chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.03
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician, the author of the literature report, concerning a 109 days infant, gender unknown. The infant was a preterm baby and had low birth weight of <1000g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010 when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date the infant was vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine. In addition 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician, the author of the literature report, concerning a 105 days infant, gender unknown. The infant was a preterm baby and had low birth weight of 1001-1500 g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010 when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date the infant was vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine. In addition 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from an unspecified reporter concerning a patient of unknown age and gender. It was reported that on an unknown date, unspecified patient might have been vaccinated with an expired dose of Hepatitis B Vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified). It was unspecified if Hepatitis B Vaccine (manufacturer unknown) was administered or not. It was inquired if Hepatitis B Vaccine (manufacturer unknown that expired 3 days ago can be used. No concomitant therapy was reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 79 year old male patient. Relevant medical history and concomitant medication were not provided. On 06-AUG-2013 the patient was vaccinated with ZOSTAVAX at a pharmacy. Lot number, dose, route and frequency were not provided. On 25-AUG-2013, the patient experienced at t2 distribution rash and was diagnosed with "shingles". The outcome of a t2 distribution rash and was diagnosed with "shingles" was unknown. The reporter causality was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On 23-AUG-2013 the patient was vaccinated with a dose of M-M-R II, lot # 1119AA, expiring 12-JUL-2013, in the left arm for school requirement (dose and route not provided). The patient's relevant medical history, relevant concomitant medications and relevant past drug history were unknown. It was reported that the patient was just administered the M-M-R II, vaccine that was expired. The pharmacist further explained that the vaccine was still in the refrigerator and that it was not realized that it was expired before it was given. It was unknown if there was any relevant laboratory data. It was unknown if the patient would continue to receive the M-M-R II vaccination. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Rash
Clinical narrative: Rash and swelling on inside forearm and fingers. Taking Benadryl at bedtime.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient. On 26-AUG-2013, the patient was vaccinated SC with a dose of ZOSTAVAX (lot # J003359, expire on 21-JUN-2014). On an unspecified date, it's reported that the patient experienced redness and swelling at the injection site. The patient was given treatment instructions to use ice on affected redness and swelling, around injection site. Additionally, if pain increased, it was reported, that the patient was to use over the counter ibuprofen. During the week of 02-SEP-2013, date unspecified. The pharmacist had spoken to the patient. The patient reported that redness and swelling had resolved. This is one of several reports received from the same source. It was linked to MARRS# 1309USA000812. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chlamydial infection, Delivery, Exposure during pregnancy, Nausea
Clinical narrative: Information has been received from an 18 year old, for GARDASIL, a Pregnancy Registry product, with no pertinent medical history and no known drug reactions/allergies, who in August 2010, was vaccinated with the first dose of GARDASIL (lot number not provided), on approximately 2010 was vaccinated with the second dose of GARDASIL (lot number not provided) and on 01-MAR-2011 was vaccinated SQ with the third dose of GARDASIL (lot number not provided). There was no concomitant medication reported. The patient reported that she was pregnant at the time of the third dose administration, on 03-JAN-2011. On an unspecified date a blood work test was performed. Patient's last menstrual period was not reported. Expected date of delivery was unspecified. Follow up information has been received via complete questionnaire from the medical assistant, concerning the 18 year old female patient with no concurrent medical conditions and no previous pregnancies, who in August 2010, on 01-NOV-2010 and on 01-MAR-2011, was vaccinated with the first, second and third doses, respectively of GARDASIL (lot# 0450Z, 0644Z and 1560Z, respectively). The medical assistant reported that concomitant medication using during this pregnancy included CITRANATAL. The medical assistant also reported that patient's last menstrual period was on 18-NOV-2010 and estimated delivery date was 26-AUG-2011. It was reported that on 29-MAR-2011 an official ultrasound was performed (result: normal). On approximately 26-JAN-2011, during pregnancy the patient experienced chlamydia infection and was treated with azithromycin 2g once. On the same date the patient also experienced urinary tract infection, nausea and vomiting and was treated with KEFLEX 500mg, once an PHENERGAN 25mg, prn, respectively. At the time of the report the patient's outcome was unknown. On 19-AUG-2011, at 39 weeks from LMP, the patient delivered a normal female baby with no congenital anomalies and no other complications or abnormalities. The baby's weight was 7 pounds 4 ounces, length was 20 inches, APGAR score was 8/9. It was reported that there were no complications during pregnancy, labor or delivery. Follow up information had been received from the registered medical assistant refers to the currently 21 year old female patient. The patient was given 3 series GARDASIL intramuscularly on 20-AUG-2010, 01-NOV-2010 and 01-MAR-2011 respectively. There was no adverse reaction reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen normal, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from an 18 year old, for GARDASIL, a Pregnancy Registry product, with no pertinent medical history and no known drug reactions/allergies, who in August 2010, was vaccinated with the first dose of GARDASIL (lot number not provided), on approximately 2010 was vaccinated with the second dose of GARDASIL (lot number not provided) and on 01-MAR-2011 was vaccinated SQ with the third dose of GARDASIL (lot number not provided). There was no concomitant medication reported. The patient reported that she was pregnant at the time of the third dose administration, on 03-JAN-2011. On an unspecified date a blood work test was performed. Patient's last menstrual period was not reported. Expected date of delivery was unspecified. Follow up information has been received via complete questionnaire from the medical assistant, concerning the 18 year old female patient with no concurrent medical conditions and no previous pregnancies, who in August 2010, on 01-NOV-2010 and on 01-MAR-2011, was vaccinated with the first, second and third doses, respectively of GARDASIL (lot# 0450Z, 0644Z and 1560Z, respectively). The medical assistant reported that concomitant medication using during this pregnancy included CITRANATAL. The medical assistant also reported that patient's last menstrual period was on 18-NOV-2010 and estimated delivery date was 26-AUG-2011. It was reported that on 29-MAR-2011 an official ultrasound was performed (result: normal). On approximately 26-JAN-2011, during pregnancy the patient experienced chlamydia infection and was treated with azithromycin 2g once. On the same date the patient also experienced urinary tract infection, nausea and vomiting and was treated with KEFLEX 500mg, once an PHENERGAN 25mg, prn, respectively. At the time of the report the patient's outcome was unknown. On 19-AUG-2011, at 39 weeks from LMP, the patient delivered a normal female baby with no congenital anomalies and no other complications or abnormalities. The baby's weight was 7 pounds 4 ounces, length was 20 inches, APGAR score was 8/9. It was reported that there were no complications during pregnancy, labor or delivery. Follow up information had been received from the registered medical assistant refers to the currently 21 year old female patient. The patient was given 3 series GARDASIL intramuscularly on 20-AUG-2010, 01-NOV-2010 and 01-MAR-2011 respectively. There was no adverse reaction reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Pruritus, Rash, Rhinorrhoea
Clinical narrative: Hives - patient received PROQUAD and KINRIX on 9/10/13. He had redness to injection site. Today he developed urticaria and redness around injection site is 10x5 cm. Urticaria is widespread. Pt had 4 year vaccines 2 days ago, including PROQUAD and KINRIX. That evening, he had redness to right leg shortly after getting shots. Yesterday, he still just had redness to thigh, but no other rash. About 10am today, he started scratching and mom noticed he had a rash on abdomen, neck, arms, and legs. The area around injection site is still very red. He had varicella and MMR separately at age 1 year and had no problems. His nose is runny. No breathing problems. No wheezing. No abdominal pain. He has never had hives. No fever. No joint pain. He has been outside some at soccer, but he plays outside a lot. No new foods, detergents, or other exposures.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives - patient received PROQUAD and KINRIX on 9/10/13. He had redness to injection site. Today he developed urticaria and redness around injection site is 10x5 cm. Urticaria is widespread. Pt had 4 year vaccines 2 days ago, including PROQUAD and KINRIX. That evening, he had redness to right leg shortly after getting shots. Yesterday, he still just had redness to thigh, but no other rash. About 10am today, he started scratching and mom noticed he had a rash on abdomen, neck, arms, and legs. The area around injection site is still very red. He had varicella and MMR separately at age 1 year and had no problems. His nose is runny. No breathing problems. No wheezing. No abdominal pain. He has never had hives. No fever. No joint pain. He has been outside some at soccer, but he plays outside a lot. No new foods, detergents, or other exposures.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from an approximately 83 year old female patient regarding herself with chronic lymphocytic leukemia. The patient had no drug reactions or allergies to prescription medication. On 25-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported). On an unknown date in JUL-2013, the patient stated that she had a very sore arm where she received the shot which seemed to get worse to the point where she had trouble raising her arm and she could not sleep on that arm. She stated that she does put heat on her arm at night. She already had prosthesis in her right shoulder and could not raise that arm fully. She stated that if she had known this could be a problem she would have had the injection in her right arm. No treatment was given and lab diagnostic studies were performed. The outcome of the reported events were not recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Mental status changes
Clinical narrative: Pt complained of vertigo, slurred speech and trouble walking.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Dysarthria, Full blood count normal, Gait disturbance
Clinical narrative: Pt complained of vertigo, slurred speech and trouble walking.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Metabolic function test normal, Neurological examination normal, Toxicologic test normal, Vertigo
Clinical narrative: Pt complained of vertigo, slurred speech and trouble walking.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Death.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Death.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 20 year old female patient with no pertinent medical history and no drug reactions or allergies. On 12-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number H018528 and expiry date 09-OCT-2014, dose and route unspecified) and the patient was found to be pregnant. Last menstrual period (LMP) was reported as 17-JUL-2013. Estimated date of delivery (EDD) was found to be 23-APR-2014. The pregnancy outcome was pending. There were no concomitant medications. No adverse event was reported other than pregnancy. The patient sought medical attention (office contact). No treatment was given to the patient. On an unknown date, a pregnancy blood test was performed. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 20 year old female patient with no pertinent medical history and no drug reactions or allergies. On 12-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number H018528 and expiry date 09-OCT-2014, dose and route unspecified) and the patient was found to be pregnant. Last menstrual period (LMP) was reported as 17-JUL-2013. Estimated date of delivery (EDD) was found to be 23-APR-2014. The pregnancy outcome was pending. There were no concomitant medications. No adverse event was reported other than pregnancy. The patient sought medical attention (office contact). No treatment was given to the patient. On an unknown date, a pregnancy blood test was performed. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Eye irritation, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a 65 year old male consumer with no pertinent medical history and no drug reactions/allergies refers to himself. On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX dose and route unknown, lot # J002868, expiry: 14-JUN-2014. There were no concomitant medication. Within 24 hours of receiving vaccination the patient experienced allergic reaction to ZOSTAVAX, his arm swelled up to the size of a football. The swelling went from his elbow up to his shoulder area. This swollen area was hard as a rock. He also developed water blisters around the injection site. The blisters spread outward from the injection site to be the size of a coffee cup. This area also itched and caused him to have a burning sensation all over. The water blisters broke and are now scabbed over. The injection sit was still red and the swelling has gone down. The patient packed injection site with ice and took BENADRYL and an unspecified antihistamine. The patient sought medical attention by visiting the physician. The patient was not hospitalized. There were no lab diagnostics performed. The patient's outcome was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Burning sensation, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 65 year old male consumer with no pertinent medical history and no drug reactions/allergies refers to himself. On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX dose and route unknown, lot # J002868, expiry: 14-JUN-2014. There were no concomitant medication. Within 24 hours of receiving vaccination the patient experienced allergic reaction to ZOSTAVAX, his arm swelled up to the size of a football. The swelling went from his elbow up to his shoulder area. This swollen area was hard as a rock. He also developed water blisters around the injection site. The blisters spread outward from the injection site to be the size of a coffee cup. This area also itched and caused him to have a burning sensation all over. The water blisters broke and are now scabbed over. The injection sit was still red and the swelling has gone down. The patient packed injection site with ice and took BENADRYL and an unspecified antihistamine. The patient sought medical attention by visiting the physician. The patient was not hospitalized. There were no lab diagnostics performed. The patient's outcome was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a 65 year old male consumer with no pertinent medical history and no drug reactions/allergies refers to himself. On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX dose and route unknown, lot # J002868, expiry: 14-JUN-2014. There were no concomitant medication. Within 24 hours of receiving vaccination the patient experienced allergic reaction to ZOSTAVAX, his arm swelled up to the size of a football. The swelling went from his elbow up to his shoulder area. This swollen area was hard as a rock. He also developed water blisters around the injection site. The blisters spread outward from the injection site to be the size of a coffee cup. This area also itched and caused him to have a burning sensation all over. The water blisters broke and are now scabbed over. The injection sit was still red and the swelling has gone down. The patient packed injection site with ice and took BENADRYL and an unspecified antihistamine. The patient sought medical attention by visiting the physician. The patient was not hospitalized. There were no lab diagnostics performed. The patient's outcome was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 04-SEP-2013 the patient was vaccinated subcutaneously with an expired 0.65 ml dose of ZOSTAVAX lot # 672428/1599AA (exp. date 13-JAN-2013). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: VIIth nerve paralysis, Vision blurred
Clinical narrative: Case number PHEH2013US019091, is an initial spontaneous report received from a consumer on 10 Sep 2013. This report refers to a female patient on unspecified age. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: not reported), on an unspecified date. After vaccination on 03 Jul 2013, she experienced right side facial paralysis and recovered on 20 Jul 2013. On 06 Jul 2013, she also experienced eye vision was blurred on the right eye and recovered on 26 Jul 2013. The seriousness and causality of the events was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Fall, Head injury, Immediate post-injection reaction, Laceration, Loss of consciousness
Clinical narrative: Case number PHEH2013US019158, is an initial spontaneous report received from a lawyer on 10 Sep 2013: This case refers to a female patient of unspecified age. Past medical history and concomitant medications of the patient were not reported. She was vaccinated with MENVEO (batch number: A12097 and expiry date: Aug 2014), on an unspecified date. Right after vaccination, she lost consciousness, falling sustaining a laceration to her right hand which required ten stitches and sustained a head injury. The seriousness, outcome and causality of the events were not reported. No more information was provided.
Sex: F
Vaccine: MNQ
Symptoms: Suture insertion
Clinical narrative: Case number PHEH2013US019158, is an initial spontaneous report received from a lawyer on 10 Sep 2013: This case refers to a female patient of unspecified age. Past medical history and concomitant medications of the patient were not reported. She was vaccinated with MENVEO (batch number: A12097 and expiry date: Aug 2014), on an unspecified date. Right after vaccination, she lost consciousness, falling sustaining a laceration to her right hand which required ten stitches and sustained a head injury. The seriousness, outcome and causality of the events were not reported. No more information was provided.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased activity, Irritability, Pyrexia
Clinical narrative: Fever 101 - 102 within 24 hours of vaccine administration. No other sxs initially, then fussy and not same activity level for next 2 days.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pustular, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse via the company representative refers to a 12 month old female patient, the child of the reporter. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, lot number and expiration date were not reported). Other suspect therapies included M-M-R II (dose, route, lot number and expiration date was not reported) and unspecified hepatitis A vaccine. No concomitant medications or patient's medical history were reported. On an unknown date the child developed a chickenpox, consisting of varying patches on the body overall. No symptoms other than pustules were reported. The patient sought medical attention and was seen by the pediatrician. On an unknown date the patient recovered. The relatedness between the vaccination with VARIVAX (Merck), M-M-R II and the events of chickenpox and pustules was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-APR-2013 the patient was vaccinated with a dose of M-M-R II that was reconstituted with sterile diluent that had expired. Lot number strength, and dose of M-M-R II were unknown. Lot number of sterile diluent was 6104Y. Per reporter sterile diluent had expired on an unspecified date in February 2012. Per manufacturer records lot 6104Y of sterile diluent has an expiry date of 20-FEB-2013. The M-M-R II had not expired. No adverse symptoms were reported. This is one of multiple reports from the same reporter (other case IDs 1308USA013861 and 1308USA014141). Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 35 year old male patient. On 06-SEP-2013, the patient was vaccinated with PROQUAD, .5 ml, one dose subcutaneous (not number was not provided). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 05-SEP-2013 the patient was vaccinated with a dose of M-M-R II, lot # 1375AA, expiry date 26-AUG-2013 (dose, route, injection site not provided). No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old female patient with rheumatoid arthritis, sulfa and aspirin allergy and a history of Lyme disease. On 14-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX injection (route and dose not provided, lot  number J003483, exp. date 29-JUN-2014). The physician reported that in August 2013 the patient had a flare up of the rheumatoid arthritis following vaccination with ZOSTAVAX. The patient sought medical attention -contacted office. There was no treatment of adverse events. The physician reported that the patient was previously on ENBREL, but received the last injection of ENBREL in July 2013 (date unspecified). The ENBREL was stopped , but received the last injection of ENBREL in July 2013 (date unspecified). The ENBREL was stopped so the patient could receive the ZOSTAVAX vaccination. The physician also mentioned that the patient and his wife ached all over after receiving Lyme vaccine (date of administration and manufacturer of Lyme vaccine was unspecified), but were recovered (date not reported). None of lab diagnostics studies where performed. The outcome of event was reported as not recovered. Relatedness of the event of the ZOSTAVAX was not provided by reporting physician.  Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 60 year old patient (gender unknown). No information regarding the patient's medical history was provided. Or an unknown date the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash all over body. No itching or pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal growth restriction, Hypertension
Clinical narrative: Initial report received from a healthcare professional on 17 October 2012. A 31-year-old pregnant female patient had received an intramuscular dose 1 of ADACEL (lot number U4421AA, site of administration was not reported) on 17 October 2012. The patient's last menstrual period date was 15 March 2012. The estimated date of delivery was 20 December 2012. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, risk factors was reported as not applicable. Concomitant medications and past medical history was not reported. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been updated to serious. The pregnant female received an injection of RHOGAM (other manufacturer, lot number, site, side, and route of administration not reported). Relevant illness during pregnancy/ongoing was reported as chronic hypertension (CHTN) and intrauterine growth restriction (IUGR). The patient had two previous pregnancies with normal outcomes. The last menstrual period was 15 March 2012. On 05 December 2012, the patient delivered a normal infant. The patient's outcome for the events of CHTN and IUGR was not reported. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Macrosomia, Polyhydramnios
Clinical narrative: Initial report received from a healthcare professional on 27 November 2012. A female patient whose age was not reported, had received an intramuscular dose of ADACEL vaccine (lot number U4421AA, dose number was not reported) in the right deltoid on an unspecified date. The patient was pregnant. The last menstrual period date was 12 April 2012 and the expected date of delivery was reported as "25 January 2012". The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 27 November 2012, the patient did not experience any adverse event. Follow-up information was received on 03 September 2013 from a health care professional. A 35 year-old female patient's last menstrual period was 20 April 2012. The patient relevant illness during pregnancy was reported as polyhydramnios and macrosomia. According to the reporter, the patient experienced no adverse events following vaccination. The patient's pregnancy history included one pregnancy. The end of pregnancy was reported as 18 January 2013. The infant's outcome was normal. No further information was provided at the time of the report. List of documents held by the sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Crohn's disease, Exposure during pregnancy, Hypothyroidism, Premature rupture of membranes
Clinical narrative: Initial report received from a healthcare professional on 12 December 2012. A 28-year-old female patient had received an intramuscular first dose of ADACEL (Lot number U4421AA, anatomical site of vaccination was not reported) on 11 December 2012. The patient was pregnant at the time of vaccination. The last menstrual period date was 09 May 2012 and the expected date of delivery is 13 February 2013. The patient's health during pregnancy, risk factors, medical history and concomitant medications were not reported. As of 11 December 2012, the patient did not experience any adverse event. Follow-up information received from a health care professional on 03 September 2013. The patient's maternal age was 26 years old. The last menstrual period was 05 September 2012. The patient experienced hypothyroidism and Crohn's on unreported dates during pregnancy. The patient was administered Tdap and SYNTHROID during pregnancy on unreported dates. The patient did not experience any adverse events following vaccination. The number of pregnancies for the mother was one with a normal outcome. The patient experienced a premature rupture of membranes at 33 weeks. The end of pregnancy was 26 December 2012 and the birth outcome was infant normal. List of documents held by the sender: None.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 11-SEP-2013, the patient was vaccinated with an expired dose of 0.5ml M-M-R II, (lot # 1123AA, expiry date 12-JUL-2013, route was subcutaneous). No adverse effect reported was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal growth restriction, Hypertension, Thrombocytopenia
Clinical narrative: Initial report received from a healthcare professional on 14 December 2012. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (Lot number: U4421AA, dose number not reported) in right deltoid on an unspecified date. The patient was pregnant. The last menstrual period date was not reported. The estimated date of delivery is 09 January 2013. The patient's health during pregnancy, medical history, concomitant medications and risk factors were not reported. As of 14 December 2012, the patient did not experience any adverse event. Follow-up information received from a health care professional on 03 September 2013. The patient maternal age was 32 years. The patient last menstrual period was 09 April 2012. The patient experienced IUGR, HTN, thrombocytopenia on unreported dates during pregnancy. The patient was administered Tdap, flu, manufacturer not reported, RHOGAM and SUBOXONE during pregnancy on unreported dates. The patient did not experience any adverse events following vaccination. The mother's pregnancy history was one pregnancy with a normal outcome. The end of pregnancy date was 20 December 2012. The birth outcome was infant normal. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Breast pain, Herpes zoster, Rash erythematous, Scab
Clinical narrative: This spontaneous report was received from a 75 year old female patient regarding herself. Patient's current conditions included high blood pressure and ceclor allergy. The patient had a history of kidney stones. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) in the left arm. No concomitant medications were reported. On an unknown date in April 2013, the patient experienced broke out in shingles. Patient sought medical attention. Patient was prescribed in antiviral for 7 days and some percocet things for a few days. Urine was processed about 2 weeks ago as follow up to the kidney stones (result not reported). She admits she sill has red bumps that have crusted over and some pain in her right breast area and other parts of her abdomen. The patient was recovering from shingles. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: This spontaneous report was received from a 75 year old female patient regarding herself. Patient's current conditions included high blood pressure and ceclor allergy. The patient had a history of kidney stones. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) in the left arm. No concomitant medications were reported. On an unknown date in April 2013, the patient experienced broke out in shingles. Patient sought medical attention. Patient was prescribed in antiviral for 7 days and some percocet things for a few days. Urine was processed about 2 weeks ago as follow up to the kidney stones (result not reported). She admits she sill has red bumps that have crusted over and some pain in her right breast area and other parts of her abdomen. The patient was recovering from shingles. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 27 year old female patient with no pertinent medical history or drug reactions/allergies. On an unknown date in 2013 the patient was vaccinated with her third dose of GARDASIL (lot # 0518AE, expiration date 21-NOV-2014, 0.5ml, intramuscularly) for vaccination while she was pregnant. There was no concomitant medication. The patient became pregnant with LMP of 12-JUL-2013 and EDD of 18-APR-2014. The patient's date of conception estimated on 26-JUL-2013. The pregnancy outcome was unknown. No congenital anomaly was known of at the time of the report. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event, Viral test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 26 year old female patient. On 28-JUN-1996 and 22-MAY-2007 the patient was vaccinated with VARIVAX (Merck). Route and dose were not provided. The patient failed to seroconvert. On an unknown date antibody titer was drawn and was negative. On 22-JUL-2013 the patient was vaccinated with VARIVAX (Merck) dose 3. It was reported that the patient is a college student and needs to have the Varicella vaccine. No adverse effects were reported. The patient sought medical attention by contacting the office. The outcome of antibody titer was drawn and was negative: failed to seroconvert, was unknown. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report has been received from a consumer, a male, 68 years old patient with drug reactions/allergies to KEFLEX with none pertinent medical history who was referring to himself. In approximately September 2012, reported as about a year ago, the patient was vaccinated with ZOSTAVAX (lot# not reported) injection (strength, dose, route not reported) one time. Concomitant therapies included prednisone (manufacturer unknown) and COLCRYS. It was reported that approximately in June 2013, reported as 3 months ago, the patient developed shingles and experienced rash to the right of the eye that was mildly painful and painful bumps in his head. Routine blood work was performed, no results provided. The patient sought medical attention by seeing the dermatologist every 3 months. It was reported that the patient was treated with valacyclovir hydrochloride but the shingles did not fully go away. The outcome of developed shingles, rash to the right of the eye and painful bumps in his  head was reported as recovering/resolving. The reporter did not assess the relatedness between the ZOSTAVAX and the adverse events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This pharmacist reports that a patient of unknown age and gender received PNEUMOVAX 23, at an unknown dose, on 27Aug2013. The patient's relevant medical history, concomitant medications, and past drug history are unknown. On 28Aug2013, the patient reported pain in the whole upper arm where the PNEUMOVAX 23 was given and there was a little lump and redness on the muscle at the back of the upper arm. It is unknown if any relevant laboratory testing was performed. As of 28Aug2013, the patient has not received another PNEUMOVAX 23 vaccine and the events continue. The lot number and expiration date of the vaccine are unknown as the pharmacist declined to provide any further information for the report.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from medical assistant refers to an adult patient of unknown gender. On 26-AUG-2013, the patient was administered two pediatric doses of VAQTA injection, (lot number, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 65 year old female patient with allergic to insects and seasonal allergies. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported). On an unknown date, the patient experienced 8cm swelling with erythema at the injection site. The patient sought medical attention and went to the emergency room for the same. The patient was treated with Clindamycin. On an unknown date, the event of 8cm swelling with erythema at the injection site was recovered/resolved. The physician saw the patient 3 months after the event transpired and was not the prescribing or treating physician associated with the event. This is one of the two reports received from the same reporter (MARRS#1309USA005640). Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site vesicles, Pyrexia
Clinical narrative: 8-28-13 onset of fever - 101 max - rash started around injection site on 8-30-13 - varivax vesicles at site of injection only.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a consumer refers to the consumer him or herself, a patient of unknown age and gender. The patient's medical history was unknown. On an unknown date, the patient was vaccinated with (one shot of) ZOSTAVAX. No co-suspected or concomitant medications were reported. The patient complained that the vaccine didn't work (onset date 04-SEP-2013), and complained that he or she got a raging case of shingles (onset date 04-SEP-2013). The outcome of shingles was unknown. The reporter did not provide a causality assessment. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed hives on (L) side of face 2 hours after receiving flu vaccine.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, via a field employee, refers to a 18 year old male patient. On 21-AUG-2013 the patient was vaccinated with GARDASIL lot # J006587 (dosing information and route were not provided). The patient experienced syncope following the administration of GARDASIL on 21-AUG-2013. The outcome of syncope is unknown. No reporter causality provided. 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 refers to a patient of unknown age. The patient was vaccinated with GARDASIL 0.5 ml (dose strength not provided), intramuscular, and received the first dose on 28-NOV-2006, the second dose on 05-FEB-2007 and the third dose on 22-JAn-2008. On 31-AUG-2011 the patient was vaccinated with a fourth dose of GARDASIL, lot number 668819/0477AA. On 08-JUL-2013 was administered a fifth dose of GARDASIL, Lot number H021861. The last two doses were administered in the nurse's office, the previous three in another practice. No adverse experiences were reported. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Initial report was received from a health care professional on 30 August 2013 which involved a cluster of two patients (two siblings). The other patient has been captured in case number 2013-09269. A male patient (age and date of birth not reported) had received a fifth dose injection of DTaP "some years ago" (manufacturer, lot number, route and site of administration unknown) and an unspecified amount of time later, the patient developed urticaria and lip swelling. It was unknown if the patient had any concurrent illness, pre-existing allergies or medical conditions. Outcome was recovered. No additional information was provided at the time of the event. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: At 9:00 PM on 9/7/13. Pt. noticed itching at neck - noted bumps at neck with quarter sized red area. Few bumps at neck with quarter sized red  area. Few bumps noted down to chest and back area (very few) - still itching. Has stayed the same through today. Oral benadryl has not helped . Topical benadryl has helped. No new jewelry or lotions at neck area.
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Initial report was received from a health care professional on 30 August 2013 which involved a cluster of two patients (siblings). The other patient has been captured in case number 2013-09268. A female patient (age and date of birth not reported) had received a fifth dose injection of DTaP "some years ago" (manufacturer, lot number, route and site of administration unknown) and an unspecified amount of time later, the patient developed urticaria and lip swelling. It was unknown if the patient had any concurrent illness, pre-existing allergies or medical conditions. Outcome was recovered. No additional information was provided at the time of the event. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Client passed out, dizzy after coming to. Elevated feet, had client lay down for a few minutes prior to standing/sitting up.
Sex: U
Vaccine: FLUX, TDAP
Symptoms: Foetal exposure during pregnancy, Respiratory disorder neonatal
Clinical narrative: Initial report was received on 03 September 2013 from a health care professional. An unknown infant (end of pregnancy reported as 30 September 2012) had received during mother's pregnancy, Tdap (manufacturer, lot number, route and date of administration not reported) and Influenza vaccine (manufacturer, lot number, route and date of administration not reported) and an unspecified amount of time later was found to have a birth outcome of other: lack of respiratory effort. The mother had a history of depression and concomitant medication was reported as CYMBALTA. No further information was available at the time of the report. This case is linked to mother case 2012-08664. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Pt's arm very red and warm from injection site to wrist.