chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX on 21-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 23-JUL-2012 the patient experienced red swelling a couple of inches around the injection site and the area was hot to the touch after receiving ZOSTAVAX (lot # reported as "0255AE", exp date: 14-MSAR-2013). The patient sought medical attention by contacting the pharmacist. Cold packs were given for treatment. At the time of the report, the patient was recovering. This is third of three AE cases reported by this pharmacist. Lot check requested by the pharmacist. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female patient with a history of anxiety and no drug reactions/allergies who on 07-MAY-2012, was vaccinated IM with a 0.5 ml dose of GARDASIL (lot# 672233/1561AA, exp date: 26-AUG-2014, site not reported). Concomitant therapy included FEMCON FE. It was reported that the patient developed an injection site reaction after receiving a dose of GARDASIL in May 2012. The reaction area was about 3 inches and it was red, swollen, and little painful. The patient had not lab diagnostics studies performed. At the time of the report, the patient had not recovered. The patient saw the physician. Follow-up information has been received from a reporter from the physician's facility via B-form, concerning a 20 year old female student with no drug reactions/allergies, no illness at the time of vaccination and no adverse events following prior vaccination, who on 07-MAY-2012, was vaccinated with the first dose of GARDASIL at her left arm. The reporter stated that the patient had rash, redness and tenderness at injection site, and was advised to be seen in office. On 14-MAY-2012 the patient pronounced wheal subcutaneous at injection site. No new streaks, denied fever and chills. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female patient with a history of anxiety and no drug reactions/allergies who on 07-MAY-2012, was vaccinated IM with a 0.5 ml dose of GARDASIL (lot# 672233/1561AA, exp date: 26-AUG-2014, site not reported). Concomitant therapy included FEMCON FE. It was reported that the patient developed an injection site reaction after receiving a dose of GARDASIL in May 2012. The reaction area was about 3 inches and it was red, swollen, and little painful. The patient had not lab diagnostics studies performed. At the time of the report, the patient had not recovered. The patient saw the physician. Follow-up information has been received from a reporter from the physician's facility via B-form, concerning a 20 year old female student with no drug reactions/allergies, no illness at the time of vaccination and no adverse events following prior vaccination, who on 07-MAY-2012, was vaccinated with the first dose of GARDASIL at her left arm. The reporter stated that the patient had rash, redness and tenderness at injection site, and was advised to be seen in office. On 14-MAY-2012 the patient pronounced wheal subcutaneous at injection site. No new streaks, denied fever and chills. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cough, Malaise, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). No other co-suspects were reported. No concomitant medications were reported. The patient reported that she became very sick 48 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She stated that she had both coughing and congestion. The patient had sought unspecified medical attention. The outcome of coughing and congestion was reported as recovered/resolved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female patient with no medical history and with bilateral maxillary sinusitis as pre-existing illness was vaccinated with the second dose of GARDASIL (Lot # 671994/1537AA, route not reported) in her left arm on 13-MAR-2012. Suspect therapy included a first dose of BOOSTRIX (Lot# AC52B063BA, route not reported) given into the left arm, and HAVRIX (Lot # AHAVB539DA, route not reported) and MENACTRA (Lot # U4081AA, route not reported) given into right arm. Other medications included CEFZIL. CLARITIN and NASONEX. On 14-MAR-2012 the patient developed macular erythema with tenderness at immunization site measuring 8*5 mm (R) and 4.5*5 mm (L) arm. No wheezing both lungs clear. No lab diagnostic test performed. The patient was treated with cold compresses as needed, BENADRYL capsule 25 mg every 6 hours as needed, TYLENOL or ibuprofen as needed for pain. Return to clinic if got worse or having problems breathing. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # is 451939-1. No further information is available.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Tonic clonic movements
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS #452700-1). A 16 years old male patient was vaccinated with the first dose of GARDASIL (lot # 672233/1561AA) intramuscular on the right arm on 29-MAR-2012. Other Suspect therapies included VAQTA (672470/1697AA) intramuscular on the left arm on 29-MAR-2012. No concomitant medications were reported. On 29-MAR-2012 after needle removed from right arm the patient experienced loss of consciousness, tonic-clonic movements 1-2 minutes and stiffening. No treatment information was reported. At time of the report, the patient's outcome was unknown. Upon internal review, loss of consciousness and tonic-clonic movements were considered to be a medically significant event. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female was vaccinated with the first dose of GARDASIL (lot # 666162/0565Z, expiration date 15-SEP-2012) on 10-APR-2012 intramuscularly into her left arm. The patient had no medical history or pre-existing illness. The patient's mother reported that the patient complained of (c/o) fever, headache at 7 PM on 10-APR-2012. The patient was treated with ADVIL 4 tsp. On 11-APR-2012 AM, the patient continued to c/o lethargy, nausea, fever (100.2) and she was to take ADVIL 4 tsp at 01:30 PM. On 11-APR-2012 at 04:30 PM, when spoke to the patient, it was reported that she improved of symptoms. The agency considered the events to be non-serious and no conditions. The original reporting source was provided by a consumer. The VAERS ID # is 454088. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female was vaccinated with the first dose of GARDASIL (lot # 672232/1495AA) on 29-MAY-2012 intramuscularly into her left arm. The patient had no pre-existing illness. The patient had itchy rash starting at early AM on 30-MAY-2012. She was seen in office and assessed by a doctor as hives which was possible reaction to injection. The agency considered the events to be non-serious and no conditions. The original reporting source was not provided. The VAERS ID # is 456571. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pain in extremity, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the freedom of information Act. A 14 years old female patient was vaccinated into the left arm with the first dose of GARDASIL (lot # 670049/1171AA) on 04-JUN-2012. No other co-suspects were reported. Concomitant medications was given on the same date included: the first dose of HAVRIX (lot # AHAVB509AA). On 04-JUN-2012 the patient had passed out in chair. The doctor was called to come in. The patient experienced arm stiff, calf pain and emesis. The patient heart rate was 60, and recovered to 72. No treatment information was reported. At the time of the report, the patient status was unknown. On internal review, lost consciousness was determined to be an other important medical event. This report was considered not serious, no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 456800-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Heart rate abnormal, Loss of consciousness, Musculoskeletal stiffness, Pain in extremity, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the freedom of information Act. A 14 years old female patient was vaccinated into the left arm with the first dose of GARDASIL (lot # 670049/1171AA) on 04-JUN-2012. No other co-suspects were reported. Concomitant medications was given on the same date included: the first dose of HAVRIX (lot # AHAVB509AA). On 04-JUN-2012 the patient had passed out in chair. The doctor was called to come in. The patient experienced arm stiff, calf pain and emesis. The patient heart rate was 60, and recovered to 72. No treatment information was reported. At the time of the report, the patient status was unknown. On internal review, lost consciousness was determined to be an other important medical event. This report was considered not serious, no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 456800-1. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Face injury, Fall, Haemorrhage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old female was vaccinated with the first dose of GARDASIL (lot# 672834/0131AE) on 04-JUN-2012 injected into her left arm. Concomitant medications included the first dose of MENACTRA injected into her right arm on the same day. The patient had no pre-existing illness. There were no other medications. The patient's mother told that on 04-JUN-2012 after the patient got vaccinations, the patient had to stay in room because could get dizzy from GARDASIL. After GARDASIL was administered, leaned table so the patient could lay down. Patient was sitting on exam table when the mother turned around for 1 second to grab her notepad. Patient fell face forward on floor and was bleeding. She had a seizure for less than a minute. At the time of reporting, the patient's outcome was unknown. The patient sought medical attention via ER visit. The agency considered the events to be non-serious. Upon internal review, seizure was determined to be an other important medical event. This was originally reported by a consumer. The VAERS ID # is 457208. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dry mouth, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female was vaccinated with the second dose of GARDASIL (lot # reported as 671463/1359AA, expiration date 23-JUN-2014) on 29-MAY-2012 intramuscularly into her left arm. The patient had peanut allergies and no pre-existing illness. There were no other medications. On 29-MAY-2012 at 05:10 pm, the patient felt dizzy after vaccine was given, her arm felt like its asleep, and she experienced dry mouth. The patient was given water and BP was taken. On 29-MAY-2012 at 05:30pm, the patient had much improved. There was no lab data. The agency considered the event to be non-serious and no conditions. The original reporting source was not provided. The VAERS ID # 457212. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dry mouth, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female was vaccinated with the second dose of GARDASIL (lot # reported as 671463/1359AA, expiration date 23-JUN-2014) on 29-MAY-2012 intramuscularly into her left arm. The patient had peanut allergies and no pre-existing illness. There were no other medications. On 29-MAY-2012 at 05:10 pm, the patient felt dizzy after vaccine was given, her arm felt like its asleep, and she experienced dry mouth. The patient was given water and BP was taken. On 29-MAY-2012 at 05:30pm, the patient had much improved. There was no lab data. The agency considered the event to be non-serious and no conditions. The original reporting source was not provided. The VAERS ID # 457212. No further information is available.
Age: 67.7
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Incorrect dose administered, Musculoskeletal pain
Clinical narrative: PNEUMOVAX booster administered 2/29/2012 and accidentally revaccinated with PNEUNOVAX on July 12, 2012. Patient c/o of increased shoulder and joint pain (hx rheumatoid arthritis. Treatment = Use pain meds prn and continue prednisone. Monitor for fever. Any SOB, rash go directly to ED.
Sex: U
Vaccine: FLUN3
Symptoms: Multiple sclerosis
Clinical narrative: A report has been received from a Licensed Practical Nurse via Merck concerning an adult patient of unknown gender. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. The dosage, frequency and indication of use of this medication were not provided. The nurse reported, that the patient was diagnosed with multiple sclerosis several weeks after receiving FLUMIST. At the time of reporting the action taken with FLUMIST and the outcome of the event were unknown. According to the reporter the event of multiple sclerosis was considered to be serious and the serious criterion for the report was as follows: important medical event.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated that her left arm was sore, red, swollen, & feverish. From elbow up. Pt went to Emergency Room on 7/28/12, she was diagnosed with cellulitis on her left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Vision blurred
Clinical narrative: Shortly after providing vaccination pt reported lightheadedness, chest tightness, and blurry vision. We did monitor pt she wanted to leave and go home before chest tightness completely resolved. We did contact pcp, but pt chose not to go. We made additional follow up calls to check pt condition.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Seizure like phenomena, Syncope, Throat irritation
Clinical narrative: Pt received 4 vaccines, 2 in R arm Hep A, HPV #1, then 2 in L arm Tdap, & MENACTRA. Pt then fainted & had seizure-like activity. Was coming around & started c/o feeling nauseous & then started c/o throat feeling funny. Sat always 96-97%, vs stable, no difficulty breathing. Epi was given 0.3 mg IM & pt was transported via ambulance to hospital. Given BENADRYL & FAMOTIDINE & sent home on prednisone (oral).
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 7/27/12 patient went to Urgent Care c/o swelling about size of tennis ball, redness and warm to touch.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cough, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Began with slight swelling & pain at injection site.  Difficulty lifting arm above head.  Lasted about a week.  A couple weeks later there was itching, redness, and a lump at the site, lasting about a week, then subsiding. Another time, about 1 month post injection, the local reaction of itching, lump, redness resulted in clear fluid filled, pin head sized, blisters (reminded me of smallpox vaccination reaction).  There is now a darkened area, nickel to quarter size, that has not gone away.  During one flare-up there was a night time episode of a "croupy type" cough of short duration. The local reaction of itching, a palpable lump, some swelling, and redness, continues to occur at intervals of about 2 weeks, today, 4 months later.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Mobility decreased
Clinical narrative: Began with slight swelling & pain at injection site.  Difficulty lifting arm above head.  Lasted about a week.  A couple weeks later there was itching, redness, and a lump at the site, lasting about a week, then subsiding. Another time, about 1 month post injection, the local reaction of itching, lump, redness resulted in clear fluid filled, pin head sized, blisters (reminded me of smallpox vaccination reaction).  There is now a darkened area, nickel to quarter size, that has not gone away.  During one flare-up there was a night time episode of a "croupy type" cough of short duration. The local reaction of itching, a palpable lump, some swelling, and redness, continues to occur at intervals of about 2 weeks, today, 4 months later.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, lethargy lasted until approximately 2:30 PM the same day. Treated with Tylenol and hydration.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Pt. had rash on body and stated he was feeling really itchy and it is getting worse.
Age: 1.02
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Blister, Irritability, Rash, Scab
Clinical narrative: RASH SPREADING, CRUSTING AND BLISTERING, FUSSY ESP AT NIGHT.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had MMR and Varicella sq. in Right Arm: area is raised, inflammed and warm to the touch. (About 3 and 1/2 inches length and width). Pt. also says she has some pain and itching at the site. Pt says that she did take some Benadryl and has been applying ice.
Age: 46.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: Took oral typhoid completed 7/28/12, rash developed 7/29/12 on thighs, & legs with she reports some bruising took BENADRYL for itching, instructed to contact PMD.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Malaise, Pain, Swelling
Clinical narrative: Started 7/12/12 at date of vaccination, felt sore & bruised over night began swelling & turned red. Today pt began not feeling well. Treated with ice, BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever, Red area on Left leg where injection was given. Benadryl given for treatment.
Age: 0.97
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: Extremely tired at 4:30 PM, then fever of 102.6 at 6:30 PM. Then, fever of 101.2 on 7/30, and fever of 100.6 on 7/31. Then, cold symptoms beginning on 8/1.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Discomfort, Headache, Injection site joint pain, Injection site pain
Clinical narrative: Swollen sore arm at injection site on left arm; left side of face also swollen; jaw pain, headache; fever, chills, difficulty lifting left arm above head; achy feeling in left shoulder; trouble sleeping due to discomfort and pain.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Insomnia, Mobility decreased, Pain, Pain in jaw
Clinical narrative: Swollen sore arm at injection site on left arm; left side of face also swollen; jaw pain, headache; fever, chills, difficulty lifting left arm above head; achy feeling in left shoulder; trouble sleeping due to discomfort and pain.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling face
Clinical narrative: Swollen sore arm at injection site on left arm; left side of face also swollen; jaw pain, headache; fever, chills, difficulty lifting left arm above head; achy feeling in left shoulder; trouble sleeping due to discomfort and pain.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt stated that she was fine until 7/23/12 when pt noticed a red, swollen, warm to the touch. Pt came in the following day to check up.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Telephone call from childs mother stating childs has "welts" on both legs and elbow areas. Mother states the welts started today.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache, Pain, Pyrexia, Secretion discharge
Clinical narrative: Drainage from (R) arm, body aches, H/A, fever. To ER on 7/29/12 tx BACTRIM.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pain, Swelling
Clinical narrative: TC to MOC. Stats child developed soreness about 1 am (7-31-12) and a 5" x 5" reddened area by noon (7-31-12) with swelling extending approx 1" beyond reddened area.
Age: 20.0
Sex: M
Vaccine: TTOX
Symptoms: Cough, Fatigue, Rhinorrhoea
Clinical narrative: Patient had a cough, runny nose and tiredness for approximately 2 days.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Disorientation, Pyrexia, Sleep terror
Clinical narrative: Initial report was received from a healthcare professional on 19 July 2012. An 11-year-old male patient received dose one of a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc. lot number U4103AA (corresponding sanofi pasteur Ltd. lot number C3971); dose one of a right deltoid intramuscular injection of MENACTRA, sanofi pasteur Inc., lot number U4033AA; and dose one of right deltoid injection (route not reported) GARDASIL, Merck, lot number 1537AA on 18 July 2012. Within 24 hours of vaccination, on 19 July 2012 the patient experienced "night terrors" along with disorientation during the night, diarrhea and low grade fever of 100.6 degrees. The patient had not been evaluated by a physician. The reporter (nurse) stated she felt "this could be a form of encephalopathy caused by the ADACEL," and advised the parent to have the patient evaluated by a physician. Laboratory or diagnostic testing had not been done at this time. Corrective treatments were not reported. The patient's outcome was reported as unknown. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction redness (large) and swelling.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Given chickenpox vaccine to left arm on 7-31-12 youth complaint sore left arm on 8-1-12 0900 left arm with 7 cm red raised induration over injection site. 1. Tx. warm compresses BID x 3 days. 2. BACTRIM DS 1 tab PO BID x 7 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema
Clinical narrative: Red spot on the back of her right arm where she received varicella vaccine 2 days ago. Denies any fever or other s/sx treated with ibuprofen prn and diphenhydramine prn and warm compresses.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red, raised rash at injection site, about 1 inch in diameter.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Breath holding, Crying, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient was given 5 vaccines. 1 oral and 2 injections in right leg and 2 in left leg.  Oral Rota was given first, then 2 shots in right leg.  Patient began crying and then holding breath.  Parent blew in face and child began crying.  Continued to administer 2 shots in left leg.  Patient began holding breath again and lost consciousness.  Was unresponsive for 30 seconds to 1 minute.  Nurse practitioner came into room and Dr. Both began blowing in face and patient awoke and was responsive.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Patient complains of pain in upper left arm, severe at times, that worsens upon exertion. Pain continues now, more than one month later, and limits patients activities.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Chest pain, Injection site mass, Injection site pain, Pain, Swelling
Clinical narrative: Pt. reported painful lump (L) deltoid within a few hours of receiving Tdap. 3 days later on 7/28/12 noticed tender swelling (L) axilla. Lump was the size of a nickel. On 7/31/12 developed soreness across upper chest and unable to relate to any other cause. Painful to sit up down with movement of torso/arms. Some relief with ibuprofen. As of 8.1.12 only mild tenderness of deltoid and axilla. Advised to see PCP for the chest pain but declined- will wait to see if it resolves.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Tenderness
Clinical narrative: Pt. reported painful lump (L) deltoid within a few hours of receiving Tdap. 3 days later on 7/28/12 noticed tender swelling (L) axilla. Lump was the size of a nickel. On 7/31/12 developed soreness across upper chest and unable to relate to any other cause. Painful to sit up down with movement of torso/arms. Some relief with ibuprofen. As of 8.1.12 only mild tenderness of deltoid and axilla. Advised to see PCP for the chest pain but declined- will wait to see if it resolves.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt called reporting fever and persistent shaking chills at 11:30pm. Earlier that day had tetanus shot w/ subsequent site pain and slight redness/swelling. Sent to ED-no treatment given.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Pt called reporting fever and persistent shaking chills at 11:30pm. Earlier that day had tetanus shot w/ subsequent site pain and slight redness/swelling. Sent to ED-no treatment given.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient - right lower extremity swollen, painful with motion (evening of vaccination). Following day (7/21/12) - increased swelling, decreased movement and mother noticed she was favoring other leg (left) when standing- 7/22 - fevers also noticed. Came to hospital on 7/24.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Weight bearing difficulty
Clinical narrative: Patient - right lower extremity swollen, painful with motion (evening of vaccination). Following day (7/21/12) - increased swelling, decreased movement and mother noticed she was favoring other leg (left) when standing- 7/22 - fevers also noticed. Came to hospital on 7/24.
Sex: F
Vaccine: FLUX
Symptoms: Coma, Condition aggravated, Escherichia urinary tract infection, Multiple sclerosis relapse, Syncope
Clinical narrative: Initial report was received from a consumer on 20 July 2012 with follow-up information received on 24 July 2012. A female patient (age and birth date not reported) received an INFLUENZA VACCINE, manufacturer unknown, (lot number, route and site not reported) on an unspecified date. On an unspecified date after the patient received a flu shot, she acquired a strain of flu that was not covered by the flu vaccine and eventually had a "very serious exacerbation of Multiple Sclerosis (MS)." She reported that she then got very ill with an Escherichia coli (E. Coli) urinary tract infection that resulted in her collapsing at home in a coma, for which she was hospitalized for nine days and was not expected to live. The patient's past medical history included several chronic health problems: Multiple Sclerosis, Systemic Lupus, a low functioning thyroid issue and diabetes (also reported as had diabetes since she got very sick) for which she takes clear, round pill that starts with an "A". She also takes many Vitamins. The patient reported she is in a wheelchair. On follow-up, the patient clarified that she did not know what brand of flu vaccine she received as she was already in the hospital for MS when she received the flu vaccine during hospitalization to protect her. The patient clarified that she did not believe that the vaccine caused any of her problems and she could not provide any further information. The patient's outcome was not recovered. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Flushing, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after injection had body/muscle aches, arm painful/swollen/red at injection site, warm, flushed, weakness. Dr. prescribed Tylenol 500mg three times daily as needed/rest/fluids, Benadryl 25mg 1-2 twice daily prn and if symptoms become severe/increased will need to go to urgent care for evaluation.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia, Pain
Clinical narrative: 24 hours after injection had body/muscle aches, arm painful/swollen/red at injection site, warm, flushed, weakness. Dr. prescribed Tylenol 500mg three times daily as needed/rest/fluids, Benadryl 25mg 1-2 twice daily prn and if symptoms become severe/increased will need to go to urgent care for evaluation.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Redness at injection site, no hives, no rash, had pain 1 day and resolved, no treatment, redness at injection site at office visit 08/01/2012, no rash, no hives, no other symptoms, no pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, VIIth nerve paralysis
Clinical narrative: Pt had left sided facial drooping starting at 9:00 PM. Pt reported to ER at 11:05 PM cause symptoms were not resolved.
Age: 15.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Malaise, Pallor, Vomiting
Clinical narrative: Administered Tdap and varicella in client's right deltoid.  Client stated that he felt dizzy and appeared pale.  I asked if he felt like he was going to be sick he said yes.  I placed the trash can in front of him and he started vomiting within a minute.  He vomited 3 times and remained pale and dizzy.  He remained seated with a cold compress on his forehead.  BP was 90/62, lungs clear and denied difficulty breathing.  Client stayed 15 minutes after vomiting and said he felt better.  Instructed to call if any other s/s.  Was not given MCV4 as planned.  Will return with mother for future imms.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Fatigue
Clinical narrative: FATIGUE & DIARRHEA DAY OF VACCINATION AND DIARRHEA CONTINUED THIS DAY (08/01/2012).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Chills, Echocardiogram, Electrocardiogram, Erythema
Clinical narrative: I had several adverse events, the most significant of which was at the time listed above. I developed pericarditis (and a mild fever of 99.4 F the next day) in the absence of anything else that could have contributed to it. In the full week after receiving the vaccination, my arm was red (about a 3" diameter red rash) and extremely itchy. I also had significant chills in the time between receiving the vaccine and the pericarditis appearing (so much so that I had them in 102-degree weather).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: I had several adverse events, the most significant of which was at the time listed above. I developed pericarditis (and a mild fever of 99.4 F the next day) in the absence of anything else that could have contributed to it. In the full week after receiving the vaccination, my arm was red (about a 3" diameter red rash) and extremely itchy. I also had significant chills in the time between receiving the vaccine and the pericarditis appearing (so much so that I had them in 102-degree weather).
Age: 9.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Convulsion, Immediate post-injection reaction, Musculoskeletal stiffness, Tremor
Clinical narrative: The patient was sitting in a chair. I administered two vaccines (Td and Hepatitis A), and he immediately had a seizure (became very stiff and was  shaking). I picked him up and placed him on the exam table. His feet were elevated. The seizure lasted approximately ten seconds. Another nurse joined me at that time and took his blood pressure--it was 140/96. His blood pressure was checked again at 12:11 PM and was 120/82. The patient was able to correctly answer questions relating to his name, date of birth, and current location. We sat him up and gave him Sierra Mist to drink. His blood pressure was re-checked at 12:21. It was 110/72. He indicated he was feeling better and was able to stand at 12:30 PM. At that point, his family exited the health department and was instructed to follow up with a physician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: I started by the site swelling, and got fatigued. The next day I was weak, headache, the swelling was very red, hard about the size of a pop can. 5 inches outside the site I got an infection, the skin was red.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site swelling
Clinical narrative: I started by the site swelling, and got fatigued. The next day I was weak, headache, the swelling was very red, hard about the size of a pop can. 5 inches outside the site I got an infection, the skin was red.
Age: 32.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient reports injection site soreness followed by severe burning pain in L arm from posterior L shoulder to fingertips immediately after receiving anthrax vaccine.  Pain lasted for six hours; pain severity 8 to 9/10.  Pain was less severe the following day, however, pain caused limited mobility.  Patient could not move L elbow above/superior to L deltoid.  Patient used Tylenol and Aleve PRN to control the pain.  During 28-29 July, patient reports a decrease in pain and increase in mobility.  30 July, patient states pain was 3/10, with full mobility.  Patient did not seek medical attention until today.  Reports minor soreness in the L deltoid at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: REDNESS AND SWELLING TO THE LEFT ARM.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Grip strength decreased, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Started with muscle soreness at injected arm, progressed to entire body by morning of 30 Jul 2012. Soreness became more severe to the point were walking was not possible without severe pain or grip a pen adequately to write by 31 Jul 2012. Doctor Visit on 01 August, performed tests, determined it was a delayed reaction to the TDAP vaccine.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: Started with muscle soreness at injected arm, progressed to entire body by morning of 30 Jul 2012. Soreness became more severe to the point were walking was not possible without severe pain or grip a pen adequately to write by 31 Jul 2012. Doctor Visit on 01 August, performed tests, determined it was a delayed reaction to the TDAP vaccine.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, sweats.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: After the receiving the HPV - the patient sat on the table for several minutes. He stated he was feeling OK. He got up, walked down the hallway and when entering the waiting room, he fainted. His B/P was taken and his legs were elevated. He came to quickly and sat on chair behind him. Initial B/P was 62/37. After sitting for a few minutes he was moved to a room where he was laid on the table and large pillow were put under his legs to elevate his legs. His B/P was taken several times and was 103/68, 103/68 and 110/70. At about 6:45 he stated he was feeling good and his mother put him in the Car to take him home. The mother was instructed to call the Clinic if he had any ongoing problems. A waiver was put into his state record - to permanently remove him from receiving any more HPV IZs. This was the first one (Gardasil) he received.
Age: 0.21
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Inflammation, Insomnia, Laceration, Pruritus
Clinical narrative: This is my son's first and only vaccine. He did not receive the Hep B at birth. Less than 24 hour after he received his DTaP shot he started to develop an unexplained red spotty rash on his face, especially his cheeks. At first it looked like heat rash but, as it became redder in color with raised hive like bumps over the next few days, I became concerned. He was also running a mild fever, 100.2 on March 28, 2012. I emailed his doctor a picture of his inflamed cheek on April 1, 2012 and asked what it is and if an office visit was required. His doctor said it was just eczema, which is very common in babies. Be assured my son had no issues prior to the vaccination. He now suffers from severe eczema requiring hydrocortisone for flare ups, daily oatmeal baths, and heavy creams applied 5-6 times per day. He also scratches his face and head at night resulting is bloody cuts, even with trimmed and filed nails. I often put socks on his hands at night to help reduce the cuts. He also has trouble sleeping when he has flare-ups. The eczema appears on his cheeks, eyebrows, forehead, ear lobes, scalp, back of neck, elbows, shoulders, thighs, front of ankles and lower back. His doctor has dismissed my concerns as a "coincidence". I am deeply troubled by the amount of aluminum in this vaccine and now the ongoing condition my son suffers from. For his body size (20 lbs, 1 oz as of July 10, 2012) he should not be exposed to more than 45.5 mcg's of aluminum at any given time. Whereas this vaccine (Sanofi Pasteur, lot # C40358A) contained 170 mcg's!
Age: 0.21
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash erythematous, Skin haemorrhage, Urticaria
Clinical narrative: This is my son's first and only vaccine. He did not receive the Hep B at birth. Less than 24 hour after he received his DTaP shot he started to develop an unexplained red spotty rash on his face, especially his cheeks. At first it looked like heat rash but, as it became redder in color with raised hive like bumps over the next few days, I became concerned. He was also running a mild fever, 100.2 on March 28, 2012. I emailed his doctor a picture of his inflamed cheek on April 1, 2012 and asked what it is and if an office visit was required. His doctor said it was just eczema, which is very common in babies. Be assured my son had no issues prior to the vaccination. He now suffers from severe eczema requiring hydrocortisone for flare ups, daily oatmeal baths, and heavy creams applied 5-6 times per day. He also scratches his face and head at night resulting is bloody cuts, even with trimmed and filed nails. I often put socks on his hands at night to help reduce the cuts. He also has trouble sleeping when he has flare-ups. The eczema appears on his cheeks, eyebrows, forehead, ear lobes, scalp, back of neck, elbows, shoulders, thighs, front of ankles and lower back. His doctor has dismissed my concerns as a "coincidence". I am deeply troubled by the amount of aluminum in this vaccine and now the ongoing condition my son suffers from. For his body size (20 lbs, 1 oz as of July 10, 2012) he should not be exposed to more than 45.5 mcg's of aluminum at any given time. Whereas this vaccine (Sanofi Pasteur, lot # C40358A) contained 170 mcg's!
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Noted relatively transient, superficial wheals scattered on abdomen x 4 measures .5 to 1 cm on circular shape. Pruritis - BENADRYL 50mg orally.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Pyrexia, Streptococcus test negative
Clinical narrative: Mom states at 5:00 pm approximately fever began to elevate (101.8 degrees F) reaching & c/o HA & gave 200mg Ibuprofen then went to ER & mom states temp there was 103.6 degrees F.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: - Body ache. - Headache. - Runny nose. - Sore throat. - No fever.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hypoaesthesia, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Left shoulder pain, weakness, numbness since injection of Hep B vaccination on 6/8/12.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Culture, Herpes zoster
Clinical narrative: On 6th day after vaccination pt felt burning on his toes, later developed blisters on feet, went to MD on Tues => MD suspects shingles.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: 7-25-12 7:00 pm (L) arm started to hurt 7-26-12 headache 7-27-12 fever - temp not taken 7-27 & 7-28-12 headache 7-29-12 rash in a band around arm (2") itched 7-30-12 redness upper arm 7-31-12 saw her physician - on antihistamine.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: 7-25-12 7:00 pm (L) arm started to hurt 7-26-12 headache 7-27-12 fever - temp not taken 7-27 & 7-28-12 headache 7-29-12 rash in a band around arm (2") itched 7-30-12 redness upper arm 7-31-12 saw her physician - on antihistamine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fatigue, Feeling abnormal, Hypotonia, Somnolence, Staring
Clinical narrative: Blank stares, unresponsive to name or touch/stimuli and limp during blank stares which lasted a few seconds, sleepy, tired and spaced out for about a week.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Blank stares, unresponsive to name or touch/stimuli and limp during blank stares which lasted a few seconds, sleepy, tired and spaced out for about a week.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Pyrexia
Clinical narrative: Pt given PNEUMOVAX 23. The next day, Pt called to inform nurse he had a fever & (R) hand was swollen. Pt advised to come in immed. Pt Dx with cellulitis, placed on KEFLEX.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt had developed warm rash at injection site getting better but red and itchy. Pt is taking TYLENOL and BENADRYL.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt developed rash at injection site. Rash is itchy and red. Pt is getting better. Pt also developed flu like systems on 7/27/12. System went away in 1 day.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site mass
Clinical narrative: Lumps on both legs where vaccines were given.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Swelling to right shoulder area.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Right deltoid with 4-5 cm warm to touch lump occurred day after vaccine. Denies pain or itchiness.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Swollen, painful, red rash on 3 separate sites on arm. Rash on leg & feet.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Joint injury, Presyncope
Clinical narrative: Pt received Hepatitis A vacc and HIV vaccine and has vasovagal syncope; injured - (L) maxilla joint.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm because very swollen and painful to move. Symptoms lasted approx 3 days, but were improved each day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old female patient with penicillin allergy and with a history of localized reactions to vaccines (names unspecified). The patient was vaccinated subcutaneously in arm with a single 0.65ml dose of ZOSTAVAX (Lot# 671786/0254AE) on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient experienced an injection site reaction. The patient developed "a rash that went from the injection site on her arm up to her neck". The patient had reported this to the office but there was no emergency room or doctor's visit. No lab diagnostics studies were performed. The patient took some ibuprofen and was using cold compresses for treatment. At the time of this report the patient's status was not known. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The patients were vaccinated with the second and third doses of GARDASIL (Lot#, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was not known if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a consumer refers to her 16 years old son. The patient was vaccinated with dose 1 GARDASIL in April 2011. The patient had not yet received a 2nd dose. It was unknown if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from register nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of M-M-R II (lot # 667244/0919Z, exp: 15-JUL-2012) on 17-JUL-2012. It was unknown if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.