chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased, Hyperhidrosis, Loss of consciousness, Pallor, Urinary incontinence
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. No concomitant medications were reported. On 01-MAR-2013 the patient was vaccinated with the first dose of GARDASIL lot # 0420AE, expiration date December 2014, intramuscular in the left arm. Shortly after the vaccination on 01-MAR-2013, "she almost passed out and lost consciousness. The patient became pale and sweaty, she involuntarily urinated on herself, her heart rate dropped to 42, and her blood pressure was 112/80. The patient went to the back of the office to lie down and her heart rate increased to 89, her blood pressure was 120/78, and in five minutes she was back to normal status" on the same date and recovered. The patient did not received treatment for the adverse events. Upon internal review lost of consciousness was considered as an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac operation, Cerebrovascular accident, Endocarditis, General symptom, Heart valve replacement
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old female patient with allergy to penicillin, allergy to sulfa and unspecified symptoms prior to her first dose of GARDASIL. The patient had no pertinent medical history. On 10-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number were not provided). On 12-NOV-2012, the patient received of second dose of GARDASIL (dose, route, lot number were not provided). Concomitant therapies included COUMADIN, doxycycline and PRILOSEC. The nurse reported that the patient developed endocarditis after her second dose GARDASIL (Approximately  in November 2012) which required open heart surgery and a valve replacement. Also reported the patient developed unspecified symptoms on an unspecified date in November 2012. The nurse also mentioned the patient had 2 strokes (date unspecified) when she was hospitalized. The patient was hospitalized (date unspecified). The patient's outcome was reported as recovering. Endocarditis, open heart surgery, valve replacement, unspecified symptoms and 2 strokes were considered disabling, medically significant and life threatening by the reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb, Induration, Pain
Clinical narrative: Initial report received from a healthcare professional on 25 July 2012. A patient (age and gender not reported) whose medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine on an unspecified date (batch number, route and site of administration not reported). On an unspecified date, after vaccination the patient had experienced extensive arm swelling, induration and pain. Laboratory investigations and corrective treatment was not reported. On an unspecified date after 1 week, the patient had recovered. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Serum sickness-like reaction, Swelling, Tenderness
Clinical narrative: Initial report received from a healthcare professional on 14 June 2012. A 16-year-old male patient, who had no known allergies or concomitant medication and whose medical history included ADHA, received a dose MENACTRA on 7 June 2012. On 7 June 2012, same day of vaccination, the patient developed urticaria with itchy red swollen hands and soles of the feet, swelling and reddening of palms of hands and soles of feet on an off. It is tender to touch and swelling and redness is progressing up the arms. The patient received ALLEGRA during the day and BENADRYL at night as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received on 14 September 2012: The patient did not receive any other vaccine within 4 weeks of the MENACTRA. The patient was receiving STRATTERA and RAPIDUS since as unknown date. The patient visited an allergist and was diagnosed was found to have urticaria and serum sickness type reaction (Arthus type reaction) to MENACTRA. He was treated with oral steroids after which the patient was fine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Initial report received from a healthcare professional on 14 June 2012. A 16-year-old male patient, who had no known allergies or concomitant medication and whose medical history included ADHA, received a dose MENACTRA on 7 June 2012. On 7 June 2012, same day of vaccination, the patient developed urticaria with itchy red swollen hands and soles of the feet, swelling and reddening of palms of hands and soles of feet on an off. It is tender to touch and swelling and redness is progressing up the arms. The patient received ALLEGRA during the day and BENADRYL at night as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received on 14 September 2012: The patient did not receive any other vaccine within 4 weeks of the MENACTRA. The patient was receiving STRATTERA and RAPIDUS since as unknown date. The patient visited an allergist and was diagnosed was found to have urticaria and serum sickness type reaction (Arthus type reaction) to MENACTRA. He was treated with oral steroids after which the patient was fine.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Insomnia, Malaise, Pain in extremity, Poor quality sleep
Clinical narrative: Initial report received from a Healthcare professional on 08 June 2012. A male patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine on right arm (Sanofi pasteur batch number U3906AB and route of administration- not reported) and a dose of GARDASIL vaccine on left arm (merck co batch number and route of administration- not reported) on an unspecified date. It was reported that same day after 4-5 hours complained of significant soreness in the right arm. About 12 hours after vaccination, the patient complained of chest pain. The patient took Ibuprofen bed as corrective treatment and then woke up throughout night every 2 hours. At 4 am, the patient was unable to go back to sleep. At 8 am, the following day, the patient still felt sore and did not feel well. The outcome of event was not reported. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: This case was reported by a physician and described the occurrence of unintentional overdose in a 14-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 24 August 2012 at 10:07 the subject received unspecified dose of HAVRIX (unknown, left arm) "14, 040 units" and experienced unintentional overdose. The physician reported the vaccine was unidose and disposed of in the sharps container. Lot number was not available. This is the second of two cases reported by the physician, for the first case please see A0991345A. Follow-up information was received on 27 September 2012 via physician. Concurrent medical conditions included asthma, attention deficit hyperactivity disorder and oppositional defiant disorder. Concurrent medications included CONCERTA and albuterol MDI. The physician reported an adult dose was given in place of pediatric dose. The physician noted the subject's mother was called to inform her of the dosage error and to call the physician to inform them of any signs/symptoms other than local soreness at in the site. Immunization series with HAVRIX was not delayed or discontinued. The unintentional overdose was due to erroneous administration. The physician considered the event was "definitely" related to vaccination with HAVRIX.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional (also the mother of the subject), via a sale representative, and described the occurence of "significant" swelling arm in a 5-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). In June 2012 the subject received 1st dose of HAVRIX (details unknown). In 2012, 1 day after vaccination with HAVRIX, the subject experienced "significant" swelling arm and swelling of eyes. The subject went to the emergency room one day following the vaccination with HAVRIX. At the time of reporting the events were resolved.
Sex: M
Vaccine: HEPA
Symptoms: No therapeutic response, Viral titre
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 September 2011 and 9 March 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 20 April 2012, 42 days after vaccination with 2nd dose of HAVRIX, 7 months after vaccination with the 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 20 April 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994238A - A0994246A.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of body pain in a 48-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included glucose elevated. Concurrent medications included glipizide. On 10 August 2012 at 14:00 the subject received 1st dose of HAVRIX (1 cc, unknown, left arm). On 12 August 2012, 2 days after vaccination with HAVRIX, the subject experienced body aches, sore throat, fatigue, cough and nasal congestion. The subject was advise to take OTC (over the counter) medication to control the symptoms. At the time of reporting the body aches, sore throat, fatigue, cough and nasal congestion were unresolved. The healthcare professional considered the events were unrelated to vaccination with HAVRIX. Follow-up information was received on 31 August 2012 via healthcare professional who reported the subject had not received HAVRIX before. The events resolved on unspecified date. No relevant laboratory tests or biopsy performed.
Sex: M
Vaccine: HEPA
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 12 December 2011 and 14 June 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 20 July 2012, 36 days after vaccination with HAVRIX, 7 months after 1st vaccination with HAVRIX, the subject experienced not responding to therapy. The had a titer performed on 20 July 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see cases A0994236A, A0994239A-A0994246A.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 6 January 2012 and 17 July 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX series, the subject experienced not responding to therapy. The subject had a titer performed on an unspecified date and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A- A0994242A, A0994244A, A0994246A.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR
Symptoms: Diarrhoea, Epistaxis, Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unintentional overdose in a 12-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included mmr vaccine (non-gsk); Merck; unknown; unknown given on 1 October 2012. On 1 October 2012 the subject received 1st dose of HAVRIX (1ml, unknown, right thigh) and experienced unintentional overdose. A 12-month old subject received an adult dose of HAVRIX. Follow up was received from healthcare professional (nurse) on 2 January 2013. The nurse documented that the unintentional overdose and the bloody nose occurred on "the morning of the injection" on 2 October 2012, not 1 October 2012 as previously reported. Concurrent vaccination included mmr vaccine (non-gsk); Merck; unknown; unknown given on 2 October 2012. On 2 October 2012, the subject received 1st dose of HAVRIX (1ml, unknown, right thigh) and experienced unintentional overdose. A 12-month old subject received an adult dose of HAVRIX. On 2 October 2012, less than a day after vaccination with HAVRIX, the subject experienced diarrhea. The nurse stated that the blood nose resolved on 2 October 2012 and the diarrhea resolved on 26 October 2012. The nurse did not consider these events to be serious.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash in a 51-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine; manufacturer unspecified; unknown given on 20 October 2012. Concurrent medical history included sulfa allergy. On 20 October 2012 the subject received 1st dose of HAVRIX (1 ml, unknown details). On 25 October 2012, 5 days after vaccination with HAVRIX, the subject experienced rash and itching. At the time of reporting the events were unresolved.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Cough, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of nausea in a 56-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included active hepatitis a. Concurrent medical conditions included chronic obstructive pulmonary disorder, fever and rheumatoid arthritis. Concurrent medications included Unknown (Unspecified medications) reported as "alot of injectables for rheumatoid arthritis." On 3 December 2012 at 08:45 the subject received 1st dose of HAVRIX (.5 ml, unknown route, right arm) and experienced vaccine underdose. The subject was older than the indicated age for the 0.5ml dose of HAVRIX. The subject received 0.5ml instead of the indicated 1ml dose of HAVRIX. On 3 December 2012, less than one day after vaccination with HAVRIX, the subject experienced nausea, vomiting, joint pain, and cough. Less than a week after vaccination with HAVRIX, the subject experienced possible flu virus. The subject "presented to the office with a fever (103F) on 3 December 2012 and received HAVRIX." It was unclear if the possible flu virus occurred before or after the vaccination with HAVRIX. Relevant test results included body temperature which was documented as 103 degrees Fahrenheit. At the time of reporting the outcome of the events were unknown. Follow-up information was received on 28 January 2013 via healthcare professional who stated "suspect he was ill prior to vaccination" administration. The reporting the healthcare professional associated the event to the subject's medical history/ concurrent illness "subject had fever greater than 102 within 24 hours prior to vaccine" and to erroneous administration "should not have been given, subject already has Hep A". No action was taken with HAVRIX; the subject had not received the vaccine before. The events resolved on an unspecified date.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site anaesthesia, Nervousness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 18-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included ADACEL (non-gsk); Sanofi Pasteur; unknown; unknown given on 7 May 2012. There were no concurrent medications. On 7 May 2012 at 09:56 the subject received 1st dose of HAVRIX (.5 ml, unknown, left arm). On 7 May 2012, 24 minutes after vaccination with HAVRIX, the subject experienced arm numbness and numbness spread. The numbness started in his upper left deltoid extending down to the left proximal elbow. the subject was very nervous about getting injections. At the time of reporting the arm numbness and numbness spread were unresolved. Follow-up information was received on 29 May 2012 via healthcare professional who reported the events resolved on 23 May 2012. The reporting healthcare professional attributed the events to erroneous administration and the subject "was very anxious about receiving vaccines."
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Rash pruritic, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itchy skin rash both forearms in a 40-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 20 March 2012 at 08:50 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm and experienced vaccine underdose. The indicated adult dose for HAVRIX is 1 ml and the subject was only administered 0.5 ml. On 20 March 2012, 10 minutes after vaccination with HAVRIX, the subject experienced itchy skin rash both forearms (rash that was itchy on the lower part of both arms). The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE and BENADRYL. The events improved after 15 minutes of administration of EPINEPHRINE and BENADRYL. No other events were noted. It was additionally noted that the actual injection site had no reaction at all. It was unknown if the subject had experienced any adverse events following previous vaccinations. The lot number was reported as AHAVB4938A from the reporter; however, based on safety lot number review, the lot number was corrected at initial entry to AHAVB493BA.
Sex: M
Vaccine: HEPA
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 3 November 2011 and 14 May 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 11 June 2012, 28 days after vaccination with 2nd dose of HAVRIX, 7 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 11 June 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A, A0994240A - A09942446A.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 October 2013 and 17 April 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 24 May 2012, 37 days after vaccination with 2nd dose of HAVRIX, 7 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 24 May 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A, A0994239A, A0994241A - A0994246A.
Sex: M
Vaccine: HEPA
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 14 October 2011 and 16 April 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 30 May 2012, 44 days after vaccination with 2nd dose of HAVRIX, 8 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 30 May 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A- A0994240A, A0994242A - A0994246A.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 12 October 2011 and 23 April 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown) On 5 June 2012, 43 days after vaccination with 2nd dose of HAVRIX, 8 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 05 June 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A- A0994241A, A0994243A - A0994246A,
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a physician and described the occurrence of unintentional overdose in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 24 August 2012 at 10:10 the subject received unspecified dose of HAVRIX (unknown, left arm) "14,040" units and experienced unintentional overdose. The physician reported the vaccine was unidose and disposed of in the sharps container. Lot number was not available. This is one of two cases reported by the physician, for the second case please see A0991622A. Follow-up information was received on 27 September 2012 via physician. Concurrent medications included FLUTICASONE and Loratadine. The physician reported an adult dose was given in place of pediatric dose. The physician noted the subject's mother was called to inform her of the dosage error and to call the physician to inform them of any signs/symptoms other than local soreness at in the site. Immunization series with HAVRIX was not delayed or discontinued. The unintentional overdose was due to erroneous administration. The physician considered the event was "definitely" related to vaccination with HAVRIX.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of soreness in a 23-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Historic vaccination included previous completion of a two dose HAVRIX (GlaxoSmithKline) series given in 2007 (one dose possibly administered in June 2007). On the evening of 11 January 2012 the subject inadvertently received a 3rd dose of HAVRIX in an unknown deltoid. This was an extra dose administered. In January 2012, within 9 days or less, of vaccination with HAVRIX, the subject experienced soreness. At the time of reporting the outcome of the event was unspecified. Follow up from the pharmacist on 13 February 2012. The pharmacist noted that he did not say there was an adverse event. He reported that he said she had previously been vaccinated and wanted to know if there would or could be a problem. However, the initial report from the pharmacist stated the patient noted soreness to the pharmacist.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Oedema peripheral, Pain in extremity, Skin discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pinkie swollen in a 17-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 1 May 2012 at 15:00 the subject received two vaccinations for the 1st dose of HAVRIX (1 ml, unknown, right deltoid) and experienced overdose. On 3 May 2012, approximately 48 hours after vaccination with HAVRIX, the subject experienced pinkie swollen. On 05 May 2012, four days after vaccination with HAVRIX, the subject experienced skin discoloration, and pinky pain. It was reported that the facility uses the pediatric doses of ENGERIX B for adult patients due to cost and normally they draw up two syringes of pediatric doses of ENGERIX B to equal an adult dose. The medical assistant did the same thing for HAVRIX, not realizing it was an adult dose of HAVRIX already. The subject received two 1ml injections of HAVRIX in the right deltoid on 01 May 2012. About 48 hours after the vaccinations the subject developed swelling of his left pinky, the opposite hand of the side of injection. He denied any trauma. This past weekend he developed pain and pink discoloring on the same pinky as well. He has been requested to come into the office for medical attention. The healthcare professional reported they plan to draw a titre in about a month and will proceed from there if necessary. At the time of reporting the pinkie swollen, skin discoloration, and pinky pain were unresolved.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of hives in a 19-year-old female subject whow as vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and asthma. Concurrent medications included ZYRTEC and ALBUTEROL. On 8 May 2012 at 16:15 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 8 May 2012 at 23:00, 6 hours and 45 minutes after vaccination with HAVRIX, the subject experienced hives. The patient was advised to tae ZYRTEC and BENADRYL. The healthcare professional considered the event was "possibly" clinically significant (or requiring intervention). At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with HAVRIX.
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Condition aggravated, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a consumer, who was also the subject, and described the occurrence of rash in a 42-year-old female subject, who was vaccinated with HAVRIX (GlaxoSmithKline), ADACEL (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal hayfever. Concurrent medications included PRISTIQ, LEVOTHYROXINE and ORTHO TRICYCLEN LO. On 8 June 2012, at 16:00 the subject received 1st dose of HAVRIX (details unknown, left arm). On 8 June 2012 the subject received unspecified dose of ADACEL (details unknown). On 9 June 2012, 1 day after vaccination with ADACEL and HAVRIX, the subject experienced rash, generalized hives all over body, itching and condition aggravated. The subject reported she has had a rash since receiving a HAVRIX vaccination. It started about a day after the vaccination and was generalized hives all over her body. The hives are very itchy, and was still itchy 8 weeks in. She has flare ups of this rash where it is more itchy and she did not feel the rash had really improved since the vaccination. She received a ADACEL vaccination at the time same and was unsure which vaccine had caused the rash. She sought medical attention at the doctor's office. The subject was treated with CLARITIN and SINGULAIR. At the time of reporting the events were unresolved. The vaccination course with HAVRIX was discontinued.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 7-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). Concurrent medical conditions included allergy to ZITHROMAX. There were no concurrent medications. On 9 August 2012 at 16:30 the 7 year old subject inadvertently received 1st dose of HAVRIX adult in the right arm. Less than one day after vaccination with HAVRIX adult (09 or 10 August 2012), the subject experienced injection site soreness. The subject also experienced overdose as he received an adult dose of HAVRIX. At the time of reporting the outcome of injection site soreness was unspecified.
Age: 1.99
Sex: U
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 24-month-old subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On 8 March 2012 the subject received unspecified dose of HAVRIX (details unknown). In March 2012, less than one week after vaccination with HAVRIX, the subject experienced swelling injection site and injection site redness. The subject had a "large swollen red area" at the injection site. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 02-AUG-2012, the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot# unknown) intramuscular and on 30-JAN-2013, the patient received her second dose of 0.5 ml GARDASIL intramuscular. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. The outcome and action taken was not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. 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 healthcare worker refers to a patient of unknown age (gender unspecified). The healthcare worker reported the patient was vaccinated with GARDASIL INJ 120 Y on 13-JAN-2010, 30-JUN-2010, 20-JUL-2011, 30-JUL-2012 and 04-OCT-2012. No adverse symptoms reported. No information about patient's medical history, concomitant medication or drug allergy. Causality was not provided. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) instead of a first dose of VARIVAX (Merck). No concomitant medications were reported. No adverse effect was reported. 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 concerning a patient of unknown age who was vaccinated with GARDASIL doses (dosages, route and lot number not provided) on the following dates 21-SEP-2010, 22-FEB-2011, and 05-OCT-2012. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a 4 or 5 months old patient of unknown gender. On 18-MAR-2013, the patient was vaccinated with MMR II (dose, route and lot not reported). Other suspect therapies included VARIVAX (Merck) (dose, route and lot not reported). The office manager reported that the patient who was 4 or 5 months of age received a dose of MMR II and VARIVAX (Merck). No symptoms reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: this spontaneous report as received from a pharmacist refers to a 36 year old female patient with hospitalization and with a medical history of excision of styloid (January 2013). In January 2013, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, subcutaneous (Lot # H012972, exp: on 09-MAR-2014) for prevention of pneumococcal disease. Concomitant therapy included vaccination given at the same time included a dose of FLUZONE. The reporter stated that the patient was hospitalized for excision of styloid at an unspecified time in the last 2 months and received PNEUMOVAX 23 as part of vaccine protocol in the hospital. At an unspecified time after vaccination in 2013, the patient was diagnosed with cellulitis at the injection site. The outcome of excision of styloid and cellulitis at injection site was unknown. The causality for cellulitis at injection site was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from 50 year old female patient with no pertinent medical history and allergy to amoxicillin, AUGMENTIN concerning herself. On 15-AUG-2012, the patient was vaccinated with ZOSTAVAX, lot reported as: 0422AC; Exp. date 27-MAR-2013 or 2018, (dose not reported0 subcutaneous. Past drug therapy included DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE. The patient reported that two days after receiving the vaccine the patient began to have pain in her face, right side, lips to nose to cheek and into eye and forehead. It became progressively worse each day. After two weeks of pain she went to see her doctor. He thought it was a minor reaction to the shot and put her on a 6 day course of prednisone (manufacturer unknown). The patient continued to grow worse. In mid-September the physician sent her for a nuclear magnetic resonance imaging (MRI), which showed nothing wrong, such as a brain tumor, MS, etc. He suggested that the patient see a neurologist, which she did. He diagnosed Transgeminal Neuralgia. She was quite sure the vaccine caused it, but no doctor would come out and say so. He put her on TEGRETOL, which she could not tolerate, it made her sick. He then switched her to oxcarbazepine, which helped a great deal, but as the dosage built up in her system she developed an allergy to it, and was covered in itchy blister like eruptions which would not go away. She had to see an allergist, who said it was from dry skin-right. The patient then saw a dermatologist who said it resembled a shingles rash, but not 100%. The dermatologist put her on a megadose of prednisone (manufacturer unknown) for 3 weeks and the patient said could not take any other medications, not even for her transgeminal neuralgia, so needless to say she was in tremendous pain. Dermatologist said she was trying to "re-set" the patient's immune system, since "something" had thrown it completely out of whack. The patient asked if the vaccine could have done it. Dermatologist was pretty evasive about it, but did not rule it out. Unfortunately, as soon as the patient finished the prednisone (manufacturer unknown) she broke out in the same rash all over again. Dermatologist had the patient on a two week course of prednisone (manufacturer unknown), trying to quiet this down, but as the patient wrote this she had only two more days of prednisone (manufacturer unknown) left to take at the time of the report, and she was already itching and the skin was starting to peel on her hands and feet, as it did before. Biopsy of the rash and related tests were performed (results not provided). No one seems to know quite what to do with the patient. The patient did not know what her next steps would be, and it was quite frightening to think that she may never know. Living with the pain of transgeminal Neuralgia every day was a nightmare, and it was a nightmare the patient blamed on the MERCK product. This is one of several reports received from the same source (MARRS#1303USA002276). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from 50 year old female patient with no pertinent medical history and allergy to amoxicillin, AUGMENTIN concerning herself. On 15-AUG-2012, the patient was vaccinated with ZOSTAVAX, lot reported as: 0422AC; Exp. date 27-MAR-2013 or 2018, (dose not reported0 subcutaneous. Past drug therapy included DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE. The patient reported that two days after receiving the vaccine the patient began to have pain in her face, right side, lips to nose to cheek and into eye and forehead. It became progressively worse each day. After two weeks of pain she went to see her doctor. He thought it was a minor reaction to the shot and put her on a 6 day course of prednisone (manufacturer unknown). The patient continued to grow worse. In mid-September the physician sent her for a nuclear magnetic resonance imaging (MRI), which showed nothing wrong, such as a brain tumor, MS, etc. He suggested that the patient see a neurologist, which she did. He diagnosed Transgeminal Neuralgia. She was quite sure the vaccine caused it, but no doctor would come out and say so. He put her on TEGRETOL, which she could not tolerate, it made her sick. He then switched her to oxcarbazepine, which helped a great deal, but as the dosage built up in her system she developed an allergy to it, and was covered in itchy blister like eruptions which would not go away. She had to see an allergist, who said it was from dry skin-right. The patient then saw a dermatologist who said it resembled a shingles rash, but not 100%. The dermatologist put her on a megadose of prednisone (manufacturer unknown) for 3 weeks and the patient said could not take any other medications, not even for her transgeminal neuralgia, so needless to say she was in tremendous pain. Dermatologist said she was trying to "re-set" the patient's immune system, since "something" had thrown it completely out of whack. The patient asked if the vaccine could have done it. Dermatologist was pretty evasive about it, but did not rule it out. Unfortunately, as soon as the patient finished the prednisone (manufacturer unknown) she broke out in the same rash all over again. Dermatologist had the patient on a two week course of prednisone (manufacturer unknown), trying to quiet this down, but as the patient wrote this she had only two more days of prednisone (manufacturer unknown) left to take at the time of the report, and she was already itching and the skin was starting to peel on her hands and feet, as it did before. Biopsy of the rash and related tests were performed (results not provided). No one seems to know quite what to do with the patient. The patient did not know what her next steps would be, and it was quite frightening to think that she may never know. Living with the pain of transgeminal Neuralgia every day was a nightmare, and it was a nightmare the patient blamed on the MERCK product. This is one of several reports received from the same source (MARRS#1303USA002276). Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Got shot 2/22/13 2 day later severe arm pain 3 days all joints much pain go to ER got pain meds, no relief, went to personal physician prescribed Prednisone relief in 4 hrs as I was getting off meds pain back in all joints.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Got shot 2/22/13 2 day later severe arm pain 3 days all joints much pain go to ER got pain meds, no relief, went to personal physician prescribed Prednisone relief in 4 hrs as I was getting off meds pain back in all joints.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Lethargy, Myalgia
Clinical narrative: Got shot 2/22/13 2 day later severe arm pain 3 days all joints much pain go to ER got pain meds, no relief, went to personal physician prescribed Prednisone relief in 4 hrs as I was getting off meds pain back in all joints.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Headache
Clinical narrative: Migraine: pounding headache, nausea, double vision, weakness on right side of body, pain in joints and right arm, sternum pain, difficulty breathing, pain under left rib, pain left upper abdominal quadrant, dilated pupils, pain in shoulder, neck stiffness, vomiting.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Chest pain, Diplopia
Clinical narrative: Migraine: pounding headache, nausea, double vision, weakness on right side of body, pain in joints and right arm, sternum pain, difficulty breathing, pain under left rib, pain left upper abdominal quadrant, dilated pupils, pain in shoulder, neck stiffness, vomiting.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Dyspnoea, Electrocardiogram, Headache, Hemiparesis, Migraine
Clinical narrative: Migraine: pounding headache, nausea, double vision, weakness on right side of body, pain in joints and right arm, sternum pain, difficulty breathing, pain under left rib, pain left upper abdominal quadrant, dilated pupils, pain in shoulder, neck stiffness, vomiting.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Musculoskeletal stiffness, Mydriasis, Nausea
Clinical narrative: Migraine: pounding headache, nausea, double vision, weakness on right side of body, pain in joints and right arm, sternum pain, difficulty breathing, pain under left rib, pain left upper abdominal quadrant, dilated pupils, pain in shoulder, neck stiffness, vomiting.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Neurological examination, Pain in extremity, Ultrasound scan, Vomiting
Clinical narrative: Migraine: pounding headache, nausea, double vision, weakness on right side of body, pain in joints and right arm, sternum pain, difficulty breathing, pain under left rib, pain left upper abdominal quadrant, dilated pupils, pain in shoulder, neck stiffness, vomiting.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Biopsy liver abnormal, Mitochondrial cytopathy
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 4 months old male infant. Medical history and concomitant medication was not provided. On 28-DEC-2012 the patient was vaccinated with ROTATEQ, orally (Lot number was not provided. Product circular #: USPI-OS-V2601212R018). Patient went to the emergency room late November 2012 for an influenza like illness and while there elevated liver enzymes were discovered via a liver function tests. The patient was sent home and recovered from the influenza like illness (date unspecified). In March 2013 (reported as last week) the patient had an electron microscopy of a liver biopsy and an unspecified Mitochondrial disease was discovered. The physician report that the unspecified Mitochondrial disease could have been present at birth. The outcome of mitochondrial disease and elevated liver function tests was reported as not recovered. Mitochondrial disease was determined as life threatening by the reporter. The relatedness for the SAEs was not reported for ROTATEQ. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Abdominal pain upper, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection site and arm numbness immediately, then started to have severe headaches, stomach aches began a few days later. Headaches were documented prior to vaccine. Dx'd with intractable migraines and IBS.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Irritable bowel syndrome, Migraine, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Pain at injection site and arm numbness immediately, then started to have severe headaches, stomach aches began a few days later. Headaches were documented prior to vaccine. Dx'd with intractable migraines and IBS.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Headache, Laboratory test, Nuclear magnetic resonance imaging normal, Pain in extremity, Sensation of heaviness
Clinical narrative: Pain at injection site and arm numbness immediately, then started to have severe headaches, stomach aches began a few days later. Headaches were documented prior to vaccine. Dx'd with intractable migraines and IBS.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Sinusitis
Clinical narrative: Pain at injection site and arm numbness immediately, then started to have severe headaches, stomach aches began a few days later. Headaches were documented prior to vaccine. Dx'd with intractable migraines and IBS.
Sex: U
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus test negative, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to 2 unspecified patients of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date the patients were vaccinated orally with a dose of oral ROTATEQ. There was no concomitant medication. On an unknown date the patients experienced vomiting and diarrhea. Stool cultures for both patients were negative for rotavirus. The outcome of vomiting and diarrhea is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown patients of unknown ages and gender. On an unknown date the patients were vaccinated with GARDASIL (lot #, expiration date and route not reported). The patients had been coming to the office later than recommended schedule for GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, route and site not reported) on 16-FEB-2011 and 14-mAR-2013 respectively. No adverse symptoms reported. The outcome was unknown. The same event of the twin of the patient was captured in MARRS # 1303USA007957. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, route and site not reported) on 16-FEB-2011 and 14-MAR-2013 respectively. No adverse symptoms reported. The outcome was unknown. The same event of the twin of the patient was captured in MARRS # 1303USA010070. Additional information has been requested.