chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Induration
Clinical narrative: 27mm red induration, temp 99 degrees.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 60 mm red induration tender, temp 98.7.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Local reaction at injection site. Redness, warm to touch. Itching. Pt had these symptoms for 5 days.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Pt had a major reaction to pneumonia shot. Dr said pt got cellulitis, red & swollen arm down to elbow.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Haemoglobin normal, Pallor, Postictal state, Syncope
Clinical narrative: 10 min after getting Tdap & Flu vaccines pt. looked pale then had a syncopal episode & per mom was not breathing well. She then had 10-15 sec of tonic clonic activity in arms & legs plus loss of bladder after episode pt very mildly postictal but was awake & alert with nl VS. No prior hx of szs. No URI or other sxs before vaccines. Obs. in clinic >1 hour & back to baseline.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Tonic clonic movements, Urinary incontinence
Clinical narrative: 10 min after getting Tdap & Flu vaccines pt. looked pale then had a syncopal episode & per mom was not breathing well. She then had 10-15 sec of tonic clonic activity in arms & legs plus loss of bladder after episode pt very mildly postictal but was awake & alert with nl VS. No prior hx of szs. No URI or other sxs before vaccines. Obs. in clinic >1 hour & back to baseline.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large, swollen redness around injection site 1 day after admin. Pt. given 3 vaccines, all in the same arm per his & parents request. Parents say he had had previous imm. reactions. But they are unsure as to when.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Patient experienced shooting pain and tingling in her arm after being vaccinated. Patient believes she was given shot incorrectly into a nerve after consulting w/ a doctor.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue for 1 week 2 days post vaccine. Mild to moderate. Significant dizziness.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: Pt said she had bruising at site of injection. The bruise spread down her arm to elbow. She said she's had the high dose last year but did not have the same reaction. The pt reported this today on 10/30/12.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Asthenia, Fatigue, Rash
Clinical narrative: Rash 10/30, fatigue/decrease energy 10/30.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flushing, Musculoskeletal discomfort, Neck mass
Clinical narrative: Discomfort to left neck with 3 swollen lumps. Fatigue. Flushing.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dysgeusia, Laboratory test, Nausea
Clinical narrative: 15 mins, dizzy, faint feeling, weakness, nausea and given toast, juice, cold pack behind neck, elevated lower extremities. BP 140/88, metallic taste that left mouth after 10 min. Went back to work. Presented to ER around 1 PM.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: Day of vaccine - vaccine given at 3pm, and at 7 pm she started feeling lightheaded, dizzy, nauseous, headache, body ache. Came on gradually throughout evening. 5 days later still having symptoms - mainly dizziness, nausea and headache.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Muscular weakness, Pain in extremity
Clinical narrative: Pt stated from flu shot given on 10/9/12 there was pain & weakness in arm. Pt stated shot was given on top of shoulder, not in arm.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Child given TDAP/MCV at 11:00 a. Child already had both vaccines 9-14-10 - No issues at time of event. The shots were not entered into records so it looked as though did not have them.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Approx. 12 hr. after vaccine was given I developed muscle aches/pain/weakness (& some minor tingling in fingers & toes occurring approx 7 days after vaccine). Joints (fingers, wrists, knees, feet) ache along with generalized muscle aches & weakness. Headache almost continuous as well. NSAID's help but does not eliminate symptoms. Symptoms continuing & getting worse.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after shot felt a tingly numbness all the way down arm to fingers. Then later in the day her legs, arms, & face was itchy & tingly. She said also felt lightheaded & nauseous. Has had previous flu shots & never felt this way. Did not report this to nurse until the next day. Never went to MD or took medication. Also felt weak.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Immediately after shot felt a tingly numbness all the way down arm to fingers. Then later in the day her legs, arms, & face was itchy & tingly. She said also felt lightheaded & nauseous. Has had previous flu shots & never felt this way. Did not report this to nurse until the next day. Never went to MD or took medication. Also felt weak.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain at injection site, erythema, induration 1x1 cm with larger area of erythema 10x10. Tx - antihistamine, 0.1% triamcinolone.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, diarrhea, vomiting x 3 within 24 hours of vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Head injury, Induration, Laceration, Skin warm, Suture insertion
Clinical narrative: Pt. received ADACEL and MENACTRA to LD, syncoped and hit head on window sill in room. Received staples for laceration to head in ER. Returned on 10/25 for possible concussion and vaccine reaction to LD. Raised induration 11 cm x 11 cm and warm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling, Syncope
Clinical narrative: Pt. received ADACEL and MENACTRA to LD, syncoped and hit head on window sill in room. Received staples for laceration to head in ER. Returned on 10/25 for possible concussion and vaccine reaction to LD. Raised induration 11 cm x 11 cm and warm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Administered vaccine in pt (R) deltoid. Entire dose would not go into arm. 0.1 mL left in syringe gave 0.1 mL extra. Could have been syringe malfunction. After removing syringe from arm, still wouldn't retract or finish. Vaccine was "stuck" it was as though it was frozen however it was at correct temp.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased
Clinical narrative: As per what the hospital leaflets said about 4 wks after operation my upper arms both left & right sides got very very sore could not even lift them above my chest, still to this day (Oct 30, 2012).
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Paraesthesia oral, Tongue disorder
Clinical narrative: About 10 min after giving shots pt returned to pharmacy stating tongue felt like it was getting big. Immediately gave her BENADRYL PO 25mg. 10 min after that her lips were tingling so gave her 1 dose EPIPEN to Rt thigh & called 911. Due to heart arrhythmic history paramedic took her to hospital.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her son of unknown age. The patient was vaccinated with the first dose and the second dose of GARDASIL (lot #, route and dose were unknown) on an unknown date. It was now 2 months beyond the six months between the second and third dose. The reporter did not want to provide any demographics since there were no adverse events other than the missed dose. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: 1 of 4 linked same reporter cases (other related cases: 1210USA013663, 1210USA013664 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with GARDASIL. The patients might have been vaccinated with improperly stored GARDASIL but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 12 years old female patient. On approximately 24-OCT-2012, "yesterday or today", the patient was vaccinated with the third shot of 0.5 ml GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The doctor told him that the patient received her third GARDASIL shot, and then was asked to stay seated before leaving to make sure she was okay. The patient's mother told the doctor that this wasn't necessary because the patient had no problems when she got the first 2 shots. As she was walking out through the waiting room, the patient passed out. As a treatment, the office staff sat her down and gave her water until she recovered and could leave on the same day the shot was given. It was reported that the adverse event occurred after reintroduction. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was inadvertently vaccinated with 0.5 ml GARDASIL (lot # 666595/0096Z, expire date 14-OCT-2012) intramuscularly on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
Age: 0.85
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was intramuscularly administered the three doses in the GARDASIL series on 05-OCT-2011, 25-SEP-2012 and 24-OCT-2012 respectively. No lot number was provided. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 29 years old female patient refers to herself, for GARDASIL, a pregnancy registry product. The patient had allergy to penicillin. The patient's history of previous pregnancies and live births is not known. The patient went to her doctor for two shots. She was given GARDASIL (route, dose and lot # were unknown) instead of a shot for whooping cough accidentally on 22-OCT-2012. No other co-suspects were reported. Concomitant medications included: prenatal vitamins. The Pregnant Gestation was 24 weeks. The patient was exposed to GARDASIL during trimester 2. The patient had performed lab diagnosis studies blood work a few months ago. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age with a history of allergies and no known drug reactions. On August 2011, the patient was vaccinated with dose 1 GARDASIL (dose, route and lot not provided). On October 2011, the patient was vaccinated with dose 2 GARDASIL (dose, route and lot not provided). On August 2012, the patient was vaccinated with dose 3 GARDASIL (dose, route and lot not provided). No concomitant medications were reported. The Nurse stated that the patient who received GARDASIL no experience any adverse effect. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Contusion, Pain in extremity, Ultrasound scan
Clinical narrative: This spontaneous report as received from a mother's consumer concerning a 22 year old female patient who was vaccinated with a first dose of GARDASIL at the end of July 2012 (on 31-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that her daughter began suffering from leg pain and bruising two to three days later after receiving GARDASIL. The patient sought medical attention, she was seen in the emergency room (unspecified hospital) and was prescribed ibuprofen for the pain. The mother was hesitant to allow her daughter to receive the remaining shots in the series. Ultrasound and blood works were performed. At the time of the report, the patient's had not recovered from adverse events. The relatedness for leg pain and bruising was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: The primary reporter is nurse practitioner. This nurse practitioner noted that patient, was inadvertently administered VARIVAX and PROQUAD during the same office visit today (10/25/2012). For both VARIVAX and PROQUAD, it is not known which dose these doses were in their respectively vaccination schedules. No adverse effect reported. All AE fields apply to both vaccines. No further information is available.
Age: 0.59
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed visiting nurse refers to a 7 months old female patient. The patient was inadvertently vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # 0555AE: expiration date 14-DEC-2014) on 22-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Live birth, Maternal exposure before pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a female healthcare worker for GARDASIL, a Pregnancy Registry Product, reporting on herself, who in 2006, was vaccinated with GARDASIL (dose, route and lot number were not reported). The reporter stated that the patient had a normal Pap screening test, on an unspecified date, after receiving GARDASIL, but she was also reporting that the last Pap screening test she had was abnormal. The result indicated a precursor for cervical cancer. There was no treatment given, the Pap result will be rechecked at a later unspecified date. It was reported that the patient was pregnant. Her last menstrual period was in June, 2011 and she was due to deliver in 8 weeks, estimated delivery date was 19-MAR-2012. The patient sought medical attention, an office visit. Follow up information has been received from the healthcare worker who reported that "to her knowledge", the patient had given birth to a healthy baby. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a female patient of unknown age. The patient was vaccinated with her first dose of GARDASIL (route, dose and lot # were unknown) on 09-MAR-2011, her second dose of GARDASIL (route, dose and lot # were unknown) on 11-JUN-2011 and her third dose of GARDASIL (route, dose and lot # were unknown) on 23-OCT-2012. No adverse symptoms provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (0.5 ml, route, dose and lot # were unknown) on 09-APR-2012 (also reported on 12-APR-2012), the second on 10-OCT-2012 and the third on 24-OCT-2012. No adverse event reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a company representative who was told by a physician regarding a 67 years old male patient. On 29-SEP-2012, the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot# and route not reported). No concomitant medications were reported. On an unknown date in 2012, after the patient was vaccinated at the pharmacy with PNEUMOVAX23 he developed cellulitis. No treatment information was reported. The outcome of cellulitis was unknown. The relatedness for the event was unknown for PNEUMOVAX23. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with no pertinent medical history and no known drug reactions/allergies. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX, lot # (671901/0421AE), on 20-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-OCT-2012 the patient developed a reddened area with a central vesicle on the left side of her back. The patient sought medical attention. No laboratory tests were performed. The patient was prescribed valacyclovir as treatment by an unspecified physician. At the time of reporting the patient had not recovered from the events. Relatedness was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: 1 of 4 linked same reporter cases (other related cases: 1210USA012785, 1210USA013663 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with RECOMBIVAX HB. The patients might have been vaccinated with improperly stored of RECOMBIVAX HB but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant concerning an 18 years old female patient who on and unknown date was vaccinated with the first dose of RECOMBIVAX HB 5 mcg (route and lot # not provided) and on an unknown date received the second dose of RECOMBIVAX 5 mcg (route and lot # not provided). The physician assistant reported that on an unknown date, the patient was inadvertently vaccinated with 1 mcg of RECOMBIVAX HB (route and lot # not provided) instead of 5 mcg. This was the patient's third dose in the series. No adverse effects were reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 4 months old patient of unknown gender. The patient was vaccinated with a dose of live, oral ROTATEQ (lot # 669570/1456AA; expiry date 03-OCT-2012) on 17-OCT-2012. Route was not reported. ROTATEQ was administered 2 weeks after the expiration date. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cough, Ear infection, Injection site rash, Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a consumer refers to 2 children of unknown age. On an unknown date, the patients were vaccinated with VARIVAX. Concomitant medications not reported. On an unknown date, the patients experienced rash at the injection site. They were also coughing and congested and had a fever. It was confirmed that they had experienced a mild case of chicken pox and a double ear infection. The outcome of the adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a consumer refers to 2 children of unknown age. On an unknown date, the patients were vaccinated with VARIVAX. Concomitant medications not reported. On an unknown date, the patients experienced rash at the injection site. They were also coughing and congested and had a fever. It was confirmed that they had experienced a mild case of chicken pox and a double ear infection. The outcome of the adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The primary reporter is nurse. Nurse reports a second dose of ZOSTAVAX was inadvertently administered to client. Client got the first dose of ZOSTAVAX on 12/07/2011 and the second dose of ZOSTAVAX was administered today. No adverse effects reported at this time. No other information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) on 24-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a "cherry red" spot near the injection site. The outcome was unknown at the time of report. The patient had contacted pharmacist for medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test, Pain in extremity, Paraesthesia
Clinical narrative: Primary reporter is the patient. She called to report that, after being administered ZOSTAVAX, she has had tingling, numbness and "terrible pain" in her arms and legs. She stated that about 2 weeks ago she woke up in the night with "terrible pain" in her arm and tingling and numbness at that lasted for 18 hours or more. Her symptoms continued over multiple nights and have spread to her other arm and legs. The patient visited her primary physician, who ruled out stroke, and sent her to neurologist. Neurologist results are still pending. The patient reports that her symptoms have not improved. No further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: The primary reporter is Nurse. She is reporting that a patient received an expired VARIVAX (1279Z, 09/30/2012) on 10/18/2012. No adverse event reported. No further information is available.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Ear infection, Injection site rash, Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a consumer refers to her 1 year old daughter. The patient's medical history included albuterol allergy. The patient was vaccinated with VARIVAX on 17-SEP-2012. Concomitant medications included IBUPROFEN. On 26-SEP-2012, the patient developed a rash at the injection site after she received VARIVAX. She was also coughing and congested and had a fever. She was also getting new teeth. The patient was seen at the physician's office on 01-OCT-2012 it was confirmed that she had experienced a mild case of chicken pox and a double ear infection after receiving the VARIVAX. While the patient's mother was waiting in the office, she also hear two other children had a similar experience. No treatment information was reported. No laboratory diagnostics was performed. The outcome of the adverse events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a consumer refers to her 1 year old daughter. The patient's medical history included albuterol allergy. The patient was vaccinated with VARIVAX on 17-SEP-2012. Concomitant medications included IBUPROFEN. On 26-SEP-2012, the patient developed a rash at the injection site after she received VARIVAX. She was also coughing and congested and had a fever. She was also getting new teeth. The patient was seen at the physician's office on 01-OCT-2012 it was confirmed that she had experienced a mild case of chicken pox and a double ear infection after receiving the VARIVAX. While the patient's mother was waiting in the office, she also hear two other children had a similar experience. No treatment information was reported. No laboratory diagnostics was performed. The outcome of the adverse events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Physician Assistant refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. The physician Assistant administered a dose of ZOSTAVAX that had been improperly stored. The date administered of improperly stored ZOSTAVAX was unknown at the time of the call. No adverse event reported. The outcome of event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: 1 of 4 linked same reporter cases (other related cases: 1210USA012785, 1210USA013663 and 1210USA013664). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with RECOMBIVAX HB. The patients might have been vaccinated with improperly stored of RECOMBIVAX HB but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse on behalf of a doctor of osteopathy refers to several patients of unknown age and gender. The patients were vaccinated with PNEUMOVAX 23 on unknown dates. No other co-suspects were reported. No concomitant medications were reported. The patients experienced localized reactions (swelling, pain and erythema more than typical) with the PNEUMOVAX 23. Physician stated they had had several of these reactions as well. Treatment information was not reported. At the time of reporting, the patient's outcome was unknown. Relatedness was not provided. This is one of 2 reports from the same source. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEP
Symptoms: Oedema peripheral, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 1 month old patient with no pertinent medical history and no drug allergy. On 19-SEP-2012, the patient was vaccinated intramuscularly with 0.5 ml RECOMBIVAX HB (Lot# reported as 0293AE, expiry 01-SEP-2014). There was no concomitant medications. On 21-SEP-2012, a day after vaccination with RECOMBIVAX HB the patient experienced bilateral hands and feet swelling, with "head to toe" fine red rash. The patient sought medical attention and was evaluated in the office. No treatment has been prescribed at the time of the report. No lab test was done. The outcome of events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse on behalf of a doctor of osteopathy refers to 2 patients of unknown age and gender. The patients were vaccinated with PNEUMOVAX23 on unknown dates. No other co-suspects were reported. No concomitant medications were reported. The patients experienced localized reactions (swelling, pain and erythema more than typical) with the adult PNEUMOVAX23 in the past month in September 2012. Physician stated she had never had this severity to localized reaction before. Treatment information was not reported. At the time of reporting, the patient's outcome was unknown. Relatedness was not provided. This is one of 2 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a office manager refers to a patient (third patient) of unknown demographics. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dosing details and lot number were unspecified). No concomitant medications were reported. On an unknown date, the patient experienced injection site reaction. No treatment information was reported. The outcome of injection site reaction was unknown. This is one of several reports from the same source (MARSS#12010USA000130, MARSS#12010USA000140). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a female consumer refers to a female unspecified nurse of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter heard that on an unknown date, the patient developed a chicken pox rash after receiving ZOSTAVAX. No treatment information was reported. The patient's outcome of chicken pox rash was unknown. The relatedness for chicken pox rash was not reported for ZOSTAVAX. It was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with a history of allergies and no unknown drug reactions. On unspecified date, the patient was vaccinated with ZOSTAVAX (dose and lot not provided). No concomitant medications were reported. The pharmacist stated that on unspecified date, the patient who was administered ZOSTAVAX at the pharmacy on an unspecified date, developed redness and swelling at the injection site, the patient sought medical attention by calling the pharmacist and he did not received medication and did not performed laboratory tests, subsequently the injection site reaction resolved in 4 days without requiring treatment. The relatedness for redness and swelling at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a doctor pharmacist refers to a 61 years old female patient with allergy to sulfas, who on 27-SEP-2012 was vaccinated with ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included XANAX, atropine sulfate, LOMOTIL, nortriptyline, ESTRACE and NASONEX. The pharmacist reported that the patient developed numbness and tingling on her ipsilateral arm and leg after receiving ZOSTAVAX. No treatment information was reported. The patient sought medical attention, she contacted the pharmacist. At the time of the report, the patient had not recovered from numbness and tingling. The relatedness for numbness and tingling was unknown for ZOSTAVAX. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a consumer reporting about his approximately 24 years old daughter. On an unknown date in 1994, the patient was vaccinated with dose 1 of VARIVAX (lot# and route not reported) and on an unknown date in 2012, the patient was vaccinated with dose 2 of VARIVAX (lot# and route not reported). Product circular # reported as 9904705. No concomitant medications were reported. Patient sought medical attention (office visit). Antibody titers were checked recently and the results revealed "low antibody levels". Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: This primary reporter was Pharmacist. Patient received PNEUOMVAX on 10/25/2012. "About 1-2 hours after the injection," the patient began to have numbness and tingling in the mouth and throat. The patient has not recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age (gender unspecified). On 26-SEP-2012, the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # 669382/1490Z, expiry 14-AUG-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck) (route, dose and lot # were unknown) instead of a dose of ZOSTAVAX on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. It was unknown, if the patient sought medical attention. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 year old patient of unknown gender. On 28-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number was reported as 0595AA expiration date 30-AUG-2012). Concomitant medications were not reported. The reporter stated that the patient received PNEUMOVAX 23 on 28-SEP-2012 that had expired on 30-AUG-2012. The patient did not have a prior history of vaccination with PNEUMOVAX 23. No adverse event was reported. This is a report received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with fibromyalgia, and no known drug allergies with medical history of sciatica pain always on the right side and shingles (October 2011) with lesions on right buttocks that lasted two to three months (approximately in January 2012). On 03-AUG-2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (lot 0562AE exp: 20-MAR-2013). Concomitant medications included oxycodone and CYMBALTA. The pharmacist reported that a patient that was vaccinated with ZOSTAVAX on 03-AUG-2012, told him that on approximately on 05-AUG-2012 (2 or 3 days after getting vaccinated with ZOSTAVAX she had a low grade fever that lasted 24 hours (approximately on 06-AUG-2012), in addition, client developed generalized muscle pain (approximately in August 2012) that lasted for 30 days but at the time of the report was a deeper stabbing pain, the deep muscle pain runs across the right side of the buttocks and the pain radiates down her right leg, the patient did not reported any lesions. Pharmacist stated that the patient would have a follow up doctor appointment scheduled the first week of next month. This is already mentioned in the report. At that time of the report the patient was treated with a unspecified antiviral treatment and recovered. The outcome of the fever was reported as lasted 24 hours (recovered also reported by the pharmacist as not recovered). At the time of the report the outcome of the patient for generalized muscle pain and the deep muscle pain runs across the right side of the buttocks and the pain radiates down her right leg was reported as not recovered by the pharmacist. The pharmacist confirmed that the patient did not had any shingles or lesion outbreak. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age (gender unspecified). On 25-OCT-2010, the patient was vaccinated with dose 1 of Hep B (manufacturer unknown) and with dose 2 of Hep B (manufacturer unknown) on 30-DEC-2012. No concomitant medications were reported. The patient did not get the third dose. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 years old female patient. The patient's pertinent medical history included arteriosclerotic heart disease. The patient did not have any drug reactions/allergies. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # reported as H013014 expiration date was 03-OCT-2013) on right arm subcutaneously on 05-OCT-2012. No other co-suspects were reported. Concomitant medications included METOPROLOL, ASPIRIN and NITROGLYCERIN sublingual tablets as needed. The patient called the office on 15-OCT-2012 and reported that she had a "mild case of shingles". No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient had sought medical attention via calling to office. No lab diagnosis studies performed. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site reaction, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to herself a 66 years old female patient with hypothyroidism, asthma and GERD and a medical history of drug allergies to: Penicillin, Erythromycin, SULFA, INAPSINE. On 11-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot 1098533N exp not reported) (dose, and route not reported). Concomitant medications included SYNTHROID, ascorbic acid, multivitamins (unspecified), probiotics, chondroitin sulfate sodium, glucosamine sulfate, PRILOSEC, PRAVACHOL, gemfibrozil, calcium (unspecified) and magnesium (unspecified). The retired nurse reported that on 11-OCT-2012, she developed a red raised rash around the injection site as well as all over her body, she also mentioned the rash itches and burns. The patient was put on treatment with BENADRYL and CLARITIN. The nurse stated that VZV packed was offered and declined. At the time of the report the patient's outcome for adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: 1 of 4 linked same reporter cases (other related cases: 1210USA012785, 1210USA013664 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with VAQTA. The patients might have been vaccinated with improperly stored of VAQTA but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a 4 months old patient. On 03-OCT-2012 (also reported as on 04-OCT-2012), the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # reported as 1420Y, expiry: 03-AUG-2012, route not reported). No adverse effect were reported. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old female patient. Pertinent medical history, drug reactions and allergies were none. Approximately on an unspecified date in September 2012 (reported as a couple of weeks ago), the patient was vaccinated with ROTATEQ. Lot number and the dosing details were not reported. Secondary suspect vaccinated included HepB vaccine (manufacturer was not specified). Concomitantly the patient received PREVNAR and PENTACEL. On an unspecified date in 2012, the patient developed rash on lower extremities and buttocks and was seen in allergist office. The patient had sought medical attention for the same. No treatment information was reported. The outcome of the event rash on lower extremities and buttocks was reported as recovering/resolving. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Malaise
Clinical narrative: This spontaneous report as received from a company representative via Physician's nurse refers to a 2 months old male patient. Pertinent medical history was none. On an unspecified date, the patient was vaccinated with dose 1 of ROTATEQ 2 milliliter (ml) orally. Lot number and the dosing details were not reported. Concomitantly the patient received PEDIARIX, PEDVAXHIB and PREVNAR. On an unknown date, the patient experienced explosive, bloody diarrhea and general malaise without fever after receiving the first dose of ROTATEQ. The patient sought medical attention and the patient was taken to the emergency room and checked for hydration levels and did not need to be treated for dehydration. The outcome of explosive, bloody diarrhea and general malaise was reported as recovered/resolved. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Herpes zoster, Scab, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 8 years old female patient with seasonal asthma. The patient was vaccinated with the first dose of (Merck) VARIVAX (lot# unspecified) on 30-DEC-1999 with no concomitant medications. No other co-suspects were reported. On 08-AUG-2007 the patient was diagnosed with shingles. It was noted by physician that the patient had a patch on the forehead. There is no documented culture that was done to confirm the diagnosis of shingles. The patient was treated with acyclovir (800 mg, 4 times a day for 5 days). The patient had a follow up office visit to physician on 10-AUG-2007 and the notes stated the patch was drying up and scabbing, improving and the patient was to be using NEOSPORIN. In approximately 2010, the patient had a titer done at age 12 and the results were equivocal. The outcome of the events was reported as recovered. No lab test was performed. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# reported as H012523, Exp date: 09-OCT-2013) on 23-OCT-2012. There was no concomitant medications therapy. Subsequently on an unknown date in October 2012 the patient developed redness at the injection site. The affected area was the size of a softball. The patient had sought medical attention and it was stopped by at the pharmacy. No lab diagnostics studies performed and no treatment was given for the event. The outcome of redness at the injection site was reported as not recovered. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients who have developed redness at the injection site after receiving ZOSTAVAX (Lot #, dose/frequency, route and duration were unspecified) on an unknown date in 2011, "in the past year", but the area affected was "very small". No treatment information was reported. The outcome was unknown. Additional information has been requested.