chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: CHOL
Symptoms: Diarrhoea
Clinical narrative: Single occurrence of violent, explosive diarrhea without warning (no stomach upset, cramps, etc.)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure abnormal, Nausea, Pharyngeal swelling, Vomiting
Clinical narrative: Pt states that the morning after her vaccination she had throat swelling which she took benadryl for. She also states she had extreme nausea and vomiting and blood pressure issues.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Got pneumonia; This spontaneous report has been received from a lawyer referring to an elderly male patient of unknown age. Information about concurrent condition or concomitant medication was not provided. On an unknown date in 2019, the approximately 89 year old patient was vaccinated with unspecified pneumococcal vaccine (manufacture unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient got pneumonia. The reporting lawyer considered it's adverse reaction/side effect to pneumococcal vaccine.  The outcome of pneumonia was unknown. Causality was assessed as related by lawyer.   Upon internal review, pneumonia was determined to be medically significant.  This is a split case from legal report, concerning same patient.; Sender's Comments:  US-009507513-1812USA008172:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: severe joint pain in feet, ankles, knees and hips; headache; severe nausea; diarrhea; vomiting; feeling dehydrated; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ondansetron (Zofran). On an unknown date, the outcome of the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced severe joint pain in feet, ankles, knees and hips, headache, severe nausea, vomiting and diarrhea.   The caller reported that she went to emergency room due to feeling dehydrated and was treated with IV fluids and Zofran for the nausea. The caller reported that her symptoms are improving. The reporter consented to follow up. Emergency room visit required.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: severe joint pain in feet, ankles, knees and hips; headache; severe nausea; diarrhea; vomiting; feeling dehydrated; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ondansetron (Zofran). On an unknown date, the outcome of the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced severe joint pain in feet, ankles, knees and hips, headache, severe nausea, vomiting and diarrhea.   The caller reported that she went to emergency room due to feeling dehydrated and was treated with IV fluids and Zofran for the nausea. The caller reported that her symptoms are improving. The reporter consented to follow up. Emergency room visit required.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dehydration, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: severe joint pain in feet, ankles, knees and hips; headache; severe nausea; diarrhea; vomiting; feeling dehydrated; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ondansetron (Zofran). On an unknown date, the outcome of the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced severe joint pain in feet, ankles, knees and hips, headache, severe nausea, vomiting and diarrhea.   The caller reported that she went to emergency room due to feeling dehydrated and was treated with IV fluids and Zofran for the nausea. The caller reported that her symptoms are improving. The reporter consented to follow up. Emergency room visit required.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: severe joint pain in feet, ankles, knees and hips; headache; severe nausea; diarrhea; vomiting; feeling dehydrated; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ondansetron (Zofran). On an unknown date, the outcome of the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in hip, headache, nausea, diarrhea, vomiting and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced severe joint pain in feet, ankles, knees and hips, headache, severe nausea, vomiting and diarrhea.   The caller reported that she went to emergency room due to feeling dehydrated and was treated with IV fluids and Zofran for the nausea. The caller reported that her symptoms are improving. The reporter consented to follow up. Emergency room visit required.
Age: 0.33
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave the PNEUMOVAX 23 instead of the PREVNAR 13 by mistake; gave the PNEUMOVAX 23 instead of the PREVNAR 13 by mistake; 4 month olf patient received PNEUMOVAX by mistake; No additional adverse effect; This spontaneous report has been received from a patient's mother and refers to a 4-month-old female patient. No information regarding patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies was provided.   On 27-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S029916; expiration date: 12-JUN-2021) (exact dose, route and site of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) is not indicated for children less than 2 years of age. The nurses "missed it was not the right thing" and gave pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). No adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Flushing
Clinical narrative: flushing; redness; felt lightheaded and dizzy; the physician thinks it may have went into the vein instead of the muscle; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. His pertinent medical history included diabetes. His drug reactions or allergies and concomitant medications were not reported. On 03-MAR-2020, the patient was vaccinated with a third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot number and expiration date were not reported) for "age and diabetes". It was stated that the patient had no adverse events with the previous two doses and that no additional vaccines were administered. On 03-MAR-2020, almost immediately after vaccination, the patient experienced flushing, redness, felt lightheaded and dizzy. Paramedics were called, however the patient was not taken to the hospital. The patient's symptoms resolved within 5 minutes without any treatment. The reporter stated that the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was intended to be administered by intramuscular injection but the physician thought that it might have accidentally went into the patient's vein. It was unknown if any lab diagnostics or studies were performed. The relatedness between the events and suspect therapy was not provided.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: negative reactions to PNEUMOCOCCAL 23-VALENT VACCINE; This spontaneous report was received from a physician and refers to a 69-year-old male patient. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 16-FEB-2009, the patient had negative reaction to the vaccine. The outcome of adverse event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was related.; Sender's Comments:  US-009507513-1801USA008915: US-009507513-2003USA002315:
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: an unspecified patient received the complete 3 dose treatment for GARDASIL 9 on unspecified dates when "the patient was a teenager". A HPV test was ordered and the result came back positive for HPV type 16.; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions or allergies were unknown by the reporter.  On unknown dates, also reported as when "the patient was a teenager", she received the complete 3 dose treatment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular injection (dose, frequency, lot number, and expiration date unknown by the reporter) with an indication reported as vaccination (prophylaxis).  On 05-MAR-2020, the patient sought medical attention and she was seen by the physician; a human papilloma virus (HPV) test was ordered and the result came back positive for HPV type 16. It was unknown by the reporter if treatment was given for the event and if additional laboratory diagnostics or studies were performed. The outcome of human papilloma virus test positive was reported as not resolved. No product quality complaint was reported. No further details were provided.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Rash
Clinical narrative: shingles; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around February 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and prevention of shingles. In or around July 2018, the patient was diagnosed with shingles by her primary care physician. Patient's shingles lasted for several weeks causing severe pain and suffering. The patient continued to suffer from back pain for several months after the rash resolved. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 70.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 70-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 18-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # R018732, the expiration date: 27-FEB-2020 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R018732; expirationdate: 27-FEB-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 69.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 69-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 19-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # R018732, the expiration date: 27-FEB-2020 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp. manufactureraddress: manufacturercity:  manufacturerstate: manufacturercountry: devicelotnumber: R018732; expirationdate: 27-FEB-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 10.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Pentacel but should have been given Tdap due to her age. MA discussed with HD and they stated the dose does NOT need to be repeated because it was high enough. Pt did not have any physical reaction to injection.
Age: 68.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 68-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 20-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: injection site pain and swelling beginning the evening of injection, Next morning could not raise hand up because of pain and weakness and the evening post injection reported swollen area over biceps that is red and enlarged. Also reported fatigue.  2 days post injection - Very tired, weak, skin over biceps uniformly very red, area more swollen than day before. Dizzy and lightheaded. Continued fatigue and reported shortness of breath. Patient reports almost going to the ED.  3 days post injection - Symptoms resolving - SOB gone, redness of skin almost gone. Continued to report fatigue  4 days post injection - continued to report fatigue
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: injection site pain and swelling beginning the evening of injection, Next morning could not raise hand up because of pain and weakness and the evening post injection reported swollen area over biceps that is red and enlarged. Also reported fatigue.  2 days post injection - Very tired, weak, skin over biceps uniformly very red, area more swollen than day before. Dizzy and lightheaded. Continued fatigue and reported shortness of breath. Patient reports almost going to the ED.  3 days post injection - Symptoms resolving - SOB gone, redness of skin almost gone. Continued to report fatigue  4 days post injection - continued to report fatigue
Age: 72.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 72-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 21-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) Lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 78.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 78-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 14-OCT-2010, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No informaton about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 68.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 68-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.  On 21-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis. The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported. This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 84.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 84-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 79.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 79-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 29-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 66-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 78.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 78-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 20-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate:  manufacturercountry: ; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 82.0
Sex: M
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 82-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 79.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 79-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Age: 83.0
Sex: F
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 83-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 02-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409: