chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypersensitivity, Pyrexia, Urticaria, Viral infection
Clinical narrative: Report 20020017131 describe a viral syndrome in a 7 week old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. This report was received from a nurse. Medical history included "difficult delivery: at gestational age 39 weeks and meconium aspiration treated with extracorporeal membrane oxygenation, mechanical ventilation, and continuous positive airway pressure. Concurrent conditions were not specified. Concurrent medications included paracetamol. On 10/31/2001, the infant received his first injection of Infanrix. On that date, he also received his first injection of 7-valent neumococcal conjugate vaccine combination haemophilus influenzae type b conjugate/hepatitis B vaccine and inactivated poliomyelitis virus vaccine. Eight hours post-immunization, the infant developed generalized hives and fever of 101 to 103 degrees F. He was hospitalized on 11/01/2001 with a diagnosis of viral syndrome. He was treated with diphenhydramine (Benadryl). He recovered on 11/02/01 and was discharged from the hospital on 11/03/2001. He was seen by his physician for follow-up and was treated with palivirumab (Syngais) on 11/05/01, 12/03/01, 12/31/01 and 01/29/02. The infant was evaluated by an allergist at a tertiary care center on 12/04/01. The allergist noted that, approximately one month following the viral syndrome, the infant developed "some mild atopic dermatitis" On examination, the allergist noted that "The arena of eczema was everywhere on his body  except for his groin, which is a typical pattern." The infant underwent "percutaneous skin tests... On skin testing, he was negative to cat, dog, dust mites,soy and peanut. He had an intermediate reaction to milk and eggs. i also reviewed his vaccines and his vaccines do not appear to have caused any of his reactions." The allergist recommend removing milk and egg from the infant's diet. On 01/03/02, the infant received his second injection of Infanrix (lot DTPA524A2), Prevnar and IPOL. He also received an injection of haemophilus influenzae type B conjugate vaccine (PedvaxHIB, Merck). Eight hours post-immunization, he again developed urticaria and fever. He was treated with diphenhydramine and recovered on 01/05/02. The most recent information was received from the vaccine provider on 02/25/02. The vaccine provider considered both episodes of urticaria and hives to be severe in intensity and possibly related to Infanrix administration.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypersensitivity, Lactose intolerance, Pyrexia, Urticaria, Viral infection
Clinical narrative: Report 20020017131 describe a viral syndrome in a 7 week old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. This report was received from a nurse. Medical history included "difficult delivery: at gestational age 39 weeks and meconium aspiration treated with extracorporeal membrane oxygenation, mechanical ventilation, and continuous positive airway pressure. Concurrent conditions were not specified. Concurrent medications included paracetamol. On 10/31/2001, the infant received his first injection of Infanrix. On that date, he also received his first injection of 7-valent neumococcal conjugate vaccine combination haemophilus influenzae type b conjugate/hepatitis B vaccine and inactivated poliomyelitis virus vaccine. Eight hours post-immunization, the infant developed generalized hives and fever of 101 to 103 degrees F. He was hospitalized on 11/01/2001 with a diagnosis of viral syndrome. He was treated with diphenhydramine (Benadryl). He recovered on 11/02/01 and was discharged from the hospital on 11/03/2001. He was seen by his physician for follow-up and was treated with palivirumab (Syngais) on 11/05/01, 12/03/01, 12/31/01 and 01/29/02. The infant was evaluated by an allergist at a tertiary care center on 12/04/01. The allergist noted that, approximately one month following the viral syndrome, the infant developed "some mild atopic dermatitis" On examination, the allergist noted that "The arena of eczema was everywhere on his body  except for his groin, which is a typical pattern." The infant underwent "percutaneous skin tests... On skin testing, he was negative to cat, dog, dust mites,soy and peanut. He had an intermediate reaction to milk and eggs. i also reviewed his vaccines and his vaccines do not appear to have caused any of his reactions." The allergist recommend removing milk and egg from the infant's diet. On 01/03/02, the infant received his second injection of Infanrix (lot DTPA524A2), Prevnar and IPOL. He also received an injection of haemophilus influenzae type B conjugate vaccine (PedvaxHIB, Merck). Eight hours post-immunization, he again developed urticaria and fever. He was treated with diphenhydramine and recovered on 01/05/02. The most recent information was received from the vaccine provider on 02/25/02. The vaccine provider considered both episodes of urticaria and hives to be severe in intensity and possibly related to Infanrix administration.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator regarding a 2 month old male who received a dose of Prevnar on 12/20/00. On 2/15/01, the child was found dead. The following day, a postmortem was performed and results revealed acute pulmonary edema and congestion and the cause of death was listed as Sudden Infant Death (SIDS), interval-undetermined. Both the medical examiner and the investigator agreed that this event was not related to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested.
Age: 12.0
Sex: M
Vaccine: DTP
Symptoms: Drug ineffective, Tetanus
Clinical narrative: Information has been received on 01/30/2001 from a published literature article regarding a 14 year old male. In 1997, two years after receiving his sixth dose of DTP (manufacturer unknown), he was hospitalized with a diagnosis of tetanus. The reporter indicated that the child received a puncture wound from small dog bite on the lower calf. Treatment included tetanus immune globulin administered 7-23hours post onset of symptoms. He was discharged after 3 days.
Age: 8.0
Sex: F
Vaccine: DTP
Symptoms: Drug ineffective, Tetanus
Clinical narrative: Information has been received on 01/30/2002 from a published literature article regarding a 12 year old female. In 1994, four years after receiving her 5th dose of DTP (manufacturer unknown), she was hospitalized with a diagnosis of tetanus. The reporter indicated that the child received a puncture wound after stepping on a rake. Treatment included tetanus immune globulin administered 5 to 9 days post onset of symptoms. She was discharged after 1 day and received an additional 6 weeks of home care.
Sex: F
Vaccine: PNC
Symptoms: Hyperbilirubinaemia, Premature baby
Clinical narrative: A nurse, in her 1st trimester of pregnancy, reported that she inadvertently injected herself with Prevnar on 5/22/01. On 1/29/02, follow-up information regarding the nurse was received from a physician. The nurse delivered her baby 4-5 weeks prematurely. The infant developed neonatal hyperbilirubinemia and was hospitalized for 2 days for treatment with phototherapy and IV fluids. The infant recovered. No further information was available at the date of this report. See HQ1264323MAY2001 for report on the pregnancy exposure. On 2/22/02, follow up information was received from the nurse. She reported that her son was born 4 weeks premature. He developed an ear infection during the first two months of life. He is doing fine now. He received his first dose of Prevnar on 2/21/02 and experienced no adverse reaction. When he was 2 months old, the infant's bowel movements became less frequent. He was intermittently treated with glycerin suppositories until 4/12/02. On 4/11/02, treatment with lactulose was begun. On 4/11/02 a barium enema was administered with the following results: no evidence of Hirschsprung's disease; colon normal. He was examined by a gastroenterologist on 4/22/02; a diagnosis of functional constipation was made. Ongoing treatment with lactulose was prescribed.
Sex: U
Vaccine: DTP, OPV, OPV
Symptoms: Drug toxicity, Laboratory test abnormal
Clinical narrative: A physician reported via a company representative that a child received an injection of Tri-Immunol vaccine in 3/94. Subsequently, the child developed "high blood levels of mercury". The child was seen by a physician. No further information was available at the date of this report. Follow-up information received from the company rep indicated that this child received Tri-Immunol and a fourth dose of Orimune in 1994. The reported indicated that the patient had received 3 prior doses of Orimune sometime in 1989 and 1990. Additional information received 1/31/02 indicated that the child received Tri-Immunol and a fourth dose of Orimune 3/30/94. Metal poisoning is considered to be an "Other Important Medical Event".
Sex: U
Vaccine: DTP, OPV, OPV
Symptoms: Drug toxicity
Clinical narrative: A physician reported via a company representative that a child received an injection of Tri-Immunol vaccine in 3/94. Subsequently, the child developed "high blood levels of mercury". The child was seen by a physician. No further information was available at the date of this report. Follow-up information received from the company rep indicated that this child received Tri-Immunol and a fourth dose of Orimune in 1994. The reported indicated that the patient had received 3 prior doses of Orimune sometime in 1989 and 1990. Additional information received 1/31/02 indicated that the child received Tri-Immunol and a fourth dose of Orimune 3/30/94. Metal poisoning is considered to be an "Other Important Medical Event".
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Cardio-respiratory arrest, Cerebral haemorrhage, Coma, Irritability
Clinical narrative: A physician reported that an 8 month old female received her 3rd doses of Prevnar, Hib-Titer, IPV and Infanrix vaccines on 1/19/01. On 5/26/01, at 12 months of age, the infant died of "presumed SIDS-like syndrome". An autopsy report is pending. The reporter did note that the infant had a history of seizures; however, she has been "seizure-free while on meds". The reporter also indicated that the infant's death is under investigation for "possible Munchausen's by proxy via mother" or a "possible interaction between Lamictal (lamotrigine) and phenobarbital." Both the investigator and the medical monitor agree that the event is not related to vaccine administration. This report of a serious, labeled event is being submitted as requested. COD as per autopsy report -- undetermined. Follow-up info received on 03/15/2002 indicated that on 05/26/2001, the child became fussy, then lethargic and "appeared to be breathing heavily." That same evening, the mother found the child unresponsive and not breathing. Emergency services were called. CPR attempted and the child was transported to an ER. On arrival, she was in full arrest. Resuscitation efforts continued and cardiac medications were given; however, the child was pronounced dead. A full body x-ray revealed no abnormalities. An sutopsy was performed; however, the cause of death could not be determined. The original assessments of relatedness remained the same. Per F/U 3/27/02 COD: Cardiopulmonary arrest; subdural hemorrhage and neomembrane, indeterminate age, very limited area, right fontoparietal parasagittal region, probably incidental finding. This decedent had only a partial right middle lobe (minor congenital anomaly). A fatal seizure is not ruled out, but, in view of the history of 2 recent overdoses inflicted by the mother, imposed suffocation is also considered a possible cause of death but no cause of death was determined on autopsy.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Lethargy, Respiratory tract malformation, Sudden infant death syndrome
Clinical narrative: A physician reported that an 8 month old female received her 3rd doses of Prevnar, Hib-Titer, IPV and Infanrix vaccines on 1/19/01. On 5/26/01, at 12 months of age, the infant died of "presumed SIDS-like syndrome". An autopsy report is pending. The reporter did note that the infant had a history of seizures; however, she has been "seizure-free while on meds". The reporter also indicated that the infant's death is under investigation for "possible Munchausen's by proxy via mother" or a "possible interaction between Lamictal (lamotrigine) and phenobarbital." Both the investigator and the medical monitor agree that the event is not related to vaccine administration. This report of a serious, labeled event is being submitted as requested. COD as per autopsy report -- undetermined. Follow-up info received on 03/15/2002 indicated that on 05/26/2001, the child became fussy, then lethargic and "appeared to be breathing heavily." That same evening, the mother found the child unresponsive and not breathing. Emergency services were called. CPR attempted and the child was transported to an ER. On arrival, she was in full arrest. Resuscitation efforts continued and cardiac medications were given; however, the child was pronounced dead. A full body x-ray revealed no abnormalities. An sutopsy was performed; however, the cause of death could not be determined. The original assessments of relatedness remained the same. Per F/U 3/27/02 COD: Cardiopulmonary arrest; subdural hemorrhage and neomembrane, indeterminate age, very limited area, right fontoparietal parasagittal region, probably incidental finding. This decedent had only a partial right middle lobe (minor congenital anomaly). A fatal seizure is not ruled out, but, in view of the history of 2 recent overdoses inflicted by the mother, imposed suffocation is also considered a possible cause of death but no cause of death was determined on autopsy.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a nurse (LVN) concerning her son who, in 1990, was vaccinated with MMRII. Subsequently, the pt was dx'd with autism. No other information was available. Unspecified medical attention was sought. Upon internal review, autism was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTP, HIBV, MMR
Symptoms: Antisocial behaviour, Autism, Crying, Difficulty in walking, Speech disorder
Clinical narrative: Regression of speech. Initiation of toe walking, hard flapping and unexplained crying.  Diagnosed with pervasive developmental delay. Doc # 213001, 60 day follow-up states the following: social deficiencies, lack of imaginery play. Per follow up pt has not recovered. Speech delays, requires an aide in the school classroomto assest with daily academic tasks, social deficits and temper tanterum. Dx Autism
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Henoch-Schonlein purpura, Purpura
Clinical narrative: On the evening of 1/26/02, the pt developed a maroon rash on her legs, pain in her ankle and opposite knee. She saw MD and was dx'd with allergic purpura. On 2/5/02, the rash is resolving and will continue medical evaluation for a week.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: The pt developed itchy (hives) rash on face and spreading to knees and arms following day after the flu shot was given on 11/14/2002.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Paraesthesia, Tremor
Clinical narrative: Flu vaccine given at 6pm on 11/30/2001. She developed shakiness and chills, pain both legs along with tingliness which lasted for 4 hours. Symptoms went away on 12/01/2001 am.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The day after receiving the flu vaccine, the employee complained of tingling and numbness in left arm. Still has slight tingling.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Conduction disorder, Paraesthesia
Clinical narrative: Employee complained of weakness, tingling in left arm. Symptoms began soon after employee received the flu vaccine.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Headache, Hypertension, Stomach discomfort
Clinical narrative: Headaches, dizzy, high blood pressure, upset stomach for 10 days.
Age: 55.0
Sex: F
Vaccine: ANTH
Symptoms: Sinusitis, Vaginal haemorrhage
Clinical narrative: Participant was not able to make her appt because she was ill. Cold/Sinus infection on Friday, 2/1/2002. However, she is still ill and going for chest x-ray on 2/5. Postmenopausal has started vaginal bleeding.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Lymphadenopathy, Skin warm
Clinical narrative: Day 9, Patient presented with enlarging approx 3" diameter, circular erythematons patch surrounding SP site, pustulae draining, mod amt, yellow drainage. Skin warm to touch around site. Positive axillary lymphadenopathy
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Fever of 102 degrees F. after vaccine and it lasted for 2 days. The flu-like symptoms along with sore throat resolved without treatment.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Schizophrenia
Clinical narrative: Sz disorder (new onset petit mal sz activity).
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site vesicles
Clinical narrative: Pt developed six vesicles on his trunk on red base. Induration of 3cm around injection site with 3 vesicles within indurated area. Warm and red treated with antibiotics.
Sex: U
Vaccine: TD
Symptoms: Contusion, Swelling
Clinical narrative: It was reported that a pt (1 of 2) received a TD ADS Adult vaccination. The pt experienced swelling and bruising. No specifics were provided. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Contusion, Swelling
Clinical narrative: It was reported that a patient  received a TD Adult vaccination. The pt experienced swelling and bruising. No specifics were provided. Further info is being requested.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Asthma, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: It was reported that a 37 year old male pt received a TD Adult vaccination on 09/15/2000. Reportedly, several hours later, the pt developed a fever of 102F, a sore throat and an asthma attack. He was put on oral prednisone. The pt is allergic to peas and tuna. Since tuna has mercury possible conclusion pt may be allergic to the Thimerosal in TD.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a female pt received a TD Adult vaccination on 11/07/2000. Reportedly on 11/10/2000, the pt developed a local reaction of redness and soreness at the injection site. A physician evaluated the pt; no prescribed medication was given.
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a female pt received a TD Adult vaccination on 11/02/2000. Reportedly the pt developed a local reaction of redness and soreness at the injection site. A physician evaluated the pt; no prescribed medication was given. From additional correspondence recieved on 02/27/2001, it was reported that the pt recovered from this experience. No further info is anticipated; this case is closed.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site reaction
Clinical narrative: From an initial report received on 12/13/2000, it was reported that the pt experienced "localized sweling/pain/erythema 24 hours after injection. This progressed to a large abscess requiring incision and drainage." The pt reportedly recovered from this experience.
Age: 37.0
Sex: F
Vaccine: HEP, TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: It was reported that a 37 year old female pt received a TD Adult vaccination in the right deltoid and a Hep B vaccination in the left deltoid on 10/24/2000 at 2:30om. Reportedly the pt stated "didn't hurt but the last 3 weeks it is very painful. Initially red but never hard, compress did not provide relief." Evaluated on 11/14/2000. On 11/15/2000 continued with pain to site, range of motion affected; pain radiating into right shoulder, increased complaint of pain. Pt is presently taking prescribed catominophen with relief of symptoms. On 11/16/2000 appointment confirmed with physician first for medical evaluation. Emergency dept visit not warranted at this time per associate. The pt's recovery status is unknown. An appointment is scheduled in Dec. for the emergency dept. From additional correspondence received on 02/22/2001, it was reported that the pt recovered from this experience. No further info is anticipated; this case is closed.
Age: 10.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: From an initial report received on 01/15/2001, it was reported that a 10 year old female was given TD Adult vaccine on 01/04/2001. Reportedly "1 day after vaccination" pt "developed itching at site, swelling-2 days later site grossly swollen-size of chicken egg-seen in office treated symptomaticaly-unresolved." From additional info received on 02/20/2001, additional pt, vaccine, responsible physician and vaccine administrator information was provided.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Face oedema, Rash
Clinical narrative: From the initial report received on 01/09/2001, it was reported that an 11 year old male was given TD Adult vaccine in the left arm on 01/05/2001. On 0107/2001 at 8am, pt reportedly experienced "skin rash-exanthemas papules with some confluence over trunk and upper extremities. Mild facial swelling Rx-Prednisone taper with good results." The pt reportedly recovered. From follow up information received on 4/10/01, it was reported, "No further care required, no sequellae. Reveiwed, no additional information at this time. From mailed correspondence on 6/25/01 it was stated, "Reviewed, no additional information at this time." This case is closed.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt received a TD Adult vaccination that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further info is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (3 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (4 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (5 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (6 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (7 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (8 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (9 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt (10 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Oedema peripheral, Paraesthesia, Rash
Clinical narrative: It was reported that a 21 year old female pt received a TD Adult on 2/7/01. Later in the day, the pt developed joint pain and swelling, tingling of her hands and a rash on her face. The pt was seen in an ER and treated with IV steroids and Prednisone. The pt reportedly recovered from this experience.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: It was reported that a female pt received a TD Adult on 2/9/01. Reportedly, sometime after the vaccination, the pt developed a local reaction of 4 X 5cm at the injection site. The pt also developed a fever of 102F. These symptoms are unresolved.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Eye irritation, Injection site reaction, Pruritus
Clinical narrative: It was reported that a 57 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly on 01/31/2001 in the morning the pt developed 2cm redness with .5 -1cm induration, no blisters on inner left forearm, itching and eye itching. Reportedly the pt recovered from this experience. From follow up # ! Correspondence received on 03 Apr 2001, no further information was provided. See reports U2001-00436, U2001-00438, U2001*00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Cough, Dysphonia, Erythema, Injection site reaction, Pruritus
Clinical narrative: It was reported that a 43 year old female pt received a TD Adult vaccination on 01/26/2001 at 10:30am. Reportedly on that same day at 3pm, the pt developed 1cm induration, 10,, area of erythema to inner right forearm, slight blistering to area of induration. Itching all over, raspy voice, frequent cough. Treatment of Benadryl 50-75mg per oral was given. Reportedly the pt recovered from this experience. From follow up # 1 correspondence recieve on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00438, U2001-00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 32 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly by 6pm that evening the pt developed 2cm of redness now with induration from >10cm redness. Redness started on Friday and minimal redness now. Treatment of Benadryl per oral prescribed every six hours as needed. Reportedly the pt recovered from this experience. Frm follow up # 1 correspondence received on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: It was reported that a 39 year old  female received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly between 6 and 7pm that evening the pt developed a 1cm x .8cm, red and raised - no blisters, no extended margin -left forearm volar. T99.8 Degrees F. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up # 1 correspondence received on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00448 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 48 year old female pt received a TD Adult vaccination on 01/26/2001 at 1:30pm Reportedly later that evening between 6-7pm, the pt developed 2cm of redness with 3cm of induration on her right forearm. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up #1 correspondence recieved on 03 Apr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, U2001-00449 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pruritus
Clinical narrative: It was reported that a 63 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly on 01/27/2001 at 7am the pt developed a left forearm volar 5cm x 8cm of redmess, 2cm round induration and "buli at center" with itching. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, U2001-00448, U2001-00450 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: It was reported that a 61 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001 at 9am. Reportedly on 01/28/2001 at 10am, the pt developed redness and itching. The pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Aor 2001, additional pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447 though U2001-00449, U2001-00451 through U2001-00454 and U2001-00456 through U2001-00461, same reporter
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: It was reported that a 63 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001  at 11:30am. Reportedly on 01/27/2001 at 12pm, the pt developed redness and itching. The pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, additional  pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447 through U2001-00450, U2001-00452 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: It was reported that a 43 year old female patient received a TD Adult vaccination, intradermal on 01/26/2001 at 11:30am. Reportedly on 01/27/2001 at 12pm, the pt developed redness and itching. The pt reportedly recovered from this experience. From follo wup #1 correspondence received on 03 Apr 2001, additional pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00438, U2001-00447 through U2001-00451, U2001-00453, U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: It was reported that a 36 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001 at 9am. Reportedly on 01/28/2001 at 10am, the pt developed redness and itching. the pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, additional pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, through U2001-00453, U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site reaction, Pruritus
Clinical narrative: It was reported that a 39 year old female pt received a TD Adult vaccine, intradermal on 01/26/2001 at 12:30pm. Reportedly on 01/27/2001 at 2pm, the pt developed a 5cm redness with 1-2 cm induration and itching. The pt reportedly recovered from this event.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site mass, Injection site reaction
Clinical narrative: It was reported that a 39 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001 at 1pm. Reportedly on 01/27/2001 at 2am, the pt developed 2cm redness with 1cm hard induration. The pt reportedly recovered from this experience.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Injection site reaction, Rash
Clinical narrative: It was reported that a male pt received a TD Adult vaccination, intradermal on 01/27/2001 at 11am. Reportedly on 01/26/2001 at 11:30pm the pt developed 1/4cm raised center with 1cm margin-erythemic down from 3cn erythemic margin. The pt reportedly recovered from this experience.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Eye irritation, Injection site hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: It was reported that a 60 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001 at 10am. Reportedly on 01/27/2001 the pt developed 1cm redness with 1/4cm induration, itching at site and around eyes. Treatment of Benadryl per oral was prescribed. Hydocortisone cream to area. The pt reportedly recovered from this experience.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: It was reported that a 68 year old female patient received a TD Adult vaccination, intradermal on 26 Jan 2001 at 10:30 am. Reportedly on 27 Jan 2001 at 2:00 pm the patient developed 1cm volar right forearm red and indurated, size down from 4cm on Saturday; itching. Treatment of Benadryl per oral was prescribed. The patient reportedly recovered from this experience.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass
Clinical narrative: It was reported that a 54-year-old female patient received a TD Adult vaccination on 26 Jan 2001 at 10:00am. Reportedly on 27 Jan 2001 at 1:00 pm the patient developed on her left forearm volar--1.5 cm x 1 cm, red with induration entire. No margin of red outside of induration. Treatment of Benadryl per oral was prescribed. Temperature 98.9. The patient reportedly recovered from this experience. From follow-up received on 4/3/01, no further information was provided.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration
Clinical narrative: It was reported that a 49 year old female patient received a TD Adult vaccination, intradermal on 26 Jan 2001 at 10:00am. Reportedly on 27 Jan 2001 at 9:00am the patient developed 1/2cm redness, .2cm induration. The patient reportedly recovered from this experience. From follow-up received on 4/3/01, no further information was provided.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: It was reported that a male patient received a TD Adult vaccination on 21 Feb 2001. Reportedly after the vaccination the patient developed a fever of 103F, general malaise and body aches which still persist 2 days after vaccination.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: It was reported that a female patient received a TD Adult vaccination on 21 Feb 2001. Reportedly the patient developed a fever of 102F, general malaise and body aches which persists 2 days after vaccination.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Agitation, Crying, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: It was reported that a 40 year old female patient received a TD Adult vaccination on 22 Feb 2001. Reportedly on 23 Feb 2001, the patient complained of swelling, induration, redness and warmth at site of injection. Also shaky hands, irritability, drowsiness and uncontrollable crying. From follow-up received on 4/6/01, it was reported that the patient recovered from this experience.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Somnolence, Tremor
Clinical narrative: It was reported that a 40 year old female patient received a TD Adult vaccination on 22 Feb 2001. Reportedly on 23 Feb 2001, the patient complained of swelling, induration, redness and warmth at site of injection. Also shaky hands, irritability, drowsiness and uncontrollable crying. From follow-up received on 4/6/01, it was reported that the patient recovered from this experience.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It was reported that a 65 year old female patient received a TD Adult vaccination on 21 Feb 2001. Reportedly that same day the patient developed a local reaction of redness, swelling and pain at the injection site. Patient was evaluated by physician and treated with Motrin and compresses. From follow up received on 5/7/01, it was reported that the pt recovered from this experience. Additional pt, responsible physician, vaccine administrator and vaccine info was also provided. This case is closed.
Age: 50.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a 48 year old female patient received a TD Adult vaccination on 21 Feb 2001. Reportedly that same day the patient developed a local reaction of redness and swelling.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site reaction, Swelling
Clinical narrative: It was reported that a patient received a TD Adult vaccination, date not specified. Reportedly sometime after the vaccination, the patient developed "flu-like"symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site reaction, Swelling
Clinical narrative: It was reported that a patient received a TD Adult vaccination, date not specified. Reportedly sometime after the vaccination the patient developed "flu-like" symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: It was reported that a patient received a TD Adult vaccination, date not specified. Reportedly sometime after the vaccination the patient developed "flu-like"symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site swelling
Clinical narrative: It was reported that a pt (4 of 7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site swelling
Clinical narrative: It was reported that a pt (5 of 7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site swelling
Clinical narrative: It was reported that a pt (6 of 7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
Sex: U
Vaccine: TD
Symptoms: Erythema, Influenza like illness, Injection site swelling
Clinical narrative: It was reported that a pt (7of7) rec'd a TD adult vaccination, date not specified. Reportedly sometime after the vaccination the pt developed flu-like symptoms and a local reaction, red swollen arm. Further information is requested.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: It was reported that a pt rec'd Tetanus Toxoid absorbed vaccination on 11/16/00. Approx 10 days after the vaccination the pt developed urticaria over her entire body and was hospitalized twice. No details were provided. Further information is requested.
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a female pt rec'd TTOX-tetanus Toxoid absorbed vaccination on 7/20/00. Approx 2 days later the pt developed a 3 inch by 31/2 inch local reaction at the site of injection. Further information requested. From additional correspondence rec'd on9/21/00, it was reported. Reviewed no additional information at this time. No further information is expected. This case is closed.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: It was reported that a 43 year old female pt received a Tetanus Toxoid vaccination on 10/23/00. Reportedly, on 10/25/00, the pt complained of febrile for 2 days and a red, tender, enlarged area of the left inner forearm. From additional correspondence received on 3/6/01, the correct responsible physician's name was provided.
Age: 70.0
Sex: M
Vaccine: HEPA, TD, YF
Symptoms: Rash macular, Skin ulcer, Urticaria
Clinical narrative: It was reported that a 70 year old man received a YF-vax, a Vaqta and Td vaccination on 05/15/2000. Reportedly ten days after the vaccinations the pt developed hives. Further information requested. From additional correspondence received on 07/06/2000, it was reported that physician saw the pt on 05/26/2000, at the pt had macular papular rash on his trunk an da few lesions on his scalp and extremities, no fever. A phone call was made to the pt on 05/30/2000, the pt had recovered
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Muscular weakness, Myopathy
Clinical narrative: Lower extremity weakenss, myopathy. Ongoing physical therapy. Diagnosed with sinusitis and c.diff colitis
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Diarrhoea, Infection, Injection site erythema
Clinical narrative: Left deltoid area with cellulitis; arthralgia; fever; diarrhea; nausea; paresthesia; rash and vomiting. The left arm shows erythema in the lateral aspect and the anterior lateral aspect of the upper left extremity. She has some tenderness, redness and swelling in this area which is non-pitting. She had a temperature of 100F-102F. At 20:00 the night of vaccinations, she became nauseated and at 02:00 she had an episode of diarrhea and vomiting. Consults with Orthopedics, Infectious Disease and Rheumatology. PICC line placed for IV antibiotics. This pt completed 14 days of antibiotics therapy, including Unasyn and then eventually switched to Augmentin po. She is to follow-up in 1 week.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Left deltoid area with cellulitis; arthralgia; fever; diarrhea; nausea; paresthesia; rash and vomiting. The left arm shows erythema in the lateral aspect and the anterior lateral aspect of the upper left extremity. She has some tenderness, redness and swelling in this area which is non-pitting. She had a temperature of 100F-102F. At 20:00 the night of vaccinations, she became nauseated and at 02:00 she had an episode of diarrhea and vomiting. Consults with Orthopedics, Infectious Disease and Rheumatology. PICC line placed for IV antibiotics. This pt completed 14 days of antibiotics therapy, including Unasyn and then eventually switched to Augmentin po. She is to follow-up in 1 week.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Vomiting, White blood cell count increased
Clinical narrative: Left deltoid area with cellulitis; arthralgia; fever; diarrhea; nausea; paresthesia; rash and vomiting. The left arm shows erythema in the lateral aspect and the anterior lateral aspect of the upper left extremity. She has some tenderness, redness and swelling in this area which is non-pitting. She had a temperature of 100F-102F. At 20:00 the night of vaccinations, she became nauseated and at 02:00 she had an episode of diarrhea and vomiting. Consults with Orthopedics, Infectious Disease and Rheumatology. PICC line placed for IV antibiotics. This pt completed 14 days of antibiotics therapy, including Unasyn and then eventually switched to Augmentin po. She is to follow-up in 1 week.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Blood pressure increased, Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Left upper arm cellulitis; fever; pain and tenderness and redness at the injection site. Seen in MD's office and treated with Benadryl and Darvocet and cold compresses with no relief. She reports that early in the morning, post vax, she was achy and had a fever but is feeling better since her fever has gone away. She has a soft ball size area of redness with tenderness and some heat. She was started on IV antibiotics because of allergies to Amoxil, Ampicillin, Suprax, bacitracin and adhesive tape. She is being started on Vancomycin, Tequin and Flagyl. At the time of discharge her blood pressure systolically is elevated due to anxiety.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, White blood cell count increased
Clinical narrative: Left upper arm cellulitis; fever; pain and tenderness and redness at the injection site. Seen in MD's office and treated with Benadryl and Darvocet and cold compresses with no relief. She reports that early in the morning, post vax, she was achy and had a fever but is feeling better since her fever has gone away. She has a soft ball size area of redness with tenderness and some heat. She was started on IV antibiotics because of allergies to Amoxil, Ampicillin, Suprax, bacitracin and adhesive tape. She is being started on Vancomycin, Tequin and Flagyl. At the time of discharge her blood pressure systolically is elevated due to anxiety.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Left upper arm cellulitis; fever; pain and tenderness and redness at the injection site. Seen in MD's office and treated with Benadryl and Darvocet and cold compresses with no relief. She reports that early in the morning, post vax, she was achy and had a fever but is feeling better since her fever has gone away. She has a soft ball size area of redness with tenderness and some heat. She was started on IV antibiotics because of allergies to Amoxil, Ampicillin, Suprax, bacitracin and adhesive tape. She is being started on Vancomycin, Tequin and Flagyl. At the time of discharge her blood pressure systolically is elevated due to anxiety.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Muscular weakness, Pain
Clinical narrative: Injection  in left deltoid on 10/8/01. Injection was immediately painful and deltoid area swelled. Now has decreased ROM; arm can't swing toward back or twist to hook bra or buckle seat belt; pain in neck and can't reach arm above head. It is painful at night and aches all the time. Laying down causes increased pain. Dx'd with bursitis and given Vioxx with no relief. Taking physical therapy from November to January 2-3 X a week. To see muscle therapist or orthopedic doctor. Sees physical therapist X 3 months with no relief.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Injection site swelling, Joint range of motion decreased, Neck pain
Clinical narrative: Injection  in left deltoid on 10/8/01. Injection was immediately painful and deltoid area swelled. Now has decreased ROM; arm can't swing toward back or twist to hook bra or buckle seat belt; pain in neck and can't reach arm above head. It is painful at night and aches all the time. Laying down causes increased pain. Dx'd with bursitis and given Vioxx with no relief. Taking physical therapy from November to January 2-3 X a week. To see muscle therapist or orthopedic doctor. Sees physical therapist X 3 months with no relief.