chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation, Pain
Clinical narrative: achy body; brain fog; feeling tired; Took the Booster dose 29Sep2021 at around 10:30am; This is a spontaneous report from a contactable consumer (patient) reported for himself that,  A 27-year-old male patient received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiry date: 21Dec2021), intramuscular administered in left arm on 29Sep2021 10:30 (Age at vaccination: 27 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. No, Known allergies. No, relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. The patient previously received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), intramuscular administered in left arm on 20Jan2021 11:00 AM (Age at vaccination: 27 years old) as dose 1, single for COVID-19 immunisation. The patient received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), intramuscular administered in left arm on 10Feb2021 11:00 AM (Age at vaccination: 27 years old) as dose 2, single for COVID-19 immunisation. Took the Booster dose 29Sep2021 at around 10:30am. Symptoms developed about 24 hours later around 10:30am on 30Sep2021 with achy body, brain fog, and feeling tired. No, hospitalization prolonged. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 30Sep2021 21:00 the events were recovered. At the time of reporting, the outcome of the immunization was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fatigue, Heart rate
Clinical narrative: he got his booster shot; he got his booster shot; his temperature went up to 101; he checked his oxygen level and heart rate, he was over 130; felt tired; weak; light headed; This is a spontaneous report from a contactable consumer. This 75-year-old male consumer (patient) reported for himself that. A 75-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease Saying that maybe it lasted longer because of he has COPD. The patient's concomitant medications were not reported. Historical vaccine included second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via unspecified route of administration on an unspecified date and receive first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via unspecified route of administration on an unspecified date single both for COVID-19 immunisation. It was reported that on Monday, patient got his booster shot. Monday night patient started feeling some side effects. On Tuesday, patient temperature went up to 101, patient said patient has COPD that is why patient checked his oxygen level and heart rate, patient was over 130. On wednesday 8 am, patient felt light-headed. On Friday, his heart rate was 85, still felt tired, felt tired, weak, light-headed on an unspecified date in 2021, patient got his booster shot on an unspecified date. The patient underwent lab tests and procedures which included body temperature was 101, heart rate was over 130. Patient said he has COPD, that is why he checked his oxygen level and heart rate he was over 130, heart rate was 85. On Friday, his heart rate was 85 on an unspecified date. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Immunisation, Off label use, Pyrexia
Clinical narrative: he got his booster shot; he got his booster shot; his temperature went up to 101; he checked his oxygen level and heart rate, he was over 130; felt tired; weak; light headed; This is a spontaneous report from a contactable consumer. This 75-year-old male consumer (patient) reported for himself that. A 75-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease Saying that maybe it lasted longer because of he has COPD. The patient's concomitant medications were not reported. Historical vaccine included second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via unspecified route of administration on an unspecified date and receive first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via unspecified route of administration on an unspecified date single both for COVID-19 immunisation. It was reported that on Monday, patient got his booster shot. Monday night patient started feeling some side effects. On Tuesday, patient temperature went up to 101, patient said patient has COPD that is why patient checked his oxygen level and heart rate, patient was over 130. On wednesday 8 am, patient felt light-headed. On Friday, his heart rate was 85, still felt tired, felt tired, weak, light-headed on an unspecified date in 2021, patient got his booster shot on an unspecified date. The patient underwent lab tests and procedures which included body temperature was 101, heart rate was over 130. Patient said he has COPD, that is why he checked his oxygen level and heart rate he was over 130, heart rate was 85. On Friday, his heart rate was 85 on an unspecified date. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed and no further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Musculoskeletal discomfort
Clinical narrative: Caller and his wife received the booster dose of the Comirnaty vaccine on on 27Sep.; Shoulder discomfort; This is a spontaneous report received from a contactable consumer or other non- healthcare professional (patient reported for himself). A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 27Sep2021 (at the age of 73-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date (Both at the age of 73-years-old) for COVID-19 Immunsation and patient did not had any problems after the first two doses of the vaccine. On an unspecified date of 2021 the patient experienced shoulder discomfort. The outcome of events shoulder discomfort was recovered on an unspecified date of 2021.    Follow-up (12Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Somnolence
Clinical narrative: "My mom (84 years old, female) had her Pfizer booster vaccine; some arm pain; groggy; This is a spontaneous report from a contactable consumer or other non hcp. A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Sep2021 (at the age of 84-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were reported as none. The patient previously received bnt162b2 first dose of COVID-19 Vaccine (Manufacturer unknown) via an unspecified route of administration on an unspecified date as dose 1 single and received second dose of COVID-19 Vaccine (Manufacturer unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On 30Sep2021, the patient had some arm pain; little bit of a sore arm but, she felt it more today but now it is going away. She had no diarrhea. She was groggy; she did feel sleepy after the COVID vaccine, like drunk sleepy, and she does feel sleepy now but, she is glad that she got it. On 01Oct2021, she had arm pain in the morning but, it was only when she touches it that she feels it. She did not bleed after having the COVID vaccine. The outcome of the event pain in extremity was recovering and unknown for other events.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under left armpit; administration date=30Sep2021/dose number=3; administration date=30Sep2021/dose number=3; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number FG3592), via an unspecified route of administration on 30Sep2021 11:15 AM (age at vaccination 49-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was reported as asthma, known allergies (contrast dye and penicillin). The patient's concomitant medications included patient received Flu Shot vaccine on left arm within 4 weeks prior to the COVID vaccine on 24Sep2021 for immunization. The patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number ER2613), via an unspecified route of administration on 19Mar2021 administration time 11:00 AM as single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EN6198), via an unspecified route of administration on 26Feb2021 administration time 11:00 AM as single dose for COVID-19 immunization. On 30Sep2021, patient received third dose of bnt162b2 (off label use, immunization). On 01Oct2021 03:00 PM, the patient experienced swollen lymph nodes under left armpit. Lab test was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. At the time of this report the outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Intense pain in hips and knees; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old female patient (patient was not pregnant at the time of vaccination) received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE3592, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 28Sep2021 at 15:45 pm (age at vaccination was 60 years) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included known allergy to contrast dye from an unknown date. Concomitant medications and other medications the patient received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and sumatriptan all taken for an unspecified indication. The patient previously took tigan and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Feb2021 at 13:30 pm (age at vaccination was 60 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8727, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 27Mar2021 at 10:00 am (age at vaccination was 60 years) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Doctors office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Sep2021 at 07:00 am, the patient experienced intense pain in hips and knees. No treatment was received for the adverse event. The case was assessed as non-serious. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Immunisation, Off label use, Poor quality product administered
Clinical narrative: Pharmacy saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; Pharmacy saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Had a slight reaction nothing really, we had a little chills like that; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm Right on 14Sep2021 (at the age of 74 year) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took BNT162B2 dose 1 and 2 on an unknown date for COVID-19 immunisation. Consumer stated that patient had two Pfizer shot for the vaccine, patient went on the 14Sep2021 to the Pharmacy for the booster shot (COVID 19 Vaccine). Patient had a slight reaction nothing really, had a little chills like that on Sep2021. Pharmacy saying that they don't think that it was refrigerated properly and may be would not be effective. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date. It was reported that no therapeutic measures were taken for the events experienced. At the time of reporting the outcome of the event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101301642 Same reporter/drug/AE, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pharmacy saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; Pharmacy saying they don't think vaccine was refrigerated properly, would not be effective; Didn't know if it would be effective, they didn't know if it was refrigerated properly; received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; received the booster dose of the Pfizer covid 19 vaccine on 14Sep2021.; Had a slight reaction nothing really, we had a little chills like that; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm Right on 14Sep2021 (at the age of 74 year) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took BNT162B2 dose 1 and 2 on an unknown date for COVID-19 immunisation. Consumer stated that patient had two Pfizer shot for the vaccine, patient went on the 14Sep2021 to the Pharmacy for the booster shot (COVID 19 Vaccine). Patient had a slight reaction nothing really, had a little chills like that on Sep2021. Pharmacy saying that they don't think that it was refrigerated properly and may be would not be effective. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date. It was reported that no therapeutic measures were taken for the events experienced. At the time of reporting the outcome of the event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101301642 Same reporter/drug/AE, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: another irregular cycle it came a week early and lasted 8 days; After most recent dose (3rd) I have experienced another irregular cycle; After most recent dose (3rd) I have experienced another irregular cycle; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration in left arm on 26Aug2021 10:00 (at the age of 25 years old) as dose 3 (booster), single for COVID-19 immunisation in pharmacy or drug store. Medical history were not reported. Historial vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in left arm on 15Mar2021 13:15 (at the age of 25 years old) for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0150) via an unspecified route of administration in left arm on 05Apr2021 13:15 (at the age of 25 years old) for covid-19 immunisation and experienced irregular periods for about 3 menstrual cycles after 2nd dose. Concomitant medication(s) included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for birth control from an unspecified start date and ongoing; bupropion hydrobromide (APLENZIN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 08Sep2021,after receiving third dose patient was experienced another irregular cycle it came a week early and lasted 8 days .No treatment was received for the event the another irregular cycle it came a week early and lasted 8 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 01Jul2021.The outcome of the another irregular cycle it came a week early and lasted 8 days was recovering. Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Illness, Immunisation, Lung disorder
Clinical narrative: stayed in bed for a week; very very ill/has been very, very sick; having a high, high fever; had chills up and down her body for almost a week; her lungs have been killing her; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as DOSE 3, SINGLE for covid-19 immunization. The patient medical history included the first dose of BNT162B2 on an unspecified date for COVID 19 immunization and the second dose of BNT162B2 in Apr2021 (at the age of 80 years) for COVID-19 immunization. There were no concomitant medications. On 29Sep2021, the patient experienced Off label use and administered 3rd dose of pfizer covid vaccine, the booster shot (immunization). On 30Sep2021 the patient experienced stayed in bed for a week (bedridden), very very ill/has been very, very sick (illness), having a high, high fever (pyrexia), had chills up and down her body for almost a week (chills) and her lungs have been killing her (lung disorder). Very, very, very ill: Onset time unknown. The patient thought she would have to go to the hospital but has not been seen by physician's office, emergency room or hospitalized for this event. She is going to see her doctor tomorrow due to this event; she mentioned her doctor is a she/female. The patient further described event as including her having a high, high fever; she had chills up and down her body for almost a week; she has been very, very sick; her lungs have been killing her. Today, 05Oct2021 is the first day she has felt improved, better since onset of event. The patient verified dosing information including anatomical location of administration is same for all 3 doses. The patient mentioned unrelated information that she had heard a lot of people having problems with Pfizer Covid Vaccine booster shot in her area as well as some in other location as captured in safety report. The patient daughter works for hospice and she had told her if she had known caller was going to get Pfizer Covid Vaccine booster shot she would have told her to wait because they have had so many problems with their hospice patients that have gotten Pfizer Covid Vaccine booster shot. She can't understand why the booster shot is causing so many problems. The outcome of stayed in bed for a week, very very ill/has been very, very sick, having a high, high fever, had chills up and down her body for almost a week and her lungs have been killing her was recovering. The outcome for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stayed in bed for a week; very very ill/has been very, very sick; having a high, high fever; had chills up and down her body for almost a week; her lungs have been killing her; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as DOSE 3, SINGLE for covid-19 immunization. The patient medical history included the first dose of BNT162B2 on an unspecified date for COVID 19 immunization and the second dose of BNT162B2 in Apr2021 (at the age of 80 years) for COVID-19 immunization. There were no concomitant medications. On 29Sep2021, the patient experienced Off label use and administered 3rd dose of pfizer covid vaccine, the booster shot (immunization). On 30Sep2021 the patient experienced stayed in bed for a week (bedridden), very very ill/has been very, very sick (illness), having a high, high fever (pyrexia), had chills up and down her body for almost a week (chills) and her lungs have been killing her (lung disorder). Very, very, very ill: Onset time unknown. The patient thought she would have to go to the hospital but has not been seen by physician's office, emergency room or hospitalized for this event. She is going to see her doctor tomorrow due to this event; she mentioned her doctor is a she/female. The patient further described event as including her having a high, high fever; she had chills up and down her body for almost a week; she has been very, very sick; her lungs have been killing her. Today, 05Oct2021 is the first day she has felt improved, better since onset of event. The patient verified dosing information including anatomical location of administration is same for all 3 doses. The patient mentioned unrelated information that she had heard a lot of people having problems with Pfizer Covid Vaccine booster shot in her area as well as some in other location as captured in safety report. The patient daughter works for hospice and she had told her if she had known caller was going to get Pfizer Covid Vaccine booster shot she would have told her to wait because they have had so many problems with their hospice patients that have gotten Pfizer Covid Vaccine booster shot. She can't understand why the booster shot is causing so many problems. The outcome of stayed in bed for a week, very very ill/has been very, very sick, having a high, high fever, had chills up and down her body for almost a week and her lungs have been killing her was recovering. The outcome for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Lymphadenopathy, Off label use, SARS-CoV-2 test
Clinical narrative: Painful lymphadenopathy in L axilla; Difficult to sleep.; dose number: 3; dose number: 3 (booster); This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (nonpregnant) female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number was 301558A, Expiration Date: Unknown) as dose 3 (booster), single intramuscular, administered in Arm Left on 29Sep2021 12:30 (age at vaccination 46 years) for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing. Concomitant medication in two weeks included keppra taken for an unspecified indication, start and stop date were not reported. No covid prior to vaccination. No known allergies were reported. Historical vaccines received were (BNT162B2, Formulation: Solution for injection, Lot Number was EL0142, Expiration Date: Unknown) as dose 1, single intramuscular, administered in Arm Left on 04Jan2021 for covid-19 immunisation and (BNT162B2, Formulation: Solution for injection, Lot Number was EL9261, Expiration Date: Unknown) as dose 2, single intramuscular, administered in Arm Left on 25Jan2021 for covid-19 immunisation. No other vaccine in four weeks was reported. On 30Sep2021 10:00pm the patient experienced Painful lymphadenopathy in L axilla about 36 hours after dose 3. Lasted for 3 days, difficult to sleep. On 04Oct2021 the patient underwent lab tests and procedures which included (Nasal Swab) sars-cov-2 test: negative. No treatment received. The outcome of events Painful lymphadenopathy in L axilla about 36 hours after dose 3. Lasted for 3 days. Difficult to sleep was recovered on 04Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Lymph node pain
Clinical narrative: Inflammation of lymph nodes size of baseball under left arm pit. Tender to touch.; Inflammation of lymph nodes size of baseball under left arm pit. Tender to touch.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 1301358A), dose 3 intramuscular, administered in Arm Left on 02Oct2021 15:00 (age at vaccination: 55-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included anxiety. Concomitant medication(s) included alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP6955), via Intramuscular in the left arm on 14Mar2021 (at the age of 55-years-old) and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: ER8735), via Intramuscular in the left arm on 04Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 04Oct2021, patient experienced inflammation of lymph nodes size of baseball under left arm pit. tender to touch. specific relevant test for thromboembolic events with thrombocytopenia was none. The outcome was recovered on Oct2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Peripheral swelling, Rash, Skin discolouration
Clinical narrative: she got the booster shot of the Pfizer BioNTech Covid-19 Vaccine; she got the booster shot of the Pfizer BioNTech Covid-19 Vaccine; her arm is little warm in the one spot and pink around it; her arm is little warm in the one spot and pink around it; warm rash with a bit of swelling on the arm; warm rash with a bit of swelling on the arm; This is a spontaneous report from a contactable consumer (Patient). A 88-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 04Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccines included (COVID-19 VACCINE (Primary Immunization series complete but unknown manufacturer), solution for injection, Batch number/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/Lot Number: Not reported) via an unspecified route of administration in Feb2021 as dose 2, single both for covid-19 immunisation. On an unspecified date patient got the booster shot of the pfizer BioNTech covid-19 vaccine and experienced her arm is little warm in the one spot and pink around it and warm rash with a bit of swelling on the arm. Characterization of drug role was Suspect. It was reported that, She received a covid booster shot on Monday and her arm is little warm in the one spot and pink around it. Caller wanted to know if and pinkish and warm rash with a little bit of swelling on the arm where she got the booster shot of the Pfizer BioNTech Covid-19 Vaccine is a normal adverse event and if she can put an ice pack on it. And mentioned that she had no problems with the other injections. She also stated that her husband had no reaction with the booster shot. The Outcome of the events was Unknown  Follow-up (07Oct2021): This is a follow-up spontaneous report from a contactable consumer includes: Historical vaccines details updated, clinical information updated, Product details updated   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional, reported for herself. A 23-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, on Oct 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route, on an unspecified date, single dose, for COVID-19 immunization. Patient got her booster dose yesterday and experienced headache, fever, nausea, fatigue, diarrhea, chills and sweat Oct 2021. Her side effects are really bad. She wondered what she should do with her symptoms or if she should go to doctor or wait. Report related to a study or program: no. The outcome of the events reported unknown. Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional, reported for herself. A 23-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, on Oct 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route, on an unspecified date, single dose, for COVID-19 immunization. Patient got her booster dose yesterday and experienced headache, fever, nausea, fatigue, diarrhea, chills and sweat Oct 2021. Her side effects are really bad. She wondered what she should do with her symptoms or if she should go to doctor or wait. Report related to a study or program: no. The outcome of the events reported unknown. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: this time her arm is really painful/her arm was aching/right arm so painful that she cannot put any pressure on it; received her Booster dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient).   A 78-years-old female patient received third booster dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : FE3590), via an unspecified route of administration, administered in arm right on 30Sep2021 (age at vaccination 78 years) as dose 3 (booster), single for covid-19 immunisation. The patient medical history included none. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : EL0140) via an unspecified route of administration on 27Jan2021 (age at vaccination 77 years) as dose 1, single and second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : EL0140) via an unspecified route of administration on 17Feb2021 (age at vaccination 77 years) as dose 2, single for covid-19 immunisation and she hardly had any problem, she just had a sore arm. On 02Oct2021, after third shot patient stated her arm was aching and really painful. Patient started out sore and now aching and was now painful cannot put any pressure on it. she had wanted to report that this as a side effect of the shot. Wanted to know why she was having a problem with the third one. Is for Pfizer Covid 19. Patient received treatment of two tylenol about an hour or so ago. Stated that the Tylenol had helped a little bit. The outcome of right arm sore was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Immunisation
Clinical narrative: Went to donate blood today (07Oct) and it was too thick; Product=COVID 19; Administration date=27Sep2021; Dose number=3; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female (Non pregnant) patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: 3183), via an unspecified route of administration, administered in arm left on 27Sep2021, at 10:45 (Age at vaccination 68-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have covid prior to vaccination and also not have any known allergies. The patient medical history was not reported. Concomitant medications included influenza vaccine (FLU, Lot number: 70461012103), via unspecified route, administered in arm taken for an unspecified indication from 21Sep2021 to 21Sep2021. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 08Mar2021 as DOSE 2, SINGLE and received first dose (Lot number: EM9809), via an unspecified route of administration, administered in arm left on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunization. On 07Oct2021, the patient went to donate blood today and it was too thick, she donates it every two months, never had this reaction. On 21Sep2021, patient received dose number 3 as booster dose. The patient went to physician office. No therapeutic measures were taken as a result of event. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Limb discomfort, Pruritus, Vaccination site erythema
Clinical narrative: COVID arm; large red circle near injection site developed three days post injection; itching, appears worse as day goes on; itching, appears worse as day goes on; Site pain and knot; Site pain and knot; booster; This is a spontaneous report from a contactable other hcp (patient herself). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: 301458A, Expiration date: Unknown), via an unspecified route of administration in right arm on 04Oct2021 10:30 as dose 3 (booster), single (at the age of 42-year-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. Patient was not vaccinated with other vaccine in four weeks. Patient was on other medications in two weeks. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6207, Expiration date: Unknown), via an unspecified route of administration in right arm on 12Mar2021 11:00 AM as dose 2, single (at the age of 41-year-old) for COVID-19 immunization. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267, Expiration date: Unknown), via an unspecified route of administration in right arm on 18Feb2021 03:00 PM as dose 1, single (at the age of 41-year-old) for COVID-19 immunization. On 04Oct2021 10:30, the patient experienced booster. On 05Oct2021 01:00, the patient experienced COVID arm, large red circle near injection site developed three days post injection, itching, appears worse as day goes on, Site pain and knot lessening since it began day two. Therapeutic measures were not taken as a result of events. The outcome of the events booster was unknown. The outcome of other events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pain
Clinical narrative: COVID arm; large red circle near injection site developed three days post injection; itching, appears worse as day goes on; itching, appears worse as day goes on; Site pain and knot; Site pain and knot; booster; This is a spontaneous report from a contactable other hcp (patient herself). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: 301458A, Expiration date: Unknown), via an unspecified route of administration in right arm on 04Oct2021 10:30 as dose 3 (booster), single (at the age of 42-year-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. Patient was not vaccinated with other vaccine in four weeks. Patient was on other medications in two weeks. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6207, Expiration date: Unknown), via an unspecified route of administration in right arm on 12Mar2021 11:00 AM as dose 2, single (at the age of 41-year-old) for COVID-19 immunization. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267, Expiration date: Unknown), via an unspecified route of administration in right arm on 18Feb2021 03:00 PM as dose 1, single (at the age of 41-year-old) for COVID-19 immunization. On 04Oct2021 10:30, the patient experienced booster. On 05Oct2021 01:00, the patient experienced COVID arm, large red circle near injection site developed three days post injection, itching, appears worse as day goes on, Site pain and knot lessening since it began day two. Therapeutic measures were not taken as a result of events. The outcome of the events booster was unknown. The outcome of other events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: felt sick; was sleeping all day; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 05Oct2021 at 11:00 (Lot Number: FC3183) as dose 3 (booster), single (age at vaccination 49-year-old) for covid-19 immunization. Medical history included ongoing diabetes, Gastroparesis, Blood pressure high and Carcinomic tumour in colon from an unknown date and unknown if ongoing. It was confirmed that all of her medical conditions mentioned were diagnosed prior to the COVID vaccine/booster shot. Concomitant medication included semaglutide (OZEMPIC) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 24Feb2021 (lot number: EL3247, Route, Anatomical Location: probably right arm) and second dose of bnt162b2 on 17Mar2021, lot number: EN6207, Route, Anatomical Location: probably right arm) (age at vaccination 48-year-old) for covid-19 immunization. The other product was not reported. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior to vaccinations. The patient experienced injection site swollen, warm, and hurts on 06Oct2021 and felt sick and was sleeping all day on an unspecified date. The patient stated she does not know what happened to her, she guesses the side effects got her. It was stated the first 2 shots wasn't as bad, but after booster, she had injection site, was still swollen and warm and still hurts. The patient wanted to know how many more days she will felt like she was about dead. She should not have said she was about to die and clarified she just felt sick. The patient stated that yesterday was not a good day. She did not know what was wrong with her, she was sleeping all day. She was told to take Acetaminophen instead of Ibuprofen because she needs inflammation or something like that. However, she doesn't want to take that, Acetaminophen/Tylenol does not do absolutely nothing for her. Ibuprofen does better for her, and she asked can she take Ibuprofen. Emergency Room and physician Office visit not required due to events. The outcome of event was sleeping all day was unknown and outcome of other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt sick; was sleeping all day; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 05Oct2021 at 11:00 (Lot Number: FC3183) as dose 3 (booster), single (age at vaccination 49-year-old) for covid-19 immunization. Medical history included ongoing diabetes, Gastroparesis, Blood pressure high and Carcinomic tumour in colon from an unknown date and unknown if ongoing. It was confirmed that all of her medical conditions mentioned were diagnosed prior to the COVID vaccine/booster shot. Concomitant medication included semaglutide (OZEMPIC) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 24Feb2021 (lot number: EL3247, Route, Anatomical Location: probably right arm) and second dose of bnt162b2 on 17Mar2021, lot number: EN6207, Route, Anatomical Location: probably right arm) (age at vaccination 48-year-old) for covid-19 immunization. The other product was not reported. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior to vaccinations. The patient experienced injection site swollen, warm, and hurts on 06Oct2021 and felt sick and was sleeping all day on an unspecified date. The patient stated she does not know what happened to her, she guesses the side effects got her. It was stated the first 2 shots wasn't as bad, but after booster, she had injection site, was still swollen and warm and still hurts. The patient wanted to know how many more days she will felt like she was about dead. She should not have said she was about to die and clarified she just felt sick. The patient stated that yesterday was not a good day. She did not know what was wrong with her, she was sleeping all day. She was told to take Acetaminophen instead of Ibuprofen because she needs inflammation or something like that. However, she doesn't want to take that, Acetaminophen/Tylenol does not do absolutely nothing for her. Ibuprofen does better for her, and she asked can she take Ibuprofen. Emergency Room and physician Office visit not required due to events. The outcome of event was sleeping all day was unknown and outcome of other events was not recovered.   Follow-up attempts are completed. No further information is expected.