chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) and dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 11.0
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020) and VARIVAX lot number N021720 (expiration date 10-AUG-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 13.0
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-year-old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) and VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-months-old patient of unknown gender. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 10 weeks old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Impaired work ability, Influenza
Clinical narrative: After 24 hours, developed flu symptoms, headache, fever, chills, cough. Was unable to work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: After 24 hours, developed flu symptoms, headache, fever, chills, cough. Was unable to work.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site rash
Clinical narrative: Patient received injection on 12/19/18 at 845 AM. At 11 PM patient presented to ER for tenderness and rash to left arm below the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Patient recieved immunization on 12/19/18 around 12:20 PM. Patient called pharmacy around 9:15 AM on 12/21/18 to report adverse reaction. Patient states she had aches and pains most of the day on 12/20/18 and rested most of the day. Patient woke up on 12/21/18 with a welt the size of a baseball and called pharmacy. Patient said she had been using ice/cold compress but still has a welt the size of a baseball. Recommend pt to continue using ice/cold compress, rest as much as possible, and seek medical treatment. Patient stated she would ice through the weekend (today is Friday) and contact doctor next week if still needed. I encouraged patient to seek medical treatment sooner than that.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Insomnia, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Patient recieved immunization on 12/19/18 around 12:20 PM. Patient called pharmacy around 9:15 AM on 12/21/18 to report adverse reaction. Patient states she had aches and pains most of the day on 12/20/18 and rested most of the day. Patient woke up on 12/21/18 with a welt the size of a baseball and called pharmacy. Patient said she had been using ice/cold compress but still has a welt the size of a baseball. Recommend pt to continue using ice/cold compress, rest as much as possible, and seek medical treatment. Patient stated she would ice through the weekend (today is Friday) and contact doctor next week if still needed. I encouraged patient to seek medical treatment sooner than that.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pruritus, Sensitive skin
Clinical narrative: Patient recieved immunization on 12/19/18 around 12:20 PM. Patient called pharmacy around 9:15 AM on 12/21/18 to report adverse reaction. Patient states she had aches and pains most of the day on 12/20/18 and rested most of the day. Patient woke up on 12/21/18 with a welt the size of a baseball and called pharmacy. Patient said she had been using ice/cold compress but still has a welt the size of a baseball. Recommend pt to continue using ice/cold compress, rest as much as possible, and seek medical treatment. Patient stated she would ice through the weekend (today is Friday) and contact doctor next week if still needed. I encouraged patient to seek medical treatment sooner than that.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin induration, Skin warm
Clinical narrative: Patient recieved immunization on 12/19/18 around 12:20 PM. Patient called pharmacy around 9:15 AM on 12/21/18 to report adverse reaction. Patient states she had aches and pains most of the day on 12/20/18 and rested most of the day. Patient woke up on 12/21/18 with a welt the size of a baseball and called pharmacy. Patient said she had been using ice/cold compress but still has a welt the size of a baseball. Recommend pt to continue using ice/cold compress, rest as much as possible, and seek medical treatment. Patient stated she would ice through the weekend (today is Friday) and contact doctor next week if still needed. I encouraged patient to seek medical treatment sooner than that.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient C/O red rash noted for 3-4 days following vaccination. Fine red rash that was warm to touch noted upon assessment. No S/S of infection noted upon assessment.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Abnormal behaviour, Asthenia, Decreased appetite, Dehydration, Fluid intake reduced
Clinical narrative: December 16, 2018: Excessive Vomiting, 102.5 fever, Malaise, Excessive sleeping. December 17, 2018: Dehydration/I.V., Vomiting, Loss of appetite, Decreased Fluids, Decreased wet diapers, Weakness, excessive sleeping, 103.5 fever. December 18-Present 2018: Malaise, weakness, excessive sleeping, poor appetite, not responding to name and not acting as normal.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Hepatic enzyme increased, Hypersomnia, Malaise, Pyrexia, Unresponsive to stimuli
Clinical narrative: December 16, 2018: Excessive Vomiting, 102.5 fever, Malaise, Excessive sleeping. December 17, 2018: Dehydration/I.V., Vomiting, Loss of appetite, Decreased Fluids, Decreased wet diapers, Weakness, excessive sleeping, 103.5 fever. December 18-Present 2018: Malaise, weakness, excessive sleeping, poor appetite, not responding to name and not acting as normal.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Urinary system X-ray, Urine output decreased, Vomiting
Clinical narrative: December 16, 2018: Excessive Vomiting, 102.5 fever, Malaise, Excessive sleeping. December 17, 2018: Dehydration/I.V., Vomiting, Loss of appetite, Decreased Fluids, Decreased wet diapers, Weakness, excessive sleeping, 103.5 fever. December 18-Present 2018: Malaise, weakness, excessive sleeping, poor appetite, not responding to name and not acting as normal.
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Presyncope
Clinical narrative: Pt had a presyncope episode from the injection. Advised staff he did not eat anything prior to injection.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Full blood count, Hyperhidrosis
Clinical narrative: 12/20/2018, started with vertigo/near-syncope, manifested over several hours to include chills, fever (101.7 F), achy joints, swollen/painful injection site, nausea, vomiting, diaphoresis, diarrhea.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Metabolic function test, Nausea, Presyncope
Clinical narrative: 12/20/2018, started with vertigo/near-syncope, manifested over several hours to include chills, fever (101.7 F), achy joints, swollen/painful injection site, nausea, vomiting, diaphoresis, diarrhea.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo, Vomiting
Clinical narrative: 12/20/2018, started with vertigo/near-syncope, manifested over several hours to include chills, fever (101.7 F), achy joints, swollen/painful injection site, nausea, vomiting, diaphoresis, diarrhea.
Age: 61.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Muscle tightness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Spouse described patient having muscle pain and tightness radiating from the arm into the right side of the neck. Patient visited ER on 12/20 and was prescribed Naproxen 500mg and baclofen 10mg.
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an elderly male patient of approximately 65 years-old. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history. On an unknown date in 2018, (reported as within the past few months) the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, route of administration, anatomical location, lot #, and expiration date were not reported) for immunisation. On an unknown date in 2018, the patient experienced an injection site reaction which was described as a rash after administration of PNEUMOVAX 23, which the reporter was learned weeks later and reported on 07-DEC-2018 (reported as: today). It was reported that he contacted the pharmacist for medical attention. Also, was unknown by the reporter if any diagnostic lab and studies were performed or if any treatment was given. At the time of this report the patient was fine. The outcome of the event was reported as recovered. The causal relationship between the events and PNEUMOVAX 23 was not reported. This is one of the two reports received from the same reporter.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right Upper arm redness, swelling, tenderness, warmth around flu vaccine injection site. Denies fevers or chills. Started the day after vaccine administration.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and abdominal pain.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Cellulitis, Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid became red, swollen, and hot to touch, was seen in office and advised: return to office if redness or red streak started more than 48 hours (2 days) after the shot and Redness around the shot becomes larger than 3 inches (7.5 cm). Advised to only get one vaccine at a time from now on as child has had reaction in the past (could not walk all day with 4 year vaccines). Will cover with AUGMENTIN for cellulitis. Will give MOTRIN for inflammation, dose administered in office. Will monitor for worsening and seek ER care.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Patient complained about fever over 101 for 24 hours diarrhea (watery for more than 3 days). Aches for more than 72 hours took 3 days for pt to get back to normal.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 04-APR-2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9 weeks old patient of unknown gender. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 6-year-old patient of unknown gender. On 27-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N034554 (expiration date 05-DEC-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache and chills. On an unknown date, the outcome of the headache and chills were recovered/resolved. It was unknown if the reporter considered the headache and chills to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported for the patients. The reporter stated that many of his patients that had received BEXSERO complained of headaches and chills. The side effects last about 2 days. The reporter said he would withhold vaccination if a patient had a school exam the following day. The reporter did agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX over two months before the date of reporting. The patient asked how long should they wait after shingles occurs to obtain the second dose of SHINGRIX and could SHINGRIX be administered with an active case of shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever was unknown and the outcome of the injection site pain was not reported. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per product indication. It was stated that, a few patients experienced fever (body temperature: less than 101 degree F) and other patients had pain at injection site. Some patients did not realize how much SHINGRIX would impact them. None of these events deterred receipt of second dose. Lab Comments: On unknown date, the body temperature was less than 101 degree F.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of welts in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced welts and product supply issue. On an unknown date, the outcome of the welts and product supply issue were unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in the first week of June 2018, at that time he made an appointment for the 2nd dose in December. The patient kept the appointment only to find out that the doctor did not have vaccine, they had ordered and been shorted. The patient then checked with their local pharmacy where the pharmacist informed him that not only had they been out for weeks, but no other pharmacy in the area had any. They had heard anecdotal reports from many customers regarding their inability of finding the vaccine at this point, if he wish to get the vaccine, was to start the sequence again. Of course, there was no guarantee that the 2nd dose would be available after he restart. It would seem that either he or their insurance carrier would had to pay for the initial dose a second time. The patient was asking asked how many customers would find themselves in this state. A nice bump to GlaxoSmithKline bottom line he thought. The patient had developed welts on the inside of both arms and belly. The patient asked if this was a delayed reaction to the 1st dose or perhaps a side effect of not getting the 2nd dose.
Sex: F
Vaccine: FLU4
Symptoms: Death
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter reported that nasty poison's flu shot killed the patient last January. Reported Cause(s) of Death: Unknown cause of death.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Headache, Injection site erythema, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 84-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (for tolerance of 1st dose refer link case US2018226084). On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 µg. On 11th December 2018, 7 hrs after receiving SHINGRIX, the patient experienced headache, fever and feeling bad. On 12th December 2018, the patient experienced injection site erythema, feeling hot, red rash and muscle pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, fever and feeling bad were recovered/resolved and the outcome of the injection site erythema, feeling hot and red rash were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the headache, fever, feeling bad, injection site erythema, feeling hot, red rash and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever of 99.7 degrees F. Her normal temperature usually would be 97.6 degrees F. The patient received TYLENOL 650 mg extended release. On 12th December 2018 in the morning, the patient experienced muscle aches, headache and fever of 98.9 degrees F. The patient's arm was bright red around the injection site, about the size of the bottom of a coffee cup. It was hot to the touch and rashy down to her elbow. The patient again received TYLENOL in the evening and felt better with no fever. She experienced a rash that extended from her right elbow, up her arm, across her chest and down her left arm to the elbow. The rash was not itchy or burning, but it was fine reddish rash. It was reported that the patient thought that the rash looked similar to the rash her children had when they had measles. The fever returned a couple hours after waking up, but at the time of reporting fever gone away. The reporter was consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 84-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (for tolerance of 1st dose refer link case US2018226084). On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 µg. On 11th December 2018, 7 hrs after receiving SHINGRIX, the patient experienced headache, fever and feeling bad. On 12th December 2018, the patient experienced injection site erythema, feeling hot, red rash and muscle pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, fever and feeling bad were recovered/resolved and the outcome of the injection site erythema, feeling hot and red rash were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the headache, fever, feeling bad, injection site erythema, feeling hot, red rash and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever of 99.7 degrees F. Her normal temperature usually would be 97.6 degrees F. The patient received TYLENOL 650 mg extended release. On 12th December 2018 in the morning, the patient experienced muscle aches, headache and fever of 98.9 degrees F. The patient's arm was bright red around the injection site, about the size of the bottom of a coffee cup. It was hot to the touch and rashy down to her elbow. The patient again received TYLENOL in the evening and felt better with no fever. She experienced a rash that extended from her right elbow, up her arm, across her chest and down her left arm to the elbow. The rash was not itchy or burning, but it was fine reddish rash. It was reported that the patient thought that the rash looked similar to the rash her children had when they had measles. The fever returned a couple hours after waking up, but at the time of reporting fever gone away. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Incomplete course of vaccination, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of back pain in a female patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX. On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced back pain, injection site pain and pain in arm. On an unknown date, the outcome of the back pain, injection site pain and pain in arm were unknown. It was unknown if the reporter considered the back pain, injection site pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine and on the same day the patient experienced back pain, pain radiating from the injection site down her arm. The patient refused to get the 2nd dose. This case has been linked to cases US2018226062 and US2018226065, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a swollen arm after getting the SHINGRIX dose. No further clarification on the event was provided. The patient chose not to get the 2nd dose of SHINGRIX vaccine. This case has been linked to cases US2018226058 and US2018226065, reported by the same reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (subcutaneous). On 10th December 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In December 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX subcutaneously, which led to wrong route of vaccine administration. Less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site. The pharmacist did not know when the events started and consented to follow up. This case has been linked with case US2018226103, reported by the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from non-contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's concomitant medications were not reported. The patient was post partum and supposedly received the vaccine at another office. The patient developed cellulitis on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, vaccination details and event term descriptions including onset date and location of cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site warmth
Clinical narrative: Let arm very red and inflamed. Warm to touch, Knot under skin at injection site. Redness goes all the way down to the elbow.
Age: 1.75
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on cheeks and chest
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: I had a two degree fever; extreme chills with violent shaking for three or four hours. (I say two degrees of fever because my normal temp is 96.5 to 97, but my temp during this experience was 99.1).
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 week old male patient. The patient had no medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 20-NOV-2018, the patient was vaccinated with the first dose of ROTATEQ lot number R002515 and expiration date of 13-SEP-2019 for prophylaxis (dose was not reported). On 05-DEC-2018, the patient experienced diarrhea and vomiting and was examined at an unspecified emergency room and seen by the physician and an unspecified stool test was performed which was positive for rotavirus. The patient did not received treatment to aforementioned events. The outcome of rotavirus test positive, vomiting and diarrhoea was reported as resolved on an unspecified date in December 2018. Additionally, the reporter did not provide causality assessment between the events and vaccination with ROTATEQ.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-DEC-2016, the patient was treated by a healthcare provider for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.