chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Paralysis
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 499176. A 23-year-old male patient had received the following vaccinations on 28 February 2003: TdaP intramuscularly, lot # U0816AA, (manufacturer and site not reported), Smallpox vaccine, lot # 4020071 (manufacturer not reported), into the left arm and Hepatitis A, (manufacturer not reported) lot # VHA733B6 intramuscularly into the left arm. On 01 May 2003, the patient experienced severe low back pain, intermittent paralysis and severe joint pain. The patient was diagnosed with ankylosing spondylitis. The patient concomitant medications, medical history and current illness were reported as none. Laboratory data included HLB27 gene testing positive. All other labs that could be run for these issues were negative. Cytogenetic analysis was abnormal. The patient was treated with LORTAB, Meloxicam and muscle relaxers. The patient required an emergency room visit. The patient outcome was not recovered. No further details were available at the time of this report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Cytogenetic analysis normal, HLA marker study
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 499176. A 23-year-old male patient had received the following vaccinations on 28 February 2003: TdaP intramuscularly, lot # U0816AA, (manufacturer and site not reported), Smallpox vaccine, lot # 4020071 (manufacturer not reported), into the left arm and Hepatitis A, (manufacturer not reported) lot # VHA733B6 intramuscularly into the left arm. On 01 May 2003, the patient experienced severe low back pain, intermittent paralysis and severe joint pain. The patient was diagnosed with ankylosing spondylitis. The patient concomitant medications, medical history and current illness were reported as none. Laboratory data included HLB27 gene testing positive. All other labs that could be run for these issues were negative. Cytogenetic analysis was abnormal. The patient was treated with LORTAB, Meloxicam and muscle relaxers. The patient required an emergency room visit. The patient outcome was not recovered. No further details were available at the time of this report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Laboratory test normal, Paralysis
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 499176. A 23-year-old male patient had received the following vaccinations on 28 February 2003: TdaP intramuscularly, lot # U0816AA, (manufacturer and site not reported), Smallpox vaccine, lot # 4020071 (manufacturer not reported), into the left arm and Hepatitis A, (manufacturer not reported) lot # VHA733B6 intramuscularly into the left arm. On 01 May 2003, the patient experienced severe low back pain, intermittent paralysis and severe joint pain. The patient was diagnosed with ankylosing spondylitis. The patient concomitant medications, medical history and current illness were reported as none. Laboratory data included HLB27 gene testing positive. All other labs that could be run for these issues were negative. Cytogenetic analysis was abnormal. The patient was treated with LORTAB, Meloxicam and muscle relaxers. The patient required an emergency room visit. The patient outcome was not recovered. No further details were available at the time of this report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: CSF test normal, Chills, Electroencephalogram normal, Flank pain, Hyperhidrosis
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Photopsia, Tonic clonic movements
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Acrochordon, Blood glucose increased, Blood glucose normal, Blood pressure diastolic increased, Blood pressure systolic increased
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blood prolactin increased, CSF cell count normal, Chills, Computerised tomogram abnormal, Computerised tomogram head abnormal
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Confusional state, Convulsion, Cyst, Cystitis, Electroencephalogram normal
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Encephalopathy, Fall, Flank pain, Grand mal convulsion, Hyperhidrosis
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Photopsia, Pyrexia, Sinus polyp
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 500209. A 27 year-old female patient had received the following vaccination on 15 August 2013: an injection of ACAM2000 (lot number VV04003A) (site was not reported) and four day later on 19 August 2013 woke with right flank at 0500. At 0600 began to have chills with diaphoresis which immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures x 2" of 6 minutes duration. The patient was transported to the emergency room by ambulance for evaluation and was hospitalized from 19 to 23 August 2013. According to the report, the patient fell down, unresponsive, confused seized. Emergency room diagnosis: vaccinal encephalopathy, generalized convulsive seizure, acute cystitis and combined systolic and diastolic elevation. The patient also had a possible infection or superficial phlebitis of forearm skin at site of IV placement, limb pain; low grade fever and skin tag on face. Treatment included ATIVAN, valproic acid and antibiotics (not specified). Laboratory data included a negative MRI, normal EEG, normal CSF, Glucose 114 (high), prolactin 39.1 ng/ml (high), and an abnormal CT scan of the head which revealed a retention cyst or large polyp in the floor of the left maxillary sinus, otherwise unremarkable. The patient has a past medical history of adjustment disorder, astigmatism, myopia, arthralgia of knee/patella/tibia/fibula, limb pain, reactive airway disease, refractive error, cigarette No smoker and occasional alcohol. No further information was available at the time of the report. The patient's outcome was recovered. All events were included in the coding from the VAERs database and coded for this case; however only the event of low grade fever had been mentioned in the narrative. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Dyspnoea, Muscle spasms, Skin discolouration
Clinical narrative: Information had been received from a third party claims examiner for a pharmacy regarding a female who on 09-SEP-2013 had an adverse reaction to the PNEUMOVAX23 (lot# J004747, expiration date 20-JUL-2014). No other information has been provided. This spontaneous report as received from a pharmacist via a company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX23. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Information was received from the husband of a patient who was vaccinated on 09SEP2013 with PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014) at a pharmacy where the husband works as a pharmacist. In less than one minute after receiving the shot, the patient complained that the injection area was hurting and that she battled to breath. Her skin turned red and she complained of back spasms. She choked and stopped breathing. She was immediately given a shot of EPIPEN followed, followed by a second shot after five minutes due to her anaphylactic shock condition not improving and she was about to faint. 911 was called who in turn called the paramedics. They arrived promptly and checked her vital signs. The primary physician was called and he advised that her to go to the emergency room. In the emergency room she was given bolus intravenous treatment and kept the rest of the day for observation (previously reported as hospitalized). She followed up with her primary care physician who suggested she see an Allergist for a full screening. Upon internal review the events of "stopped breathing" and anaphylactic shock condition was considered to be medically significant. The events of "stopped breathing", "face turned beet red", anaphylactic shock condition and choking were considered to be life threatening. It has been determined that MARRS case # 1311USA006926 is a duplicate of MARRS case # 1309USA011049. Therefore MARRS case #1311USA006926 is being deleted from our files and the cases consolidated into MARRS case # 1309USA011049. Additional information has been requested. All available medical records will be provided upon request.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Erythema, Respiratory arrest
Clinical narrative: Information had been received from a third party claims examiner for a pharmacy regarding a female who on 09-SEP-2013 had an adverse reaction to the PNEUMOVAX23 (lot# J004747, expiration date 20-JUL-2014). No other information has been provided. This spontaneous report as received from a pharmacist via a company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX23. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Information was received from the husband of a patient who was vaccinated on 09SEP2013 with PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014) at a pharmacy where the husband works as a pharmacist. In less than one minute after receiving the shot, the patient complained that the injection area was hurting and that she battled to breath. Her skin turned red and she complained of back spasms. She choked and stopped breathing. She was immediately given a shot of EPIPEN followed, followed by a second shot after five minutes due to her anaphylactic shock condition not improving and she was about to faint. 911 was called who in turn called the paramedics. They arrived promptly and checked her vital signs. The primary physician was called and he advised that her to go to the emergency room. In the emergency room she was given bolus intravenous treatment and kept the rest of the day for observation (previously reported as hospitalized). She followed up with her primary care physician who suggested she see an Allergist for a full screening. Upon internal review the events of "stopped breathing" and anaphylactic shock condition was considered to be medically significant. The events of "stopped breathing", "face turned beet red", anaphylactic shock condition and choking were considered to be life threatening. It has been determined that MARRS case # 1311USA006926 is a duplicate of MARRS case # 1309USA011049. Therefore MARRS case #1311USA006926 is being deleted from our files and the cases consolidated into MARRS case # 1309USA011049. Additional information has been requested. All available medical records will be provided upon request.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Anaphylactic shock, Choking, Dyspnoea, Erythema, Injection site pain
Clinical narrative: Information had been received from a third party claims examiner for a pharmacy regarding a female who on 09-SEP-2013 had an adverse reaction to the PNEUMOVAX23 (lot# J004747, expiration date 20-JUL-2014). No other information has been provided. This spontaneous report as received from a pharmacist via a company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX23. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Information was received from the husband of a patient who was vaccinated on 09SEP2013 with PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014) at a pharmacy where the husband works as a pharmacist. In less than one minute after receiving the shot, the patient complained that the injection area was hurting and that she battled to breath. Her skin turned red and she complained of back spasms. She choked and stopped breathing. She was immediately given a shot of EPIPEN followed, followed by a second shot after five minutes due to her anaphylactic shock condition not improving and she was about to faint. 911 was called who in turn called the paramedics. They arrived promptly and checked her vital signs. The primary physician was called and he advised that her to go to the emergency room. In the emergency room she was given bolus intravenous treatment and kept the rest of the day for observation (previously reported as hospitalized). She followed up with her primary care physician who suggested she see an Allergist for a full screening. Upon internal review the events of "stopped breathing" and anaphylactic shock condition was considered to be medically significant. The events of "stopped breathing", "face turned beet red", anaphylactic shock condition and choking were considered to be life threatening. It has been determined that MARRS case # 1311USA006926 is a duplicate of MARRS case # 1309USA011049. Therefore MARRS case #1311USA006926 is being deleted from our files and the cases consolidated into MARRS case # 1309USA011049. Additional information has been requested. All available medical records will be provided upon request.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Muscle spasms, Presyncope, Respiratory arrest
Clinical narrative: Information had been received from a third party claims examiner for a pharmacy regarding a female who on 09-SEP-2013 had an adverse reaction to the PNEUMOVAX23 (lot# J004747, expiration date 20-JUL-2014). No other information has been provided. This spontaneous report as received from a pharmacist via a company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX23. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Information was received from the husband of a patient who was vaccinated on 09SEP2013 with PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014) at a pharmacy where the husband works as a pharmacist. In less than one minute after receiving the shot, the patient complained that the injection area was hurting and that she battled to breath. Her skin turned red and she complained of back spasms. She choked and stopped breathing. She was immediately given a shot of EPIPEN followed, followed by a second shot after five minutes due to her anaphylactic shock condition not improving and she was about to faint. 911 was called who in turn called the paramedics. They arrived promptly and checked her vital signs. The primary physician was called and he advised that her to go to the emergency room. In the emergency room she was given bolus intravenous treatment and kept the rest of the day for observation (previously reported as hospitalized). She followed up with her primary care physician who suggested she see an Allergist for a full screening. Upon internal review the events of "stopped breathing" and anaphylactic shock condition was considered to be medically significant. The events of "stopped breathing", "face turned beet red", anaphylactic shock condition and choking were considered to be life threatening. It has been determined that MARRS case # 1311USA006926 is a duplicate of MARRS case # 1309USA011049. Therefore MARRS case #1311USA006926 is being deleted from our files and the cases consolidated into MARRS case # 1309USA011049. Additional information has been requested. All available medical records will be provided upon request.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Started as numbness in both arms, it then went to numbness in feet, neck, ear lobes. Went to primary doctor - it was diagnosed as peripheral neuropathy. Given Methylprednisolone 4 mg to relieve symptoms but I still have symptoms. Sometimes it feels numb and other times I feel a mild burning sensation and other times the burning sensation is stronger.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Started as numbness in both arms, it then went to numbness in feet, neck, ear lobes. Went to primary doctor - it was diagnosed as peripheral neuropathy. Given Methylprednisolone 4 mg to relieve symptoms but I still have symptoms. Sometimes it feels numb and other times I feel a mild burning sensation and other times the burning sensation is stronger.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Atrial fibrillation, Ventricular extrasystoles
Clinical narrative: This medically confirmed report (initial receipt 22-Nov-2013) concerns a 66 year old female patient who had a history of PVC's (Premature Ventricular Contractions) and an unspecified heart condition. The patient did not have allergies. On the 03-Oct-2013, the patient received influenza (manufacturer and batch number not reported) in the physician's office. On the same day, the patient also received PNEUMOVAX (batch number not reported) in the physician's office and ZOSTAVAX (batch number J005720) in the pharmacy. On the same day, the patient developed premature ventricular contractions or atrial fibrillation and was admitted to hospital. The patient recovered and was discharged. Outcome was reported as recovered.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Ventricular extrasystoles
Clinical narrative: This medically confirmed report (initial receipt 22-Nov-2013) concerns a 66 year old female patient who had a history of PVC's (Premature Ventricular Contractions) and an unspecified heart condition. The patient did not have allergies. On the 03-Oct-2013, the patient received influenza (manufacturer and batch number not reported) in the physician's office. On the same day, the patient also received PNEUMOVAX (batch number not reported) in the physician's office and ZOSTAVAX (batch number J005720) in the pharmacy. On the same day, the patient developed premature ventricular contractions or atrial fibrillation and was admitted to hospital. The patient recovered and was discharged. Outcome was reported as recovered.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient states that pain was associated with injection site. Report that pain is still present 3 weeks after injection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states that pain was associated with injection site. Report that pain is still present 3 weeks after injection.
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Cough, Lacrimation increased, Myalgia, Oropharyngeal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 26-Nov-2013) concerns a male patient. The patient had received flu vaccinations in the past without experiencing symptoms. On the 29-Oct-2013, the patient received AFLURIA (batch number not reported) 0.5 mL via the intramuscular route. On the 08-Nov-2013, the patient developed symptoms of myalgia, a fever that reached 101, runny nose, runny eyes, sore throat which went into the patient's chest and developed a cough. The patient treated the coughing with TYLENOL and saw a physician who recommended a short course of antibiotics. The patient was sick for 2 weeks until 22-Nov-2013.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed health authority report (initial receipt 26-Nov-2013) concerns a male patient. The patient had received flu vaccinations in the past without experiencing symptoms. On the 29-Oct-2013, the patient received AFLURIA (batch number not reported) 0.5 mL via the intramuscular route. On the 08-Nov-2013, the patient developed symptoms of myalgia, a fever that reached 101, runny nose, runny eyes, sore throat which went into the patient's chest and developed a cough. The patient treated the coughing with TYLENOL and saw a physician who recommended a short course of antibiotics. The patient was sick for 2 weeks until 22-Nov-2013.
Age: 4.0
Sex: F
Vaccine: DTPIPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever of 102. Redness and soreness at site.
Age: 13.0
Sex: F
Vaccine: FLUX, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: A large (4"x 8") welt raised on her left, upper arm. The welt is hot, red, and definitely raised. Painful to touch or arm movement. She states it is very, very itchy. Today is day 4 after injection and she still has the welt with redness, warmth, pain, itching, and raised welt still there. Welt is firm to touch.
Age: 13.0
Sex: F
Vaccine: FLUX, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain, Urticaria
Clinical narrative: A large (4"x 8") welt raised on her left, upper arm. The welt is hot, red, and definitely raised. Painful to touch or arm movement. She states it is very, very itchy. Today is day 4 after injection and she still has the welt with redness, warmth, pain, itching, and raised welt still there. Welt is firm to touch.
Age: 96.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Edema, warm, to right deltoid area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This spontaneous report has been received from a certified nurse practitioner concerning to a 63 year old female patient who was also a nurse with none pertinent medical history and none drug reactions/allergies. On 21-OCT-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml once, subcutaneous, (lot# not provided) at the hospital. Concomitant therapies included betablocker (unspecified), proton pump inhibitor (unspecified) and calcium channel blocker (unspecified). On 23-OCT-2013, within 2 days of receiving ZOSTAVAX the patient experienced internal tremors or shaking. The reporter stated that the patient never experienced anything like that before. No treatment was given for the adverse event. The patient sought medical attention by contacting office. At the time of reporting, the outcome of internal tremors or shaking was recovering (reported as the patient was 75 percent better). The reporter stated that the patient felt the adverse event was due to vaccine. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse (reported as primary contact) refers to an approximately 9 week old patient. On 04-DEC-2013 the patient was vaccinated with ROTATEQ 2 ml, orally from lot number H010322, and expiry date 30-NOV-2013 for routine vaccination. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 15-JAN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # and expiry date not provided) dose 1 for vaccination. On 02-DEC-2013, the patient was vaccinated with the second dose of PNEUMOVAX23. No adverse event reported. Additional information is expected.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative and refers to a 44 weeks old patient. No medical history or concurrent conditions were reported. On an unknown date, when the patient was 44 weeks old, he or she was vaccinated with ROTATEQ dose 1. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Herpes zoster, Pain
Clinical narrative: This spontaneous report refers to an 80 year old male patient (also the reporter) with drug reaction/allergies to penicillin. Within 2013, and thyroid cancer The patient's medical history included surgery to correct clogged arteries, 2 heart attacks, 2 strokes and surgery to correct clogged arteries. On 14-JUL-2013 the patient was vaccinated with ZOSTAVAX injection. Dose, lot and expiry date were not reported. Concomitant medications included unspecified medications for his heart and other conditions. On 28-JUL-2013, 2 weeks after vaccination, the patient developed shingles. The patient explained that he was given unspecified pain-killer tablets for the treatment of the outbreak that had not worked. The outbreak had occurred under his arms and up to the top of his shoulder and neck. The outbreak was not itchy, but rather painful. The patient mentioned that the sensation also occurred within his stomach, which he described as spasms or waves of pain that occurred periodically. The outcome of events was reported as not resolved. The patient had spoken to his physician to seek medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This spontaneous report was received from a 62 year old male consumer referring on himself. The patient stated that his good cholesterol was low. On 14-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported). Concomitant therapies included an unspecified tetanus shot. Within 12 hours after received ZOSTAVAX the patient developed a tingling on skin, sharp pain on lower back; over the next few days he noticed lumps and spots. On 20-NOV-2013 he went to healthcare professional and was diagnosed with shingles. He was prescribed valacyclovir and lidocaine patch, and the next day after, presumably after taking the valacyclovir, a rash grew around his side and back. In addition, patient said that "statins" give him a heat rash. The outcome of shingles was unknown. This is one of two reports from the same reporter source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 01-JUL-2012, the patient was vaccinated with GARDASIL dose 1 0.5 ml, intramuscular. On 04-DEC-2013 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein, Full blood count, Injection site erythema, Injection site swelling, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old female patient. On 20-JUL-2012 the patient was vaccinated with MMR II lot # 0134AE and expiry date 10-JAN-2014, dose 0.5 milliliters, route intramuscular for prevention of mumps, measles and rubella. On an unknown date in July 2012, the patient experienced redness and swelling around injection site after receiving the vaccine. The patient was seen in office on 23-JUL-2013 and site of reaction measured 10 centimeters (cm x 11 cm. The patient was treated with BENADRYL, AUGMENTIN, ZANTAC and cool compresses. On 25-JUL-2012, redness and swelling had decreased to 6 cm x 6 cm. No other symptoms were reported. The outcome of redness and swelling around injection site was reported as recovering/resolving. Laboratory studies performed on unknown dates were complete blood count (CBC), sedimentation rate (SedRate) and C-reactive protein (CRP) with unknown results. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that the patient received dose 1 of GARDASIL (injection, strength, lot #, dose, route were unspecified) on 31-AUG-2009 and dose 2 (injection, strength, lot #, dose, route were unspecified) on 09-FEB-2010, would be receiving dose 3 (injection, strength, lot #, dose, route were unspecified) today on 27-NOV-2013. No symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: This spontaneous report refers to a 60 year old female patient with drug reactions/allergies to penicillin. The patient had no pertinent medical history. On 30-SEP-2013 the patient was vaccinated with ZOSTAVAX vial, subcutaneous. Dose, lot and expiry date were unknown. Concomitant therapies included LIPITOR and estradiol, ACTIVELLA. On 30-SEP-2013, 1 day after onset of therapy the patient developed chicken pox, itching and raging rash. The patient called in to report that she had been diagnosed with chicken pox ever since getting ZOSTAVAX. She received the vaccine in the morning and by that evening had experienced a raging rash that appeared 3 times in the following weeks and also experienced an outbreak of chicken pox. She was prescribed VALTREX (manufacturer and dosage unspecified) for 7 days and also received an unspecified steroid shot (manufacturer and dosage unspecified). She was given an unspecified steroid cream (manufacturer and dosage unspecified) to use on the rash. She was also advised to take BENADRYL (manufacturer and dosage unspecified) and CLARITIN (manufacturer and dosage unspecified) as needed for relief of the itching. The outcome of events was reported as not recovered/not resolved. The patient had sought medical attention (seen by physician). Additional information has been requested.