chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Headache, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: massive headache 24/7; life has turned to shit cant do any thing; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient got the Pfizer vaccine second shot on 28Sep2021 and have had a massive headache 24/7 since. Patient had MRI done, CAT scans on an unspecified date in 2021, any idea of this or a way to get rid of it. Patient stated that he can't take it no more, his life has turned to shit and can't do anything from an unspecified date in 2021. Patient wanted to know if there was a cure for this, patient never had headaches before now this one never goes away stays all day all night. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hives; Palpitations; Swelling of tongue; Fever; Dizziness; Stomach pain; Fatigue; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm (also reported as left shoulder) on 29Oct2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hives, positional vertigo, solar urticaria and allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received ibuprofen (MOTRIN) and experienced drug allergy. On 29Oct2021, the patient experienced hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting were resolved with lasting effects on an unknown date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Palpitations
Clinical narrative: Hives; Palpitations; Swelling of tongue; Fever; Dizziness; Stomach pain; Fatigue; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm (also reported as left shoulder) on 29Oct2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hives, positional vertigo, solar urticaria and allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received ibuprofen (MOTRIN) and experienced drug allergy. On 29Oct2021, the patient experienced hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting were resolved with lasting effects on an unknown date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swollen tongue, Urticaria, Vomiting
Clinical narrative: Hives; Palpitations; Swelling of tongue; Fever; Dizziness; Stomach pain; Fatigue; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm (also reported as left shoulder) on 29Oct2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hives, positional vertigo, solar urticaria and allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received ibuprofen (MOTRIN) and experienced drug allergy. On 29Oct2021, the patient experienced hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, palpitations, swelling of tongue, fever, dizziness, stomach pain, fatigue, diarrhea and vomiting were resolved with lasting effects on an unknown date in 2021.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Symptoms started on 10/30/2021- Dry cough, lethargic, agitation, apneic, tachypnea. COVID-19 positive on 10/30/21, passed on 11/05/2021.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Agitation, Apnoea, COVID-19, Cough, Death
Clinical narrative: Symptoms started on 10/30/2021- Dry cough, lethargic, agitation, apneic, tachypnea. COVID-19 positive on 10/30/21, passed on 11/05/2021.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lethargy, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: Symptoms started on 10/30/2021- Dry cough, lethargic, agitation, apneic, tachypnea. COVID-19 positive on 10/30/21, passed on 11/05/2021.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Headache
Clinical narrative: normal adverse of the vaccine for patient after 2 days after lower back pain gone but came back tingling began 4 days after vaccine at the 7 of nov was pronunced and patient went to emergency room for the pain.... to follow up with a neurogist for the tingling. to this day patient has that tingling in his legs  feet arms and hands.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Pain, Paraesthesia
Clinical narrative: normal adverse of the vaccine for patient after 2 days after lower back pain gone but came back tingling began 4 days after vaccine at the 7 of nov was pronunced and patient went to emergency room for the pain.... to follow up with a neurogist for the tingling. to this day patient has that tingling in his legs  feet arms and hands.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Cognitive disorder, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: Tremors; twitches; brain fog; cognitive changes; extreme fatigue; insomnia; neurological symptoms; gastro symptoms; headaches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 02:00 (age at vaccination 53 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history included none. There were no known allergies. There were no concomitant medications. Facility type vaccine other was Stadium. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. On 26Feb2021 02:30 PM the patient experienced tremors, twitches, brain fog, cognitive changes, extreme fatigue, insomnia, neurological symptoms, gastro symptoms, headaches. Seriousness criteria was assessed as hospitalization for all events. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. COVID was tested post vaccination. Covid test type post vaccination was blood test. There was no received any treatment. The outcome of events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided. Follow-up attempts are completed. no further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Muscle twitching, Neurological symptom, Palpitations
Clinical narrative: Tremors; twitches; brain fog; cognitive changes; extreme fatigue; insomnia; neurological symptoms; gastro symptoms; headaches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 02:00 (age at vaccination 53 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history included none. There were no known allergies. There were no concomitant medications. Facility type vaccine other was Stadium. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. On 26Feb2021 02:30 PM the patient experienced tremors, twitches, brain fog, cognitive changes, extreme fatigue, insomnia, neurological symptoms, gastro symptoms, headaches. Seriousness criteria was assessed as hospitalization for all events. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. COVID was tested post vaccination. Covid test type post vaccination was blood test. There was no received any treatment. The outcome of events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided. Follow-up attempts are completed. no further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stool analysis, Tremor, Weight decreased
Clinical narrative: Tremors; twitches; brain fog; cognitive changes; extreme fatigue; insomnia; neurological symptoms; gastro symptoms; headaches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 02:00 (age at vaccination 53 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history included none. There were no known allergies. There were no concomitant medications. Facility type vaccine other was Stadium. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. On 26Feb2021 02:30 PM the patient experienced tremors, twitches, brain fog, cognitive changes, extreme fatigue, insomnia, neurological symptoms, gastro symptoms, headaches. Seriousness criteria was assessed as hospitalization for all events. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. COVID was tested post vaccination. Covid test type post vaccination was blood test. There was no received any treatment. The outcome of events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided. Follow-up attempts are completed. no further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Fatigue, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: Tremors; twitches; brain fog; cognitive changes; extreme fatigue; insomnia; neurological symptoms; gastro symptoms; headaches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 02:00 (age at vaccination 53 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history included none. There were no known allergies. There were no concomitant medications. Facility type vaccine other was Stadium. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. On 26Feb2021 02:30 PM the patient experienced tremors, twitches, brain fog, cognitive changes, extreme fatigue, insomnia, neurological symptoms, gastro symptoms, headaches. Seriousness criteria was assessed as hospitalization for all events. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. COVID was tested post vaccination. Covid test type post vaccination was blood test. There was no received any treatment. The outcome of events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided. Follow-up attempts are completed. no further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscle twitching, Neurological symptom, SARS-CoV-2 test, Tremor
Clinical narrative: Tremors; twitches; brain fog; cognitive changes; extreme fatigue; insomnia; neurological symptoms; gastro symptoms; headaches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 02:00 (age at vaccination 53 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history included none. There were no known allergies. There were no concomitant medications. Facility type vaccine other was Stadium. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. On 26Feb2021 02:30 PM the patient experienced tremors, twitches, brain fog, cognitive changes, extreme fatigue, insomnia, neurological symptoms, gastro symptoms, headaches. Seriousness criteria was assessed as hospitalization for all events. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. COVID was tested post vaccination. Covid test type post vaccination was blood test. There was no received any treatment. The outcome of events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided. Follow-up attempts are completed. no further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient reported the next day after the vaccine she had all symptoms of the flu along with a high fever that lasted 3 days... she had severe pain in the arm injected... was taking Advil for the pain... vision a little bury...high temp was gone but still has aches and chills
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reported the next day after the vaccine she had all symptoms of the flu along with a high fever that lasted 3 days... she had severe pain in the arm injected... was taking Advil for the pain... vision a little bury...high temp was gone but still has aches and chills
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Patient reported the next day after the vaccine she had all symptoms of the flu along with a high fever that lasted 3 days... she had severe pain in the arm injected... was taking Advil for the pain... vision a little bury...high temp was gone but still has aches and chills
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; dizziness; feels off balance; his head spinning; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (COVID-19 Vaccine, solution for injection, Lot Number: EN6204, Expiry Date and NDC Number: Unknown), dose 2 via an unspecified route of administration, administered in the right arm on 11Mar2021 (at the age of 79-years-old) as dose 2, single for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), rehabilitation therapy from an unknown date left rehab on 11Mar2021. The patient concomitant medication was not reported. The patient previously took bnt162b2 (COVID-19 Vaccine, solution for injection, Lot Number: EL9264, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in the right arm on 30Jan2021 (at the age of 79 years ago) as dose 1, single for COVID-19 immunisation and experienced positive for COVID-19. On an unspecified date, the patient experienced shortness of breath, dizziness, feels off balance, his head spinning. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on Feb2021, sars-cov-2 test resulted negative on an unknown date. Product complaint was reported with description of complaint: Reporter was a patient who reported he tested negative for COVID-19 several times before his first dose of the vaccine. Patient received his first dose on 30Jan2021, and he tested positive for COVID in Feb2021, prior to receiving his second dose of the product. Patient received his second dose on 11Mar2021. The clinical outcome of the events was reported as unknown. No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Dyspnoea, SARS-CoV-2 test, Vertigo
Clinical narrative: shortness of breath; dizziness; feels off balance; his head spinning; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (COVID-19 Vaccine, solution for injection, Lot Number: EN6204, Expiry Date and NDC Number: Unknown), dose 2 via an unspecified route of administration, administered in the right arm on 11Mar2021 (at the age of 79-years-old) as dose 2, single for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), rehabilitation therapy from an unknown date left rehab on 11Mar2021. The patient concomitant medication was not reported. The patient previously took bnt162b2 (COVID-19 Vaccine, solution for injection, Lot Number: EL9264, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in the right arm on 30Jan2021 (at the age of 79 years ago) as dose 1, single for COVID-19 immunisation and experienced positive for COVID-19. On an unspecified date, the patient experienced shortness of breath, dizziness, feels off balance, his head spinning. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on Feb2021, sars-cov-2 test resulted negative on an unknown date. Product complaint was reported with description of complaint: Reporter was a patient who reported he tested negative for COVID-19 several times before his first dose of the vaccine. Patient received his first dose on 30Jan2021, and he tested positive for COVID in Feb2021, prior to receiving his second dose of the product. Patient received his second dose on 11Mar2021. The clinical outcome of the events was reported as unknown. No follow-up attempts are needed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Myalgia, Vaccination site inflammation, Vaccination site pain
Clinical narrative: inflammation of vaccination site and under her arm; Headache; Inflammation under her arm projecting to breast; body aches (all over her body); acute pain in the arm where shot was administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered), VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm). At the time of the report, INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered), VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received included no new information. On 04-Nov-2021: Follow up was received and included no new information.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; No adverse event/ there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), unknown dose, lot # T016195, expiration date reported as 11-MAY-2022, but upon internal validation established as 11-JUN-2022 (dose number and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event). No product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2109USA001290: US-009507513-2110USA003605: US-009507513-2110USA003601: US-009507513-2110USA003604: US-009507513-2110USA003603: US-009507513-2110USA003602:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003602: US-009507513-2110USA003601: US-009507513-2110USA003604: US-009507513-2110USA003605: US-009507513-2110USA003600: US-009507513-2109USA001290: US-009507513-2110USA003599:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2109USA001290: US-009507513-2110USA003605: US-009507513-2110USA003601: US-009507513-2110USA003603: US-009507513-2110USA003602: US-009507513-2110USA003599:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines were administered following a temperature excursion; there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2110USA003601: US-009507513-2110USA003602: US-009507513-2110USA003603: US-009507513-2110USA003604: US-009507513-2110USA003599: US-009507513-2109USA001290:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Ear pain, Eye swelling, Injection site pain, Nasal oedema
Clinical narrative: Patient's nose and eyes are swollen; Patient's nose and eyes are swollen; ears are hurting; experiencing severe injection sight pain; This spontaneous report was received from a patient's mother and refers to a 11 years old male patient. His concomitant therapies included cetirizine hydrochloride (ZYRTEK). No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On an unknown dates, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for Human papillomavirus (HPV) prevention. On 08-OCT-2021, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for HPV prevention. The anatomical location for the three doses was reported as arm - 2 times left arm and 1 right arm. On 09-OCT-2021, the patient experienced adverse events: his nose and eyes were swollen, ears were hurting and he was experiencing severe injection site pain. The patient sought medical attention. No treatment was given for adverse events. The outcome of the events was reported as not recovered/not resolved.        The causality assessment between the events and the suspect therapy was not provided.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE reported; expired vaccine administered; This spontaneous report was received from a nurse and refers to a 12-month-old male patient. The patient had no allergies. Concomitant therapies included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), hepatitis a vaccine inact(HAVRIX), influenza vaccine(INFLUENZA VACCINE) and varicella virus vaccine live (oka/merck) (VARIVAX). Medical history included vaccination with 2 doses of pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX).  On 20-OCT-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) lot number: S031483, expiration date: 07-OCT-2021, 0.5 mL one time, subcutaneously for prophylaxis (expired vaccine administered). The patient tolerated the vaccinations well. No additional adverse event was provided.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional ae; patient was administered expired M-M-R; This spontaneous report was received from a physician assistant and refers to a 12-month-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 19-OCT-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) lot number: S031483, expiration date: 07-OCT-2021, for prophylaxis (exact dose and rout of administration were not provided) (expired vaccine administered).  No temperature excursion was reported. No additional adverse event were provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PNEUMOVAX 23 is accidentally given a third time to a patient; No additional adverse effects; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. The pharmacist asked for information if the system did not show complete vaccination system and the patient was vaccinated accidentally with a third dose, reported as a third time of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), dose: 0.5 milliliter, for prophylaxis, on an unknown date. (route of administration, lot number and expiration date were not reported) (Extra dose administered). No additional adverse event reported. No product quality complaint.
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: about an hour after receiving the vaccine, her son vomited.; This spontaneous report was received from a pharmacist referring to her son, a 6 month old male patient.  The patient did not have pertinent medical history or concomitant medication or drug reactions or allergies.     On 29-OCT-2021, the patient was vaccinated with the 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, orally, for prevention of rotavirus (lot/batch # and expiration date were not reported).    She reported that about an hour after receiving the vaccine, on the same date, her son vomited (vomiting).  The patient did not seek medical attention and did not received treatment.   The outcome of vomiting was reported as resolved on the same date.  The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Antibody test negative
Clinical narrative: did not have any antibody titers following completion of GARDASIL 9 dose series; This spontaneous report as received from an office manager refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided.  On unknown separate dates, the patient was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and anatomical location of administration, lot # and expiry date were not reported) for prophylaxis.  On an unknown date, the patient's antibody titers were tested and the result showed that he did not have any antibody titers following completion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose series (antibody test negative).  The outcome of antibody test negative was unknown. The relatedness between the event of antibody test negative and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Shingrix vac at 1 year; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. It was reported that the patient was improperly instructed to get 2nd Shingrix vaccination at 1 year, which led to lengthening of vaccination schedule.  The patient asked if he/she need a 3rd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that he/she received 1st dose of shingles vaccine and experienced just sore arm.
Sex: M
Vaccine: DTP
Symptoms: Pertussis, Pyrexia
Clinical narrative: contract a mild case; high fever; This case was reported by a consumer  interactive digital media and described the occurrence of pertussis in a child male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   The patient's past medical history included whooping cough (Family History) (experienced as a child and assumed he was immune, At 36 also the reporter caught it from his 3 year old son who had an adverse reaction to his first vaccine So did not opt for the booster for him, his course was mild) and .   On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced pertussis (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the pertussis and fever were unknown.   It was unknown if the reporter considered the pertussis and fever to be related to DTP vaccine.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. There was an adult version of the DPT vaccine available.  The reporter said you absolutely should protect yourself particularly if you were around young children or newborns. Reporter's two oldest children did not get it.  The youngest had a high fever after his 1st vaccine so the doctor thought it was not advisable to give the additional two doses.  He did contract a mild case when we had the local outbreak. Immunity was not a given, get that jab. It also includes protection against Diphtheria and Tetanus, a great trifecta of prevention. The case had been linked with US2021AMR226569 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226569:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: GB syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient had shingles shot which caused her to suffer the Guillain Barre syndrome. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine , shingles in 2017\ Suspected vaccination failure; Shingles in 2017, still have probalem; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and shingles in 2017 still had problem. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave 1 vial of Menveo, unintentional error dispensing vx; Gave 1 vial of Menveo; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that medical assistant gave 1 vial of the Menveo. Menveo vaccine was administered after being inappropriately reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse didn't know lot number and date.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site pain
Clinical narrative: soreness at injection site; tired; tummy confusion; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (Family History) (Father), blister (Family History) (Father), scab (Family History) (Father) and shingles (Family History) (father).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, tiredness and upset stomach. On an unknown date, the outcome of the injection site pain, tiredness and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, tiredness and upset stomach to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient recently did the series of two injections.  After receiving 1st dose of Shingle vaccine, the patient was tired afterwards, had soreness at injection site and felt a bit of tummy confusion. For tolerance in 2nd dose refer case US2021AMR227228. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227228:same patient same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot. I got shingles/ suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles and when they were over, he/she got the Shingle shot and just last year he/she got shingles again. The patient stated he/she going to get the new shot they had out for Shingles and hopefully would never get Shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles and the shot/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles vaccine, came up on my temple/ Suspected vaccination failure; came up on temple where I had chicken pocks; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had fibro and got the shingles vaccine, shingles came up on temple where he/she had chicken pox. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.