chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child vaccine that may have had temperature excursion (Data Logger Failure) with stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & revaccination Child Had no ill Effects thus FAR
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting and Revaccination Child had no ill effects thus far
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination  Child had no ill effects this far
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge tempts before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperatures excursion (Data Logger Failure) with stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination. Child Had No ill Effects thus FAR.
Sex: M
Vaccine: HPV9
Symptoms: Product dose omission
Clinical narrative: he missed the 3rd dose of GARDASIL 9 scheduled April 18, 2020; This spontaneous report has been received from a male patient of unknown age referring to himself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On unknown dates, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 18-APR-2020, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product dose omission) due to financial cost.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 30-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 01-MAY-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 05-MAY-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950:US-009507513-2005USA004990 US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: temperature of 100.9; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had temprature of 100.9 the next morning. The reporter wanted to know was that normal.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash macular, Skin swelling, Skin warm
Clinical narrative: skin was blotchy red; skin was blotchy red, swollen and warm to the touch; skin was blotchy red, swollen and warm to the touch; This case was reported by a nurse via sales rep and described the occurrence of red blotches in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA63AA, expiry date unknown) for prophylaxis.   On 1st May 2020, the patient received the 1st dose of Bexsero. On 6th May 2020, 5 days after receiving Bexsero, the patient experienced red blotches, skin swelling and skin warm. On 7th May 2020, the outcome of the skin swelling and skin warm were recovered/resolved. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches, skin swelling and skin warm to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. On an unknown date on friday, the patient received vaccine. On Wednesday morning the patient experinced skin was blotchy red, swollen and warm to the touch, no fever. On Thursday morning patient woke up and the redness had gone down the patients arm a little further but was no longer swollen or warm.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Influenza like illness, Wrong product administered
Clinical narrative: Mild flu like symptoms; Mild discomfort; incorrectly administered Infanrix instead of Boostrix to a 48 years old patient; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 48-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.  On an unknown date, the patient received Infanrix. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product and wrong vaccine administered were unknown.  Additional details were provided as follows: A health care provider called reporting that they incorrectly administered Infanrix instead of Boostrix to a 48 years old patient, which led to  adult use of a child product and wrong vaccine administered.   Follow up information received from other health professional on 5th May 2020: The patient demographics details were updated. On 24th February 2020, the patient received the 1st dose of Infanrix intramuscularly. Less than 3 months after the patient experienced influenza-like symptoms and discomfort. The patient was due for Tdp vaccine the medical assistants misunderstood directions of physician and drew up and administered Dtap to the patient. This could had been prevented should the MA had used critical thinking as well as educational regarding age range on Dtap vs Tdap. In speaking with the patient, he did not express any adverse events abnormal to any other vaccine he had. Reported very mild flu-like symptoms. The reporter spoke directly with patient who reported that he did know if he was experiencing adverse reactions because of similar reactions to vaccine in past. Mild discomfort and flu like symptoms. The reporter advised the patient to notify immediately should any additional or abnormal  symptoms present themselves. Till 17th April 2020 nothing additional had been reported. The VAERS details were updated. It was unknown if the reporter considered the influenza-like symptoms and discomfort to be related to Infanrix.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Injection site swelling
Clinical narrative: Burning sensation began on her upper right shoulder; Swelling at the injection site; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced headache and injection site swelling. On 25th March 2020, the patient experienced burning sensation. On an unknown date, the outcome of the headache and injection site swelling were recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the headache, burning sensation and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a severe headache and swelling at the injection site the day following the vaccine.   The headache lasted 24-30 hours and the swelling lasted 2 days.   Six weeks ago, from the day reporting a burning sensation began on her upper right shoulder. There were no visible marks.The area was next to her bra strap and was approximately a 3"x1/2" strip. It has not been diagnosed as shingles.Her dermatologist was not sure what it was. Reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Headache, Influenza like illness, Injection site discomfort, Injection site rash
Clinical narrative: barely got out of bed; ached very bad; terrible headache; light headiness; felt like bad case of the flu; fever of 100; rash at injection site; warm and uncomfortable at injection site; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of bedridden in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort. On an unknown date, the outcome of the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received shingrix vaccine and for the first two days patient could barely get out of bed, she ached very badly, had a terrible headache with light headiness, felt like she had a bad case of the flu,  a fever of 100 and a rash at the injection site which was warm and uncomfortable.  On the third day the symptoms began to resolve. The patient medical doctor recommended that she get her second shot. Reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: barely got out of bed; ached very bad; terrible headache; light headiness; felt like bad case of the flu; fever of 100; rash at injection site; warm and uncomfortable at injection site; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of bedridden in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort. On an unknown date, the outcome of the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received shingrix vaccine and for the first two days patient could barely get out of bed, she ached very badly, had a terrible headache with light headiness, felt like she had a bad case of the flu,  a fever of 100 and a rash at the injection site which was warm and uncomfortable.  On the third day the symptoms began to resolve. The patient medical doctor recommended that she get her second shot. Reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Bedridden, Multiple sclerosis
Clinical narrative: She's bed bound at home with MS; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced she's bed bound at home with ms (multiple sclerosis) on an unspecified date with outcome of unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 5/7/20 vaccine was given and patient s arm was sore and she was unable to sleep on that side . On 5/10/20 patient developed a bruise around injection site, on 5/13/20 patient arm was red , warm to touch, swollen and itchy. the area was 4in L by 3 in W. Advised to place cool compress on site. Spoke with PAC and he stated to have her use cool compress , take Benadryl or antihistamine. If no improvements call to be evaluated. 5/14/20 called patient and she stated  she took Benadryl and reaction was resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Sleep disorder
Clinical narrative: 5/7/20 vaccine was given and patient s arm was sore and she was unable to sleep on that side . On 5/10/20 patient developed a bruise around injection site, on 5/13/20 patient arm was red , warm to touch, swollen and itchy. the area was 4in L by 3 in W. Advised to place cool compress on site. Spoke with PAC and he stated to have her use cool compress , take Benadryl or antihistamine. If no improvements call to be evaluated. 5/14/20 called patient and she stated  she took Benadryl and reaction was resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site that extends to lower arm
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Injection site pain, Metabolic function test
Clinical narrative: Near Syncope episode Acute pain of Left shoulder
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Presyncope, Urine analysis
Clinical narrative: Near Syncope episode Acute pain of Left shoulder
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Muscle fatigue
Clinical narrative: sore at injection site, treatment resistant headache (over 36 hours so far), joint and muscle fatigue
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever to 104F started 2 days after vaccination and had 5-10 minute long seziure 4 days after vaccination.  Fever continued until 6 days post-vaccination with brief seizure activity once per day until fever resolved.  No other symptoms
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Mom of patient called and stated that patient had a rash around the injection site and was advised to just monitor it for a day and then call back if it got worse. Called again the next day and stated that the rash seemed to have gotten worse and it was now looking like hives. Was started on an oral steroid since it was a reaction to the vaccination and the mother was told to call back if symptoms worsen or she has any questions.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Eye movement disorder, Pyrexia, Seizure like phenomena, Tremor, Unresponsive to stimuli
Clinical narrative: Wed 5/13/20: around midnight, ~13-15 hrs after late 4-mo shot series was given at age 6 mos 1 day, he woke w/an emesis, mom felt tactile temp, checked him & had a mild temp of 101. Gave Tylenol & slept. Thursday 5/14/20: Tmax 101.8, controlled w/Tylenol. Afeb off Tylenol by evening of 5/14 w/temp 98 around 1800 hrs Thursday, 5/14. Friday 5/15/20 around 1400 hrs: was being fed when mom noted arms out akimbo w/shaking in a vibratory manor of arms, less so in bilateral legs, & eyes rolled up & was unresponsive for ~45 secs. No gagging or emesis prior to sz & no cyanosis of perioral area.  Sz activity stopped, eyes were closed but tried to feed again. After a few secs had recurrent seizure type, but just lasted 5-10 secs. Slept thereafter for 10-20 mins & has been fine since as of parent calling me at ~1530 hrs. Told to take to Immediate Care for recurrent fever over 100.4, or a recurrent seizure of >=60 secs.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Wed 5/13/20: around midnight, ~13-15 hrs after late 4-mo shot series was given at age 6 mos 1 day, he woke w/an emesis, mom felt tactile temp, checked him & had a mild temp of 101. Gave Tylenol & slept. Thursday 5/14/20: Tmax 101.8, controlled w/Tylenol. Afeb off Tylenol by evening of 5/14 w/temp 98 around 1800 hrs Thursday, 5/14. Friday 5/15/20 around 1400 hrs: was being fed when mom noted arms out akimbo w/shaking in a vibratory manor of arms, less so in bilateral legs, & eyes rolled up & was unresponsive for ~45 secs. No gagging or emesis prior to sz & no cyanosis of perioral area.  Sz activity stopped, eyes were closed but tried to feed again. After a few secs had recurrent seizure type, but just lasted 5-10 secs. Slept thereafter for 10-20 mins & has been fine since as of parent calling me at ~1530 hrs. Told to take to Immediate Care for recurrent fever over 100.4, or a recurrent seizure of >=60 secs.
Sex: F
Vaccine: HEP
Symptoms: Immunoglobulin therapy, Inflammation, Kawasaki's disease, Pyrexia, Rash
Clinical narrative: Fever and Rash. She was treated with IVIG on 5/13 for concerns for systemic inflammation and symptoms of Kawasaki disease.
Age: 1.17
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Body temperature increased, Rash
Clinical narrative: temp of 101 at the highest, and rash all over body.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: Patient got the 1st Shingrix in 03/25/2020, and came back today reported to us that not long after the Shingrix shot patient had chickenpox rash on her left hand. Which was very itchy and painful but gone away on its own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Hypersomnia, Injection site erythema
Clinical narrative: Within 12 hours, I had severe body, muscle and joint aches. I was initially unable to sleep. I had severe fatigue and weakness and was only able to get out of bed for meals and then had to return to bed and slept for the next 16 hours or more.  At the time of this report (55 hours later), I continue to have a large, red, raised mark on my arm at injection site which was initially painful and is currently very itchy. Fatigue is diminishing. Joint and muscle pain is diminishing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Insomnia, Myalgia
Clinical narrative: Within 12 hours, I had severe body, muscle and joint aches. I was initially unable to sleep. I had severe fatigue and weakness and was only able to get out of bed for meals and then had to return to bed and slept for the next 16 hours or more.  At the time of this report (55 hours later), I continue to have a large, red, raised mark on my arm at injection site which was initially painful and is currently very itchy. Fatigue is diminishing. Joint and muscle pain is diminishing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Within 12 hours, I had severe body, muscle and joint aches. I was initially unable to sleep. I had severe fatigue and weakness and was only able to get out of bed for meals and then had to return to bed and slept for the next 16 hours or more.  At the time of this report (55 hours later), I continue to have a large, red, raised mark on my arm at injection site which was initially painful and is currently very itchy. Fatigue is diminishing. Joint and muscle pain is diminishing.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccinations. Child Had No ill Effects thus FAR
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination. Child Had No ill Effects thus FAR
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be AT Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination  Child had no ill effects thus far
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far