chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac stress test normal, Chest pain, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram normal
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Neck pain, Troponin increased
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Injection site erythema, Lethargy, Neck pain, Troponin I increased
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 10 year old male patient. The patient has seasonal allergies. The patient has no pertinent medical history. On 03-AUG-2013, the patient was vaccinated with second dose of 0.5 ml VARIVAX (Merck) (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were none. Approximately on 07-AUG-2013, the patient developed varicella type rash on the abdomen give days after receiving second dose of VARIVAX (Merck). Treatment rendered for the event was calamine lotion. There was no laboratory studies performed. The outcome of the event was unknown. The patient sought medical attention. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no relevant medical history and past drug history. On 03-AUG-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # 1716AA, expiration date 02-FEB-2013) subcutaneously in the left arm for prevention of shingles. The patient had no relevant medical history, concomitant medication, and past drug history. There was no concomitant therapy. The patient was no longer taking ZOSTAVAX and at the time of the reported, the patient was not experienced any adverse events from receiving expired ZOSTAVAX. There was no relevant laboratory data. The patient did not seek medical attention.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a grandmother regarding a 5 year old male patient (grandson). The patient had no pertinent medical history or drug allergies or reactions. On 29-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was not reported). No concomitant medications were reported. On 09-AUG-2013, the patient experienced chicken pox following administration of VARVIAX (Merck). There was no treatment rendered for the event. The outcome of chicken pox was reported as not recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unspecified date prior to 22-APR-2009 the patient was vaccinated with the first dose in vaccination series of GARDASIL (intramuscularly, dose and lot numbers were not reported) and subsequently was administered the second and third doses of GARDASIL (intramuscularly, doses and lot numbers were not reported) on 22-APR-2009 and 29-06-2009 respectively. The patient was administered a fourth dose of GARDASIL (intramuscularly, dose and lot number were not reported) on 18-JUL-2013. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 year old female patient. No medical history or drug reactions were reported. On 30-JUL-2013, the patient was vaccinated with dose 1 of GARDASIL (lot # H021346). Concomitant therapies included MENACTRA, VAQTA and BOOSTRIX. On 30-JUL-2013, the patient developed a fever, felt dizzy and tired with leg and knee pain, loss of appetite and felt weak with body aches following vaccination with the first dose of GARDASIL. The nurse reported that the patient's mom also called the office today on 08-Aug-2013 and reported that immediately following the GARDASIL vaccination the patient had a fever, felt dizzy and tired and had leg and knee pain. The patient's mom also reported that today on 08-AUG-2013, the patient had no appetite, felt weak and had body aches. Patient sought medical attention-contacted office. No treatment was given to patient. No laboratory tests were performed. The outcomes of the events were reported as not recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 year old female patient. No medical history or drug reactions were reported. On 30-JUL-2013, the patient was vaccinated with dose 1 of GARDASIL (lot # H021346). Concomitant therapies included MENACTRA, VAQTA and BOOSTRIX. On 30-JUL-2013, the patient developed a fever, felt dizzy and tired with leg and knee pain, loss of appetite and felt weak with body aches following vaccination with the first dose of GARDASIL. The nurse reported that the patient's mom also called the office today on 08-Aug-2013 and reported that immediately following the GARDASIL vaccination the patient had a fever, felt dizzy and tired and had leg and knee pain. The patient's mom also reported that today on 08-AUG-2013, the patient had no appetite, felt weak and had body aches. Patient sought medical attention-contacted office. No treatment was given to patient. No laboratory tests were performed. The outcomes of the events were reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient currently in her 20's. The patient was vaccinated with an unspecified number of doses of VARIVAX (route, lot number and expiration date not reported) in her childhood (exact date not reported). The reporter stated that the patient was recently diagnosed with shingles. The patient's outcome was not reported. The relatedness between the shingles and the vaccination with VARIVAX was not reported. The patient sought medical attention via phone call. 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 a patient of unknown age and gender. On unknown dates the patient was vaccinated with GARDASIL dose 1 and 2. Lot number, expiry date, route of administration and anatomical location were not reported for the doses. On an unknown date the patient received a 3rd dose of GARDASIL at 10 weeks an 2 day after the second dose. Route of administration, anatomical location, lot number and expiry date  were not reported. No adverse event was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 67 year old female patient. On 10-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date not reported) (one time injection, subcutaneously). On 12-JUL-2013, the patient developed a rash at the injection site after receiving ZOSTAVAX. At the time of reporting, the outcome was unknown. It's unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age. On 28-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, strength, route and anatomical site of vaccination not reported). In approximately 28-JUL-2013 the patient developed red, hot circular area with tiny rash at the injection site of ZOSTAVAX. None lab test were performed. No treatment was given. The outcome of red, hot circular area with tiny rash was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and red hot circular area with tiny rash at the injection site of ZOSTAVAX was not reported. The patient sought medical attention via contact with pharmacist. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Nausea
Clinical narrative: After 1st dose: nausea/headache.
Age: 66.0
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a physician via Novartis refers to a 66 year old patient (gender unknown). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). Other suspect therapies included FLUVIRIN. On 04-JAN-2013, the patient called to discuss long standing rash with itchy blisters in right arm, right shoulder, and back and in left arm. The event was ongoing. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 9 year old female patient. The patient has seasonal allergies. The patient has no pertinent medical history. On 03-AUG-2013, the patient was vaccinated with second dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were none. Approximately on 07-AUG-2013, the patient developed varicella type rash on the abdomen five days after receiving second dose of VARIVAX. Treatment rendered for the event was calamine lotion. There was no laboratory studies performed. The outcome of the event was unknown. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. On 06-AUG-2013 the patient was vaccinated with PROQUAD (Merck) (lot #, dose and route not provided) and then, on the same date, the patient was inadvertently administered VARIVAX (Merck) (lot # not provided) 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a female patient of unknown age. On 20-JAN-2009 the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, lot# not provided). On 18-JUL-2013, the patient was subsequently administered an expired dose of VARIVAX (Merck) (dose and route not provided) (Lot# reported as 1066AA, expiration date 05-JUL-2013) for the second dose in the vaccine series. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly rather than subcutaneously. The pharmacist reported that the patient received the ZOSTAVAX at another unspecified facility late last week (date of administration unspecified). The pharmacist reported that the ZOSTAVAX injection site was bruised and raised. The outcome of injection site was raised and bruised was reported as recovering. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). The reporter was unsure if the patient received ZOSTAVAX or not. On an unknown date the patient developed shingles. The outcome of event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was meant to be vaccinated with VARIVAX (Merck). Instead, the patient was vaccinated with ZOSTAVAX. Dose, route, anatomical location, lot number and expiry date were not reported. No product confusion was discovered, no adverse event was reported and no product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.), refers to a patient of unknown age and gender. On 08-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported), instead of ZOSTAVAX (Merck). No product confusion discovered, just medication error. No adverse event reported and no other information to report. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to her cousin's daughter who on an unknown date was vaccinated with the first and second dose of GARDASIL (doses, routes and lot numbers not reported). The physician reported that the patient had an extended interval between her first and second doses of GARDASIL. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 13-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). On 16-JUL-2013 the patient received a partial second dose of GARDASIL (dose, route and lot number were not reported) due to a syringe leakage. Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 17 months old female patient. On 04-JAN-2013 the patient was vaccinated with her first dose of VAQTA (Lot number unspecified). On 15-MAY-2013, the patient received her second dose of VAQTA (Lot # AHAVB692AA). The nurse practitioner reported that the patient did not experience any side effects related to the second dose of VAQTA given off schedule. This is one of two reports received from the same source (other MARRS#1306USA013101). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown dates, was vaccinated with an unspecified number of doses of GARDASIL (doses, routes and lot numbers not reported). The physician reported that on an unspecified date a Pap smear was performed and the result was a diagnosis of unspecified strains of high risk HPV's. At the time of the report, the patient's outcome was unknown. The relatedness for unspecified strains of high risk HPV's and GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown dates, was vaccinated with an unspecified number of doses of GARDASIL (doses, routes and lot numbers not reported). The physician reported that on an unspecified date a Pap smear was performed and the result was diagnosis of unspecified strains of high risk HPV. At the time of the report, the patient's outcome was unknown. The relatedness for unspecified strains of high risk HPV's and GARDASIL was unknown. This is one of several reports from the same source. 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 License Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. In 29-JUL-2012 the patient received the first dose of GARDASIL (Lot #, dose and route not reported) and in July 2013 received the second dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient. On an unknown date the patient was vaccinated with ROTATEQ (lot # not reported) dose 1, oral, at the age of 4 months due to a data error that resulted in the administration of ROTATEQ outside of the prescribing information for the recommended age. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Bacteraemia, Pneumonia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who in approximately 2013, was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (route and lot number not reported). The physician reported that within the past week in approximately July 2013, the patient presented with pneumonia and bacteremia after receiving PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The relatedness for pneumonia and bacteremia and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an 8 week old patient with no pertinent medical history reported. On 09-AUG-2013 the patient was vaccinated with RECOMIBAX HB (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included PEDIARIX (lot number and expiration date not reported) (dose and route not reported). The nurse reported that the patient received both RECOMIBAX HB and PEDIARIX due to human error. No adverse effect was reported. 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 healthcare worker refers to a patient of unknown age and gender. On 08-DEC-2009 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 661527/0112Y, exp date 29-NOV-2009), 0.5 ml, intramuscular. Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1307USA015839, 1307USA015842, 1307USA015841, and 1307USA015840, via same reporter link. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a 72 year old female patient (reporting on herself). On 19-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) in the arm. Concomitant therapy was not reported. In 2013, the patient reported her arm was red at the injection site and the redness moved down to her elbow as well. Arm was red and it did not give a scar like the small pox vaccine did. The outcome of elbow redness and her arm was red at the injection site was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX Vial 19400 PFU (lot # J000494, Exp date: 14-APR-2014) (dose and route unspecified). Patient experienced "redness that was spreading down the patient's arm and a bulge at the injection site" on an unspecified date after receiving ZOSTAVAX. The patient contact pharmacist for medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. 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 healthcare worker refers to a patient of unknown age and gender. On 05-OCT-2010 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 662747/1086X, exp date 06-JUN-2010), 0.5 ml (route unspecified). Concomitant medications were not reported. No adverse effect reported. This case is linked to case 1307USA013390, 1307USA015839, 1307USA015841, 1307USA015842 via same reporter link. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Premature separation of placenta
Clinical narrative: Initial report received from a health care professional on 21 August 2012. A 33-year-old female patient, whose concurrent conditions and relevant medical history was not reported, received a intramuscular dose one of ADACEL vaccine (batch lot number: U4393BA, expiry date reported as 29 November 2014, site of administration: not reported) on 21 August 2012. The reporter stated that the patient was pregnant at  the time of vaccination. The patient's last menstrual period was on: 02 January 2012 and expected date of delivery is (EDD) was: 08 October 2012. As of 21 August 2012, the patient had no adverse event. Follow-up information was received 02 August 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and will be upgraded from non serious to serious (reported event of partial placental abruption). The patient was 33 years of age and her date of last menstrual period was 02 January 2012. Maternal drug exposures consisted of ADACEL and iron. Past obstetrical history included two pregnancies, both with normal outcomes. The patient experienced a partial placental abruption. She delivered a normal infant. No additional information was provided. List of documents held by the sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age with no pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not reported). It was reported that the patient had received a "steroid block" (unspecified) before vaccination. The pharmacist reported that the patient developed a blistering rash at the injection site "over a year ago" (approximately in 2012). Outcome for blistering rash was reported as recovered on an unspecified date. No treatment information was reported. The pharmacist did not assess the causality between blistering rash and ZOSTAVAX. Pharmacist reported that the physician reported the rash to VAERS. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Asthenia, Musculoskeletal pain, Tremor
Clinical narrative: Ten days after 2nd anthrax vaccine for deployment. Tremors in left hand and arm, blackout, muscle strength has decreased.
Age: 53.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Loss of consciousness, Muscular weakness, Tremor
Clinical narrative: Ten days after 2nd anthrax vaccine for deployment. Tremors in left hand and arm, blackout, muscle strength has decreased.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysphemia
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a 12 year old female patient with none of pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL, intramuscularly, for vaccination (dose, injection site and lot # not provided). There was no concomitant medication. It was reported that 4 and 1/2 hours after the patient received the dose, the patient's movement became slow and the patient started to have stuttering speech. The patient was taken to an emergency room. The patient's mother gave 4 Lifesaver candies and within 15 minutes the patient recovered. Then the patient went home. On 06-AUG-2013 the patient developed slow movements and stuttering again so she was taken to the physician's office. The physician gave 2 cups of carbohydrates (unspecified), electrolytes (unspecified) (GATORADE) and the patient recovered within 15 minutes. It was noted that no treatment was given for the adverse events. The physician did not do a blood sugar test on her but he did not think the symptoms were due to hypoglycemia. CBC (complete blood count), CHEM 20, CT (Computerized tomogram) of head was performed, no result available. The causality between GARDASIL and adverse event were unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dysphemia, Full blood count, Laboratory test, Mobility decreased
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a 12 year old female patient with none of pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL, intramuscularly, for vaccination (dose, injection site and lot # not provided). There was no concomitant medication. It was reported that 4 and 1/2 hours after the patient received the dose, the patient's movement became slow and the patient started to have stuttering speech. The patient was taken to an emergency room. The patient's mother gave 4 Lifesaver candies and within 15 minutes the patient recovered. Then the patient went home. On 06-AUG-2013 the patient developed slow movements and stuttering again so she was taken to the physician's office. The physician gave 2 cups of carbohydrates (unspecified), electrolytes (unspecified) (GATORADE) and the patient recovered within 15 minutes. It was noted that no treatment was given for the adverse events. The physician did not do a blood sugar test on her but he did not think the symptoms were due to hypoglycemia. CBC (complete blood count), CHEM 20, CT (Computerized tomogram) of head was performed, no result available. The causality between GARDASIL and adverse event were unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Blood glucose, Blood test, Computerised tomogram, Dysphemia
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a 12 year old female patient with none of pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL, intramuscularly, for vaccination (dose, injection site and lot # not provided). There was no concomitant medication. It was reported that 4 and 1/2 hours after the patient received the dose, the patient's movement became slow and the patient started to have stuttering speech. The patient was taken to an emergency room. The patient's mother gave 4 Lifesaver candies and within 15 minutes the patient recovered. Then the patient went home. On 06-AUG-2013 the patient developed slow movements and stuttering again so she was taken to the physician's office. The physician gave 2 cups of carbohydrates (unspecified), electrolytes (unspecified) (GATORADE) and the patient recovered within 15 minutes. It was noted that no treatment was given for the adverse events. The physician did not do a blood sugar test on her but he did not think the symptoms were due to hypoglycemia. CBC (complete blood count), CHEM 20, CT (Computerized tomogram) of head was performed, no result available. The causality between GARDASIL and adverse event were unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Pain in extremity, Psychomotor skills impaired, Speech disorder
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a 12 year old female patient with none of pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL, intramuscularly, for vaccination (dose, injection site and lot # not provided). There was no concomitant medication. It was reported that 4 and 1/2 hours after the patient received the dose, the patient's movement became slow and the patient started to have stuttering speech. The patient was taken to an emergency room. The patient's mother gave 4 Lifesaver candies and within 15 minutes the patient recovered. Then the patient went home. On 06-AUG-2013 the patient developed slow movements and stuttering again so she was taken to the physician's office. The physician gave 2 cups of carbohydrates (unspecified), electrolytes (unspecified) (GATORADE) and the patient recovered within 15 minutes. It was noted that no treatment was given for the adverse events. The physician did not do a blood sugar test on her but he did not think the symptoms were due to hypoglycemia. CBC (complete blood count), CHEM 20, CT (Computerized tomogram) of head was performed, no result available. The causality between GARDASIL and adverse event were unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Epistaxis, Fatigue, Gait disturbance, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the vaccine GARDASIL, my vision blurred and went dark. I had to receive help walking to the car as I felt I was about to faint. Over the next 3 weeks, I experienced extreme fatigue and a weakened immune system. Frequent nose bleeds occurred which has never happened before.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immune system disorder, Vision blurred, Visual impairment
Clinical narrative: Immediately after receiving the vaccine GARDASIL, my vision blurred and went dark. I had to receive help walking to the car as I felt I was about to faint. Over the next 3 weeks, I experienced extreme fatigue and a weakened immune system. Frequent nose bleeds occurred which has never happened before.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site joint swelling, Injection site swelling
Clinical narrative: Left lower thigh and joint swelling, referred to hospital, did fine.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Clinic nurse administered PROQUAD and VARIVAX. Child was due for MMR and Varicella and DTAP/POLIO vaccines.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant (nurse) refers to a 78 year old female patient with type II diabetes, high blood pressure and no known drug reactions/allergies. On 05-OCT-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose route and frequency not provided). Concomitant therapies included atorvastatin (manufacturer unknown), GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), FOSAMAX, aspirin (manufacturer unknown) and enalapril maleate (manufacturer unknown). On 29-JUL-2013, the patient began to experience pain and lots of red spots on her right arm. The patient was seen in the office on 04-AUG-2013, and presented with left shoulder, posterior aspect a dermatome pattern with papules and vesicles, some in clusters. The patient was diagnosed with Herpes Zoster. The patient was treated with VICODEN, but it did not agree with the patient. The patient was then treated with famciclovir (manufacturer unknown), ibuprofen (manufacturer unknown) and TYLENOL. No laboratory tests were performed. The nurse stated that she spoke with patient on 12-AUG-2013, and patient was currently experiencing pain, numbness, achiness and trouble moving the affected arm. The patient also reported that her daughter is taking care of her and if her daughter was not able to help her, the patient was going to be placed "in a home". The reporter considered the Herpes Zoster to be disabling. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a medical assistant (nurse) refers to a 78 year old female patient with type II diabetes, high blood pressure and no known drug reactions/allergies. On 05-OCT-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose route and frequency not provided). Concomitant therapies included atorvastatin (manufacturer unknown), GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), FOSAMAX, aspirin (manufacturer unknown) and enalapril maleate (manufacturer unknown). On 29-JUL-2013, the patient began to experience pain and lots of red spots on her right arm. The patient was seen in the office on 04-AUG-2013, and presented with left shoulder, posterior aspect a dermatome pattern with papules and vesicles, some in clusters. The patient was diagnosed with Herpes Zoster. The patient was treated with VICODEN, but it did not agree with the patient. The patient was then treated with famciclovir (manufacturer unknown), ibuprofen (manufacturer unknown) and TYLENOL. No laboratory tests were performed. The nurse stated that she spoke with patient on 12-AUG-2013, and patient was currently experiencing pain, numbness, achiness and trouble moving the affected arm. The patient also reported that her daughter is taking care of her and if her daughter was not able to help her, the patient was going to be placed "in a home". The reporter considered the Herpes Zoster to be disabling. Additional information has been requested.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Erythema, Induration
Clinical narrative: Red induration approximately 10-13 cm wide.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up with area feeling very warm to the touch.  Area is red and puffy over entire right deltoid region.  Also complains of itching in same area.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Complained of nausea, was diaphoretic within a few minutes of receiving the vaccine.  BP 80/50, pulse-66.  Relief with rest, after 10 minutes BP 98/70, pulse-72.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Mother brought child to the clinic at 3:00 P.M. on 6/14/2013 to see the nurse. Child was taken to Immunization Room, it was noted that a circular red area approximately 2 inches by 1 1/2 inches was visible. This was the area where the Kinrix (Dtap-IPV) vaccine was administered. The site was slightly swollen, warm and slightly splotchy looking. Child complained of pain and itching at site. No visible area of skin breakdown or drainage at site. Mother informed nurse that the family had been applying cold compresses to the site. Encouraged mother to use the cold compresses when needed. Called phone number and spoke to grandmother and informed grandmother that it would be reported, and the family may receive a phone call requesting further information about the incident. The grandmother told me that the child had a high fever but did not know how high as she did not take the temperature, and that the child was in a lot of pain. Informed grandmother and mother if the problem worsened or new problems arised to take the child to his doctor. If the family was worried about the reaction to notify the child's doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth, Pyrexia, Rash macular
Clinical narrative: Mother brought child to the clinic at 3:00 P.M. on 6/14/2013 to see the nurse. Child was taken to Immunization Room, it was noted that a circular red area approximately 2 inches by 1 1/2 inches was visible. This was the area where the Kinrix (Dtap-IPV) vaccine was administered. The site was slightly swollen, warm and slightly splotchy looking. Child complained of pain and itching at site. No visible area of skin breakdown or drainage at site. Mother informed nurse that the family had been applying cold compresses to the site. Encouraged mother to use the cold compresses when needed. Called phone number and spoke to grandmother and informed grandmother that it would be reported, and the family may receive a phone call requesting further information about the incident. The grandmother told me that the child had a high fever but did not know how high as she did not take the temperature, and that the child was in a lot of pain. Informed grandmother and mother if the problem worsened or new problems arised to take the child to his doctor. If the family was worried about the reaction to notify the child's doctor.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, pain at injection site (6x8 cm), headache; treatment: hot compresses, Advil.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Abasia, Arthralgia, Arthritis, Balance disorder, Bedridden
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Blindness unilateral, Crepitations, Decreased appetite, Dizziness, Dysphonia
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Headache, Hyperaesthesia, Increased appetite, Insomnia
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.