chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 8th September 2018, 2 days after receiving SHINGRIX, the patient experienced swelling, erythema and skin warm. In September 2018, several days after receiving SHINGRIX, the patient experienced fever, axillary lump and chills. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant) and fatigue. The patient was treated with Amoxicillin. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pain, swelling, axillary lump, chills, fatigue, erythema and skin warm were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, swelling, fever, axillary lump, chills, fatigue, erythema and skin warm to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced knot under her arm. The patient was prescribed Amoxicillin by the primary care physician (PCP) for possible cellulitis after observation.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Cellulitis, Chills, Erythema, Fatigue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 8th September 2018, 2 days after receiving SHINGRIX, the patient experienced swelling, erythema and skin warm. In September 2018, several days after receiving SHINGRIX, the patient experienced fever, axillary lump and chills. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant) and fatigue. The patient was treated with Amoxicillin. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pain, swelling, axillary lump, chills, fatigue, erythema and skin warm were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, swelling, fever, axillary lump, chills, fatigue, erythema and skin warm to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced knot under her arm. The patient was prescribed Amoxicillin by the primary care physician (PCP) for possible cellulitis after observation.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 8th September 2018, 2 days after receiving SHINGRIX, the patient experienced swelling, erythema and skin warm. In September 2018, several days after receiving SHINGRIX, the patient experienced fever, axillary lump and chills. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant) and fatigue. The patient was treated with Amoxicillin. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pain, swelling, axillary lump, chills, fatigue, erythema and skin warm were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, swelling, fever, axillary lump, chills, fatigue, erythema and skin warm to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced knot under her arm. The patient was prescribed Amoxicillin by the primary care physician (PCP) for possible cellulitis after observation.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crohn's disease aggravated in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (the patient had shingles about 20 years ago). Concurrent medical conditions included crohn's disease. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced crohn's disease aggravated (serious criteria GSK medically significant), pain and nausea. On an unknown date, the outcome of the crohn's disease aggravated was not recovered/not resolved and the outcome of the pain and nausea were unknown. It was unknown if the reporter considered the crohn's disease aggravated, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The patient said that between her two SHINGRIX doses at some point she started having Crohn's disease flare up. She started having soreness in the area where she has shingles, she also started feeling nauseated. On 23rd July 2018, the patient received 2nd dose of SHINGRIX. However, about two or three weeks after her second dose she had the shingles. She visited her physician on 24th August 2018 and was then diagnosed with shingles. She hasn't had shingles for a long time, about 20 years ago, besides her latest case. The patient called to report it to the company because she thought she would not get the shingles (lack of drug effect).
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Crohn's disease, Drug ineffective, Herpes zoster, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crohn's disease aggravated in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (the patient had shingles about 20 years ago). Concurrent medical conditions included crohn's disease. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced crohn's disease aggravated (serious criteria GSK medically significant), pain and nausea. On an unknown date, the outcome of the crohn's disease aggravated was not recovered/not resolved and the outcome of the pain and nausea were unknown. It was unknown if the reporter considered the crohn's disease aggravated, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The patient said that between her two SHINGRIX doses at some point she started having Crohn's disease flare up. She started having soreness in the area where she has shingles, she also started feeling nauseated. On 23rd July 2018, the patient received 2nd dose of SHINGRIX. However, about two or three weeks after her second dose she had the shingles. She visited her physician on 24th August 2018 and was then diagnosed with shingles. She hasn't had shingles for a long time, about 20 years ago, besides her latest case. The patient called to report it to the company because she thought she would not get the shingles (lack of drug effect).
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crohn's disease aggravated in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (the patient had shingles about 20 years ago). Concurrent medical conditions included crohn's disease. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced crohn's disease aggravated (serious criteria GSK medically significant), pain and nausea. On an unknown date, the outcome of the crohn's disease aggravated was not recovered/not resolved and the outcome of the pain and nausea were unknown. It was unknown if the reporter considered the crohn's disease aggravated, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The patient said that between her two SHINGRIX doses at some point she started having Crohn's disease flare up. She started having soreness in the area where she has shingles, she also started feeling nauseated. On 23rd July 2018, the patient received 2nd dose of SHINGRIX. However, about two or three weeks after her second dose she had the shingles. She visited her physician on 24th August 2018 and was then diagnosed with shingles. She hasn't had shingles for a long time, about 20 years ago, besides her latest case. The patient called to report it to the company because she thought she would not get the shingles (lack of drug effect).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient called 09/21/18 stating that she felt pain and soreness for approximately 5 days, then she developed a rash at the injection site. The rash is also itchy. Patient reported to have been using OTC steroid without resolve. Patient saw her family doctor 09/21/18, prescribed topical steroid.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Injection site haemorrhage
Clinical narrative: Consistant bleeding from shot location for hours now. Due date. Dec 15 2018 pregnacy history to date positive.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Bradyphrenia, Chills, Cold sweat
Clinical narrative: Sore arm after shot, I went to bed at 8:30 & I woke up at 10:30 pm with uncontrollable chills & shaking. I felt so cold & clammy. My head was aching & my stomach was very uneasy. My husband put more blankets on me because I couldn't stop shaking. I couldn't find my thermometer, so no idea what my temperature was although to me I have felt like this before when I have been very sick. I took 2 TYLENOL tablets & a drink of cold water, then back under the covers, the shaking finally subsided, but this morning I feel very weak with a headache and slowness in my thinking process & arm still sore.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling cold, Headache, Pain in extremity, Tremor
Clinical narrative: Sore arm after shot, I went to bed at 8:30 & I woke up at 10:30 pm with uncontrollable chills & shaking. I felt so cold & clammy. My head was aching & my stomach was very uneasy. My husband put more blankets on me because I couldn't stop shaking. I couldn't find my thermometer, so no idea what my temperature was although to me I have felt like this before when I have been very sick. I took 2 TYLENOL tablets & a drink of cold water, then back under the covers, the shaking finally subsided, but this morning I feel very weak with a headache and slowness in my thinking process & arm still sore.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt stated that she started with little dots of rash on the 19th and it developed into a full itchy rash across the whole upper front of her body. she has allergy to coffee but seems unrelated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: .5 cm x 6 cm erythematous and swollen lesion on left upper arm. Slightly tender and warm to touch. Two injection marks seen within circular lesion. May have ibuprofen PRN pain/swelling. Ice to lesion PRN. Oral BENADRYL PRN itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin lesion
Clinical narrative: .5 cm x 6 cm erythematous and swollen lesion on left upper arm. Slightly tender and warm to touch. Two injection marks seen within circular lesion. May have ibuprofen PRN pain/swelling. Ice to lesion PRN. Oral BENADRYL PRN itching.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were unknown. On 31-AUG-2018 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, strength, batch/lot # unknown; expiration date May 2018) for prophylaxis. No adverse effects were reported. The patient did not seek medical attention. No treatment was given. It was unknown if lab diagnostics/studies were performed. No product quality complaint (PQC) involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-AUG-2018, the patient was vaccinated with a improperly stored M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 Celsius degrees to 25 Celsius degrees for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. The medical assistant declined evaluation of improperly stored administered vaccines. No adverse events were reported. This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1809USA001804: US-009507513-1808USA011459:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. On 07-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX batch/lot number: R013565, expiration date: 13-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis, which was reconstituted with properly stored sterile water diluent. The administered doses of vaccines experienced the temperature excursion of -9 to 8 degrees Celsius for 13 hours 59 minutes and -9 to 8 degrees Celsius for l hour 43 minutes. There was not previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA007011.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report was received from a physician via field representative referring to a 2-month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ first dose (strength, dose, lot # and expiry date were not reported) orally to prevent rotavirus. On an unknown date (2 days after ROTATEQ administration), the patient was hospitalized due to rotavirus and dehydration. The patient's stool test was performed, and the result revealed as positive for rotavirus in the hospital. The physician reported that the patient was admitted to the hospital for 2 days. It was unknown if any treatment was received. On an unknown date, 2 more doses of ROTATEQ was administered when the patient was 4-month old and 6-month old with no issues respectively. On an unknown date, the outcome of rotavirus and dehydration was recovered/resolved. Causality assessment was not provided for the events. There was no product quality complaint (PQC) involved.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, drugs allergies and concomitant medications, if any, were not reported. On 07-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (dose number, dosage, route of administration, anatomical site of vaccination were not reported; lot number 0653AE) for prophylaxis instead of PREVNAR 13. Pharmacist was uncertain how the medication error occurred, and was uncertain whether product confusion was involved. Lot number 0653AE was confirmed a valid lot number for PNEUMOVAX 23 but the expiration date for this lot was reported as 02-OCT-2014. The pharmacist was certain this could not have been the correct lot number for the dose of PNEUMOVAX23, however at the reporting time, the expiration date was not confirmed. Additionally, no adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant therapies included sterile diluent. On 07-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number: R013565, expiration date: 13-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis, which was reconstituted with properly stored sterile water diluent. The administered doses of vaccines experienced the temperature excursion of -9 to 8 degrees Celsius for 13 hours 59 minutes and -9 to 8 degrees Celsius for l hour 43 minutes. There was not previous temperature. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA003427.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other related complications. On or about 17-DEC-2014, the patient was treated by a physician's assistant at a medical group for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other related complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a pharmacist via a company employee referring to a 16 years old female patient. Information about concomitant medication, concurrent condition, and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (strength, dose number, frequency, batch/lot #, and expiration date were not reported). It was unknown which shot in the GARDASIL 9 series that was being administered. On the same day, the patient experienced syncope (reported as "syncopy"). The patient sought medical attention in doctor's office at the time of the event. The patient stayed longer than required 15 minutes and required juice at doctor's office. Treatment was given for the event. No lab diagnostics were performed. It was also reported that the therapy was continued. At the time of the report, the outcome of syncope was reported as recovered. The causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA008576.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a pharmacist via a company employee referring to a 17 years old female patient. Information about concomitant medication, concurrent condition, and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (strength, dose number, frequency, batch/lot #, and expiration date were not reported). It was unknown which shot in the GARDASIL 9 series that was being administered. On the same day, the patient experienced syncope (reported as "syncopy"). The patient sought medical attention in doctor's office at the time of the event. The patient stayed longer than required 15 minutes and required juice at doctor's office. Treatment was given for the event. No lab diagnostics were performed. It was also reported that the therapy was continued. At the time of the report, the outcome of syncope was reported as recovered. The causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA008503.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 03-MAY-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Shortly after receiving ZOSTAVAX, began to experience pain and itchiness on her arms, hands, and along her back. In response to these complaints, on or about 01-OCT-2016, the patient presented to a health facility with complaints of right side pain and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of M-M-R II (lot # N023150 exp date 24-AUG-2019) (dose not reported) intramuscularly. Concomitant therapies included sterile diluent. There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009098: US-009507513-1809USA009099.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of M-M-R II (lot # N023150 exp date 24-AUG-2019) (dose not reported) intramuscularly. Concomitant therapies included sterile diluent. There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009097: US-009507513-1809USA009098: US-009507513-1809USA009099.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of ROTATEQ (lot # N030174 exp date 13-JUN-2019 (also reported as 30-JUN-2019)) (dose not reported) orally. There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096:  US-009507513-1809USA009098: US-009507513-1809USA009099:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of VAQTA (lot # R006210 exp date 22-APR-2019) (dose and route not reported). There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009099.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of VAQTA (lot # R006210 exp date 22-APR-2019) (dose and route not reported). There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009098:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 5-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 5-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site swelling, Pain, Swelling
Clinical narrative: Patient was administered PNEUMOVAX 23 in the left arm according to standard operating procedures on the morning of 09/17/2018. At the time of the vaccination there were no adverse effects or issues. At approximately 11:00 AM on 09/19/2018 patient returned to the pharmacy. She informed me that she had seen a healthcare provider at an urgent care clinic earlier that morning. She stated she was diagnosed with cellulitis. Patient told me that she experienced soreness and swelling twelve hours after the injection on 09/17/2018 in her left arm. She stated the swelling spread from the injection site down to her elbow, which prompted her to seek out treatment at urgent care on 09/19/2018. When patient came into the pharmacy on 09/19/2018 she also informed us that she received treatment from the urgent care clinic and that she was going to follow up with her primary care physician that same day.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Shot given 9/18/18  3:15 pm Within 1 hour of the vaccine, I noticed the discomfort at the injection site was still very uncomfortable. Within 3 hours there was significant swelling and the area felt warm to the touch. The same evening I had the first incident of diarrhea. 9/19/18 An additional 3 episodes of Diarrhea, my right arm (injection site) developed a large bright red area. The site was sore and the swelling was worse. The area felt hard a circle roughly 3 in diameter. On 9/20/18 I decided to seek medical attention. The injection site swelling was approximately 4-5 in diameter, the redness was more predominant and the temperature around the site was hot to the touch. On 9/20/18 I also started to experience muscle soreness around the effected area. The Diagnosis on 9/20/18 from Urgent Care, was cellulites infection. A antibiotic was administered and a prescription called in. Several employees that received this shot on the same date, by the same company are reporting similar response.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 9/18/18  3:15 pm Within 1 hour of the vaccine, I noticed the discomfort at the injection site was still very uncomfortable. Within 3 hours there was significant swelling and the area felt warm to the touch. The same evening I had the first incident of diarrhea. 9/19/18 An additional 3 episodes of Diarrhea, my right arm (injection site) developed a large bright red area. The site was sore and the swelling was worse. The area felt hard a circle roughly 3 in diameter. On 9/20/18 I decided to seek medical attention. The injection site swelling was approximately 4-5 in diameter, the redness was more predominant and the temperature around the site was hot to the touch. On 9/20/18 I also started to experience muscle soreness around the effected area. The Diagnosis on 9/20/18 from Urgent Care, was cellulites infection. A antibiotic was administered and a prescription called in. Several employees that received this shot on the same date, by the same company are reporting similar response.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Sore arm, swollen and red rash beneath the injection site.
Age: 73.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, Hepatitis A antibody negative
Clinical narrative: Pt was given Hep A #4 one month after receiving Hep A #3. Pt is repeating the series because of not showing antibodies.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Computerised tomogram head normal, Dizziness, Headache, Lumbar puncture normal, Nausea
Clinical narrative: Dizziness, headache, nausea, severe body aches, was sent to the Emergency Department right away. Patient had LP and head CT which were both negative.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pain
Clinical narrative: Dizziness, headache, nausea, severe body aches, was sent to the Emergency Department right away. Patient had LP and head CT which were both negative.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Asthenia, Headache
Clinical narrative: Dizziness, headache, nausea, severe body aches, was sent to the Emergency Department right away. Patient had LP and head CT which were both negative.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches and pains. Fever>100 degrees.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Computerised tomogram head, Echocardiogram, Electroencephalogram, Fibrin D dimer, Nuclear magnetic resonance imaging brain
Clinical narrative: Seizure (no history of seizures).
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging neck, Seizure
Clinical narrative: Seizure (no history of seizures).
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Nervous system disorder
Clinical narrative: Sore shoulder where shot was administered. Achy joints, sensitive nerves, headache.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: 24 hours after shot #1 I had a fever of 100 F and diarrhea. Fever subsided 12 hours later. Diarrhea subsided after one episode.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Injection site erythema, Injection site swelling
Clinical narrative: The day of the vaccination I was unaware I was pregnant at the time, I was 4 weeks pregnant. The day I had normal side effects swelling and redness at the injection site that lasted three days. On September 11, 2018 I took a pregnancy test. I was found pregnant. I saw my OB doctor on September 14th, who confirmed my pregnancy, however she was concerned since my line was faint and sent me for HCG testing. My HCG results proved to be low and I miscarried 9/20/2018. I do not know if the flu shot caused this, however I feel it is important to report since It was close to vaccination date. This would be my fourth pregnancy, two pregnancies to term. My last child was born 9 months prior to this last pregnancy. If this pregnancy would have continued the baby would have been born May 2019.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Computerised tomogram, Full blood count, International normalised ratio, Metabolic function test, Pneumonia
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 70-year-old, elderly, male patient. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), high blood pressure, being immunocompromised and overweight, abdominal aortic aneurysm endoleak and drug allergy to tetracycline, hydroxychloroquine sulfate (PLAQUENIL), unspecified iron and nickel. On an unknown date, reported as "since it came out, even before the 23 version came out", the patient was getting PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and was revaccinated with it once every five years since then. He had also routinely been vaccinated then revaccinated with PREVNAR 13 on an unspecified schedule. In approximately 2013 (reported as "a few months after he turned 65-year-old"), the patient was vaccinated with his last PNEUMOVAX 23 injection, in his arm, for prevention of pneumococcal disease (exact dose, frequency, route of administration, lot# and expiration date were unknown). Concomitant therapies included irbesartan (AVAPRO), metoprolol succinate (TOPROL XL), baby aspirin, warfarin sodium (COUMADIN), terazosin, tiotropium bromide (SPIRIVA), fluticasone furoate (+) vilanterol trifenatate (BREO) and rosuvastatin calcium (CRESTOR). On an unknown date in May 2018, the patient was admitted to hospital for multifocal pneumonia. He was released from the hospital one week later. According to the reporter, X-ray, CAT, complete blood count (CBC), basic metabolic tests, international normalized ratio (INR) test, all of the required tests when someone got pneumonia were performed. The patient sought medical attention. Treatment was given for the adverse event. On an unspecified date in 2018, the patient recovered from the multifocal pneumonia after he left the hospital. The causality assessment was not provided. Upon internal review, the event of multifocal pneumonia was determined as medically significant.
Sex: M
Vaccine: PNC13, PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 70-year-old, elderly, male patient. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), high blood pressure, being immunocompromised and overweight, abdominal aortic aneurysm endoleak and drug allergy to tetracycline, hydroxychloroquine sulfate (PLAQUENIL), unspecified iron and nickel. On an unknown date, reported as "since it came out, even before the 23 version came out", the patient was getting PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and was revaccinated with it once every five years since then. He had also routinely been vaccinated then revaccinated with PREVNAR 13 on an unspecified schedule. In approximately 2013 (reported as "a few months after he turned 65-year-old"), the patient was vaccinated with his last PNEUMOVAX 23 injection, in his arm, for prevention of pneumococcal disease (exact dose, frequency, route of administration, lot# and expiration date were unknown). Concomitant therapies included irbesartan (AVAPRO), metoprolol succinate (TOPROL XL), baby aspirin, warfarin sodium (COUMADIN), terazosin, tiotropium bromide (SPIRIVA), fluticasone furoate (+) vilanterol trifenatate (BREO) and rosuvastatin calcium (CRESTOR). On an unknown date in May 2018, the patient was admitted to hospital for multifocal pneumonia. He was released from the hospital one week later. According to the reporter, X-ray, CAT, complete blood count (CBC), basic metabolic tests, international normalized ratio (INR) test, all of the required tests when someone got pneumonia were performed. The patient sought medical attention. Treatment was given for the adverse event. On an unspecified date in 2018, the patient recovered from the multifocal pneumonia after he left the hospital. The causality assessment was not provided. Upon internal review, the event of multifocal pneumonia was determined as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-MAY-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent of herpes zoster, also known as shingles and other complications. On or about 25-APR-2016, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. She was prescribed valacyclovir and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.