chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Five hours post vax the pt experienced itching all over. The vaccinee was treated with Benadryl. The outcome was not reported. Follow up information indicates that the symptoms resolved within 3 days.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt experienced itching the the afternoon post vax. The following day he received an IM shot of Benadryl. The pts reaction resolved one and a half days post vax.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Erythema, Injection site rash, Lymphadenopathy, Malaise
Clinical narrative: Two hours post vax pt experienced general malaise, enlarged lymph nodes under his chin and difficulty swallowing. Pt was treated with Benadryl IM and taken to the ER where he was treated with an unspecified medication. the reporter states that the vaccinee denied and difficulty breathing or swallowing, his lungs were clear and no complaints of nausea or vomiting; heart rate was 80 bpm. The vaccinee stated he had a rash at the injection site. 10 minutes after the initial onset pts blood pressure was 120/80 and heart rate  60 bpm. 10 minutes later vaccinee complained of difficulty swallowing and felt like it was getting worse the pt was given Benadryl IM. the vaccinee was seen by a physician who noted that his throat had redness and swelling. He was taken to the ER where he was treated with an unspecified medication. The vaccinee was followed up with 3.5 hours later when he was reported to be back at work and feeling okay. The vaccinee stated that something like this happened last year after vax.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Vaccine positive rechallenge
Clinical narrative: Two hours post vax pt experienced general malaise, enlarged lymph nodes under his chin and difficulty swallowing. Pt was treated with Benadryl IM and taken to the ER where he was treated with an unspecified medication. the reporter states that the vaccinee denied and difficulty breathing or swallowing, his lungs were clear and no complaints of nausea or vomiting; heart rate was 80 bpm. The vaccinee stated he had a rash at the injection site. 10 minutes after the initial onset pts blood pressure was 120/80 and heart rate  60 bpm. 10 minutes later vaccinee complained of difficulty swallowing and felt like it was getting worse the pt was given Benadryl IM. the vaccinee was seen by a physician who noted that his throat had redness and swelling. He was taken to the ER where he was treated with an unspecified medication. The vaccinee was followed up with 3.5 hours later when he was reported to be back at work and feeling okay. The vaccinee stated that something like this happened last year after vax.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Back pain, Groin pain, Muscle spasms, Myalgia
Clinical narrative: Approximately 8.5 hours post vax the pt experienced severe deep tendon muscle pain. At 7PM pt took Biox tablet for backache. At 10PM she noticed muscle cramps on the inside of thighs which was relieved with movement. Half and hour later she was awakened by severe deep tendon pain which ran from the outside calf from ankle to knee and then up inside her thighs to her groin. She states that she was screaming and crying and could not relax. Her husband, an MD, tried to massage her muscles and the report states that he couldn't feel any spasms. The pt was inconsolable and her physician husband administered and unspecified amount of IV Valium. She woke up feeling fine. No further muscle cramps or complaints of discomfort. Pt is cold by nature and experienced an unusual feeling of extreme heat during this event.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 days post vax the pt experienced pain and redness at injection site. Pt was advised to treat with an ice pack and Tylenol. 5 days post vax the injection remains red but is no longer painful.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: One day post vax pt experienced pain, slight swelling and redness at injection site. Follow up information indicates the she developed a lump the size of a golf ball which was red in color and very painful. Pt has had many influenza vaccine in the past and never experience and reaction.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: One day post vax the pt experienced redness and heat at the injection site (4 inch circumference). Pt refused treatment and the event was ongoing.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Pt received an expired dose of Fluvirin vaccine and experienced chills, low grade fever, achiness and headache, within 24 hours post vax. Symptoms resolved quickly.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Immediately following vaccination, pt experienced itching in her whole arm. Within hours, a 4" diameter area at the injection site became red, hard, hot and itchy. Pt treated with hydrocortisone for itching. The on duty nurse described the area as induration with redness.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt experienced an area at the injection site which was swollen, red and hot to the touch, the same evening as receiving vaccination. The afflicted area was the size of a tennis ball. The arm was very sore and felt extremely heavy. The swelling lasted for 5 days but symptoms decreased daily. The stiffness lasted for 2-3 days. Pt states she received an influenza vax in 1998 without incident.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness
Clinical narrative: Pt experienced an area at the injection site which was swollen, red and hot to the touch, the same evening as receiving vaccination. The afflicted area was the size of a tennis ball. The arm was very sore and felt extremely heavy. The swelling lasted for 5 days but symptoms decreased daily. The stiffness lasted for 2-3 days. Pt states she received an influenza vax in 1998 without incident.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt experienced a fairly significant local reaction, described as firm, warm, erythematous area measuring from 60-80 mm in diameter. Pt's symptoms resolved, time to onset and duration not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt experienced fairly significant local reaction described as firm, warm, erythematous area measuring from 60 to 80 mm in diameter. Symptoms resolved, time of onset and duration not reported.
Sex: U
Vaccine: FLU3
Symptoms: Feeling hot, Injection site hypersensitivity
Clinical narrative: Pt experienced a firm, warm, erythematous area measuring 60 - 80 mm in diameter local to injection site.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: 2 hours post vax the pt experienced a 5 cm rash at the injection site. Pt was treated with Benadryl.
Age: 3.4
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Chills, Conjunctivitis, Cough, Pneumonia
Clinical narrative: 4 days post vax the pt developed viral respiratory symptoms treated with Hydrocodone nitrate, Tylenol and Motrin. Symptoms resolved 12 days post onset. The following day pt returned to the clinic complaining of conjunctivitis and a persistent cough. 19 days post vax, the pt developed a fever and cough with shaking chills and 20 days post vax pt was diagnosed with pneumonia. Pt was hospitalized the following day and on admission a chest x-ray revealed peribronchial thickening in perihilar regions which was compatible with tracheobronchitis. Pt was treated for presumptive bacterial pneumonia in hospital . The event resolved after 18 days.
Age: 3.4
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: 4 days post vax the pt developed viral respiratory symptoms treated with Hydrocodone nitrate, Tylenol and Motrin. Symptoms resolved 12 days post onset. The following day pt returned to the clinic complaining of conjunctivitis and a persistent cough. 19 days post vax, the pt developed a fever and cough with shaking chills and 20 days post vax pt was diagnosed with pneumonia. Pt was hospitalized the following day and on admission a chest x-ray revealed peribronchial thickening in perihilar regions which was compatible with tracheobronchitis. Pt was treated for presumptive bacterial pneumonia in hospital . The event resolved after 18 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Blood pressure increased, Face oedema, Pyrexia, Rash maculo-papular
Clinical narrative: 2 days post vax pt developed hives on the left cheek. Within a day of this the left cheek became a little swollen. Within one week of vax the pt developed hives to the lower body and left arm. One week post onset the vaccinee experienced severe epigastric pain and elevated blood pressure, 3 days later symptoms were persisting and her lips had become swollen. Pt developed new hives which worsened; her head had swollen down to her forehead, she had a fever of 102 and chills. The following day she was not able to open her right eye and could barely open the left eye. Follow up information states the pt experienced a pruritic rash on legs and left side of face, large erythematous macular plaque on left thigh and right popleteal and lesion on shin 4 days post vax.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 2 days post vax pt developed hives on the left cheek. Within a day of this the left cheek became a little swollen. Within one week of vax the pt developed hives to the lower body and left arm. One week post onset the vaccinee experienced severe epigastric pain and elevated blood pressure, 3 days later symptoms were persisting and her lips had become swollen. Pt developed new hives which worsened; her head had swollen down to her forehead, she had a fever of 102 and chills. The following day she was not able to open her right eye and could barely open the left eye. Follow up information states the pt experienced a pruritic rash on legs and left side of face, large erythematous macular plaque on left thigh and right popleteal and lesion on shin 4 days post vax.
Age: 1.25
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Anaphylactic reaction, Respiratory distress
Clinical narrative: A physician reported that a 15 month old female received an injection of Hibtiter on 7/13/00. Within 5 minutes, she developed a
Age: 1.25
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Oedema, Urticaria
Clinical narrative: A physician reported that a 15 month old female received an injection of Hibtiter on 7/13/00. Within 5 minutes, she developed a
Age: 3.0
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Asthenia, Autism, Convulsion, Crying, Injection site hypersensitivity
Clinical narrative: Post vax, the pt developed redness and swelling at injection site. The child cried most of the day after injection. He had a fever of 102.9; by that evening-after multiple doses of Tylenol; he was weak and not as responsive as his norm. Pt recovered from acute reaction but has seizure disorder and autism.
Age: 3.0
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Injection site oedema, Petit mal epilepsy, Pyrexia
Clinical narrative: Post vax, the pt developed redness and swelling at injection site. The child cried most of the day after injection. He had a fever of 102.9; by that evening-after multiple doses of Tylenol; he was weak and not as responsive as his norm. Pt recovered from acute reaction but has seizure disorder and autism.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Pain
Clinical narrative: The pt experienced persistent pain after the 5th Anthrax shot, she experienced numbness throughout entire left arm. The pt also stated that the pain has not subsided even after taking Tylenol, aspirin. etc.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: The pt had a large local reaction with approximately 5 cm diameter area of erythema, tenderness, mild pruritus, edema treated with oral antihistamines, Motrin, and local steroid cream.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: 3 hours post vax, the infant developed an "uncharacteristic" high - pitched crying episode for 30 minutes. The symptoms abated and has not reoccurred. No other symptoms such as fever. The child slept well after the episode and was her "usual self" upon awakening.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Decreased appetite, Pyrexia, Rash, Stupor
Clinical narrative: Pt experienced a quarter size circle on chest, rash on chest, excessive crying, lack of appetite, non-alert, extremely thirsty and auxilary temp of 100.6
Age: 0.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Thirst
Clinical narrative: Pt experienced a quarter size circle on chest, rash on chest, excessive crying, lack of appetite, non-alert, extremely thirsty and auxilary temp of 100.6
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt experienced swollen and red right arm that is painful to touch.
Age: 53.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt experienced scalp and facial itching 15 minutes post vax. Pt was given Dimetapp but hives/rash appeared on neck and shoulders 2 hours post vax. Pt was treated with Benadryl.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: 2 days post vax pt experienced fever, redness, swelling, tenderness and injection site hot to touch. Pt also experienced swelling and tenderness at lymph nodes left axillary area.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Vasodilation procedure
Clinical narrative: 2 days post vax pt experienced fever, redness, swelling, tenderness and injection site hot to touch. Pt also experienced swelling and tenderness at lymph nodes left axillary area.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Swelling, Vasodilation procedure
Clinical narrative: Pt experienced swelling, itching and heat
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Pt experienced allergic reaction after immunizations.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Pt experienced a severe local injection site reaction.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: 1 day post vax pt experienced an itchy blotchy rash with bruising at the center of the lesions. Pt was referred to the dermatologist with a very widespread urticated eruption. Pt was treated with antihistamines and topical emollients and the rash resolved after about 4 weeks.
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Pt felt a burning sensation once the vaccine was administered. Pt also reported a missing label.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Pt experienced itching after receiving influenza vaccine inadvertently. The intended vaccine was tuberculin. Itching resolved within 24 hours.
Age: 5.0
Sex: M
Vaccine: TD
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: Pt experienced a fever, occasional shaking and a mild headache one day post vax.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Two day post vax pt developed a swollen hot bicep. Physician diagnosed cellulitis and prescribed Amoxicillin for 10 days. Pt was seen again 9 days later and the arm was still sore with decreased swelling and tenderness.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, OPV, TD
Symptoms: Pyrexia, Tremor
Clinical narrative: One day post vax he developed a fever of 103 F and trembling all over his body.
Sex: M
Vaccine: RV
Symptoms: Coma, Cyanosis, Dyspnoea, Hypotonia, Nystagmus
Clinical narrative: Physician reported that a pt died following the receipt of RotaShield. The baby arrived unresponsive, blue, difficulty in breathing, hypotonic, had vertical nystagmus, had fever, stridor, wheezing, looked cyanotic.
Sex: M
Vaccine: RV
Symptoms: Pyrexia, Stridor, Unevaluable event, Wheezing
Clinical narrative: Physician reported that a pt died following the receipt of RotaShield. The baby arrived unresponsive, blue, difficulty in breathing, hypotonic, had vertical nystagmus, had fever, stridor, wheezing, looked cyanotic.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, RV
Symptoms: Constipation
Clinical narrative: For two weeks post vax pt experienced constipation, having bowel movements only every 4 days days with straining. Prior to vax, the pt had soft stools daily.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV
Symptoms: Dehydration, Diarrhoea, Irritability, Listless, Pain
Clinical narrative: Pt developed on and off episodes of vomiting, diarrhea, pain and irritability. Pt reportedly had as many as 30 bowel movements in one day. During the week of 02/20/2000, the child had a fever of 102F. Pt became dehydrated and listless.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt developed on and off episodes of vomiting, diarrhea, pain and irritability. Pt reportedly had as many as 30 bowel movements in one day. During the week of 02/20/2000, the child had a fever of 102F. Pt became dehydrated and listless.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: 60 hours post vax pt developed a fever of 105F.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Three days post vax pt developed loose stools.  On the third and fourth days post onset the pt passed gross blood in his stool. Stool culture and culture for Ecoli were negative.
Age: 0.5
Sex: U
Vaccine: RV
Symptoms: Hepatomegaly
Clinical narrative: Approximately 13 months post vax pt developed hepatomegaly with fatty infiltrates. A small portion of the liver was normal.
Age: 0.4
Sex: F
Vaccine: RV
Symptoms: Crying, Grunting, Opisthotonus
Clinical narrative: The mother of a 5 month old female reported that her daughter received her 2nd dose of Rota Shield in July, 1999. The day of IZ, the infant developed uncontrollable screaming. That resolved. The infant then became "just uncomfortable" with grunting, groaning, and arching of her back. The physician "found nothing wrong." The physician originally attributed this event to pre-existing gastroesophageal reflux. The infant outgrew the reflux but, as of 10/21/99, remained "uncomfortable at times."
Sex: U
Vaccine: RV
Symptoms: Constipation, Hyperhidrosis
Clinical narrative: Pt who participated in a RotaShield clinical study 4-5 years ago is now experiencing chronic constipation and profuse sweating.
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Subsequent to receiving vaccine pt developed a sore arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hours post vax, pt developed an injection site reaction characterized by redness, warmth and swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hours post vax, pt developed an injection site reaction characterized by redness, warmth and swelling.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hours post vax the pt developed an injection site reaction characterized by redness, warmth and swelling.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Irritability, Myalgia, Pallor, Pharyngitis
Clinical narrative: One day post vax the pt developed a fever of 104F. Pt experienced frequent urination, coughing, head cold symptoms, pallor, muscle pains in her thighs, irritability and restlessness. Pt was treated with Ditropan.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Pollakiuria, Pyrexia, Restlessness, Rhinitis
Clinical narrative: One day post vax the pt developed a fever of 104F. Pt experienced frequent urination, coughing, head cold symptoms, pallor, muscle pains in her thighs, irritability and restlessness. Pt was treated with Ditropan.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Pt developed an injection site reaction characterized by severe swelling and warmth.
Age: 1.75
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Contusion, Erythema, Oedema
Clinical narrative: One day post vax pt developed early cellulitis characterized by swelling and redness from his left thigh to his knee with mild bruising. Pt was treated with Duricef and warm soaks.
Age: 1.25
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: One day post vax pt developed an injection site reaction characterized by redness, swelling and tenderness.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Irritability, Pyrexia, Rash erythematous
Clinical narrative: Within 24 hours post vax pt developed a fever of 101F and a red, raised rash on her face, hand and at the injection site. Pt was also fussy. The fever abated within one day.
Age: 5.0
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: One day post vax the pt developed an injection site reaction characterized by redness, swelling and pain.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Irritability, Vasodilation procedure
Clinical narrative: Two days post vax pt was seen in the ER subsequent to developing an injection site reaction characterized by a 9 X 8 cm area of redness, warmth, and swelling in the right thigh. The circumference of the right thigh was 30 cm while the circumference of the left thigh of 26 cm. Pt also became fussy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: Subsequent to receiving vax pt developed a 3 X 3.25 inch area of redness, warmth and swelling at the injection site. Within 2 days post vax the swelling had doubled in size.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: Within 24 hours post vax pt developed an injection site reaction characterized by redness, warmth and swelling.
Age: 1.25
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: One day post vax pt developed an injection site reaction characterized by redness, swelling and tenderness.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Vasodilation procedure
Clinical narrative: One day post vax pt developed an injection site reaction characterized by redness and warmth. Pt was treated with warm compresses.
Age: 57.0
Sex: U
Vaccine: TD, TD
Symptoms: Ecchymosis, Headache, Influenza, Lymphadenopathy, Myalgia
Clinical narrative: p/vax pt exp fever; chills; body aches; h/a; nausea; arm from shoulder to elbow red; purple; yellow so swollen; looked like popeye's arm; so sick like pt had flu; swelling pain arm & neck x6day
Age: 57.0
Sex: U
Vaccine: TD, TD
Symptoms: Nausea, Neck pain, Oedema peripheral, Pyrexia, Vasodilatation
Clinical narrative: p/vax pt exp fever; chills; body aches; h/a; nausea; arm from shoulder to elbow red; purple; yellow so swollen; looked like popeye's arm; so sick like pt had flu; swelling pain arm & neck x6day
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Hypertension, Injection site pain, Personality disorder, Stevens-Johnson syndrome
Clinical narrative: It was reported that a 52 year old female received a Fluzone SV 99-00 vaccination on 10/26/1999 at 6:00 pm. Reportedly immediately after the vaccination, the patient experienced a warm flush all over the body, she felt "weird". Her blood pressure rose to 168/112 and pulse to 106. The patient went to the ER where the doctor prescribed Enderal. The patient then experienced pain in her chest. The patient was then taken to another hospital where a doctor prescribed Prednisone. The patient also developed large blisters on her hands and had spotted vision in her right eye. The patient had not yet fully recovered, she is still experiencing pain at the injection site. From follow up correspondence received at Aventis Pasteur Inc. On 03/10/00, it was reported, "No additional information". From follow up correspondence received at Aventis Pastreur,Inc. on 05/15/00, it was reported that the patient did fully recover from the adverse event, and there was no result of permanenet disability. It was also reported that the patient had a pre-existing condition of Stephens Johnson syndrome. The patient was being treated for this condition at the time of vaccination. Follow-up 06/14/02: during internal review of all files, it was deemed necessary to amend the report by updating Adverse Event coding (added depersonalization, chest pain and tachycardia). Also re-ranked Adverse Events which did not change the onset date.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tachycardia, Vasodilatation, Visual disturbance
Clinical narrative: It was reported that a 52 year old female received a Fluzone SV 99-00 vaccination on 10/26/1999 at 6:00 pm. Reportedly immediately after the vaccination, the patient experienced a warm flush all over the body, she felt "weird". Her blood pressure rose to 168/112 and pulse to 106. The patient went to the ER where the doctor prescribed Enderal. The patient then experienced pain in her chest. The patient was then taken to another hospital where a doctor prescribed Prednisone. The patient also developed large blisters on her hands and had spotted vision in her right eye. The patient had not yet fully recovered, she is still experiencing pain at the injection site. From follow up correspondence received at Aventis Pasteur Inc. On 03/10/00, it was reported, "No additional information". From follow up correspondence received at Aventis Pastreur,Inc. on 05/15/00, it was reported that the patient did fully recover from the adverse event, and there was no result of permanenet disability. It was also reported that the patient had a pre-existing condition of Stephens Johnson syndrome. The patient was being treated for this condition at the time of vaccination. Follow-up 06/14/02: during internal review of all files, it was deemed necessary to amend the report by updating Adverse Event coding (added depersonalization, chest pain and tachycardia). Also re-ranked Adverse Events which did not change the onset date.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Haemoglobin decreased, Hypotonia, Stupor
Clinical narrative: A physician reported that a 2 month old male, post vax, developed a cold. On 5/19/00, he had a hyotonic-hyporesponsive episode with apnea. The infant required intubation and was hospitalized in the ICU. The infant received a blood transfusion.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Hypotonia, Mental impairment, Restlessness
Clinical narrative: A physician reported that a 2 month old male, post vax, developed a cold. On 5/19/00, he had a hyotonic-hyporesponsive episode with apnea. The infant required intubation and was hospitalized in the ICU. The infant received a blood transfusion.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Depersonalisation, Dyspnoea, Hypotonia, Hypoxia, Restlessness
Clinical narrative: A physician reported that a 2 month old male, post vax, developed a cold. On 5/19/00, he had a hyotonic-hyporesponsive episode with apnea. The infant required intubation and was hospitalized in the ICU. The infant received a blood transfusion.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Gastrointestinal disorder, Pyrexia, Vomiting
Clinical narrative: Same day post vax, the pt developed a fever and vomiting and GI symptoms.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Same day post vax, the pt developed a fever and vomiting and GI symptoms.
Age: 80.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Pain, Skin depigmentation
Clinical narrative: Information has been received from a LPN concerning an 80 year old white male who on 5/17/2000 was vaccinated with 1st dose of pneumococcal vaccine 23 polyvalent (533102/1217J). On 5/17/2000, the pt developed pain, redness and swelling at the injection site. This was later checked by a physician who prescribed Zyrtec. The pt experienced difficulty elevating his arm and has an area of depigmentation under the injection site measuring about 3cm X5cms. On 5/20/00, the pt presented to the ER with redness streaking up the bicepts from the antecubital area, with significant discomford and swelling. The pt was dx'd with cellulitis and treated with Rocephin IV and placed on Keflex. Upon internal review, cellulitis was considered to be an Other Medical Event. The remaining physical exam was unremarkable. On 5/22/00, the pt was followed-up in the ER. It was noted that he still some edema of the left arm with no visible erythema and no local increased temperature. The pt did have a minimal amount of erythema still and some resolving ecchymosis noted in the left antecubital fossa. No areas of purulent material were visible. The reporter has a concern about the lot of vaccine administered (633102/1217J). An additional pt had a similar experience following exposure to pneumociccal vaccine 23 polyvalent. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Hypokinesia, Injection site cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning an 80 year old white male who on 5/17/2000 was vaccinated with 1st dose of pneumococcal vaccine 23 polyvalent (533102/1217J). On 5/17/2000, the pt developed pain, redness and swelling at the injection site. This was later checked by a physician who prescribed Zyrtec. The pt experienced difficulty elevating his arm and has an area of depigmentation under the injection site measuring about 3cm X5cms. On 5/20/00, the pt presented to the ER with redness streaking up the bicepts from the antecubital area, with significant discomford and swelling. The pt was dx'd with cellulitis and treated with Rocephin IV and placed on Keflex. Upon internal review, cellulitis was considered to be an Other Medical Event. The remaining physical exam was unremarkable. On 5/22/00, the pt was followed-up in the ER. It was noted that he still some edema of the left arm with no visible erythema and no local increased temperature. The pt did have a minimal amount of erythema still and some resolving ecchymosis noted in the left antecubital fossa. No areas of purulent material were visible. The reporter has a concern about the lot of vaccine administered (633102/1217J). An additional pt had a similar experience following exposure to pneumociccal vaccine 23 polyvalent. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Skin depigmentation
Clinical narrative: Information has been received from a LPN concerning an 80 year old white male who on 5/17/2000 was vaccinated with 1st dose of pneumococcal vaccine 23 polyvalent (533102/1217J). On 5/17/2000, the pt developed pain, redness and swelling at the injection site. This was later checked by a physician who prescribed Zyrtec. The pt experienced difficulty elevating his arm and has an area of depigmentation under the injection site measuring about 3cm X5cms. On 5/20/00, the pt presented to the ER with redness streaking up the bicepts from the antecubital area, with significant discomford and swelling. The pt was dx'd with cellulitis and treated with Rocephin IV and placed on Keflex. Upon internal review, cellulitis was considered to be an Other Medical Event. The remaining physical exam was unremarkable. On 5/22/00, the pt was followed-up in the ER. It was noted that he still some edema of the left arm with no visible erythema and no local increased temperature. The pt did have a minimal amount of erythema still and some resolving ecchymosis noted in the left antecubital fossa. No areas of purulent material were visible. The reporter has a concern about the lot of vaccine administered (633102/1217J). An additional pt had a similar experience following exposure to pneumociccal vaccine 23 polyvalent. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Blood bilirubin increased, Jaundice
Clinical narrative: FU info received states pt experienced nausea and vomiting and was diagnosed with viral illness. He then went to Guatemala and his nausea and anorexia continued. He was seen by a physician and found to have slightly jaundiced sclera and increased bilirubin. He was tentatively diagnosed with hepatitis A, blood tests were negative.
Age: 1.7
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cerebellar ataxia, Difficulty in walking, Rash vesicular
Clinical narrative: On 7/6/00, the pt was vaccinated with 1st dose of varicella. On 7/12/00, the pt resented to a physician with acute cerebellar ataxia and one varicella lesion on her soft palate. Upon internal review, the acute cerebellar ataxia was considered to an Other Medical Event. The physician noted that the ataxia is not severe, but that her walking is definitely affected. He indicated that the pt had previously been walking without any problems. On 7/12/00, at the time of the office visit, the pt struggled to walk. He stated that as of 7/13/00, the pt's symptoms remain unchanged and she has no problems with her arms, hands or eyes. Additionally, it was noted that she has no other signs or symptoms.  Additional information has been requested. Follow-up information from a physician reported that the ataxis primarily affected the pt's gait. As of 7/31/00, the ataxia had resolved entirely by exam, although the pt's "parents still report some ataxia first thing in the morning". It was noted that no tests were done and that the physician had a telephone consult with pediatric neurologist. No further information is expected.
Age: 1.7
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coordination abnormal
Clinical narrative: On 7/6/00, the pt was vaccinated with 1st dose of varicella. On 7/12/00, the pt resented to a physician with acute cerebellar ataxia and one varicella lesion on her soft palate. Upon internal review, the acute cerebellar ataxia was considered to an Other Medical Event. The physician noted that the ataxia is not severe, but that her walking is definitely affected. He indicated that the pt had previously been walking without any problems. On 7/12/00, at the time of the office visit, the pt struggled to walk. He stated that as of 7/13/00, the pt's symptoms remain unchanged and she has no problems with her arms, hands or eyes. Additionally, it was noted that she has no other signs or symptoms.  Additional information has been requested. Follow-up information from a physician reported that the ataxis primarily affected the pt's gait. As of 7/31/00, the ataxia had resolved entirely by exam, although the pt's "parents still report some ataxia first thing in the morning". It was noted that no tests were done and that the physician had a telephone consult with pediatric neurologist. No further information is expected.
Age: 1.6
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cerebellar ataxia, Difficulty in walking, Rash vesicular
Clinical narrative: Ataxic gait developed 6 days post vax.
Age: 1.6
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coordination abnormal
Clinical narrative: Ataxic gait developed 6 days post vax.
Age: 53.0
Sex: M
Vaccine: LYME, TD
Symptoms: Abnormal labour, Demyelination, Fall, Injection site pain, Multiple sclerosis
Clinical narrative: Cramping in arm, hand, and legs in a 53 year old male receiving Lymerix for prevention. This report was received from pt and confirmed by physician with follow-up medical record. His left deltoid are hurt for 32-48 hours post vax. then while taking a shower, at 08:00, he felt "waves of tingling sensation all over his body, and he went down onto his knees." He stated that he experienced cramping (muscle spasms) in his left arm, hand and "he thought" his legs. This lasted for 15-30 seconds. He confirmed that he was alert and aware of his surroundings at all times. The physician confirmed that the account of the events provided by the pt to SB was identical to that reported to him. The reporting physician does not consider these events to represent a seizure. He reported that an MRI show multiple areas in the white matter of increased signal, which did not enhance with gadolinium in the white matter. The pt complained of leg weakness not confirmed by strength testing upon physical exam. He complained of a tingling paresthesia in the radial nerve distribution of the right upper extremity extending distally form the mid-forearm. Referred to a neurologist who examined him on 06/09. It is not know if the pt underwent lumbar puncture. The reporting physician considers the differential dx to include multiple sclerosis, although he emphasized that the pt's current dx remains uncertain. Arm paresthesias is improving but ongoing. The neurologist was suspicious of a "mild post-vaccinal related demyelinative syndrome." Symptoms are improving with time consistent with monophasic illness. Neurologist stated, "It seemed reasonable that the pt may have been genetically susceptible to a post-vaccinal demyelination sydrome in view of mother with lupus." Outcome of event is ongoing.
Age: 53.0
Sex: M
Vaccine: LYME, TD
Symptoms: Muscle spasms, Muscular weakness, Nervous system disorder, Neurological examination abnormal, Paraesthesia
Clinical narrative: Cramping in arm, hand, and legs in a 53 year old male receiving Lymerix for prevention. This report was received from pt and confirmed by physician with follow-up medical record. His left deltoid are hurt for 32-48 hours post vax. then while taking a shower, at 08:00, he felt "waves of tingling sensation all over his body, and he went down onto his knees." He stated that he experienced cramping (muscle spasms) in his left arm, hand and "he thought" his legs. This lasted for 15-30 seconds. He confirmed that he was alert and aware of his surroundings at all times. The physician confirmed that the account of the events provided by the pt to SB was identical to that reported to him. The reporting physician does not consider these events to represent a seizure. He reported that an MRI show multiple areas in the white matter of increased signal, which did not enhance with gadolinium in the white matter. The pt complained of leg weakness not confirmed by strength testing upon physical exam. He complained of a tingling paresthesia in the radial nerve distribution of the right upper extremity extending distally form the mid-forearm. Referred to a neurologist who examined him on 06/09. It is not know if the pt underwent lumbar puncture. The reporting physician considers the differential dx to include multiple sclerosis, although he emphasized that the pt's current dx remains uncertain. Arm paresthesias is improving but ongoing. The neurologist was suspicious of a "mild post-vaccinal related demyelinative syndrome." Symptoms are improving with time consistent with monophasic illness. Neurologist stated, "It seemed reasonable that the pt may have been genetically susceptible to a post-vaccinal demyelination sydrome in view of mother with lupus." Outcome of event is ongoing.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Convulsion, Crying, Pain, Pyrexia
Clinical narrative: Mother states child had fever off and on until 3/26/98. She gave Tylenol and Motrin off and on for the fever. On 3/26/98, fever up to 106.7 and child had a seizure. Child was taken to hospital and was hospitalized for 1 week. Child also, had excessive crying and "aching" prior to 3/26/98 and after 3/9/98 but didn't know what they were.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Hypersensitivity, Muscular weakness, Oedema peripheral, Red blood cell count decreased
Clinical narrative: 28 year old male with complaint of intermittent rash and increasing bilateral knee and hand swelling and pain that began, post vax, 3rd dose and progressively worsened after the 4th dose on 11/23/98. Hard to climb stairs. Abnormal weight gain despite strenuous exercise program at physical training. Anthrax provider thought it might be related to vaccine received 8 or 9 months ago. Skin had mild bilateral erythematous region. Temporal region with blanches. Minimal erythema left and right of anterior neck at collar line. Questionable exercise induced urticaria vs less likely reaction to Anthrax vaccine.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria, Weight increased
Clinical narrative: 28 year old male with complaint of intermittent rash and increasing bilateral knee and hand swelling and pain that began, post vax, 3rd dose and progressively worsened after the 4th dose on 11/23/98. Hard to climb stairs. Abnormal weight gain despite strenuous exercise program at physical training. Anthrax provider thought it might be related to vaccine received 8 or 9 months ago. Skin had mild bilateral erythematous region. Temporal region with blanches. Minimal erythema left and right of anterior neck at collar line. Questionable exercise induced urticaria vs less likely reaction to Anthrax vaccine.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Redness, massive swelling of entire arm from near injection site, down arm to wrist. Pt could not bend arm. Entire arm was warm prescribed oral corticosteroids (prednisome) and Benadryl, 3 days. Pt is Aircrew (flyer) and was grounded and had follow-up with flight surgeon MD Allergist. Swelling was resolved after 3 to 4 days. Event was serious enough to warrant ER visit.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling to 10cm.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right arm swollen and red.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling, warmth and tenderness at injection site and from shoulder to elbow, width approximately, 8cm wide; within 24 hours of vaccination.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Convulsion, Depressed level of consciousness, Lethargy
Clinical narrative: Lethargy spell with seizure-like activity with 2-3 weeks of prolonged poor feeding and decreasing LOC.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Eyelid oedema, Lacrimation increased, Sneezing, Urticaria
Clinical narrative: 15 minutes, post vax, pt had generalized urticaria, eyelid edema with excessive tearing and sneezing plus wheezing and shortness of breath. Pt was given, epinephrine X 1, albuterol nebulizer X 2 and PO prednisone. Pt was transferred to the hospital via ambulance in much improved condition.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: 15 minutes, post vax, pt had generalized urticaria, eyelid edema with excessive tearing and sneezing plus wheezing and shortness of breath. Pt was given, epinephrine X 1, albuterol nebulizer X 2 and PO prednisone. Pt was transferred to the hospital via ambulance in much improved condition.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt presented to office with chickenpox.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia
Clinical narrative: Pt experienced swollen neck glands, joint pain and 102 temperature 4 hours post vax.
Age: 23.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Abdominal pain, Muscle rigidity
Clinical narrative: Pt developed motor rigidity with clenching of teeth and abdominal cramping. Pt treated with Benadryl.
Age: 1.02
Sex: U
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Nasal congestion, Otitis media, Pyrexia, Rash
Clinical narrative: 10 days post vax pt was diagnosed with otitis media with heat rash on face and temperature of 101 and stuffy nose. Pt treated with Amoxicillin. Spots noted, hard to touch, red in color, no oozing or scabbing.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Pruritus
Clinical narrative: 7 days post vax pt experienced a local reaction characterized by swelling, itchy shoulder. Pt was treated with Atarax and Tylenol.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Pt experienced redness, swelling and warmth locally surrounding the injection site.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site mass
Clinical narrative: Pt experienced large induration, warmth and redness at injection site - right arm. Pt was treated with Keflex.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Immediately  post vax pt experienced induration and redness at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling
Clinical narrative: Left upper arm to below elbow warm, swollen and tense. Pt treated with Benadryl.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: 1-2 hours post vax pt developed a rash on right side of face. 1 day post vax pts rash progressing with fever of 103. 2 days post vax pt seen in ER with hives over face, neck and arms, treated with Benadryl and steroid injections. Pt continues to be treated with Benadryl and Prednisone.
Age: 7.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Jaundice, Viral infection
Clinical narrative: 2 weeks post vax pt experienced slight jaundice. Pt was diagnosed with viral illness.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed a low grade fever of 102 that lasted for 7 days. When fever subsided the pt broke out in a rash that lasted for 3 days.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema
Clinical narrative: Pt experienced redness and bruising at injection site. Site was warm to the touch. Edematous around the area; temperature of 96.9.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Infection
Clinical narrative: Subsequent to receiving an injection of Flu Shield, pt was seen by a physician who diagnosed hepatitis B. Physician indicated in a follow-up report that he does not believe the pt developed hepatitis B as a result of the vax.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A physician reported that many pts received an injection of Flu Shield and developed the same severity of symptoms and complications as those pts who were not vaccinated.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site oedema
Clinical narrative: Within a few hours post vax, pt developed swelling at the injection site which looked like a coconut and numbness at the base of her wrist. The injection site was inside her forearm 2.5 inches from the elbow. Within two days post vax a large amount of swelling was present and she was seen in the ER.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: A pharmacist reported that several employees received Flu Shield and subsequently developed the flu. The reporter stated that the vaccine may have been left out.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Muscular weakness, Myalgia, Oedema peripheral
Clinical narrative: A few days post vax pt developed generalized muscle aches, weakness in her arms and legs, swollen hands and malaise.