chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Rash pustular, Skin lesion, Tenderness, Vaccinia test positive
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393040. A 25-year-old male patient was exposed to the following vaccine on 24 June 2010: ACAM2000 (lot number not reported). The patient had no medical history and no illness at the time. On 24 June 2010, the patient was exposed to recent vaccines of smallpox vaccine by wrestling contact and developed right arm contact transmission with vaccinial lesions and eye itching. A polymerase chain reaction (PCR) culture for vaccinia was sent to the laboratory and was declared with a positive result. His left eye symptoms progressed to swelling, leakage, and lid lesions and eventually diagnosed as Ocular Vaccinia. The patient was currently on treatment with ophthalmology. The patient's medication was reported as doxycycline. The outcome was reported as unknown. Follow-up information was retrieved from the scientific literature on 22 August 2011. Abstract: "A patient developed severe ocular vaccinia via autoinoculation after acquiring unrecognized contact-transmitted vaccinia from wrestling with vaccinated members of his unit. This case highlights both the need to reinforce infection-control measures among vaccinees and the need for providers to be familiar with the identification and treatment of cutaneous and ocular vaccinia infection." The patient presented with severe left blepharoconjunctivitis 17 days after exposure to ACAM2000. Approximately 6 to 8 days post exposure, the patient developed "multiple papular skin lesions in his right anticubital fossa that quickly increased in size, becoming erythematous and tender." The patient had a history of wrestling-associated staphylococcal skin infections. Within a few days, despite oral antibiotic treatment, the lesions pustulated and the patient began covering the site. Four days after onset, he presented with "progressively worsening left eyelid pain and swelling, conjunctival injection, eye (globe) pain, and discharge. The upper and lower eyelids were swollen and erythematous, and there was marked palpebral and bulbar conjunctival injection and abundant mucoid discharge on the lashes and in the fornix." Visual acuity was diminished at 20/50. He was treated with ophthalmic vancomycin for presumed bacterial conjunctivitis, however his symptoms worsened and pustules formed in the upper and lower lid margins, and he was unable to open his eye voluntarily. Based upon the history of smallpox vaccination of other personnel in his unit, he was tentatively diagnosed with vaccinia autoinoculation and he began treatment with ophthalmic trifluridine. Within 24 hours his symptoms improved dramatically, and blepharoconjunctivitis was completely resolved within 12 days. Subsequent PCR testing from his arm and eye lesions was positive for orthoporvirus. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia virus infection, Visual acuity reduced
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393040. A 25-year-old male patient was exposed to the following vaccine on 24 June 2010: ACAM2000 (lot number not reported). The patient had no medical history and no illness at the time. On 24 June 2010, the patient was exposed to recent vaccines of smallpox vaccine by wrestling contact and developed right arm contact transmission with vaccinial lesions and eye itching. A polymerase chain reaction (PCR) culture for vaccinia was sent to the laboratory and was declared with a positive result. His left eye symptoms progressed to swelling, leakage, and lid lesions and eventually diagnosed as Ocular Vaccinia. The patient was currently on treatment with ophthalmology. The patient's medication was reported as doxycycline. The outcome was reported as unknown. Follow-up information was retrieved from the scientific literature on 22 August 2011. Abstract: "A patient developed severe ocular vaccinia via autoinoculation after acquiring unrecognized contact-transmitted vaccinia from wrestling with vaccinated members of his unit. This case highlights both the need to reinforce infection-control measures among vaccinees and the need for providers to be familiar with the identification and treatment of cutaneous and ocular vaccinia infection." The patient presented with severe left blepharoconjunctivitis 17 days after exposure to ACAM2000. Approximately 6 to 8 days post exposure, the patient developed "multiple papular skin lesions in his right anticubital fossa that quickly increased in size, becoming erythematous and tender." The patient had a history of wrestling-associated staphylococcal skin infections. Within a few days, despite oral antibiotic treatment, the lesions pustulated and the patient began covering the site. Four days after onset, he presented with "progressively worsening left eyelid pain and swelling, conjunctival injection, eye (globe) pain, and discharge. The upper and lower eyelids were swollen and erythematous, and there was marked palpebral and bulbar conjunctival injection and abundant mucoid discharge on the lashes and in the fornix." Visual acuity was diminished at 20/50. He was treated with ophthalmic vancomycin for presumed bacterial conjunctivitis, however his symptoms worsened and pustules formed in the upper and lower lid margins, and he was unable to open his eye voluntarily. Based upon the history of smallpox vaccination of other personnel in his unit, he was tentatively diagnosed with vaccinia autoinoculation and he began treatment with ophthalmic trifluridine. Within 24 hours his symptoms improved dramatically, and blepharoconjunctivitis was completely resolved within 12 days. Subsequent PCR testing from his arm and eye lesions was positive for orthoporvirus. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Chills, Erythema, Injection site swelling, Pyrexia
Clinical narrative: 48 hrs after vaccines administered (Varicella, MCV & P) chills, fever, redness, swelling of arm near injection sites.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site (left deltoid)
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Pharyngeal oedema
Clinical narrative: Patient and eleven other patients received the anthrax vaccine intradermally. The vaccine administrator did not know the difference between intradermal and subcutaneous.   Patient experienced the feeling of throat swelling and dyspnea intermittently for 3 days after receiving the vaccine. He did not have exam findings c/w with angioedema nor did he have hypoxia. Nonetheless, his symptoms improved with methylprednisolone and a prednisone taper.   All twelve of the patients experienced erythema and pain around the injection site. Other complications by percentage (based on survey): Nodule / inudration at site: 66% Purulent drainage from site: 16% Clear fluid drainage from site: 25% Fever: 50% Chills: 50% Excessive sweating: 75% Headache: 83% Mylagias: 83% Arthralgias: 60% Axillary lymphadenopathy: 25% Pain radiating up the arm: 83% Paresthesias of affected arm: 60% Swelling of lips/face: 0% New dyspnea: 16% Chest pain: 25% Nausea and/or vomiting: 25% Diarrhea: 83% Abdominal pain: 0% Fatigue: 16%  All recovered without permanent complication.
Age: 12.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and Swelling at sight of injection. Pain. Right Deltoid.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Redness/warmth to (L) deltoid. No fever. No drainage. Seen in ED. Dx with local allergic Rx/vs cellulitis. Rx with ABX.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient reported itching denied difficulty breathing or swelling in throat. Patient given oral diphenhydramine 50mg. Patient denied transportation to ER via ambulance. Patient observed in waiting area for 90 minutes and blood pressure monitored.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Vomiting
Clinical narrative: Influenza vaccine administered 08/31/11 at 12PM. Patient notices swelling of the eye at approximately 3AM on 09/01/11. At approximately 6AM patient vomited. Steroid eye drops administered by patient.
Age: 7.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Client's mother stated child was itching and proceeded to break out in rash over his entire body after taking the second pill in the oral typhoid series. The mother gave the child a dose of Benadryl and the child's symptoms resolved by the next morning.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erosion, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient recevied Varivax vaccine SC in right arm on 08/3/11.  Redness was noted in the area 09/01/11.  On 09/02/11, patient developed fever and warmth in area of administration.  Patient was evaluated in office and was noted to have a 3 x 4 cm area of erythema, swelling, warmth, slight induration (non-tender) with irregular borders, surrounding vaccine site on RUE; also very tiny superficial scratch in middle of swelling.  Patient was treated with antibiotics.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient recevied Varivax vaccine SC in right arm on 08/3/11.  Redness was noted in the area 09/01/11.  On 09/02/11, patient developed fever and warmth in area of administration.  Patient was evaluated in office and was noted to have a 3 x 4 cm area of erythema, swelling, warmth, slight induration (non-tender) with irregular borders, surrounding vaccine site on RUE; also very tiny superficial scratch in middle of swelling.  Patient was treated with antibiotics.
Age: 51.0
Sex: F
Vaccine: HEPAB, IPV, RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting for a few hours with complete resolution.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Amnesia, Blindness, Dizziness, Eye movement disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Child did fine with vaccine & twin who received same vaccine. Mother stated that night child became light headed, and eyes were going back - forth & didn't know anyone or could see. Went to ER, transferred to hospital - MRI (neg) d/c'd next day.
Sex: M
Vaccine: HEP
Symptoms: Death, Injection site swelling
Clinical narrative: Swelling at site.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Fall
Clinical narrative: 2 minutes after shot patient was sitting and fell to the floor. Woke up in 30 seconds and refused for an ambulance. Pt parents picked him up and he went home.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Initial report was received 24 August 2011 from a health care professional. A 51-year-old female patient had received a first dose intramuscular left deltoid injection of ADACEL, lot number C3727AA on 05 April 2011, and seven days later on 12 April 2011 during an office visit with her physician, she reported swelling and rash at the injection site, fever of 103 Fahrenheit and joint pain in both wrists, knees and ankles. At the time of vaccination the patient had no concurrent illness. Other medications were reported as "none", however the patient had been taking PROTONIX and RABEPRAZOLE. Past medical history was not reported. At the time of the report, the patient continued to experience pain in both her wrists. Outcome was not recovered. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Drug screen negative
Clinical narrative: He reported to his mother on August 27, 2011, that he had been having chest pains for about two weeks but was afraid to tell her. This is because he plays football and thought she may not allow him to play. But the pain had gotten increasingly worse and more severe and he was now scared he was having a heart attack. He complained of feeling like someone was sitting on his chest and shortness of breath. Mother checked his pulse, which was normal. Mother assumed it was muscular due to football equipment or possible hit to the chest during practice? We were under hurricane warnings so mother monitored him until Monday morning and took him to his primary doctors office. There he was evaluated by his doctor. They performed an EKG. The EKG was abnormal. Doctor ordered mother to take him to emergency room. Once there, they too administered another EKG, which was also abnormal. The E.R. doctors also ordered a chest xray, echo, bloodwork and urine drug screen. All of those tests aside from the EKG were normal. Patient was discharged and told his heart was perfectly normal and they could not explain what was causing the chest pains or the abnormal EKG's.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: He reported to his mother on August 27, 2011, that he had been having chest pains for about two weeks but was afraid to tell her. This is because he plays football and thought she may not allow him to play. But the pain had gotten increasingly worse and more severe and he was now scared he was having a heart attack. He complained of feeling like someone was sitting on his chest and shortness of breath. Mother checked his pulse, which was normal. Mother assumed it was muscular due to football equipment or possible hit to the chest during practice? We were under hurricane warnings so mother monitored him until Monday morning and took him to his primary doctors office. There he was evaluated by his doctor. They performed an EKG. The EKG was abnormal. Doctor ordered mother to take him to emergency room. Once there, they too administered another EKG, which was also abnormal. The E.R. doctors also ordered a chest xray, echo, bloodwork and urine drug screen. All of those tests aside from the EKG were normal. Patient was discharged and told his heart was perfectly normal and they could not explain what was causing the chest pains or the abnormal EKG's.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic
Clinical narrative: itching rash
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: At site (Lt Deltoid) red spots (hives)/ sore to touch - appear to be shingles ready to erupt.  Patient was put on Valtrex for 7 days.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Blood glucose decreased, Ear pain, Epistaxis, Headache
Clinical narrative: Initial report was received on 29 August and 31 August 2011 from a consumer, who is also the patient. A female patient, who was 69 years of age at the time of the report and had a history of diabetes, unspecified allergies, nose bleeds since childhood, and allergies to "myacine" and sulfa drugs, had received a INFLUENZA VACCINE (manufacturer unknown, lot number, route, site and exact date of administration not reported) during the first or second week of November 2010 and approximately three months later, she developed intermittent itching at the injection site and was diagnosed with ITP. The intermittent itching occurs once in a while and persists and corrective treatment consists moisturizing cream applied to the affected area. The patient also experienced cold symptoms and a mini-flu described as sore throat, ears were sore, headache and upset stomach (onsets not reported) lasting four to five days which resolved. According to the reporter, somewhere between 27 February 2011 and 01 March 2011 she was diagnosed with ITP. She was hospitalized for four days beginning the morning of 01 March 2011 and her platelet count was 6,000 at that time. She received unspecified treatments to increase platelets described as "some type of cancer drug that started something like Restin". While hospitalized, platelets increased t0 25,000 to 40,000 and the patient was discharged. Four days later, the patient was hospitalized again due to a decrease in platelets to 12,000. Internal bleeding was suspected but was negative. After hospital discharge, she received infusions (not specified) for four weeks which were unsuccessful. The patient has also experienced nose bleeds due to her allergies on occasion which last anywhere from 30 seconds to eight minutes. Concomitant medications include Lantus and an unspecified blood pressure medication. The patient had also been taking GLYBURIDE which was not working; her blood sugar ran 210 220. She switched to LANTUS in April 2011 which reduced her blood sugar nearly 100 points; now running 120-130. According to the reporter, it seemed with her blood sugar under control her ITP was not as bad. The patient has been seen by a hematologist/oncologist and her platelet count was 40,000 - 50,000 at the time of the report. According to the reporter, the outcome for the event of ITP and itching at the injection site were not recovered. The reporter for this case is the same as for case numbers 2011-08150 and 2011-08182.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Idiopathic thrombocytopenic purpura, Influenza, Injection site pruritus, Nasopharyngitis
Clinical narrative: Initial report was received on 29 August and 31 August 2011 from a consumer, who is also the patient. A female patient, who was 69 years of age at the time of the report and had a history of diabetes, unspecified allergies, nose bleeds since childhood, and allergies to "myacine" and sulfa drugs, had received a INFLUENZA VACCINE (manufacturer unknown, lot number, route, site and exact date of administration not reported) during the first or second week of November 2010 and approximately three months later, she developed intermittent itching at the injection site and was diagnosed with ITP. The intermittent itching occurs once in a while and persists and corrective treatment consists moisturizing cream applied to the affected area. The patient also experienced cold symptoms and a mini-flu described as sore throat, ears were sore, headache and upset stomach (onsets not reported) lasting four to five days which resolved. According to the reporter, somewhere between 27 February 2011 and 01 March 2011 she was diagnosed with ITP. She was hospitalized for four days beginning the morning of 01 March 2011 and her platelet count was 6,000 at that time. She received unspecified treatments to increase platelets described as "some type of cancer drug that started something like Restin". While hospitalized, platelets increased t0 25,000 to 40,000 and the patient was discharged. Four days later, the patient was hospitalized again due to a decrease in platelets to 12,000. Internal bleeding was suspected but was negative. After hospital discharge, she received infusions (not specified) for four weeks which were unsuccessful. The patient has also experienced nose bleeds due to her allergies on occasion which last anywhere from 30 seconds to eight minutes. Concomitant medications include Lantus and an unspecified blood pressure medication. The patient had also been taking GLYBURIDE which was not working; her blood sugar ran 210 220. She switched to LANTUS in April 2011 which reduced her blood sugar nearly 100 points; now running 120-130. According to the reporter, it seemed with her blood sugar under control her ITP was not as bad. The patient has been seen by a hematologist/oncologist and her platelet count was 40,000 - 50,000 at the time of the report. According to the reporter, the outcome for the event of ITP and itching at the injection site were not recovered. The reporter for this case is the same as for case numbers 2011-08150 and 2011-08182.
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Platelet count decreased
Clinical narrative: Initial report was received on 29 August and 31 August 2011 from a consumer, who is also the patient. A female patient, who was 69 years of age at the time of the report and had a history of diabetes, unspecified allergies, nose bleeds since childhood, and allergies to "myacine" and sulfa drugs, had received a INFLUENZA VACCINE (manufacturer unknown, lot number, route, site and exact date of administration not reported) during the first or second week of November 2010 and approximately three months later, she developed intermittent itching at the injection site and was diagnosed with ITP. The intermittent itching occurs once in a while and persists and corrective treatment consists moisturizing cream applied to the affected area. The patient also experienced cold symptoms and a mini-flu described as sore throat, ears were sore, headache and upset stomach (onsets not reported) lasting four to five days which resolved. According to the reporter, somewhere between 27 February 2011 and 01 March 2011 she was diagnosed with ITP. She was hospitalized for four days beginning the morning of 01 March 2011 and her platelet count was 6,000 at that time. She received unspecified treatments to increase platelets described as "some type of cancer drug that started something like Restin". While hospitalized, platelets increased t0 25,000 to 40,000 and the patient was discharged. Four days later, the patient was hospitalized again due to a decrease in platelets to 12,000. Internal bleeding was suspected but was negative. After hospital discharge, she received infusions (not specified) for four weeks which were unsuccessful. The patient has also experienced nose bleeds due to her allergies on occasion which last anywhere from 30 seconds to eight minutes. Concomitant medications include Lantus and an unspecified blood pressure medication. The patient had also been taking GLYBURIDE which was not working; her blood sugar ran 210 220. She switched to LANTUS in April 2011 which reduced her blood sugar nearly 100 points; now running 120-130. According to the reporter, it seemed with her blood sugar under control her ITP was not as bad. The patient has been seen by a hematologist/oncologist and her platelet count was 40,000 - 50,000 at the time of the report. According to the reporter, the outcome for the event of ITP and itching at the injection site were not recovered. The reporter for this case is the same as for case numbers 2011-08150 and 2011-08182.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chills, Dehydration, Diarrhoea, Influenza like illness, Nausea
Clinical narrative: Initial report was received 25 August 2011 from a consumer, who is the patient's parent. An 18-year-old female patient had received an intramuscular injection of ADACEL, an intramuscular injection of MENACTRA, and a subcutaneous injection of VARIVAX (manufacturer Merck) on 21 July 2011 (lot numbers and sites of administration not reported) and 14 days later on 04 August 2011, the patient developed nausea, vomiting, diarrhea, shivering and flu-like symptoms resulting in two emergency room visits due to dehydration. The patient received unspecified treatments and was released. The patient had no illness at the time of vaccination, no pre-existing medical conditions and she had not been taking any concomitant medications. At the time of the report, the patient had lost eight pounds and had not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vomiting, Weight decreased
Clinical narrative: Initial report was received 25 August 2011 from a consumer, who is the patient's parent. An 18-year-old female patient had received an intramuscular injection of ADACEL, an intramuscular injection of MENACTRA, and a subcutaneous injection of VARIVAX (manufacturer Merck) on 21 July 2011 (lot numbers and sites of administration not reported) and 14 days later on 04 August 2011, the patient developed nausea, vomiting, diarrhea, shivering and flu-like symptoms resulting in two emergency room visits due to dehydration. The patient received unspecified treatments and was released. The patient had no illness at the time of vaccination, no pre-existing medical conditions and she had not been taking any concomitant medications. At the time of the report, the patient had lost eight pounds and had not recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia, Pyrexia
Clinical narrative: Onset 8/28/11 with fever near 102 degrees, difficulty breathing, wheezing, dizziness, pounding HA. Feels like arms going to sleep. Pt saw Dr (chiropractor) on 8-29-11 & told pt from Hep A/B #1.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Wheezing
Clinical narrative: Onset 8/28/11 with fever near 102 degrees, difficulty breathing, wheezing, dizziness, pounding HA. Feels like arms going to sleep. Pt saw Dr (chiropractor) on 8-29-11 & told pt from Hep A/B #1.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cyanosis, Dyspnoea, Pyrexia, Similar reaction on previous exposure to drug, Skin reaction
Clinical narrative: Initial report was received 23 August 2011 from an allergist. A four-month-old female patient had received a second dose intramuscular injection of PENTACEL (lot number not reported) and an unspecified amount of time later, the patient developed a fever, her lips turned purple and she developed breathing problems. She was taken to the emergency room and received BENADRYL, prednisone, TYLENOL and a nebulizer as corrective treatment. The patient was seen by an allergist and had skin testing performed which showed delayed reaction. She had no concurrent illness and had not been taking any concomitant medications at the time of vaccination. Outcome was recovered. The patient had a past history where she experienced a similar event after receiving her first dose of PENTACEL at two months of age. This patient previously experienced a similar event captured in case 2011-07441. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Skin test positive
Clinical narrative: Initial report was received 23 August 2011 from an allergist. A four-month-old female patient had received a second dose intramuscular injection of PENTACEL (lot number not reported) and an unspecified amount of time later, the patient developed a fever, her lips turned purple and she developed breathing problems. She was taken to the emergency room and received BENADRYL, prednisone, TYLENOL and a nebulizer as corrective treatment. The patient was seen by an allergist and had skin testing performed which showed delayed reaction. She had no concurrent illness and had not been taking any concomitant medications at the time of vaccination. Outcome was recovered. The patient had a past history where she experienced a similar event after receiving her first dose of PENTACEL at two months of age. This patient previously experienced a similar event captured in case 2011-07441. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nodule, Rash, Swelling
Clinical narrative: Pt states left arm developed rash, swelling w/ knot on left upper arm.
Sex: M
Vaccine: TDAP
Symptoms: Intra-uterine death, Maternal exposure during pregnancy, Tobacco user
Clinical narrative: Initial report received from a healthcare professional on 29 August 2011. This case pertains to a neonate; information for the mother is captured in case number: 2010-06766. A male neonate (aged between 20-27 weeks gestation) was exposed in utero to ADACEL (lot number C3490A) at approximately 1 week gestation. His mother was 25 years old and a smoker who was otherwise healthy; his father was 47 years old and healthy. On 01 April 2011 he experienced fetal death. No additional information was reported. Documents held by sender: None.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Injection site papule, Injection site rash, Rash, Rash papular
Clinical narrative: Rcd. Varicella & MMR on 8/16, on 8/26 developed rash - papules on trunk - front & back & thighs. Runny nose. Temp 99. Rechecked 8/29 & had 5 vesicles & cont. with multiple papules but most fading.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Rcd. Varicella & MMR on 8/16, on 8/26 developed rash - papules on trunk - front & back & thighs. Runny nose. Temp 99. Rechecked 8/29 & had 5 vesicles & cont. with multiple papules but most fading.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives developed later in the evening the day Tdap was administered. Per Dr recommended BENADRYL. Follow up call on 8/26/11 no answer, two voice mails left for pt. Pt to call office back.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, hardness, swelling at injection site BENADRYL topical, BENADRYL by mouth symptoms started to occur approximately 24 hours after injection went to doctor 6 days after shot.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered, Irritability, Nasopharyngitis, Otitis media, Pyrexia
Clinical narrative: A prefilled Adult 0.5 ml FLUZONE vaccine was given by mistake - Lot # UT445AA. This should have been a prefilled Pedi 0.25 ml FLUZONE vaccine. On 8/27/11 child was seen for cold sx, fever, fussiness and dx w/ otitis media.
Age: 64.0
Sex: F
Vaccine: DTP
Symptoms: Blood sodium abnormal, Chills, Dehydration, Diarrhoea, Headache
Clinical narrative: Chills, fever 102, SEVERE diarrhea, nausea feeling, unable to eat due to diarrhea, headache, general achiness, never been this sick.
Age: 64.0
Sex: F
Vaccine: DTP
Symptoms: Hypophagia, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever 102, SEVERE diarrhea, nausea feeling, unable to eat due to diarrhea, headache, general achiness, never been this sick.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Patient returned to pharmacy on 8/11/11 & complained of localized reaction to shot. She said her arm at injection site is red, painful, hot & itchy. I counselled to apply a cold compress & to continue ADVIL if needed & to let her MD aware.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Injection site induration, Musculoskeletal stiffness
Clinical narrative: Sore in arm. Next day hard injection sites, aches & pain, severe headache, sinus clogged up. 8/30/11 stiff neck, sick of stomach, couldn't eat. Headache getting better, taking more TYLENOL with codeine than usual to help. Used neti pot & ALLEGRA for congestion. Felt crosseyed. Today slight headache & stiff neck.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sinus congestion
Clinical narrative: Sore in arm. Next day hard injection sites, aches & pain, severe headache, sinus clogged up. 8/30/11 stiff neck, sick of stomach, couldn't eat. Headache getting better, taking more TYLENOL with codeine than usual to help. Used neti pot & ALLEGRA for congestion. Felt crosseyed. Today slight headache & stiff neck.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling Rt upper arm 1 d after vaccines administered. Symptoms treated with antibiotics for possible cellulitis.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Patient began having hives to arms and back, and had facial swelling. Took to ER and was given BENADRYL and SOLU-MEDROL for allergic reaction. Concerned about possible latex or Neomycin or Hepatitis A vaccine allergy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Erythema, Macule, Pruritus, Skin warm
Clinical narrative: Macular erythema, pruritis, warmth. Treatment: BENADRYL.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Intra-uterine death, Maternal exposure during pregnancy, Tobacco user
Clinical narrative: Initial report was received 29 November 2010 from a health care professional. A 24-year-old pregnant woman received an intramuscular injection of ADACEL, lot number C3490AA (site not reported) on 11 October 2010. The patient was reported to have been one week gestation at the time of vaccination. Her date of last menstrual period was reported as unknown and her estimated date of delivery was not reported. According to the reporter, the patient had not experienced any adverse event following receipt of ADACEL. Follow-up information received from a health care professional on 09 March 2011. The identifier of name of patient was provided. The outcome remained unknown. Follow-up information was received from the healthcare professional on 29 August 2011, which update the event to serious. This case now pertains to the mother; information for the baby is captured in case number 2011-07925. The patient smoked during pregnancy, but was otherwise healthy. The father of the baby was 47 years old, and was also healthy. Estimated date of delivery was July 2011. The patient was reported to have had one prior pregnancy. On 01 April 2011 she experienced early fetal death (20-27 weeks gestation) of a male fetus. Documents held by sender: None.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Projectile vomiting and diarrhea within 2 hours of vaccines approximately 08. 30.11 continues with diarrhea.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Bordetella test positive, Condition aggravated, Cough, Nasal aspiration, Pertussis
Clinical narrative: Initial report was received from a health care professional on 22 August 2011. An 18 month-old female patient with a history of a cough "for a few days" prior to vaccination, had received on 17 August 2011 dose four intramuscular left thigh injection of PENTACEL, lot number C3930AA and a dose of Hep A (manufacturer, lot number, route and site of administration not reported). On 22 August 2011, the patient's cough worsened and she was taken to the ER (emergency room) where a nasal aspirate PCR test was performed with a positive result for Bordetella pertussis. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report was received from a health care professional on 22 August 2011. An 18 month-old female patient with a history of a cough "for a few days" prior to vaccination, had received on 17 August 2011 dose four intramuscular left thigh injection of PENTACEL, lot number C3930AA and a dose of Hep A (manufacturer, lot number, route and site of administration not reported). On 22 August 2011, the patient's cough worsened and she was taken to the ER (emergency room) where a nasal aspirate PCR test was performed with a positive result for Bordetella pertussis. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Cyanosis, Pyrexia, Skin reaction, Skin test positive
Clinical narrative: Initial report was received from an allergist on 23 August 2011. A two-month-old female patient had received a first dose intramuscular injection of PENTACEL (lot number not reported) and an unspecified amount of time later, she began crying, her lips turned purple and she developed a fever. It was not reported if the patient had been medically evaluated or received treatment for this event. The patient was seen by an allergist and had skin testing performed (date not reported) which showed delayed reaction. At the time of vaccination, the patient had no concurrent illness, no pre-existing medical conditions and she had not been taking any concomitant medications. It was unknown if the patient had received any other vaccines within four weeks of PENTACEL vaccination. Outcome was recovered. This patient experienced a similar subsequent event which has been captured in case number 2011-07442. Documents held by sender: none.
Age: 1.58
Sex: M
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Chest X-ray, Convulsion, Gaze palsy, Laboratory test
Clinical narrative: 9/3 Saturday 8 pm - taken to ER for seizure - 1 seizure approx. 10 minutes. Swelling, eyes rolling back. Temp 101.8 as reported by mom. F/u with pneumonia 8/7/11.
Age: 1.58
Sex: M
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pneumonia, Swelling
Clinical narrative: 9/3 Saturday 8 pm - taken to ER for seizure - 1 seizure approx. 10 minutes. Swelling, eyes rolling back. Temp 101.8 as reported by mom. F/u with pneumonia 8/7/11.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: 8/25/11 vaccination given 4:30 PM. Adverse event occurred 8/25/11 4:40 PM after immunization. The patient (an employee) was asked to rest for 20 minutes in the managers office at which time she suffered a seizure.
Age: 59.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Tenderness
Clinical narrative: Injection site swollen and tender right arm. Reddened 2" x 3" area for one week.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Ccellulitis left upper arm.  Left Arm swollen, red and very painful. Area is warm to touch. Pt. given an Rx for Augmentin 875mg.
Age: 44.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Paraesthesia
Clinical narrative: Shoulder pain in arm where vaccination was given. Unable to move arm for 2-3 days. Steriod treatment was started and relieved the pain, but a tingling of the arm and fingers still exists.
Age: 44.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Burning sensation, Headache, Hypoaesthesia, Immediate post-injection reaction, Joint dislocation
Clinical narrative: Shoulder pain in arm where vaccination was given. Unable to move arm for 2-3 days. Steriod treatment was started and relieved the pain, but a tingling of the arm and fingers still exists.
Age: 44.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Shoulder pain in arm where vaccination was given. Unable to move arm for 2-3 days. Steriod treatment was started and relieved the pain, but a tingling of the arm and fingers still exists.
Age: 44.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Paraesthesia
Clinical narrative: Shoulder pain in arm where vaccination was given. Unable to move arm for 2-3 days. Steriod treatment was started and relieved the pain, but a tingling of the arm and fingers still exists.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 9/1/11 entire upper arm red and hot to the touch.  Swelling at site - raised area. 9/2/11 bumpy rash at injection site and area surrounding it.  Extreme itching. 9/6/11 Extreme itching on arm.  Small raised red, itchy bumps on other parts of body (e.g. hands, backs of knees, legs, underarm area, other arm)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 9/1/11 entire upper arm red and hot to the touch.  Swelling at site - raised area. 9/2/11 bumpy rash at injection site and area surrounding it.  Extreme itching. 9/6/11 Extreme itching on arm.  Small raised red, itchy bumps on other parts of body (e.g. hands, backs of knees, legs, underarm area, other arm)
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: swollen tender left upper arm (site of injection) fever 103.2 degrees, malaise, body aches
Age: 28.0
Sex: F
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Cellulitis, Orthopoxvirus test positive, Perineal infection, Polymerase chain reaction, Secondary transmission
Clinical narrative: onset date is approximate; girlfriend hospitalized with severe perineal cellulitis; viral culture grew vaccinia confirmed by state public health laboratory
Age: 28.0
Sex: F
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Viral test positive
Clinical narrative: onset date is approximate; girlfriend hospitalized with severe perineal cellulitis; viral culture grew vaccinia confirmed by state public health laboratory
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Patient's brother called reported to RNII stated patient's injection with red spot noted and seems spread to other part of her body, denies any SOB.  Vaccine administrator instructed to stop car and go to near by ER or call 911 if patient has SOB. At 4:05 RN called patient stated she is at ER and doctor is examing her.  5:27 PM RN called again patient stated she received 3 different pills one is Benadryl and was sent home.  09/03/2011 RN called at 9:50 AM patient c/o mild itch and continuing her P.O. medication RN offered to be follow again on 09/05/2011 but patient stated just call my brother on 09/06/2011.  09/06/2011 RN called 2:15 PM patient's brother stated she is OK no more rash and patient is doing fine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: SWELLING, REDNESS, AND ITCHING
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Feeling cold
Clinical narrative: felt cold, clammy
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Migraine, Nausea
Clinical narrative: Migraine Headache Nausea
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Uterine dilation and curettage
Clinical narrative: I had a miscarriage, which required a D&C.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain in injection site (left shoulder). Had problems lifting arm then and still today (9/6/2011).
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection site - As Soon as Administered Headache - Sat-Mon - Treatment Ibuprofen Redness & Swelling - Sat-Present Still Mild Fever 101 - Sat-Mon Slight Rash below injection site - Sun-Present Chills Body Aches - Sat-Mon
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Rash, Swelling
Clinical narrative: Pain at injection site - As Soon as Administered Headache - Sat-Mon - Treatment Ibuprofen Redness & Swelling - Sat-Present Still Mild Fever 101 - Sat-Mon Slight Rash below injection site - Sun-Present Chills Body Aches - Sat-Mon
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The site where the injection was has never stopped being painful and sore and I can't lift arm above head or in other positions. This shot was high on the shoulder and I have never had problems before in the many years of flu shots.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: The site where the injection was has never stopped being painful and sore and I can't lift arm above head or in other positions. This shot was high on the shoulder and I have never had problems before in the many years of flu shots.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypersomnia, Increased appetite, Pyrexia
Clinical narrative: Pt developed fever around 6pm 1-14-11. Sleeping more , eating more.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting & diarrhea x3 the day after receiving VARIVAX # 2. Mom states "I know my daughter's chemistry & this is not a typical reaction to a vaccine". "I don't think this is a virus". Mom requested that a VAERS form be filed.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Acne, Headache, Rash erythematous
Clinical narrative: Pt received Anthrax & Typhoid vaccines on Thursday. On the following Sunday, small red spots appeared on upper back. On Monday spots turned into acne-like whitehead pimples. Headache started on Monday.
Age: 1.1
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left side delt arm redness, swelling, and tenderness 45 ml x 50 ml side not painful no other symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Bone pain, Eyelid function disorder, Hypoaesthesia
Clinical narrative: Could not move, pain from back of neck to spine, down to lower back, hips, left leg & foot. After a week, left side of face numb, left arm weak & could not open left eye unless aided by hand. Nerves tingling with pain. Treated with prednisone, TYLENOL with codeine, LYRICA & physical therapies.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Neck pain, Nerve conduction studies, Neuralgia
Clinical narrative: Could not move, pain from back of neck to spine, down to lower back, hips, left leg & foot. After a week, left side of face numb, left arm weak & could not open left eye unless aided by hand. Nerves tingling with pain. Treated with prednisone, TYLENOL with codeine, LYRICA & physical therapies.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Could not move, pain from back of neck to spine, down to lower back, hips, left leg & foot. After a week, left side of face numb, left arm weak & could not open left eye unless aided by hand. Nerves tingling with pain. Treated with prednisone, TYLENOL with codeine, LYRICA & physical therapies.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Malaise, Tremor
Clinical narrative: Patient called next day (8/27). States that within 30 minutes of receiving FLUZONE, she got "real sick" with extreme diarrhea (soiled clothing), shakes/sweats went home and to bed. Sick all night. Better next day.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient received injection 8/23/11: 8/24/11 reports, soreness in arm. 8/25/11 had extreme pain, redness extending to mid forearm, difficulty lifting arm or bending fingers, and fever > 105 degrees patient went to local ER, reports was given IV medication, unsure of what meds. Pain completely resolved by 8/28/11. All effects felt only in left arm.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient received injection 8/23/11: 8/24/11 reports, soreness in arm. 8/25/11 had extreme pain, redness extending to mid forearm, difficulty lifting arm or bending fingers, and fever > 105 degrees patient went to local ER, reports was given IV medication, unsure of what meds. Pain completely resolved by 8/28/11. All effects felt only in left arm.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Subcutaneous PNEUMOVAX given on (R) posterolateral upper arm yesterday 8/26/11 & pt r/t today w/ approximately 22 x 10cm area red, hot, indurated, tender area at/around injection site. Referral to Urgent care for eval of cellulitis vs extensive localized rx w/ advice: ibuprofen, cool compresses & hydrocortisone cream as well.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local reaction
Clinical narrative: Subcutaneous PNEUMOVAX given on (R) posterolateral upper arm yesterday 8/26/11 & pt r/t today w/ approximately 22 x 10cm area red, hot, indurated, tender area at/around injection site. Referral to Urgent care for eval of cellulitis vs extensive localized rx w/ advice: ibuprofen, cool compresses & hydrocortisone cream as well.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives started 24 hours after vaccine administered, continued until parent called to inform provider on 08/24/11. Hives are relieved with BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea
Clinical narrative: Patient received flu shot around 3 PM on 8/29/11. He had headache. Chill. Nausea starting 4 PM. The symptoms last until 8 AM next day.