chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73 year old female patient. No information about medical history, drug reactions and allergies was specified. On 23-SEP-2013, the patient was vaccinated with temperature excursion supported PNEUMOVAX injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscularly). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585 and 1410USA005586). Additional information has been requested .
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62 year old male patient. No information about medical history, drug reactions and allergies was specified. On 30-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of several reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005586 and 1410USA005587. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to unknown number of patients of unkonwn age. Medical history and current conditions were not reported. On an unknown date, the unknown number of patients was vaccinated with PROQUAD (Merck), lot number: K007156, expiry date: 12-NOV-2015, 0.5 milliliter, subcutaneous. Concomitant medications were not reported. On an unknown date, the unknown number of patients have received PROQUAD (Merck), that had been stored in the refrigerator at 34-40 degrees Fahrenheit (F) for 59 days. It was unknown by the caller if any company refrigerated vaccines were exposed to temperatures below 36 degrees F and were administered to patients. No adverse effect was reported. No product quality complaint was reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 60 year old male patient. No information about medical history, drug reactions and allergies was specified. On 11-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of several reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005585, 1410USA005586 and 1410USA005587. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 31 year old female patient. No information about medical history, drug reactions and allergies was specified. On 16-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005583, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005583). Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 52 year old female patient. No information about medical history, drug reactions and allergies was specified. On 30-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K0045422, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005587). Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 year old male patient. No information about medical history, drug reactions and allergies was specified. On 01-OCT-2014 the patient was vaccinated with temperature excursion supported GARDASIL injection (lot # J015378, expiry date: 09-APR-2016, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. The patient did not seek medical attention. There was no product complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005587). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored PNEUMOVAX 23 (dose, route, lot # not reported) were administered to patients. There was one cycle that reached -40C, with the balance of the excursions at 0 C. The total excursion timeframe was less than 300 hours. PNEUMOVAX 23 excursion not supported. The nurse stated that she believed at least one or two individuals have received these various vaccines, but does not have specific data. She had not received any reports of adverse effects to patients post vaccination. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored GARDASIL 120Y (lot#, expiration date, dose not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored RECOMBIVAX HB 5mg/0.5ml (lot#, expiration date, route, dose not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 52 year old patient. The patient had no pertinent medical history. On 13-JUN-2014 the patient was vaccinated with first dose of ZOSTAVAX 19400 PFU (dose strength, route not reported) lot # J000435, expiration date 10-APR-2014. Concomitant therapies include TRAZADONE, CYMBALTA and clonazepam. The reporter stated that on 13-JUN-2014, the patient experienced red, itchy rash after receiving ZOSTAVAX 19400 PFU and rash was the size of a baseball by 16-JUN-2014.  On 29-SEP-2014 the patient received a second dose of ZOSTAVAX 19400 PFU in error. The patient was not treated for the events reported. The outcome of rash was the size of a baseball and red, itchy rash was reported as recovered/resolved approximately on an unknown date in 2014. The outcome of patient also received a second dose of ZOSTAVAX 19400 PFU in error on 29-SEP-2014 is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Feeling abnormal, Headache, Incorrect route of drug administration, Malaise
Clinical narrative: This case was reported by a pharmacist and described the occurrence of headache in a 18-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) MENVEO. On 14 August 2013 at 14:30 the subject received 1st dose of BOOSTRIX (.5 ml, subcutaneous, left arm), unspecified dose of MENVEO (subcutaneous, unknown details) and experienced intramuscular formulation administered by other route. BOOSTRIX is indicated to be administered intramuscularly. Per the pharmacist, the inappropriate route was "due to the use of wrong syringe and needle." Upon identification of the inappropriate route, a corrective action was taken "1 hour later", at 15:30, to administer a dose of BOOSTRIX (0.5 ml, intramuscular, right arm). On 14 August 2013, less than one day after vaccination, with a subcutaneous dose and an intramuscular dose of BOOSTRIX and MENVEO, the subject experienced headache (described as "severe headache"), chills, and feeling unwell (described as "feeling bad in general"). The subject medical evaluation from the urgent care clinic on the morning on 15 August 2013 and was advised to go the emergency room. At the time of reporting, the subject was at the emergency room. The subject's pediatrician had been notified. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 21 November 2013 via pharmacist who reported an additional event of exacerbated side effects. The pharmacist stated the events occurred on 15 August 2013 to approximately 22 August 2013; previously the onset date was reported as 14 August 2013. The pharmacist reported that the events were associated with erroneous administration; "was initially administered one dose subcutaneously, a second dose was also administered intramuscularly". The pharmacist considered the events were probably related to vaccination with BOOSTRIX. The pharmacist did not consider the events serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Neck pain
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of sore neck in a 4 or 5-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccine; non-GSK manufacturer; unknown given on an unspecified date. Per the nurse, the subject received 2 other vaccines from different manufacturers on the same date as KINRIX. On an unspecified date the subject received a dose of KINRIX (unknown details). On an unknown date, at an unspecified time after vaccination with KINRIX, the subject experienced sore neck. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 31 October 2013 via healthcare professional. The reporter stated they received the Adverse Event request form for additional information and that "it wasn't necessary to fill out the form because they found out that the side effects were due to a different vaccine given to the subject and not KINRIX". The outcome of the sore neck was unspecified. Follow-up information was received on 08 November 2013 via healthcare professional who reported that on 9 October 2013 the 4-year-old male subject received 5th dose of KINRIX (.5 ml, unknown), unspecified dose of VARIVAX (unknown) and unspecified dose of MMR vaccine (Non-GSK) (unknown). On 9 October 2013, less than one day after vaccination with KINRIX, MMR vaccine (Non-GSK) and VARIVAX, the subject experienced sore neck that was diagnosed as cervicalgia. On 12 October 2013, the cervicalgia was resolved. The healthcare professional did not consider the cervicalgia to be serious. The healthcare professional considered the cervicalgia not related to vaccination with KINRIX; it was unknown if the was related to VARIVAX or MMR vaccine (Non-GSK). No action was taken with KINRIX.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Electrocardiogram
Clinical narrative: This case was reported by a pharmacist via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 January 2014 the subject received unspecified dose of BOOSTRIX (unknown details). In January 2014, 1 day after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a pharmacist via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 January 2014 the subject received unspecified dose of BOOSTRIX (unknown details). In January 2014, 1 day after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP, TDAP
Symptoms: Aspiration bursa normal, Injection site pain, Musculoskeletal disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer (representative of an agency) and described the occurrence of aseptic elbow bursitis in a 66-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 9 January 2014 the subject received a dose of BOOSTRIX (.5 ml, unknown route, unknown arm). On 9 January 2014, 20 minutes after vaccination with BOOSTRIX, the subject experienced pain around injection site. Per the reporter, the "pain did not subside". On 9 January 2014, less than one day after vaccination with BOOSTRIX, the subject experienced aspetic elbow bursitis and injection site edema (described as "edema in tissue and tendon around injection site"). Per the reporter, the subject sought medical attention at the doctor's office. Relevant test results include: The subject received a nuclear magnetic resonance imaging test on 27 January 2014 with results revealing that the subject "had chemical aspetic bursitis around the injection site." At the time of reporting the outcome of the events were unknown. The reporter had no further details to provide at the time of reporting. Per the reporter, the subject "does want to take legal action; however, the [subject] has not taken any legal action as of yet."
Age: 66.0
Sex: F
Vaccine: PPV, TDAP, TDAP
Symptoms: Bursitis, Injection site oedema, Injection site pain, Injection site reaction, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer (representative of an agency) and described the occurrence of aseptic elbow bursitis in a 66-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 9 January 2014 the subject received a dose of BOOSTRIX (.5 ml, unknown route, unknown arm). On 9 January 2014, 20 minutes after vaccination with BOOSTRIX, the subject experienced pain around injection site. Per the reporter, the "pain did not subside". On 9 January 2014, less than one day after vaccination with BOOSTRIX, the subject experienced aspetic elbow bursitis and injection site edema (described as "edema in tissue and tendon around injection site"). Per the reporter, the subject sought medical attention at the doctor's office. Relevant test results include: The subject received a nuclear magnetic resonance imaging test on 27 January 2014 with results revealing that the subject "had chemical aspetic bursitis around the injection site." At the time of reporting the outcome of the events were unknown. The reporter had no further details to provide at the time of reporting. Per the reporter, the subject "does want to take legal action; however, the [subject] has not taken any legal action as of yet."
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, X-ray
Clinical narrative: This case was reported by a consumer and described the occurrence of sore joints in a 40-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included dust mites allergy, gluten intolerance, lactose intolerance, latex allergy, migraine, penicillin allergy, seasonal allergy and soy intolerance. Concurrent medications included Ibuprofen. Co-suspect medication included naproxen. On 28 January 2014 at 17:07 the subject received a dose of BOOSTRIX (.5 cc, unknown, right arm). On 30 January 2014, 2 days after vaccination with BOOSTRIX, the subject experienced sore joints, sore muscle, pain and difficulty sleeping. The subject reported that he was injured at work, a nail stabbed his palm. He was to a worker's compensation clinic and was given BOOSTRIX. The subject reported that he was also seeing his family physician and there was a disagreement between the physician if the possible side effects were coming from the BOOSTRIX or Naproxen (which was discontinued two weeks prior to BOOSTRIX administration). The subject reported that he had x-rays and was planning to see a specialist. The subject reported he contacted the CDC and reported the side effects. At the time of reporting the sore joints, sore muscle, pain and difficulty sleeping were worse. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B. Follow-up information was received on 04 March 2014 via consumer. Additional concurrent medical conditions included allergy to pet dander, grass allergy, pollen allergy and tree allergy. Historic vaccination included (non-gsk); non-GSK manufacturer; unknown; unknown given in 2008. Additional concurrent medications included Nutritional supplement "Keybiotics" (Piobiotics), BIOTIN, Ascorbic acid (Vitamin C), Calcium salt (Calcium) and Magnesium salt (Magnesium supplement). The subject reported additional information stating he has muscle aches/myalgia [sore muscles], he can't exercise or get in shape. He stated he feels like an old man [feels aged]. He feels like he has body aches that are usually associated with a fever or a big work out. He was describing his body aches and did not state he has experienced fever or had a big work out. The subject reported over the past two weeks the adverse events have not been getting better or worse. He stated they go to the highest discomfort point and stopped there. He stated the adverse events are uncomfortable. The subject also reported he experienced lower back pain that started on 11 February 2014 at 18:00. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B and with previous flu vaccine, please see case A1062563C.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Discomfort, Feeling abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of sore joints in a 40-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included dust mites allergy, gluten intolerance, lactose intolerance, latex allergy, migraine, penicillin allergy, seasonal allergy and soy intolerance. Concurrent medications included Ibuprofen. Co-suspect medication included naproxen. On 28 January 2014 at 17:07 the subject received a dose of BOOSTRIX (.5 cc, unknown, right arm). On 30 January 2014, 2 days after vaccination with BOOSTRIX, the subject experienced sore joints, sore muscle, pain and difficulty sleeping. The subject reported that he was injured at work, a nail stabbed his palm. He was to a worker's compensation clinic and was given BOOSTRIX. The subject reported that he was also seeing his family physician and there was a disagreement between the physician if the possible side effects were coming from the BOOSTRIX or Naproxen (which was discontinued two weeks prior to BOOSTRIX administration). The subject reported that he had x-rays and was planning to see a specialist. The subject reported he contacted the CDC and reported the side effects. At the time of reporting the sore joints, sore muscle, pain and difficulty sleeping were worse. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B. Follow-up information was received on 04 March 2014 via consumer. Additional concurrent medical conditions included allergy to pet dander, grass allergy, pollen allergy and tree allergy. Historic vaccination included (non-gsk); non-GSK manufacturer; unknown; unknown given in 2008. Additional concurrent medications included Nutritional supplement "Keybiotics" (Piobiotics), BIOTIN, Ascorbic acid (Vitamin C), Calcium salt (Calcium) and Magnesium salt (Magnesium supplement). The subject reported additional information stating he has muscle aches/myalgia [sore muscles], he can't exercise or get in shape. He stated he feels like an old man [feels aged]. He feels like he has body aches that are usually associated with a fever or a big work out. He was describing his body aches and did not state he has experienced fever or had a big work out. The subject reported over the past two weeks the adverse events have not been getting better or worse. He stated they go to the highest discomfort point and stopped there. He stated the adverse events are uncomfortable. The subject also reported he experienced lower back pain that started on 11 February 2014 at 18:00. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B and with previous flu vaccine, please see case A1062563C.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Insomnia, Myalgia, Pain, X-ray
Clinical narrative: This case was reported by a consumer and described the occurrence of sore joints in a 40-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included dust mites allergy, gluten intolerance, lactose intolerance, latex allergy, migraine, penicillin allergy, seasonal allergy and soy intolerance. Concurrent medications included Ibuprofen. Co-suspect medication included naproxen. On 28 January 2014 at 17:07 the subject received a dose of BOOSTRIX (.5 cc, unknown, right arm). On 30 January 2014, 2 days after vaccination with BOOSTRIX, the subject experienced sore joints, sore muscle, pain and difficulty sleeping. The subject reported that he was injured at work, a nail stabbed his palm. He was to a worker's compensation clinic and was given BOOSTRIX. The subject reported that he was also seeing his family physician and there was a disagreement between the physician if the possible side effects were coming from the BOOSTRIX or Naproxen (which was discontinued two weeks prior to BOOSTRIX administration). The subject reported that he had x-rays and was planning to see a specialist. The subject reported he contacted the CDC and reported the side effects. At the time of reporting the sore joints, sore muscle, pain and difficulty sleeping were worse. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B. Follow-up information was received on 04 March 2014 via consumer. Additional concurrent medical conditions included allergy to pet dander, grass allergy, pollen allergy and tree allergy. Historic vaccination included (non-gsk); non-GSK manufacturer; unknown; unknown given in 2008. Additional concurrent medications included Nutritional supplement "Keybiotics" (Piobiotics), BIOTIN, Ascorbic acid (Vitamin C), Calcium salt (Calcium) and Magnesium salt (Magnesium supplement). The subject reported additional information stating he has muscle aches/myalgia [sore muscles], he can't exercise or get in shape. He stated he feels like an old man [feels aged]. He feels like he has body aches that are usually associated with a fever or a big work out. He was describing his body aches and did not state he has experienced fever or had a big work out. The subject reported over the past two weeks the adverse events have not been getting better or worse. He stated they go to the highest discomfort point and stopped there. He stated the adverse events are uncomfortable. The subject also reported he experienced lower back pain that started on 11 February 2014 at 18:00. The subject experienced adverse events with Hepatitis B vaccine, for that case please see A1062563B and with previous flu vaccine, please see case A1062563C.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm0. On 18 June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Infection, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm0. On 18 June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pyrexia, Urine analysis abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm0. On 18 June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Injection site pain, Injection site swelling, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm0. On 18 June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Urine analysis abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm0. On 18 June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 65 year old male patient. Medical history and current conditions were not reported. Drug Reactions/allergies were reported as none. On 25-SEP-2014, the patient was vaccinated with ZOSTAVAX vial lot # K007177, expiry date 21-AUG-2015, 0.65 milliliter, subcutaneously in the right arm from prevention of shingles. Concomitant medications were not reported. On an unknown date approximately in 2014, the patient experienced shingles on his back after receiving ZOSTAVAX. Patient was treated with Valacyclovir, MEDROL and ZOVIRAX. The outcome of shingles of his back was unknown. Patient saw his physician, who was treating patient for shingles. VZVIP packet accepted and faxed to pharmacist and physician. Product complaint was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 65 year old male patient. Medical history and current conditions were not reported. Drug Reactions/allergies were reported as none. On 25-SEP-2014, the patient was vaccinated with ZOSTAVAX vial lot # K007177, expiry date 21-AUG-2015, 0.65 milliliter, subcutaneously in the right arm from prevention of shingles. Concomitant medications were not reported. On an unknown date approximately in 2014, the patient experienced shingles on his back after receiving ZOSTAVAX. Patient was treated with Valacyclovir, MEDROL and ZOVIRAX. The outcome of shingles of his back was unknown. Patient saw his physician, who was treating patient for shingles. VZVIP packet accepted and faxed to pharmacist and physician. Product complaint was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Dehydration, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. No concurrent conditions or medical were provided. On 01-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K006681 with expiry date 21-OCT-2015; strength, dose and route of administration unspecified) for pneumonia prevention. The patient was also administered an unspecified flu shot (influenza virus vaccine) (manufacturer unknown) on 01-OCT-2014. In October 2014 (exact date unknown), the patient had a fever of 101.9F and was slightly dehydrated. She also complained of injection site pain at the site of PNEUMOVAX 23 injection. The patient sought medical attention and was given saline intravenous drip in the emergency room, on an unspecified date, after receiving the PNEUMOVAX 23. She was not admitted to the hospital. The outcome of the events was reported as recovered on an unknown date in October 2014. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Dehydration, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. No concurrent conditions or medical were provided. On 01-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K006681 with expiry date 21-OCT-2015; strength, dose and route of administration unspecified) for pneumonia prevention. The patient was also administered an unspecified flu shot (influenza virus vaccine) (manufacturer unknown) on 01-OCT-2014. In October 2014 (exact date unknown), the patient had a fever of 101.9F and was slightly dehydrated. She also complained of injection site pain at the site of PNEUMOVAX 23 injection. The patient sought medical attention and was given saline intravenous drip in the emergency room, on an unspecified date, after receiving the PNEUMOVAX 23. She was not admitted to the hospital. The outcome of the events was reported as recovered on an unknown date in October 2014. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Dizziness, Dyspnoea, Fasciitis, Injection site erythema, Injection site swelling
Clinical narrative: 1 hour after receiving vaccines began experiencing dizziness, shortness of breath and overall felt bad. Developed temp of 102.5 that evening. Dizziness, weakness in arms and legs continued into next day - 10/8/14 which is when she was seen by Dr.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site warmth, Myositis, Pyrexia
Clinical narrative: 1 hour after receiving vaccines began experiencing dizziness, shortness of breath and overall felt bad. Developed temp of 102.5 that evening. Dizziness, weakness in arms and legs continued into next day - 10/8/14 which is when she was seen by Dr.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Muscular weakness
Clinical narrative: 1 hour after receiving vaccines began experiencing dizziness, shortness of breath and overall felt bad. Developed temp of 102.5 that evening. Dizziness, weakness in arms and legs continued into next day - 10/8/14 which is when she was seen by Dr.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema, Pain of skin, Skin warm
Clinical narrative: On 10/8/14, 59 yo F presented to clinic for follow up visit. During this visit, the pt received vaccination with Pneumococcal Polysaccharide (23-Valent) 0.5 mL in left deltoid (NDC #0006-4837-03, lot #k009105). Pt tolerated injection without incident & was discharged home. On afternoon of 10/8, pt developed severe pain at injection site, accompanied by erythema, hives & edema. Pt self-treated with diphenhydramine & ibuprofen, but reported that the pain persisted throughout the night. Pt also reported new onset diarrhea. On 10/10, pt returned to clinic for evaluation. On evaluation, pt was diagnosed with allergic reaction & cellulitis. Pt was prescribed clindamycin 300 mg PO TID x 7 days & prednisone of 40 mg daily x 3 days, then 20mg daily x 3 days, then 10mg daily x 3 days. Pt was also advised to take ranitidine 150 mg BID 30 minutes prior to other medications & diphenhydramine 25 mg prior to sleep.  On 10/10, pt's allergy profile was updated to include Pneumovax 23 [Pneumococcal 23-valps Vaccine] (rxn: Hives).
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Allergy to vaccine, Cellulitis, Diarrhoea, Hypersensitivity, Injection site erythema
Clinical narrative: On 10/8/14, 59 yo F presented to clinic for follow up visit. During this visit, the pt received vaccination with Pneumococcal Polysaccharide (23-Valent) 0.5 mL in left deltoid (NDC #0006-4837-03, lot #k009105). Pt tolerated injection without incident & was discharged home. On afternoon of 10/8, pt developed severe pain at injection site, accompanied by erythema, hives & edema. Pt self-treated with diphenhydramine & ibuprofen, but reported that the pain persisted throughout the night. Pt also reported new onset diarrhea. On 10/10, pt returned to clinic for evaluation. On evaluation, pt was diagnosed with allergic reaction & cellulitis. Pt was prescribed clindamycin 300 mg PO TID x 7 days & prednisone of 40 mg daily x 3 days, then 20mg daily x 3 days, then 10mg daily x 3 days. Pt was also advised to take ranitidine 150 mg BID 30 minutes prior to other medications & diphenhydramine 25 mg prior to sleep.  On 10/10, pt's allergy profile was updated to include Pneumovax 23 [Pneumococcal 23-valps Vaccine] (rxn: Hives).
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site urticaria
Clinical narrative: On 10/8/14, 59 yo F presented to clinic for follow up visit. During this visit, the pt received vaccination with Pneumococcal Polysaccharide (23-Valent) 0.5 mL in left deltoid (NDC #0006-4837-03, lot #k009105). Pt tolerated injection without incident & was discharged home. On afternoon of 10/8, pt developed severe pain at injection site, accompanied by erythema, hives & edema. Pt self-treated with diphenhydramine & ibuprofen, but reported that the pain persisted throughout the night. Pt also reported new onset diarrhea. On 10/10, pt returned to clinic for evaluation. On evaluation, pt was diagnosed with allergic reaction & cellulitis. Pt was prescribed clindamycin 300 mg PO TID x 7 days & prednisone of 40 mg daily x 3 days, then 20mg daily x 3 days, then 10mg daily x 3 days. Pt was also advised to take ranitidine 150 mg BID 30 minutes prior to other medications & diphenhydramine 25 mg prior to sleep.  On 10/10, pt's allergy profile was updated to include Pneumovax 23 [Pneumococcal 23-valps Vaccine] (rxn: Hives).
Age: 44.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Pt presented to the clinic on 10/13/2014 describing symptoms of fatigue, pain, soreness, and flu like symptoms following vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Pain, Rash
Clinical narrative: Rash until now; body-flu symptoms (generalized musculoskeletal aching) extreme exhaustion for several days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site of injection turned red 10/11/2014. Site of injection became sore, still red and starting itching a lot on 10/12/2014.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen glands in left side of neck. Sore collarbone.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme Pain in arm and shoulder. Cannot lay on shoulder. Primary care doc on Oct 2. Doc said bursitis from injection. Got worse, went to Walk in ER on Mon Oct 6, recd an anti-inflammatory. Doctor said I have frozen shoulder. Inflammatories helped for 48 hours. Very limited range of motion, cannot move arm above the elbow, cannot sleep on that arm.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, Sleep disorder
Clinical narrative: Extreme Pain in arm and shoulder. Cannot lay on shoulder. Primary care doc on Oct 2. Doc said bursitis from injection. Got worse, went to Walk in ER on Mon Oct 6, recd an anti-inflammatory. Doctor said I have frozen shoulder. Inflammatories helped for 48 hours. Very limited range of motion, cannot move arm above the elbow, cannot sleep on that arm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Exfoliative rash, Rash, Rash pruritic
Clinical narrative: Redness, itchy and scaling rash on face only. She took Allegra every day since the reaction and states that rash is getting better.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, joint and muscle aches, headache.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Diarrhoea, Pain, Pain in extremity, Vomiting
Clinical narrative: Vomiting and diarrhea (see above). Lost day from work.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Carpal tunnel syndrome, Condition aggravated, Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: Injection was in upper left arm, leading to numbness, pain and arm weakness, decreasing over the next 3.5 days to return to normal. Carpal tunnel syndrome is historically worse in the left arm for patient.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Activities of daily living impaired, Chills, Dizziness
Clinical narrative: 10/9/14: felt dizzy after shot. Evening of 10/9/14: Stomach discomfort (stabbing pains, gas), intense headache, difficulty sleeping, slight muscle ache. On 10/10/14, I went to work, left early due to extreme tiredness, stomach pain and intense headache. Chills and hot flashes all day. I then slept on and off for 24 hours, continuing to experience symptoms listed above. Evening on 10/11/14, I felt well enough to get out of bed. Still intense pounding headache. Managed to eat some soup. Took Advil and ibuprofen all day for headache on 10/11/14 and 10/12/14. Still headache on 11/13/14, and stomach still feels tentative -- only able to eat bland foods.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flatulence, Headache, Hot flush, Insomnia
Clinical narrative: 10/9/14: felt dizzy after shot. Evening of 10/9/14: Stomach discomfort (stabbing pains, gas), intense headache, difficulty sleeping, slight muscle ache. On 10/10/14, I went to work, left early due to extreme tiredness, stomach pain and intense headache. Chills and hot flashes all day. I then slept on and off for 24 hours, continuing to experience symptoms listed above. Evening on 10/11/14, I felt well enough to get out of bed. Still intense pounding headache. Managed to eat some soup. Took Advil and ibuprofen all day for headache on 10/11/14 and 10/12/14. Still headache on 11/13/14, and stomach still feels tentative -- only able to eat bland foods.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: 10/9/14: felt dizzy after shot. Evening of 10/9/14: Stomach discomfort (stabbing pains, gas), intense headache, difficulty sleeping, slight muscle ache. On 10/10/14, I went to work, left early due to extreme tiredness, stomach pain and intense headache. Chills and hot flashes all day. I then slept on and off for 24 hours, continuing to experience symptoms listed above. Evening on 10/11/14, I felt well enough to get out of bed. Still intense pounding headache. Managed to eat some soup. Took Advil and ibuprofen all day for headache on 10/11/14 and 10/12/14. Still headache on 11/13/14, and stomach still feels tentative -- only able to eat bland foods.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever (100+) and chills vomiting.  Fever has persisted through following morning.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Syncope
Clinical narrative: Patient received his Hepatitis A vaccine then fainted after receiving his influenza injection.  He has never fainted before. He did not eat breakfast this morning.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Irritability, Ultrasound scan abnormal
Clinical narrative: Started with fussiness about 2 days before she started with bloody stools. She made apt for our office. Dr sent them to medical center. They diagnosed with intussusception. They performed air barium which resolved the intussusception.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: Started with fussiness about 2 days before she started with bloody stools. She made apt for our office. Dr sent them to medical center. They diagnosed with intussusception. They performed air barium which resolved the intussusception.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Rash, Rash erythematous
Clinical narrative: Cold chills, headache, lightheaded, red rash on abdominal area front and back.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: Joint and Muscle Pain, Fever, Chills, Nausea, Light Headedness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Joint and Muscle Pain, Fever, Chills, Nausea, Light Headedness.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Systemic Rash / Hives.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Aphasia, Decreased appetite, Decreased eye contact, Irritability, Pyrexia
Clinical narrative: FEVER, POOR APPETITE, MADE HIM DROWSY, IRRITABLE. WAS INSTRUCTED TO GIVE TYLENOL AND LIQUIDS AND MONITOR FOR 24 HOURS. LATER LOST SPEECH AND EYE CONTACT.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Somnolence
Clinical narrative: FEVER, POOR APPETITE, MADE HIM DROWSY, IRRITABLE. WAS INSTRUCTED TO GIVE TYLENOL AND LIQUIDS AND MONITOR FOR 24 HOURS. LATER LOST SPEECH AND EYE CONTACT.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever of 101.5 degrees F presented on 10/08/14 after child woke up.  Fever persisted until 10/10/14 at approximately noon.  On 10/11/14, red bumps appeared on child's neck and chest area.  Within 24 hours, child was covered head to toe in red bumpy rash.  Rash also coincided with lethargy and loss of appetite.  Was taken to Pediatrician 10/13/14 at 9:00AM, confirmed reaction to MMR vaccine by Pediatrician, currently rash is still present (10/13/14).
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Red swollen & hot around injection site by end of work day red swollen area extended down from right deltoid injection site to elbow (lasted 48 hours) low grade fever from 10/8/14 - present day 10/13/14 with highest temp being 100 on 10/8/14. Muscle aches, stiffness, headache, nausea and low grade fever of 99.5 ongoing symptoms today 10/13/2014.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Red swollen & hot around injection site by end of work day red swollen area extended down from right deltoid injection site to elbow (lasted 48 hours) low grade fever from 10/8/14 - present day 10/13/14 with highest temp being 100 on 10/8/14. Muscle aches, stiffness, headache, nausea and low grade fever of 99.5 ongoing symptoms today 10/13/2014.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Heart rate increased, Throat tightness
Clinical narrative: Almost immediately after receiving the shot, my throat started to close up. I became dizzy. A nurse took my vitals and my blood pressure was higher than it has ever been in my life - 130/87. My normal blood pressure (even in times of stress) is right around 110/70 or lower. In addition, my pulse was 100. Again, this was way out of the ordinary for my body. About two hours after I received the shot, my experienced a warming sensation all over my body. This happened three separate times.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site pain, Injection site urticaria, Pain
Clinical narrative: Arm pain at injection site, headache, generalized pain over entire body, chills.  Day two large welt developed over a larger area than injection site.  Continued through days 3 & 4.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Rash pustular, Swelling face
Clinical narrative: Awoke with 3 pustules on right side of face associated with right sided facial swelling. (pustules remain today, this RN questions whether bug bite or adverse reaction). Left arm painful, red & swollen.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Urticaria
Clinical narrative: Bad headache. Diarrhea.  Hives.