chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724 (same vaccine). Abstracts: Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivery at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compare with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at lest two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 526 numbers of neonate patients out of which 99 (1 percentage) patients gestational age at delivery was 34 or less weeks and 427 (6 percentage) patients gestational age at delivery was 36 or less weeks. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Blood pH decreased, Foetal exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092724, 2015SA092725 (same vaccine). ). Abstracts: Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivery at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compare with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at lest two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 50 (0.7 perentage) neonate patients had blood pH 7.0 or less. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza, Malaise
Clinical narrative: Initial unsolicited report received from a pharmacist on 03 June 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, patient had experienced symptoms headache and didn't feel well for days which diagnosed as flu. It was also reported that, patient was not pregnant during the Tdap vaccination. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had recovered. Documents held by sender:: none.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Based on additional information received on 15 June 2015, this case became medically confirmed. Initial unsolicited report received from a consumer on 03 April 2015. A 13-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of DTAP (batch number, expiry date, dose, dose number, route of administration and site of administration were not reported) in the year 2015. On an unspecified date in the year 2015 after the vaccination, the patient had experienced slight swelling of arm after the immunization. Laboratory investigations were not reported. The patient was treated with KALBITOR as needed 30 mg subcutaneously. At the time of this report, the outcome of event was unknown. Documents held by sender: none. Follow up information received form a non-health care professional on 06 May 2015. No new additional information reported. Documents held by sender: none. Follow-up information received from a physician on 15 June 2015. It was reported that patient had a history of hereditary angioedema which predisposed the patient to frequent swelling episodes that could be either spontaneous or related to minor trauma. Kalbitor was prescribed to treat acute swelling reactions. Documents held by sender: none.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 exp date 17-JUN-2017) (dose and route not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Occult blood positive
Clinical narrative: Information has been received from a nurse via a field representative referring to a 4 month old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with the second dose of ROTATEQ (dose, strength and lot# unknown, oral). On an unknown date the patient had weeks of guaiac positive stools. The patient sought medical attention by seeing unspecified physician. The patient was milk-free for a month to rule out a milk allergy. However even without the milk the patient still had heme positive stool. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot# and expiration date were not reported) and then received a second dose of ZOSTAVAX on an unknown date (extra dose administered). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L021367 exp date 05-NOV-2016) (dose and route not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has ben requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot # K003822 exp date 14-MAR-2016 and lot # K024038 exp date 26-NOV-2016) (dose and route not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Limb discomfort, Musculoskeletal discomfort, Neck pain
Clinical narrative: Initial unsolicited report received from a physician on 29 June 2015. A female patient (age not reported), whose medical history and concomitant medication were not reported, had received a dose of TDAP (batch number: U4886AA, expiration date: 29 October 2016, dose and dose number were not reported) intramuscularly in right deltoid on 29 August 2014. On an unspecified date post-vaccination, the patient experienced tingling and numbness at injection site, up and down arm and neck with discomfort and pain. Physician characterized as paresthesia. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Follow up information received from a consumer on 13 August 2051. The age of patient was 52 years (age reported as 53 years). On 31 August 2014, two days after vaccination, patient experienced the adverse events. At the time of this report, the patient had not recovered from the above mentioned events. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a physician on 29 June 2015. A female patient (age not reported), whose medical history and concomitant medication were not reported, had received a dose of TDAP (batch number: U4886AA, expiration date: 29 October 2016, dose and dose number were not reported) intramuscularly in right deltoid on 29 August 2014. On an unspecified date post-vaccination, the patient experienced tingling and numbness at injection site, up and down arm and neck with discomfort and pain. Physician characterized as paresthesia. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Follow up information received from a consumer on 13 August 2051. The age of patient was 52 years (age reported as 53 years). On 31 August 2014, two days after vaccination, patient experienced the adverse events. At the time of this report, the patient had not recovered from the above mentioned events. Documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ by oral route (dose and frequency were not reported) lot # K023537, expiration date 22-JUN-2016. No adverse experiences were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L007228, expiration date 03-SEP-2016; lot # K020750, expiration date 30-APR-2016, dose and route unknown). No adverse effects reported. No PQC involved. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB lot # K006682, expiration date 17-DEC-2015 (dose, frequency and route were not reported). No adverse experiences were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from pharmacist refers to a female patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient had received first dose with GARDASIL and on an unknown date, the next dose was given GARDASIL 9 (unknown route, dose and strength). It was reported that GARDASIL and GARDASIL 9 were interchanged with a patient. No additional doses have been administered and no symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MEN, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 21 July 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (batch number, route, dose in series not reported) in left deltoid and also received a dose of MCV4 (batch number not reported) in left deltoid on an unspecified date. On an unspecified date after the vaccination the patient experienced redness, swelling and pain at the injection site. The patient was vaccinated at a clinic. Laboratory investigations and corrective treatments were not reported. At the time of this report the event outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Pratical Nurse, referring to an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions and the patients was not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of MMR II lot # K002816, expiration date 25-FEB-2016 (dose, frequency and route were not reported). No adverse experiences were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a consumer on 15 July 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of DTaP (batch number, route and site of administration were not reported) on unspecified date 11 years ago. On unspecified date after vaccination, the patient had an extreme reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a physician on 10 August 2015. A female pediatric patient, whose medical history and concomitant medications were not reported, had received multiple shots at one time as per standard protocol of HIB and DTAP (batch number, dose, route of administration and site of administration were not reported for both vaccines) on an unspecified date. On an unspecified date after vaccination, the patient experienced urticaria twice. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as K022995 exp date 22-JUL-2016 and lot # K020181 exp date 24-JUN-2016) (dose not reported) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # reported as L020162 exp date 23-JUL-2017) (dose and route not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (dose, frequency and route were not reported). No adverse experiences were reported. No product quality complaint. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt. received vaccine on 1/13/15. She reports 30 minutes after receiving PREVNAR 13 she had swelling at injection site and severe itching for 2 weeks. She reports gradually itching spread to other area of her body with rash. She has seen dermatology and an allergist. She is using clobetasol exfoliate 0.05% and hydroxyzine 25 mg bid. She continues to have rash and itching.
Sex: U
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. On an unspecified date, the patient experienced an anaphylactic reaction while on therapy with GARDASIL. The physician indicated that the patient recovered on an unspecified date. The relatedness between the anaphylactic reaction and GARDASIL was not reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender who on 25-SEP-2015, was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L023118, expiry date 24-SEP-2016). No adverse event were reported. Additional information has been requested. Lot number L023118 is a valid lot number for ZOSTAVAX.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood test normal, Computerised tomogram normal, Injection site swelling, Pruritus generalised
Clinical narrative: About 6 hours after receiving second shot, severe stomach pains that have never been experienced. So bad ended up in emergency room. Morphine was given with little effect to pain, just stopped extreme pains if not moved. Had CAT scans to rule out appendicitis or cysts. Blood work came back fine, nothing found in CAT scan. Was sent home with pain meds. Next day severe itchy all over. 6 days later still swelling where shot was given along with still painful stomach. Was told by our doctor and emergency doctor that the shot does not have these side effect. Website proves different. Are these doctors not informed. Read that 1 in 7 show these signs of reactions. Is it safe to receive last shot? 1 week of pain!
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: My sons pediatrician began the HPV series 10 weeks ago, received the second dose 8 weeks later, and today (12 weeks later) gave him a third dose by mistake when in the office for a flu shot. Should I bring him back in four months for the originally scheduled third dose (now the fourth)?
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received a ZOSTAVAX shot 9-8-15, said it caused rash on arms and spots on hands, saw Dr and got Rx for ZYRTEC to ease the symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a 77 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, in her arm (dose, route and lot# were not reported). Information regarding concomitant medication was not reported. On an unknown date of September 2015 the patient developed a rash on her opposite arm where she vaccinated with ZOSTAVAX. The patient contacted the pharmacist to seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed shingles on left flank, buttock 2 days after having ZOSTAVAX injection.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 14-AUG-2015 the patient was vaccinated with a dose of expired ZOSTAVAX (unknown route and strength) lot # K003596 with expiry date of 12-MAR-2015. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 14-AUG-2015 the patient was vaccinated with a dose of expired ZOSTAVAX (unknown route and strength) lot # K003596 with expiry date of 12-MAR-2015. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biliary cirrhosis primary, Blood alkaline phosphatase increased, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of primary biliary cirrhosis in a 57-year-old female patient who received BOOSTRIX. The patient's past medical history included H1N1 influenza (the patient experienced fatigue when she had H1N1 flu in 2009). Concomitant products included Vitamin D. On 1st May 2015, the patient received BOOSTRIX. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced primary biliary cirrhosis (serious criteria GSK medically significant), muscle cramp, elevated liver enzymes and fatigue. On an unknown date, the outcome of the primary biliary cirrhosis and elevated liver enzymes were not recovered/not resolved and the outcome of the muscle cramp and fatigue were recovered/resolved. It was unknown if the reporter considered the primary biliary cirrhosis, muscle cramp, elevated liver enzymes and fatigue to be related to BOOSTRIX. Additional details were provided as follows: The patient has herself reported the case who is a registered pharmacist. She was unsure of the dose given because she received it from a multidose vial and was not certain if the person who administered it at the pharmacy drew it up correctly. She described her fatigue, which she experienced in May 2015, as exactly how she felt in 2009 when she had the H1N1 flu. She had labs performed starting on 10th June 2015 and her levels were as follows, alkaline phosphatase 142, AST 42 and ALT 95. On 3rd July, AST was 51 and was ALT 127. On 28th July 2015, alkaline phosphatase was 173, AST 62 and ALT 84. On 8th September 2015, alkaline phosphatase was 232, AST 73, ALT 138. She had labs drawn at other clinic on 16th September 2015 and the levels were alkaline phosphatase 236, AST 68 and ALT 116. On 18th September 2015, she was diagnosed with primary biliary cirrhosis. She had testing done before was predisposed to primary biliary cirrhosis and was convinced that the condition was precipitated by the vaccine and especially since she was not sure if she received an accurate dose due to the multidose vial. She also mentioned that there was thiomersal in the multidose and that could have contributed to the primary biliary cirrhosis.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of primary biliary cirrhosis in a 57-year-old female patient who received BOOSTRIX. The patient's past medical history included H1N1 influenza (the patient experienced fatigue when she had H1N1 flu in 2009). Concomitant products included Vitamin D. On 1st May 2015, the patient received BOOSTRIX. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced primary biliary cirrhosis (serious criteria GSK medically significant), muscle cramp, elevated liver enzymes and fatigue. On an unknown date, the outcome of the primary biliary cirrhosis and elevated liver enzymes were not recovered/not resolved and the outcome of the muscle cramp and fatigue were recovered/resolved. It was unknown if the reporter considered the primary biliary cirrhosis, muscle cramp, elevated liver enzymes and fatigue to be related to BOOSTRIX. Additional details were provided as follows: The patient has herself reported the case who is a registered pharmacist. She was unsure of the dose given because she received it from a multidose vial and was not certain if the person who administered it at the pharmacy drew it up correctly. She described her fatigue, which she experienced in May 2015, as exactly how she felt in 2009 when she had the H1N1 flu. She had labs performed starting on 10th June 2015 and her levels were as follows, alkaline phosphatase 142, AST 42 and ALT 95. On 3rd July, AST was 51 and was ALT 127. On 28th July 2015, alkaline phosphatase was 173, AST 62 and ALT 84. On 8th September 2015, alkaline phosphatase was 232, AST 73, ALT 138. She had labs drawn at other clinic on 16th September 2015 and the levels were alkaline phosphatase 236, AST 68 and ALT 116. On 18th September 2015, she was diagnosed with primary biliary cirrhosis. She had testing done before was predisposed to primary biliary cirrhosis and was convinced that the condition was precipitated by the vaccine and especially since she was not sure if she received an accurate dose due to the multidose vial. She also mentioned that there was thiomersal in the multidose and that could have contributed to the primary biliary cirrhosis.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hepatic enzyme increased, Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of primary biliary cirrhosis in a 57-year-old female patient who received BOOSTRIX. The patient's past medical history included H1N1 influenza (the patient experienced fatigue when she had H1N1 flu in 2009). Concomitant products included Vitamin D. On 1st May 2015, the patient received BOOSTRIX. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced primary biliary cirrhosis (serious criteria GSK medically significant), muscle cramp, elevated liver enzymes and fatigue. On an unknown date, the outcome of the primary biliary cirrhosis and elevated liver enzymes were not recovered/not resolved and the outcome of the muscle cramp and fatigue were recovered/resolved. It was unknown if the reporter considered the primary biliary cirrhosis, muscle cramp, elevated liver enzymes and fatigue to be related to BOOSTRIX. Additional details were provided as follows: The patient has herself reported the case who is a registered pharmacist. She was unsure of the dose given because she received it from a multidose vial and was not certain if the person who administered it at the pharmacy drew it up correctly. She described her fatigue, which she experienced in May 2015, as exactly how she felt in 2009 when she had the H1N1 flu. She had labs performed starting on 10th June 2015 and her levels were as follows, alkaline phosphatase 142, AST 42 and ALT 95. On 3rd July, AST was 51 and was ALT 127. On 28th July 2015, alkaline phosphatase was 173, AST 62 and ALT 84. On 8th September 2015, alkaline phosphatase was 232, AST 73, ALT 138. She had labs drawn at other clinic on 16th September 2015 and the levels were alkaline phosphatase 236, AST 68 and ALT 116. On 18th September 2015, she was diagnosed with primary biliary cirrhosis. She had testing done before was predisposed to primary biliary cirrhosis and was convinced that the condition was precipitated by the vaccine and especially since she was not sure if she received an accurate dose due to the multidose vial. She also mentioned that there was thiomersal in the multidose and that could have contributed to the primary biliary cirrhosis.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Dysphagia, Eyelid oedema, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: On 9/22/15, 75 yo F presented to clinic with c/o feeling tired, having low BP. During visit, pt was ordered and administered routine vaccines of Flu vaccine, age 65yo , high dose IM (TRIVALENT) and Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). Flu vaccine was administered in right deltoid (Lot #ui466aa, Mfg: Sanofi Pasteur, NDC: 49281-397-88) and pneumococcal vaccine was given in left deltoid (lot #L84631, Mfg: Wyeth-Ayerst, NDC: 0005-1971-01). Pt tolerated injections without incident and was discharged in stable condition. At ~1700 that evening, pt developed a tingling sensation in her tongue. By 1845, this progressed to a burning and prickly sensation with 9/10 pain in tongue and throat with swollen, erythematous eyes, low grade fever (99) and elevated BP. Pt self- administered diphenhydramine 50 mg PO and went to an outside hospital ED. Per ED notes: "The patient has suffered a allergic reaction to either the flu or the pneumococcal vaccine, she states she already is improving after receiving 50 g of Benadryl by mouth. Vitals are well within normal limits she does have a low-grade fever. I suspect this is all secondary to the Vaccines. The patient will get 60 mg of Prednisone [PO] and Pepcid [20 mg PO]." After treatment interventions and observation, pt was discharged home on 9/23 with prescriptions for famotidine 20 mg PO BID and prednisone 7 day dose-pak. On 9/24, pt returned to clinic for evaluation. At that time, MD found that symptoms had resolved. MD noted "Symptoms in my mind are not typical of allergic reaction. The cause of her symptoms are not clear to me."
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood pressure increased, Fatigue, Glossodynia, Hypersensitivity, Hypotension
Clinical narrative: On 9/22/15, 75 yo F presented to clinic with c/o feeling tired, having low BP. During visit, pt was ordered and administered routine vaccines of Flu vaccine, age 65yo , high dose IM (TRIVALENT) and Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). Flu vaccine was administered in right deltoid (Lot #ui466aa, Mfg: Sanofi Pasteur, NDC: 49281-397-88) and pneumococcal vaccine was given in left deltoid (lot #L84631, Mfg: Wyeth-Ayerst, NDC: 0005-1971-01). Pt tolerated injections without incident and was discharged in stable condition. At ~1700 that evening, pt developed a tingling sensation in her tongue. By 1845, this progressed to a burning and prickly sensation with 9/10 pain in tongue and throat with swollen, erythematous eyes, low grade fever (99) and elevated BP. Pt self- administered diphenhydramine 50 mg PO and went to an outside hospital ED. Per ED notes: "The patient has suffered a allergic reaction to either the flu or the pneumococcal vaccine, she states she already is improving after receiving 50 g of Benadryl by mouth. Vitals are well within normal limits she does have a low-grade fever. I suspect this is all secondary to the Vaccines. The patient will get 60 mg of Prednisone [PO] and Pepcid [20 mg PO]." After treatment interventions and observation, pt was discharged home on 9/23 with prescriptions for famotidine 20 mg PO BID and prednisone 7 day dose-pak. On 9/24, pt returned to clinic for evaluation. At that time, MD found that symptoms had resolved. MD noted "Symptoms in my mind are not typical of allergic reaction. The cause of her symptoms are not clear to me."
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Ocular hyperaemia, Paraesthesia oral, Pharyngeal oedema, Pyrexia
Clinical narrative: On 9/22/15, 75 yo F presented to clinic with c/o feeling tired, having low BP. During visit, pt was ordered and administered routine vaccines of Flu vaccine, age 65yo , high dose IM (TRIVALENT) and Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). Flu vaccine was administered in right deltoid (Lot #ui466aa, Mfg: Sanofi Pasteur, NDC: 49281-397-88) and pneumococcal vaccine was given in left deltoid (lot #L84631, Mfg: Wyeth-Ayerst, NDC: 0005-1971-01). Pt tolerated injections without incident and was discharged in stable condition. At ~1700 that evening, pt developed a tingling sensation in her tongue. By 1845, this progressed to a burning and prickly sensation with 9/10 pain in tongue and throat with swollen, erythematous eyes, low grade fever (99) and elevated BP. Pt self- administered diphenhydramine 50 mg PO and went to an outside hospital ED. Per ED notes: "The patient has suffered a allergic reaction to either the flu or the pneumococcal vaccine, she states she already is improving after receiving 50 g of Benadryl by mouth. Vitals are well within normal limits she does have a low-grade fever. I suspect this is all secondary to the Vaccines. The patient will get 60 mg of Prednisone [PO] and Pepcid [20 mg PO]." After treatment interventions and observation, pt was discharged home on 9/23 with prescriptions for famotidine 20 mg PO BID and prednisone 7 day dose-pak. On 9/24, pt returned to clinic for evaluation. At that time, MD found that symptoms had resolved. MD noted "Symptoms in my mind are not typical of allergic reaction. The cause of her symptoms are not clear to me."
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fever of 101 degrees F, Severe body aches, Chills, Nausea, Headache, Fatigue, Inject Site Soreness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 101 degrees F, Severe body aches, Chills, Nausea, Headache, Fatigue, Inject Site Soreness.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Employee was called for her 2nd Varicella vaccine, she informed me that she just found out she was pregnant, about 9 weeks. This would make her pregnant when she received the vaccine, even though she denied it at the time and sign a consent that states you cannot get vaccine if you are pregnant. No issues to date, her OB doctor has been notified.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pruritus, Myalgia, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: Itching at site of injection spread to entire upper arm then to body this lasted about 2 days.  Then have muscle aches and pains.  Feel feverish and sore throat.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Crohn's disease
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 60 year old female patient. The patient had a medical history with Crohn's disease in the past prior to the vaccination. The patient's drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated subcutaneously with ZOSTAVAX (dose, lot number and expiration date were not reported). Concomitant therapies included HUMIRA and prednisone (manufacturer unknown). On an unknown date, shortly after receiving the injection, the patient presented at a local hospital with unspecified symptoms and was admitted. She was diagnosed with Crohn's disease (date not reported). The outcome of the event was not reported. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Skin burning sensation
Clinical narrative: Pt c/o experiencing extreme pain, discomfort in shoulder with decreased mobility and decreased strength. Pt c/o burning sensation in shoulder, extending toward elbow.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Cough, Headache, Hyperthermia, Lacrimation increased
Clinical narrative: Pt has autoimmune disorder (Graves), hives, swollen and hurt arms to elbows (knots 4 days), palpitations, confusion, headache, nausea (lasts 4 days), sore throat, runny eyes and nose which increased hyperthymia, raspy cough. Pt on sedatives and antihistamines,
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Pt has autoimmune disorder (Graves), hives, swollen and hurt arms to elbows (knots 4 days), palpitations, confusion, headache, nausea (lasts 4 days), sore throat, runny eyes and nose which increased hyperthymia, raspy cough. Pt on sedatives and antihistamines,
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Pt has autoimmune disorder (Graves), hives, swollen and hurt arms to elbows (knots 4 days), palpitations, confusion, headache, nausea (lasts 4 days), sore throat, runny eyes and nose which increased hyperthymia, raspy cough. Pt on sedatives and antihistamines,
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen starting from the left arm injection site to left elbow. Patient also report tired.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HPV9, IPV, TD, VARCEL, FLU4, HEP, HPV9, IPV, TD, VARCEL
Symptoms: Dizziness, Tremor
Clinical narrative: Client was given hep B, Td, Var, PPD, Flu and HPV9 vaccine was given last at 10:45 AM. Client was already on exam table, c/o of dizziness. Pt remained responsive, no injuries or fall observed. Ice pack applied. Pt said he didn't eat and afraid of needles. V/S at 10:50 AM 99 F, 60, 16, 134/76. No pain. Color pink, not diaphoretic, but shaking. BP 140/90 at 11 AM. Pt had warm water at 11:05 AM. Vitals at 11:15 AM 140/80, 60, 18, Temp 98.6, still c/o shaking. 911 called, directed to go to ER. Pt stated feeling better, denied dizziness and shakiness when leaving the clinic, ambulatory without difficulties.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HPV9, IPV, TD, VARCEL, FLU4, HEP, HPV9, IPV, TD, VARCEL
Symptoms: Dizziness, Fear of injection, Tremor
Clinical narrative: Client was given hep B, Td, Var, PPD, Flu and HPV9 vaccine was given last at 10:45 AM. Client was already on exam table, c/o of dizziness. Pt remained responsive, no injuries or fall observed. Ice pack applied. Pt said he didn't eat and afraid of needles. V/S at 10:50 AM 99 F, 60, 16, 134/76. No pain. Color pink, not diaphoretic, but shaking. BP 140/90 at 11 AM. Pt had warm water at 11:05 AM. Vitals at 11:15 AM 140/80, 60, 18, Temp 98.6, still c/o shaking. 911 called, directed to go to ER. Pt stated feeling better, denied dizziness and shakiness when leaving the clinic, ambulatory without difficulties.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site scab
Clinical narrative: She developed a small scab at injection site. Its lasted 2 weeks. Scab shows no sign of infection. Told her to follow up with PCP.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site rash, Pruritus generalised, Rash erythematous
Clinical narrative: Red rashes on upper extremities, and left shoulder with generalize itching. Took allergy medication Xyzal 25mg PO.
Age: 1.0
Sex: M
Vaccine: FLUX, MEA, VARCEL
Symptoms: Generalised erythema, Hypersensitivity, Swelling face
Clinical narrative: Swollen in the face. Red in the face, ears, stomach, and diaper area. Gave some lemonade and Motrin. Within 2 hours the allergic reaction went down. Went back to the Dr. to document later that afternoon.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Vaccination site pain
Clinical narrative: Patient stated to me on Tuesday 9-29-2015 that on Friday 9-25-2015 she notice the area where the vaccine was given it had redness, itching soreness and burning. She did not contact the employee health nurse until Monday 9-28-2015. When I returned her call Monday afternoon around 1:00pm I attempted to meet with her to assess the area and file report. She stated she was unable to meet with me but will come by at 11:00am Tuesday 9-29-2015. Upon assessment she has 2 areas. 1 measures 50mmX30mm and the 2nd is 30mmX30mm. In the center of the 2nd red area there is a small fluid filled blister.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis, Lip swelling, Pharyngeal oedema
Clinical narrative: Flu shot given about 2 pm-by 4-4:30 pm throat lips swollen, inside lips very red-Patient went to clinic-practitioner called medical director and prednisone for 3 days and ZYRTEC for 10 days was prescribed. Lips better but still a little swollen today.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Staff member received flu vaccination at 13:00 on 9/22/15. Around 15:00 noticed chest getting tight similar to having a chest cold. By 16:45 it was difficult for her to breath with nonproductive cough. At 19:20 BENADRYL 25mg PO taken and by 19:40 symptoms began resolving. Staff member made full recovery with no side effects.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Discomfort, Headache, Myalgia
Clinical narrative: COUGH, CHILLS, LOW GRADE FEVER (99.8), BODY DISCOMFORT, MUSCLE ACHES, SORE THROAT, STUFFY NOSE, HEADACHE. LASTING 18 HOURS, TREATED AT HOME WITH TYENOL, 500MG. SOME SYMPTOMS ON GOING. GETTING BETTER?
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: COUGH, CHILLS, LOW GRADE FEVER (99.8), BODY DISCOMFORT, MUSCLE ACHES, SORE THROAT, STUFFY NOSE, HEADACHE. LASTING 18 HOURS, TREATED AT HOME WITH TYENOL, 500MG. SOME SYMPTOMS ON GOING. GETTING BETTER?
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: REDNESS AT INJECTION SITE ON LEFT ARM APPROX 5-7 DAYS AFTER INJECTION.  AT 7 DAYS, REDNESS/ERYTHEMATOUS AREA PRROX 3"WIDE X 6"LONG.  RECOMMENDED BENADRYL AND FOLLOW UP WITH PCP.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient describes sore arm around injection site and sore neck 10 days after administration.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Injection site erythema, Throat irritation
Clinical narrative: Face, chest and arm around the injection site became very red for a sold half hour. Also my chest felt tight like when my asthma is acting up and my throat was slightly itchy.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 9-10 cm diameter around injection site. Treatment: Ice, ADVIL, BENADRYL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Head discomfort, Pain, Respiratory tract infection viral, Rhinorrhoea
Clinical narrative: Employee is a Pharmacy Technician who got her Flu-Inactivated, vaccine at Flu clinic in hospital on 9/26/15 at 8 pm and 2 hours later, at 10 pm felt, chills, head congestion w/ clear runny watery nose, achy. She went to ER and was diagnosed with a "viral respiratory illness". Note-exam of left deltoid=normal.
Age: 52.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Redness around injection site, heat around injection area, swelling in entire arm, pain and numbness and tingling in entire arm.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Heart rate increased, Pyrexia, Throat irritation, Vomiting
Clinical narrative: Pt had elevated pulse (130) and felt short of breath. Also had scratchy throat, fever, and vomited x 2. Pt took BENADRYL and TYLENOL on Friday and Sat. Symptoms gone by Sunday.
Age: 8.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Pyrexia, Skin warm
Clinical narrative: Rednes, hot to touch, fever of 102.8 orally site soreness.