chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of low grade fever in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In February 2012 the subject received a dose of BOOSTRIX at 0.5 ml in an unknown deltoid. Less than one month after vaccination with BOOSTRIX, the subject experienced low grade fever and body pain. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Sex: U
Vaccine: TDAP
Symptoms: Axillary pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain underarm in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX. It was reported that the subject was experiencing underarm pain a few days after receiving BOOSTRIX. The nurse had not yet spoken with the subject and did not have more detail to provide at the time of reporting. Within days of vaccination with BOOSTRIX, the subject experienced pain underarm. At the time of reporting the outcome of the event was unspecified.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 54-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. There were no concurrent medications. On 1 May 2012 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. Within days of vaccination with BOOSTRIX (between the time of vaccination on 1 May 2012 and the date of reporting 8 May 2012), the subject experienced injection site redness, swelling injection site, hotness at injection site and injection site irritation. The subject went to see her physician. At the time of reporting the events were unresolved.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 54-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 25 April 2012 the subject received a dose of BOOSTRIX in the left deltoid. Within weeks of vaccination with BOOSTRIX, the subject experienced injection site pain. At the time of reporting, it was 5 weeks post vaccination and the statement was made that the subject was still complaining of pain at the injection site (unresolved). No date of onset was provided. No further information was shared.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via a sale representative and described the occurrence of injection site pain in a 28-year-old female subject who was vaccinated with BOOSTRIX. On 4 November 2011 the subject received a dose of BOOSTRIX (unknown route). On 4 November 2011, less than one day after vaccination with BOOSTRIX, the subject experienced injection site pain, injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
Age: 46.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bruise injection site in a 46-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included TWINRIX (GlaxoSmithKline) given on 15 September 2011. On 15 September 2011 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 17 September 2011, 2 days after vaccination with BOOSTRIX, the subject experienced bruise injection site and injection site pain. The bruise was black and blue to purplish and moved down the arm to just above the elbow. TWINRIX was administered in the opposite arm and no event was reported due to TWINRIX. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information was received on 13 October 2011. It was reported that the events of injection site bruise and injection site pain began on the day of vaccination, 15 September 2011. The outcome of the events was unknown. The events were considered to be possibly related to BOOSTRIX vaccination.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of lymph node swelling in a 66-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In February 2012 the subject received a dose of BOOSTRIX (unknown route, unknown arm). In February 2012, less than one month after vaccination with BOOSTRIX, the subject experienced lymph node swelling. The subject sought medical attention at a physician's office. At the time of reporting the event was resolved.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 10-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk) ;Merck; unknown; unknown given on 7 March 2012. On 7 March 2012 at 11:30 the subject received a dose of BOOSTRIX (unknown route, left arm). On 8 March 2012 at 11:30, 1 day after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site, warmness to touch at injection site and injection site pruritus. The subject was seen by his healthcare provider. At the time of reporting the events were unresolved. Follow up received from the healthcare professional on 03 April 2012. According to the healthcare professional, the subject received BOOSTRIX booster on 07 March 2012 and experienced the events less than a day after vaccination with BOOSTRIX on 07 March 2012 (previously reported as 08 March 2012). On 10 March 2012, the events were resolved. The subject was diagnosed with an "exaggerated local reaction" due to the events described above. The healthcare professional noted that the events were not serious.
Sex: U
Vaccine: DTAP
Symptoms: Convulsion, Dyskinesia
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer (Merck), and described the occurrence of convulsing in a subject of unspecified age and gender who was vaccinated with Tdap (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Tdap (unknown). The vaccine was reported as "Tdap (unspecified manufacturer)". On 18 August 2011, at an unspecified time after vaccination with "Tdap", the subject experienced "convulsing and rolling around". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 25-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that the recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1210USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle twitching
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of muscle twitching in a 42-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included muscle "issues". Concurrent medications included SYNTHROID. On 15 July 2011 at 19:00 the subject received a dose of BOOSTRIX (.5 cc, unknown route, left arm) due to stepping on a nail. On an unspecified date in July 2011, within 2 to 3 days after vaccination with BOOSTRIX, the subject experienced muscle twitching. The muscle twitching started in her index finger and at the time of reporting was occurring between where her torso and leg meets, right foot, left shoulder and right thigh. The subject reported that her finger bothers her most during the day, but when she lies down at night she notices the other areas within her body. At the time of reporting the event was worse.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Local swelling, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of localized pain in a 15-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 9 August 2011 at 15:45 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. On 9 August 2011, 6 hours after vaccination with BOOSTRIX, the subject experienced localized pain and local swelling. It was also reported that the dose of BOOSTRIX administered was an extra dose as the subject had received a vaccination of tdap (unspecified) 2 years earlier. Two days later, on 11 August 2011, the subject had considerable improvement of localized pain and swelling, but had developed a sore throat. Localized pain and swelling were considered to be probably related to BOOSTRIX. Sore throat was unrelated with outcome unknown.
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Tinnitus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tinnitus in a teenager female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced tinnitus and palpitations. At the time of reporting the outcome of the events was unspecified. The reporting pharmacist was questioning a possible bad batch of BOOSTRIX, product complaint. No other events noted. Follow-up information received via an investigational report from GlaxoSmithKline Biologicals on 18 August 2011 indicated that no sample was available for return. An investigational report received via GlaxoSmithKline Biologicals on 20 September 2011 indicated that based on the fact that no precise technical problem was reported, no technical investigational was performed accordingly. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intermittent fever in a 51-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 August 2011 at 12:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 15 August 2011, 3 days after vaccination with BOOSTRIX, the subject experienced intermittent fever, right arm pain and right arm tingling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a certified nurse practitioner concerning two patients of unknown age and gender, who on an unknown date were vaccinated with PNEUMOVAX 23 (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date patients experienced severe reactions after administration of PNEUMOVAX 23. The outcome of the patients was unknown. The patients sought unspecified medical attention. The relatedness for the event was unknown for PNEUMOVAX 23. Attempts are being made to distinguish individual patients mentioned in this report. Additional information will be provided if available.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein, Maternal exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. On 14 September 2011 the subject received unspecified dose of BOOSTRIX (.5 unknown, intramuscular). Her last menstrual period was on 10 February 2011 and estimated date of delivery is 11 December 2011. The subject was exposed to BOOSTRIX during third trimester. On 14 September 2011, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. On an unspecified date, LVIEF (left ventricular echogenic intracardiac focus) was performed indicating evidence of defect [prenatal screening test normal]. Relevant test results included ultrasound performed on 16 April 2011, 21 April 2011 and 21 July 2011: results not provided. On 30 June 2011: AFP (alpha-fetoprotein), results not provided. On an unspecified date The outcome of the pregnancy was unknown.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of hive in a 56-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to erythromycin, allergy to PROZAC, allergy to the metal nickel, allergy to wool, hypothyroidism, menopausal and urinary tract infection. Concurrent medications included SYNTHROID, CELEXA and MICROBID. On 16 November 2011 at 16:00 the subject received a dose of BOOSTRIX (unknown route, left arm). The subject reported that she received Tdap vaccine by GSK. On 18 November 2011, 2 days after vaccination with BOOSTRIX, the subject experienced hive. The subject went to an emergency room. The subject was treated with prednisone, ZYRTEC and SINGULAIR. At the time of reporting the event was improved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: This spontaneous report as received from a Bachelor Science Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated once with a 0.65 ml dose of ZOSTAVAX. Route and lot n number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced an inflammatory reaction at the injection site. No rash was reported. the patient sought medical attention. No treatment information was reported. The outcome of quite an inflammatory reaction at the injection site was unknown. The relatedness for quite an inflammatory reaction at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer refers to his wife of unknown age. On unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot not reported). No concomitant medications were reported. The consumer reported that on unspecified date, his wife was vaccinated with PNEUMOVAX 23 and he believed that he and his wife received PNEUMOVAX 23 twice. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning 2 patients of unknown age and gender, who on an unknown date were vaccinated with a doses of PNEUMOVAX 23 (doses and routes not reported) (lot # 672394/1853AA). No other co-suspects were reported. No concomitant medications were reported. On an unknown date patients developed injection site reaction consisting of redness and warmth extending the length of the arm. The outcome of the events was unknown. The patient sought unspecified medical attention. The relatedness for the events was unknown for PNEUMOVAX 23. Attempts are being made to distinguish individual patients mentioned in this report. Additional information will be provided if available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a 76 years old female patient with allergy to "Sippro", "Codine", ibuprofen (reported as ibuprohen) and "Pene". The patient's medical history included minor case of shingles approximately in 2007 (about 5 years ago). On 27-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medications included: BENADRYL. On 28-SEP-2012, the patient experienced 5 red, very itchy bumps around the site of injection. Unspecified treatment was given for the events. The outcome of the events was unknown. The patient sought unspecified medical attention. The relatedness was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unspecified date the patient was vaccinated with 3 doses of RECOMBIVAX HB (lot # not reported). On an unspecified date the patient failed to seroconvert after receiving 3 doses of RECOMBIVAX HB. The outcome of event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist stated that the patient who was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route unspecified), "2 days ago", on 09-OCT-2012, now(on 11-OCT-2012) had a prescription for Prednisone. The pharmacist believed the Prednisone might have been prescribed for an upper respiratory infection. The pharmacist stated that this was not related to the patient receiving ZOSTAVAX and that she would not provided any additional information unless she knew this situation was related to the administration of ZOSTAVAX. At the time of reporting the outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/1733AA, expiration date 04-FEB-2013, dose not reported) on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a 61 years old female patient with unspecified allergies. The patient was vaccinated with one shot 0.65 ml ZOSTAVAX on 11-OCT-2012. Lot# was unspecified. Concomitant medications included: AMITIZA. The patient reported that, on 11-OCT-2012, the ZOSTAVAX was given to her in her muscle, not subcutaneously. She had been back to the office 3 times and each time the office had repeatedly told her that the vaccine was given in her muscle. Her arm at the injection site on the right arm was sore from Thursday (11-OCT-2012) to Saturday (13-OCT-2012) and currently it was just sore when touched. No treatment was given for the event. No lab diagnostic study performed. The patient was not recovered. The patient was seen at the office to seek medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a 61 years old female patient with unspecified allergies. The patient was vaccinated with one shot 0.65 ml ZOSTAVAX on 11-OCT-2012. Lot# was unspecified. Concomitant medications included: AMITIZA. The patient reported that, on 11-OCT-2012, the ZOSTAVAX was given to her in her muscle, not subcutaneously. She had been back to the office 3 times and each time the office had repeatedly told her that the vaccine was given in her muscle. Her arm at the injection site on the right arm was sore from Thursday (11-OCT-2012) to Saturday (13-OCT-2012) and currently it was just sore when touched. No treatment was given for the event. No lab diagnostic study performed. The patient was not recovered. The patient was seen at the office to seek medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with allergic to sulfa. The patient has no pertinent medical history. The patient was vaccinated with, 1 vial ZOSTAVAX (lot number reported as H0100427; Expired date 12-SEP-2013) subcutaneously on 11-OCT-2012 on unknown injection site. No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012 the patient developed "a red ring" and soreness at the site of injection after receiving ZOSTAVAX. There was no treatment given for adverse events and no laboratory diagnostics study performed. The patient was not recovered at the time of report. The patient had called the pharmacist for medical attention. Additional information is not expected.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, route, dose not reported) on an unknown date. Other suspect therapies included PNEUMOVAX 23 (lot number unknown). No concomitant medications were reported. By the evening of 26-JUN-2012 the patient experienced a fever of 101 degrees and that her arm was sore and red. By the next day on 27-JUN-2012 her arm was extremely red and swollen. The patient went to the after hours clinic (and saw a different doctor) and was given antibiotics and a steroid. She had read the information about ZOSTAVAX and saw that ZOSTAVAX was not supposed to be given with PNEUMOVAX 23. She said the type of PNEUMOVAX that she was given did not have Polyvalent after the name. She didn't remember what it was but it was a word that reminded her of sodium. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # 669579/0595AA) which had expired on 30-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with PNEUMOVAX 23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that PNEUMOVAX 23 had been exposed to multiple (unsupported by stability data) 24-48 hours excursions to 55 degrees Fahrenheit and were likely administered to multiple unspecified patients on unspecified dates. No adverse effects reported. At the time of reporting the patient's status was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 07-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that the recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1209USA006055,  1209USA006056, 1209USA006058, 1209USA006059, 1209USA006060,1209USA006061, 1209USA006062, 1209USA006063, 1209USA006064, 1209USA006065, 1209USA006066, 1209USA006067, 1209USA006068, 1209USA006069, 1209USA006070, 1209USA006071, 1209USA006072, 1209USA006073, 1209USA006074. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with dose 1 and dose 2 of  (oka/merck) VARIVAX (lot #, dose and route not reported) when she was younger on an unspecified date and was accidentally vaccinated with a third dose of (oka/merck) VARIVAX (lot #, dose and route not reported) on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included MENACTRA (unspecified), tetanus toxoid (manufacturer unspecified). The patient's mother reported that on 10-OCT-2012 her daughter's arms hurt but other than that there were no other adverse reactions. The mother stated that the patient had two shots in her right arm and one shot in her left arm. The patient sought medical attention by calling the physician. The patient was given TYLENOL as treatment for the event and no lab diagnostic tests were performed. The outcome of arms hurt was reported as recovering. The relatedness for arms hurt was not provided for (Oka/Merck) VARIVAX. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Local reaction, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated intradermally with 0.1 ml of PNEUMOVAX 23 (lot# H013847; exp date March 2014). No other co-suspects were reported. No concomitant medications were reported. On 10-OCT-2012 the patient experienced an unspecified localized reaction. The patient sought unspecified medical attention. She was given TYLENOL and applied cool compresses for the treatment of localized reaction. No lab diagnostic tests were performed. The outcome of unspecified localized reaction was reported as recovering. The relatedness for unspecified localized reaction was not provided for PNEUMOVAX 23. Additional information is not expected.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of 75 years old and unknown gender. The patient was vaccinated intramuscularly (IM) with dose of PNEUMOVAX 23 (lot: 0491AE, exp. date: 15-SEP-2012) (dose not reported) on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that during intramuscular administration of PNEUMOVAX 23 to the patient, the syringe malfunctioned and most of the PNEUMOVAX 23 ran down the patient's arm. No adverse experienced had been observed or reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 73 years old, smoker female patient with no drug reactions/allergies, who on 03-OCT-2012, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml IM (lot # reported as H009826, exp: 11-FEB-2014 - in validation process). Concomitant medications included: FLUZONE (injection site and date of vaccination not reported). The pharmacist reported that on 03-OCT-2012 a patient developed redness, swelling, and burning sensation at the injection site after receiving a dose of PNEUMOVAX 23. The patient had hard time lifting her arm. No treatment was given. The outcome of the events was reported as not recovered. No laboratory diagnostic studies were performed. The patient sought medical attention via calling pharmacist. The relatedness for the events was unknown for PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number not reported) 0.65 ml on 01-OCT-2012. NO other co-suspects were reported. No concomitant medications were reported. It was reported that on 02-OCT-2012, the next morning after vaccination with ZOSTAVAX, the patient experienced a half-egg shaped swelling with redness and heat at the injection site and in the afternoon the patient went to his doctor because he had a couple of vesicles (location unspecified). On 02-OCT-2012, the patient's wife also experienced half-egg shaped swelling with redness and heat at the injection site and vesicles on both sides of her body from her armpit to her waist (MARRS # 1210USA003999). At the time of the report, the patient's outcome was unknown. The relatedness for half-egg shaped swelling with redness and heat at the injection site and vesicles (location unspecified) was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning five patients of unknown age and gender, who on an unspecified dates were vaccinated with lot # (671786/0254AE; Exp: 08-MAR-2013) ZOSTAVAX (doses and routes not reported) and developed a similar injection site reaction described as a rash following vaccination (all five patients were reported to have received the same lot of ZOSTAVAX.  No other co-suspects were reported. No concomitant medications were reported.  The five patients were reported to have developed a hot, raised, red, itchy "4 by 4" area that was about 2 inches below the injection site (pharmacist called it a rash), but no vesicles or bumps were present. The pharmacist reported that the injection site reaction developed about a day or two after each of the five ZOSTAVAX vaccinations and that the injection site reaction had resolved in all five patients at the time of the call (exact dated of vaccination, development of rash and date of resolution was not available at the time of the call). The pharmacist reported that the five injection site reactions reported with ZOSTAVAX, occurred between this August (2012) and the end of September of this year (2012). The patients sought unspecified medical attention - contacted pharmacist. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 24-APR-2012. No other co-suspects were reported. NO concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062,1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062,1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 18-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown deltoid) and experienced vaccine administered at inappropriate site. It was relayed to the pharmacist that an RN gave the BOOSTRIX "too high up on the deltoid". At an unspecified time after vaccination with BOOSTRIX, the subject experienced local site injection soreness. At the time of reporting the outcome of injection site soreness was unknown.  The pharmacist did not have any further details.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 42-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 November 2011 at 13:00 the subject received a booster dose of BOOSTRIX (unknown route, left arm). On 18 November 2011 (around 14:00 to 14:30) approximately one hour after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling at injection site, and flu like symptoms. At the time of reporting the events were worse. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pounding headache in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical condition included allergy to amoxicillin and erythromycin. On 17 November 2011 the subject received a dose of BOOSTRIX (unknown route, right arm) and almost immediately after vaccination experienced pounding headache. On 17 November 2011, the event was resolved in about an hour. The lot number was reported as AC528073AA from the reporter; however, based on safety lot number review, the lot number was updated to AC52B073AA.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 23-APR-2012. No other co-suspects were reported.  No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Ear pruritus, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of left arm pruritus in a 59-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and asthma. Concurrent medications included unknown blood pressure medication and unknown given for hypercholesterolemia. On 25 January 2012 at 15:45 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 25 January 2011, same day after vaccination with BOOSTRIX, the subject experienced l arm pruritus and ear pruritus. It was reported that the subject experienced itching on the left arm and itching on the left ear. The subject was treated with BENADRYL. At the time of reporting the itching on the left arm resolved and the outcome of the itching on the left ear was unspecified. Follow-up information was received on 10 February 2012. It was reported that the events of left arm pruritus and ear pruritus began on the day of vaccination with BOOSTRIX, 25 January 2012, and resolved the same day. There was no history of tobacco use.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site pruritus in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. On 27 October 2011 at 12:00 the subject received a dose of BOOSTRIX (unknown route, left arm) and experienced experienced vaccine exposure during pregnancy during the third trimester of her pregnancy. On 27 October 2011, less than one day after vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness and injection site tenderness. On 31 October 2011, approximately 4 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus. The gestational age at the time of the vaccination was not specified. Date of last menstrual period was not provided. Estimated date of delivery was 17 November 2011. At the time of reporting the events were unresolved and the pregnancy was ongoing.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that  he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nodule injection site in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 28 May 2012 at 11:00 the subject received 1st dose of BOOSTRIX (unknown, left deltoid). On 30 May 2012, 2 days after vaccination with BOOSTRIX, the subject experienced nodule injection site and hardness injection site. The healthcare professional reporter the subject developed a hard knot at the injection site. Heat application was used. At the time of reporting the nodule injection site and hardness injection site were unresolved. The healthcare professional considered the nodule injection site and hardness injection site were possibly related to vaccination with BOOSTRIX.
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swelling injection site in a female of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). During the week of 16th August 2011 the subject received a dose of BOOSTRIX (.5 ml, unknown route and site). Less than one week after vaccination with BOOSTRIX, the subject experienced swelling at injection site. The event was described as a local reaction. likely swelling based on the healthcare professional's questions to the GSK representative. At the time of reporting the outcome of the event was unspecified.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers concerning a 75 years old female patient who on 24-AUG-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 672675/0068AE) (subcutaneous, dose not reported). Concomitant medications included VALTREX, PROZAC, PLAVIX, potassium, PRAVACHOL, digoxin, "DEMEDEX", "AEROCEPT" and "BACTROVON". On 27-AUG-2012 the patient experienced rash which occurred in 72 hours on an unknown portion of the body after receiving the medication. The patient was not given any information of the location of the rash. At the time of reporting, the outcome of rash was unknown. Additional information has been requested.