chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: - Shingrix #1 2-27-2020 no issue  - Shingrix #2 6-9-2020 530p. During night arm hurt, nerve pain down to (L) elbow. Felt - very sick 6/10 - stayed in bed most of day. Temp 100.1 oral. (L) upper arm getting red.  - 6/11 increased red, induration /hard - pain/itch.  - 6/12 worse, thought I might have cellulitis, Redness extending medially around arm Temp 100.1, oral  - 6/13 red, painful, itchy, indurated but Better/ but some chills & HA  - 6/14 way better No fever  Chills & headache every day until 6/14, felt sickest June 10, June 12 arm the worst.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Neuralgia
Clinical narrative: - Shingrix #1 2-27-2020 no issue  - Shingrix #2 6-9-2020 530p. During night arm hurt, nerve pain down to (L) elbow. Felt - very sick 6/10 - stayed in bed most of day. Temp 100.1 oral. (L) upper arm getting red.  - 6/11 increased red, induration /hard - pain/itch.  - 6/12 worse, thought I might have cellulitis, Redness extending medially around arm Temp 100.1, oral  - 6/13 red, painful, itchy, indurated but Better/ but some chills & HA  - 6/14 way better No fever  Chills & headache every day until 6/14, felt sickest June 10, June 12 arm the worst.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Kinrix given in place of Pediarix
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Cold sweat, Disturbance in attention, Dizziness, Head discomfort
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Headache, Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site rash, Injection site reaction, Lethargy, Musculoskeletal stiffness, Pallor
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Peripheral swelling, Rash macular, Tinnitus, Vision blurred, Visual impairment
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Adverse reaction, Dizziness, Erythema, Head discomfort, Headache
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lethargy, Muscular weakness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Rash macular, Skin warm, Tenderness, Tinnitus, Urticaria
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Vision blurred
Clinical narrative: Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Inflammation, Pruritus
Clinical narrative: 7/9/20 Fever the day after vaccine (101.2 F) and extreme fatigue.  7/10/20  No fever, less latigue.  Inflammation, redness, itching of arm. 7/11/20  increased inflammation and severe itching. went to urgent care, diagnosed with cellulitis. prescribed cephalexin,  advised to use benadryl cream and zyrtec tablets. 7/12/20  and 7/13/20  inflammation improving, still some fatigue
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 7/9/20 Fever the day after vaccine (101.2 F) and extreme fatigue.  7/10/20  No fever, less latigue.  Inflammation, redness, itching of arm. 7/11/20  increased inflammation and severe itching. went to urgent care, diagnosed with cellulitis. prescribed cephalexin,  advised to use benadryl cream and zyrtec tablets. 7/12/20  and 7/13/20  inflammation improving, still some fatigue
Sex: U
Vaccine: HEPA, HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 13-SEP-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 23-JUN-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003651: US-009507513-2007USA003647: US-009507513-2007USA003646: US-009507513-2007USA003645: US-009507513-2007USA003648: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA, HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 04-APR-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 24-JUN-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA002536: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 07-AUG-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 25-JUN-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Yes; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA002536: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 01-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA002536: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 28-JUN-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 03-JUL-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source.   combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA002536: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 02-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA002536: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 29-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA002536: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 29-JUN-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S034636, expiration date on 14-NOV-2020), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA002536: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm very swollen and red; arm very swollen and red; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported events for three patients. This is the second of 3 reports.    An 18-year-old female patient receive the 2nd dose of meningococcal group b rlp2086 (TRUMENBA) (lot # CM1497), via an unspecified route of administration at single dose in the arm on 07Jul2020 for immunisation. The patient medical history and concomitant medications were not reported.   On 07Jul2020, the patient experienced arm very swollen and red with outcome of recovering. Therapeutic measures were taken as a result of arm very swollen and red included to apply ice and take Motrin.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Skin warm, Somnolence
Clinical narrative: has been sleeping all day; warm to touch (but had not checked temperature); significant headache; fatigue; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported events for three patients. This is the third of 3 reports.    A 19-year-old male patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) (lot # CM1497), via an unspecified route of administration at single dose on 08Jul2020 for immunisation. The patient medical history and concomitant medications were not reported.   On 08Jul2020, the patient experienced warm to touch (but had not checked temperature), significant headache, fatigue. On 09Jul2020, he has been sleeping all day. The outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site paraesthesia, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: PATIENT DEVELOPED SHINGLES AROUND INJECTION SITE ABOUT 1 MONTH AFTER 2ND SHINGRIX DOSE. HE FELT A TINGLING SENSATION AND SOME ITCHING AROUND THE SITE AND LATER OBSERVED A RASH WHICH HAS NOW LASTED ABOUT 3 WEEKS. HE DID NOT TAKE ANY MEDICATION FOR THE RASH AS HE WAS UNABLE TO SECURE AN APOINTMENT WITH HIS PHYSICIAN. HE DID NOT EXPERIENCE ANY PAIN, JUST MILD ITCHINESS. HE LATER SPOKE TO HIS PHYSICIAN WHO DID NOT PRECRIBE ANY MEDICATION SINCE PATIENT WAS GETTING BETTER.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient became sweaty and pale  and nauseous shortly after the administration of the vaccines.  She was laid down on the bench in the room, feet put up and given apple juice.  She and he mother said in the room with me for approximately 15 minutes prior to us sitting patient up for a short time then to a standing position prior to her leaving the clinic.
Age: 1.58
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever up to >102 and febrile seizures x at least 4d post
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: nausea, vomiting, sore arm, severe  headache, and overall malaise and tiredness.  unable keep  down water x 2 days
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: nausea, vomiting, sore arm, severe  headache, and overall malaise and tiredness.  unable keep  down water x 2 days
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (101.9), headache, body aches, fatigue, sore arm
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Very sore arm, lots of swelling and redness at the injection site, nausea Starting after midnight:  chills, nausea Nausea and aches lasted through the next day Sore arm and swelling lasted a few days Also - I have developed a few sores on my chest that look like shingles ... very itchy but not painful. They remind me of what I had when I had shingles years ago.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash pruritic, Rash vesicular
Clinical narrative: Very sore arm, lots of swelling and redness at the injection site, nausea Starting after midnight:  chills, nausea Nausea and aches lasted through the next day Sore arm and swelling lasted a few days Also - I have developed a few sores on my chest that look like shingles ... very itchy but not painful. They remind me of what I had when I had shingles years ago.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Eczema, Faeces discoloured, Injection site pain, Insomnia
Clinical narrative: First few days was groggy, legs were tender.  Then vomiting began 2-3 days later. Was up a lot at night and crying; lasted 10 days.  Poops were a weird, slimy green. No curds.  Did not feel hot. Sleepwise still recovering. Nursed more often to soothe and still wanting that. Eczema flares up with his vaccines.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: First few days was groggy, legs were tender.  Then vomiting began 2-3 days later. Was up a lot at night and crying; lasted 10 days.  Poops were a weird, slimy green. No curds.  Did not feel hot. Sleepwise still recovering. Nursed more often to soothe and still wanting that. Eczema flares up with his vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Zoster given instead of HIB. Patient appeared fine. Realized when documenting vaccines that incorrect vaccine was given. Notified PCP.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Scab
Clinical narrative: Developed red blisters to his torso Friday July 10, 2020 a few more have developed after the first and the first are now crusted. No fever or cough. Not bothered by the spots. Had telemed visit 7/13/20 to verify and it could be mild reaction, nothing significant.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash in abdominal area, generalized itching feeling.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left shoulder swelling and redness at the injection site and surrounding area
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Disturbance in attention, Fatigue
Clinical narrative: (had a shingles shot in 2015 - no issues) this new shot - extreme temperature and pain to touch at injection site for 5 days / I felt out of it / no energy tired/ slight headache / stomach upset joint aches left side of body / trouble focusing  I have never had a shot reaction like this before in all my years. I have grave concerns regarding getting dose 2 of this vaccine. I need to know why I had such an adverse reaction and if it safe for me to take dose 2. My hope is that others are not impacted as I was and that this medication is analyzed and deemed truly safe for use.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site pain
Clinical narrative: (had a shingles shot in 2015 - no issues) this new shot - extreme temperature and pain to touch at injection site for 5 days / I felt out of it / no energy tired/ slight headache / stomach upset joint aches left side of body / trouble focusing  I have never had a shot reaction like this before in all my years. I have grave concerns regarding getting dose 2 of this vaccine. I need to know why I had such an adverse reaction and if it safe for me to take dose 2. My hope is that others are not impacted as I was and that this medication is analyzed and deemed truly safe for use.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Localized Redness - swelling 6 cm to Left Buttocks hot to touch, started one day after initial immunization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: Similar to 1st dose (given early Jan. 2020), arm became inflamed, hot to touch, red, and slightly swollen within 3 hours even though an ice pack was applied immediately. 2 Ibuprophen taken when arm movement & touch became more painful. More ice applied evening and 2 more Ibuprophen at bedtime. Around 10:30 next morning (6/24), nose started running, slight headache, chilled, extremely tired, achy, coughing, soreness in lower arm, particularly R side, Thinking foggy. Returned to bed for 4 hours. Took temperature 2x oral = 100.4, underarm = 99.5. Phoned physician, could not reach. Called VAERS. Applied more ice and rested. 2 more Ibuprophen at bedtime. Thursday morning 6/25/20 Temp back to normal, arm still painful, head still foggy but respiratory better. Concluded that recovery was too swift to be flu; reaction (likely) to vaccine (physician when she returned my calls next day 6/25, concurred). Slight heat and swelling in the arm persisted for another day. Returned to fully functioning by 6/26/2020.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Pain in extremity, Peripheral swelling, Rhinorrhoea
Clinical narrative: Similar to 1st dose (given early Jan. 2020), arm became inflamed, hot to touch, red, and slightly swollen within 3 hours even though an ice pack was applied immediately. 2 Ibuprophen taken when arm movement & touch became more painful. More ice applied evening and 2 more Ibuprophen at bedtime. Around 10:30 next morning (6/24), nose started running, slight headache, chilled, extremely tired, achy, coughing, soreness in lower arm, particularly R side, Thinking foggy. Returned to bed for 4 hours. Took temperature 2x oral = 100.4, underarm = 99.5. Phoned physician, could not reach. Called VAERS. Applied more ice and rested. 2 more Ibuprophen at bedtime. Thursday morning 6/25/20 Temp back to normal, arm still painful, head still foggy but respiratory better. Concluded that recovery was too swift to be flu; reaction (likely) to vaccine (physician when she returned my calls next day 6/25, concurred). Slight heat and swelling in the arm persisted for another day. Returned to fully functioning by 6/26/2020.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction, Skin warm, Vaccine positive rechallenge
Clinical narrative: Similar to 1st dose (given early Jan. 2020), arm became inflamed, hot to touch, red, and slightly swollen within 3 hours even though an ice pack was applied immediately. 2 Ibuprophen taken when arm movement & touch became more painful. More ice applied evening and 2 more Ibuprophen at bedtime. Around 10:30 next morning (6/24), nose started running, slight headache, chilled, extremely tired, achy, coughing, soreness in lower arm, particularly R side, Thinking foggy. Returned to bed for 4 hours. Took temperature 2x oral = 100.4, underarm = 99.5. Phoned physician, could not reach. Called VAERS. Applied more ice and rested. 2 more Ibuprophen at bedtime. Thursday morning 6/25/20 Temp back to normal, arm still painful, head still foggy but respiratory better. Concluded that recovery was too swift to be flu; reaction (likely) to vaccine (physician when she returned my calls next day 6/25, concurred). Slight heat and swelling in the arm persisted for another day. Returned to fully functioning by 6/26/2020.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Vision blurred
Clinical narrative: Pt was given her 1st dose of HPV. She became light headed dizzy & clammy. Pt vision became blurry. Pt was assisted to lay down & vitals were taken. BP @ admission - 109/71 BP @ occurrence 100/61
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Mydriasis
Clinical narrative: Pt. was given Gardasil @ 10:45 am. As I was throwing away items - (MA) Noticed that pt's pupils were dilated and she looked flushed. Pt was immediately laid back And was made to sit for 15 min. Pt was examined by Dr. I was instructed to take vitals & if stable pt could go.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Rash
Clinical narrative: pt had fever/chills x 2 days headache x 3 days. pt had rash on back of neck inner arms and upper thighs bilaterally
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Shingles like rash on torso; Large circular rash at the injection site; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2015US151526).  This spontaneous report has been received from a health care professional, referring to a 55-year-old female patient. Information about the patient's pertinent medical history and concurrent conditions was not provided. Her concomitant medications included vortioxetine hydrobromide (BRINTELLIX), insulin detemir (LEVEMIR), promethazine, montelukast sodium (SINGULAIR), topiramate (TOPAMAX) and losartan (manufacturer unknown). The patient's previous drug reactions and allergies was not provided.  On 07-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), at a dose of 1 dosage form, administered subcutaneously, lot number L012477 and expiration date 10-JUL-2016, for immunization (strength, frequency and anatomical location were not provided). On this day, the patient was vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN), at a dose of one dosage form (1DF), administered intramuscularly, lot number 15724P, for immunization (strength, frequency, anatomical location and expiration date were not reported).   On 09-SEP-2015, the patient experienced a large circular rash at the injection site (vaccination site rash) and shingles like rash on torso (herpes zoster).  At the time of reporting, the outcome of vaccination site rash and herpes zoster was unknown.  The causality assessment between influenza virus sag 3v vaccine inactivated (FLUVIRIN) and vaccination site rash was reported as "not assessable" by the reporter. The causality assessment between influenza virus sag 3v vaccine inactivated (FLUVIRIN) and herpes zoster was considered "suspected" by the reporter.  The causal relationship between zoster vaccine live (ZOSTAVAX) and vaccination site rash and herpes zoster was not provided.  The agency considered the events of vaccination site rash and herpes zoster as medically significant events(conflicting information since vaccination site rash was also considered as non serious).; Sender's Comments:  594758:
Sex: F
Vaccine: FLUX, HBHEPB, MMR, VARZOS
Symptoms: Product administered to patient of inappropriate age, Pustule, Rash, Varicella
Clinical narrative: Chicken pox rash - 20 plus pocks all over body; 1 year old patient vaccinated with seasonal influenza vaccine; Information has been downloaded from Regulatory Authority (US-CHIRONMA-PHHY2017US012707).  This spontaneous report has been received from a health care professional, referring to a 1-year-old female patient. Information about the patient's concurrent conditions included cough and runny nose. Her concomitant medications and previous drug reactions and allergies was not provided.  On 10-NOV-2016, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown), at a dose of one dosage form for immunization (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided. On this same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), at a dose of 1 dosage form, administered at an unknown route of administration for immunization (strength, frequency, anatomical location was not provided; lot number was unknown). The patient was vaccinated also with Hib conj vaccine (OMPC), hepatitis B virus vaccine rHBsAg (yeast) (COMVAX), at a dose of 1 dosage form, administered at an unknown route of administration for immunization (strength, frequency, anatomical location was not provided; lot number was unknown). On this same date, the patient was vaccinated with influenza virus vaccine (INFLUENZA VIRUS VACC SEASONAL INN), at a dose of 1 dosage form, administered at an unknown route of administration for immunization (strength, frequency, anatomical location was not provided; lot number was unknown) (product administered to patient of inappropriate age).  On 12-NOV-2016, the patient experienced Chicken pox rash - 20 plus pocks all over body (varicella).  At the time of reporting, the patient had no recovered from varicella.  The causality assessment between influenza virus vaccine (INFLUENZA VIRUS VACC SEASONAL INN) and product administered to patient of inappropriate age and varicella was considered "not assessable" by the reporter.  The causal relationship between zoster vaccine live (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and Hib conj vaccine (OMPC), hepatitis B virus vaccine rHBsAg (yeast) (COMVAX) and product administered to patient of inappropriate age and varicella was not provided.  The agency considered the events of product administered to patient of inappropriate age and varicella as medically significant events.; Sender's Comments:  665992:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Hyperventilation, Rash, Urticaria
Clinical narrative: Parent contacted office approximately 3 hours after administration - patient had developed rash all over and already been given 25 mg Benedryl.  Nurse triage advised additional 25 mg benedryl.  noted injection site clear.  Mother unable to visualize site. No difficulty breathing or swallowing, no swelling of eyes, face, mouth, tongue, or throat at this time. Advised visit to ER if developed noted symptoms.   Patient admitted to ER at 9pm.  intake states patient developed shortness of breath and hyperventilated.  Prednisone given and patient observed for two hours.  Continued improvement and asymptomatic at discharge 11 pm. Given 5 day course of steroid and advised Benedryl PRN.  Call to Pediatrician office 8/31 stating also hives due to prednisone, advised by pharmacist to give Benedryl and follow up with PCP.   Follow up appt at Pediatrician office 9/4:  last dose of prednisone 9/3, no hives observed. suspected reaction to component of HPV vaccine, no further HPV vaccine indicated.  given VAERS reporting information.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Cold sweat, Disturbance in attention, Dizziness, Head discomfort
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Headache, Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site rash, Injection site reaction, Lethargy, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Peripheral swelling, Rash macular, Tinnitus, Vision blurred, Visual impairment
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Adverse reaction, Dizziness, Erythema, Head discomfort, Headache
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lethargy, Muscular weakness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Rash macular, Skin warm, Tenderness, Tinnitus, Urticaria
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Vision blurred
Clinical narrative: Pt. had reaction in office 3 minutes after receiving vaccine. Pt. felt light headed and dizzy. MA at the time gave patient water and had patient elevate his legs and lay down.  Pt. had additional reaction upon coming home. Pt. c/o ringing in ears, vision change, dark and cloudy. Pt. had low grade temp. 100*F, Per  Mother, administered Tylenol . Mother states that Saturday pt. c/o head pressure in forehead that lead to HA Associated sx include: arm weakness, arm tenderness. Mother states that arm is blotchy, red, swollen and has rash that is described as hive-like, warm to touch, more painful and lethargic.  Pt. is currently stable at home.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: bad reaction to a live vaccine; This spontaneous report was received from a 66-year-old female patient reporting on herself, via Pfizer (manufacturer control # 2020239584). The patient's medical history and concurrent conditions were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose number, route, lot # and expiration date were not reported). Concomitant medications were not reported.  On an unknown date (reported as "a number of years ago"), the patient experienced a bad reaction to the "live vaccine" pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(vaccination complication.)   The outcome of vaccination complication was unknown.    The reporter considered vaccination complication to be related to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).