking the second dose the patient experienced the same symptoms (weakness, myalgia, temperature of 102.8 degrees, a severe left temporal headache and chills). She was evaluated approximately 16 hours after her second dose. Her temperature was 99.8 and neuro examination was negative. The subject's outcome was unknown for weakness, myalgia, a temperature of 102.8 degrees, temporal headache and chills, although the physician reported that the events were 'mostly gone' by 48 hours after the second dose of TYPHOID VACCINE ORAL TY21A. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. This report was serious (permanent disability).
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac failure congestive, Death
Clinical narrative: Wife states that her husband (patient) went into congestive heart failure and died a few days after receiving the flu vaccine.
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: After receiving these vaccine on 10/13/14 pt. stated that on or about November 1, 2014 he started to develop an itchy rash that spread over all his body; pt went to doctor on 11/14/14 and he was prescribed prednisone 10 mg po TID x 4 days afterwards pt was advised to us BENADRYL when itching. Finally, on November 24, 2014, pt stated most of rash had subsided.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Local swelling
Clinical narrative: Patient had local swelling and cellulitis. Patient seen in ER 2 days afterwards and treated with clindamycin. Symptoms have improved. No other reported symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient admin. influenza virus vaccination (L) deltoid on 11/14/14. Arm felt "achey" on 11/16 during the day. At 9 p.m. that eve. s/p brushing her teeth developed abrupt onset "searing pain" "on fire" from shoulder to finger tips, (L) arm. Denies rash, swelling erythema at inj. site or generalized (-) fever. Visual inspect of site on ofc on 11/18/14. (-) erythema/red/heat at site of LA. Swelling (-) decreased grip strength. No tx by RN.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: CLIENT ARRIVED 11/24/14 AT PUBLIC HEALTH CLINIC ASKING FOR ASSISTANCE RE VACCINE GIVEN AT SCHOOL ON 11/21/14.  CLIENT CO'S OF DIZZINESS/NOT FEELING WELL AT BEDTIME ON 11/20/14.  CLIENT STATES THAT ON THE NEXT DAY, SHE HAD RIGHT SORE ARM WITH REDNESS AND SWELLING, FATIGUE.  SHE ALSO CO'S OF OCCASIONAL SOB, SORE THROAT, CHILLS.  SHE DID NOT TAKE TEMP.  TOOK IBUPROFEN ON SATURDAY AND YESTERDAY.  FEELS SHE IS IMPROVING.  11 X 11 CM RED AREA WITH SWELLING AND TENDERNESS IS NOTED ON THE RIGHT ARM.  COLD PACK APPLIED DURING VISIT.  RECOMMENDED TO CONTACT MD (WRITTEN INFO GIVEN ON LOW COST MEDICAL FACILITIES)  IF CONDITION DOES NOT IMPROVE, COLD PACK TO RIGHT ARM, AND USE OF IBUPROFEN/TYLENOL AS NEEDED.  ENC TO TAKE FLUIDS AND MOVE ARM AS MUCH AS POSSIBLE.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Local swelling, Malaise, Oropharyngeal pain, Pain in extremity, Tenderness
Clinical narrative: CLIENT ARRIVED 11/24/14 AT PUBLIC HEALTH CLINIC ASKING FOR ASSISTANCE RE VACCINE GIVEN AT SCHOOL ON 11/21/14.  CLIENT CO'S OF DIZZINESS/NOT FEELING WELL AT BEDTIME ON 11/20/14.  CLIENT STATES THAT ON THE NEXT DAY, SHE HAD RIGHT SORE ARM WITH REDNESS AND SWELLING, FATIGUE.  SHE ALSO CO'S OF OCCASIONAL SOB, SORE THROAT, CHILLS.  SHE DID NOT TAKE TEMP.  TOOK IBUPROFEN ON SATURDAY AND YESTERDAY.  FEELS SHE IS IMPROVING.  11 X 11 CM RED AREA WITH SWELLING AND TENDERNESS IS NOTED ON THE RIGHT ARM.  COLD PACK APPLIED DURING VISIT.  RECOMMENDED TO CONTACT MD (WRITTEN INFO GIVEN ON LOW COST MEDICAL FACILITIES)  IF CONDITION DOES NOT IMPROVE, COLD PACK TO RIGHT ARM, AND USE OF IBUPROFEN/TYLENOL AS NEEDED.  ENC TO TAKE FLUIDS AND MOVE ARM AS MUCH AS POSSIBLE.
Sex: M
Vaccine: CHOL, TYP
Symptoms: Cellulitis, Culture negative, Ocular hyperaemia, Pyrexia
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative and concerns a male subject of unspecified age: US 9104. The subject's weight, height and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 115382A) on 12-MAY-1991 as a prophylactic vaccination. Non-company suspect drugs included: cholera vaccine (injection) as a prophylactic vaccination. Concomitant medications were not reported. On 16-MAY-1991, 07:00, the subject experienced cellulitis, high fever and red eyes. He was hospitalised for 1 day. Cultures (not specified) were taken on an unspecified date, and the results were negative. Action taken with typhoid vaccine oral ty21a and cholera vaccine was unknown. The subject had recovered from cellulitis, high fever and red eyes on an unspecified date. This report was serious (hospitalization).
Age: 85.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Shoulder pain, restricted movement.
Age: 85.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Shoulder pain, restricted movement.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea increased, Computerised tomogram head abnormal
Clinical narrative: Initial report received on 09 Dec 2009: This subject was enrolled in a study. The subject received the first dose of 15mcg A/H1N1 with 50% MF59 on 15 Sep 2009. The subject received the second dose on 06 Oct 2009. The subject's medical history included allergy to penicillin. On 16 Oct 2009, the subject was seen in the emergency room with right sided facial paralysis. The subject was diagnosed with Bell's palsy. The subject received treatment with Acyclovir and prednisone. The paralysis gradually resolved and the subject had completely recovered by 18 Nov 2009. The Bell's palsy was not considered serious, however Novartis considered the event to be medically significant. The investigator did suspect a relationship between the event and the study vaccine. Follow-up received on 14 Dec 2009: The patient did not drop out of the study due to the event. Follow-up received on 25 Jan 2010: The subject experienced facial droop with weakness of the right face (moderate) and headache. On 16 Oct 2009, the subject underwent an electrocardiogram (EKG) which was normal and a computerised tomogram (CT) of the head to evaluate the left sided facial droop. The appearance of the brain was normal with no ischemic areas or gross temporal bone lesions. Mild sinus changes were noted. The subject was discharged from hospital in good condition. The subject was treated Acyclovir, prednisone and 'Lacri-lube ophthalmic ointment'. Follow up literature report received on 17 Nov 2014: The reported event of "Bell's palsy" was cited in an article.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Electrocardiogram P wave normal, Electrocardiogram QRS complex normal, Electrocardiogram ST segment normal, Electrocardiogram T wave normal, Electrocardiogram abnormal
Clinical narrative: Initial report received on 09 Dec 2009: This subject was enrolled in a study. The subject received the first dose of 15mcg A/H1N1 with 50% MF59 on 15 Sep 2009. The subject received the second dose on 06 Oct 2009. The subject's medical history included allergy to penicillin. On 16 Oct 2009, the subject was seen in the emergency room with right sided facial paralysis. The subject was diagnosed with Bell's palsy. The subject received treatment with Acyclovir and prednisone. The paralysis gradually resolved and the subject had completely recovered by 18 Nov 2009. The Bell's palsy was not considered serious, however Novartis considered the event to be medically significant. The investigator did suspect a relationship between the event and the study vaccine. Follow-up received on 14 Dec 2009: The patient did not drop out of the study due to the event. Follow-up received on 25 Jan 2010: The subject experienced facial droop with weakness of the right face (moderate) and headache. On 16 Oct 2009, the subject underwent an electrocardiogram (EKG) which was normal and a computerised tomogram (CT) of the head to evaluate the left sided facial droop. The appearance of the brain was normal with no ischemic areas or gross temporal bone lesions. Mild sinus changes were noted. The subject was discharged from hospital in good condition. The subject was treated Acyclovir, prednisone and 'Lacri-lube ophthalmic ointment'. Follow up literature report received on 17 Nov 2014: The reported event of "Bell's palsy" was cited in an article.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Facial paresis, Headache, Sinus disorder, Sinus polyp, VIIth nerve paralysis
Clinical narrative: Initial report received on 09 Dec 2009: This subject was enrolled in a study. The subject received the first dose of 15mcg A/H1N1 with 50% MF59 on 15 Sep 2009. The subject received the second dose on 06 Oct 2009. The subject's medical history included allergy to penicillin. On 16 Oct 2009, the subject was seen in the emergency room with right sided facial paralysis. The subject was diagnosed with Bell's palsy. The subject received treatment with Acyclovir and prednisone. The paralysis gradually resolved and the subject had completely recovered by 18 Nov 2009. The Bell's palsy was not considered serious, however Novartis considered the event to be medically significant. The investigator did suspect a relationship between the event and the study vaccine. Follow-up received on 14 Dec 2009: The patient did not drop out of the study due to the event. Follow-up received on 25 Jan 2010: The subject experienced facial droop with weakness of the right face (moderate) and headache. On 16 Oct 2009, the subject underwent an electrocardiogram (EKG) which was normal and a computerised tomogram (CT) of the head to evaluate the left sided facial droop. The appearance of the brain was normal with no ischemic areas or gross temporal bone lesions. Mild sinus changes were noted. The subject was discharged from hospital in good condition. The subject was treated Acyclovir, prednisone and 'Lacri-lube ophthalmic ointment'. Follow up literature report received on 17 Nov 2014: The reported event of "Bell's palsy" was cited in an article.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: White blood cell count increased
Clinical narrative: Initial report received on 09 Dec 2009: This subject was enrolled in a study. The subject received the first dose of 15mcg A/H1N1 with 50% MF59 on 15 Sep 2009. The subject received the second dose on 06 Oct 2009. The subject's medical history included allergy to penicillin. On 16 Oct 2009, the subject was seen in the emergency room with right sided facial paralysis. The subject was diagnosed with Bell's palsy. The subject received treatment with Acyclovir and prednisone. The paralysis gradually resolved and the subject had completely recovered by 18 Nov 2009. The Bell's palsy was not considered serious, however Novartis considered the event to be medically significant. The investigator did suspect a relationship between the event and the study vaccine. Follow-up received on 14 Dec 2009: The patient did not drop out of the study due to the event. Follow-up received on 25 Jan 2010: The subject experienced facial droop with weakness of the right face (moderate) and headache. On 16 Oct 2009, the subject underwent an electrocardiogram (EKG) which was normal and a computerised tomogram (CT) of the head to evaluate the left sided facial droop. The appearance of the brain was normal with no ischemic areas or gross temporal bone lesions. Mild sinus changes were noted. The subject was discharged from hospital in good condition. The subject was treated Acyclovir, prednisone and 'Lacri-lube ophthalmic ointment'. Follow up literature report received on 17 Nov 2014: The reported event of "Bell's palsy" was cited in an article.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Decreased appetite, Eye pruritus, Lacrimation increased, Lip swelling, Ocular hyperaemia
Clinical narrative: Received two vaccinations on 11-14-14. Woke up at 5:30 AM on 11-15-14 vomiting every 20 minutes for approximately 4 to 5 hours. At about 5 PM developed itchy rash (hives) all over (breasts, genitals, back, shoulder, neck, stomach, legs, hands, feet) 102.5 fever, tingling to fingers and feet (and swelling) and lips began to swell, eyes were also red, watery and itchy. Next two days feet stayed swollen and painful to walk on.  Loss of appetite for a few days also. Feet still swollen on writing this report 11/19/14.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia, Rash pruritic
Clinical narrative: Received two vaccinations on 11-14-14. Woke up at 5:30 AM on 11-15-14 vomiting every 20 minutes for approximately 4 to 5 hours. At about 5 PM developed itchy rash (hives) all over (breasts, genitals, back, shoulder, neck, stomach, legs, hands, feet) 102.5 fever, tingling to fingers and feet (and swelling) and lips began to swell, eyes were also red, watery and itchy. Next two days feet stayed swollen and painful to walk on.  Loss of appetite for a few days also. Feet still swollen on writing this report 11/19/14.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria, Vomiting
Clinical narrative: Received two vaccinations on 11-14-14. Woke up at 5:30 AM on 11-15-14 vomiting every 20 minutes for approximately 4 to 5 hours. At about 5 PM developed itchy rash (hives) all over (breasts, genitals, back, shoulder, neck, stomach, legs, hands, feet) 102.5 fever, tingling to fingers and feet (and swelling) and lips began to swell, eyes were also red, watery and itchy. Next two days feet stayed swollen and painful to walk on.  Loss of appetite for a few days also. Feet still swollen on writing this report 11/19/14.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortly after flu vaccine, chest tightness and SOB began.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Limb discomfort, Pain
Clinical narrative: Call from clt. on 11/24/14, stated received TDAP on 10/23/14 and left arm has been "tender with movement" since. States no fever noted, redness or drainage from injection site following immunization. States left arm at injection site feels sore when attempting to lie on left side. No medical attention has been sought, advised clt. to speak to her primary medical doctor about left arm discomfort.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Purulent discharge
Clinical narrative: Pt went to doctors office w/swollen arm, producing pus. Pt now on abx w/arm in sling.
Age: 1.26
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Culture throat, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Fever up to 104 starting the night after receiving vaccines.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Palpitations, Pyrexia
Clinical narrative: About 12 hrs. following shot woke with racing heart rate and fever of 102. Took TYLENOL. Fever and rapid heart rate gone in about 6 hrs. Sore arm at needlestick site for 5 days - red, swollen.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 11/7/14 Received flu vaccine in upper left deltoid. Shoulder pain decreased mobility has slowly increased. Unable to raise left arm over shoulder. Unable to step on left side.
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions noted or reported by parent.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: 11/19/2014 at 1120 pt. seen at clinic for allergic rhinitis at 1200 pt. receives flu vaccine. Pt. states around 1500 arm starts hurting. On 11/20/2014 at 0730 pt. notices red rash near injection site, cont. tenderness to area. On 11/21/2014 at 1525, pt contacts clinic and reports rash, warm to touch and tenderness. Pt advised to apply ice, ibuprofen and BENADRYL. Pt. reports had influenza vaccine in past and never had a reaction. Denied any angioedema. Pt. then went to urgent care on 11/21/2014 at 1800 for eval. Pt. notes received scanned in (HAIMS). Physician assessment indicated (+) tenderness to palpation of (L) deltoid - pain at injection site - (+) red rash in lateral mid-arm about 5 cm in diameter, well demarcated, warm to touch. Fine macular rash on (R) upper arm. Pt. diagnosed with cellulitis and instructed to use cold compresses and BENADRYL and F/U with PCM if no improvement. 11/24/2014 at 1400 pt. contacted to see how she is doing. Pt. states doing better, rash slowly fading.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: 11/19/2014 at 1120 pt. seen at clinic for allergic rhinitis at 1200 pt. receives flu vaccine. Pt. states around 1500 arm starts hurting. On 11/20/2014 at 0730 pt. notices red rash near injection site, cont. tenderness to area. On 11/21/2014 at 1525, pt contacts clinic and reports rash, warm to touch and tenderness. Pt advised to apply ice, ibuprofen and BENADRYL. Pt. reports had influenza vaccine in past and never had a reaction. Denied any angioedema. Pt. then went to urgent care on 11/21/2014 at 1800 for eval. Pt. notes received scanned in (HAIMS). Physician assessment indicated (+) tenderness to palpation of (L) deltoid - pain at injection site - (+) red rash in lateral mid-arm about 5 cm in diameter, well demarcated, warm to touch. Fine macular rash on (R) upper arm. Pt. diagnosed with cellulitis and instructed to use cold compresses and BENADRYL and F/U with PCM if no improvement. 11/24/2014 at 1400 pt. contacted to see how she is doing. Pt. states doing better, rash slowly fading.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia
Clinical narrative: Hoarseness for 4 days so far.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Pruritus, Rash erythematous, Skin burning sensation, Skin exfoliation
Clinical narrative: Light raised red rash involving tops of thighs, elbows and knees - very itchy.  This then progressed to systemic rash, initally itchy and dry, then very heavy skin flaked off entire body followed by 7 days of burning (on fire) skin condition.  Now on 3 weeks of steroids.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Facial pain, Fatigue, Malaise, Night sweats
Clinical narrative: Fatigue, chills, malaise beginning night of vaccine; getting worse over two weeks and including night sweats. She had a slight rash a few days after vaccine.  After two weeks symptoms improved but still fatigued a month later with occasional night sweats. Week 3 developed pain over left eyebrow that continued for 2 weeks.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Fatigue, chills, malaise beginning night of vaccine; getting worse over two weeks and including night sweats. She had a slight rash a few days after vaccine.  After two weeks symptoms improved but still fatigued a month later with occasional night sweats. Week 3 developed pain over left eyebrow that continued for 2 weeks.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Strong pain at injection site during the full injection. Continued pain still. Pain runs from injection site of front for arm down to left thumb, sometimes sharp pain. Have weakness and pain in shoulder, bicep and hand. Continues.
Age: 12.0
Sex: F
Vaccine: TYP
Symptoms: Malaise
Clinical narrative: FATHER CAME TO CLINIC WITH USED MEDS STATING CHILD HAD BECOME ILL.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Clients states rash about 11:00 PM on 11/24/2014.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Musculoskeletal pain, Tenderness
Clinical narrative: Soreness of shoulder girdle muscles, progressive weakness of deltoid, biceps, and triceps muscles.  Tenderness of above muscles plus trapezius of right.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Dyspepsia, Headache
Clinical narrative: Sigestive, stomach and head hurting severly, lasted 4 days.  Dr prescribed dexilant.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Eczema, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Began with a sudden fever of 102.6 (11/1/14) then rash on trunk and inside of arms, then spread to face. Urgent care visit (11/4/14) followed by an ER visit the next morning due to rash all over face (11/5/14). She has never had any allergies, or had any chronic eczema or skin conditions, and since the immunizations on 10/24/14 she has been diagnosed with eczema. Last night (11/24/14) she had an immediate allergic reaction to something she ate at dinner, which has never happened before. We believe this all came about after the immunizations administered on 10/24/14. She received DTaP, Hib-PRP-OMP, MMRV, and Pneumococcal Conjugate PCV13.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edema & deep purple skin tone top L shoulder to L elbow w/ moderate to severe pain x 2 days, tx w/ heat.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Muscle tightness, Muscular weakness, Pain, Sensory disturbance
Clinical narrative: Woke up for work around 6 AM and noticed a dull throbbing sensation around the injection site, like a muscle cramp.  The next day it began to spread and by the Friday 11/21/2014 morning my shoulder, neck, and arm were aching, felt like a cramp.  The muscle in my bicep was tense.  This morning, 11/25/2014 I noticed my index and middle finger tips were numb-ish on the same arm I got the shot. I could feel pain if I poked it with a needle or bit my finger tip but pressing on a hard surface left me with no sensation. That arm is also very weak. I was advised to submit this report by my company's employee health dept. The pain is still there as of submitting this report.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Skin warm, Swelling
Clinical narrative: Pt noticed on 11/18/14 that she got a baseball-size swollen area that was red & warm to the touch. Had just regular muscle pain after the injection with no swelling, but then noticed the above sx on 11/18/14. Did come in to our office where she got her injection yesterday, 11/24/14 & area was still approx. Apple size, red, warm to the touch.