chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Female 9 years old 4cm red, swollen circle and tender to the touch; Female 9 years old 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; This is a spontaneous report received from contactable reporter(s) (Physician).  A 9 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Female 9 years old 4cm red, swollen circle and tender to the touch"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "4cm red, swollen circle and tender to the touch".  Additional information: It was reported that event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Mild fever; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): -PFIZER INC-202101573857 (Pfizer).  A female patient received bnt162b2 (BNT162B2, Formulation: solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Mild fever"; FATIGUE (non-serious), outcome "recovered", described as "Tired".  Action taken for bnt162b2 (BNT162B2) was not applicable.   Follow-up (08Nov2021): This is a spontaneous follow up report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): -PFIZER INC-202101573857 (Pfizer).   Updated information: Proprietary medicinal product name (Comirnaty) updated.   Follow-up (12Nov2021): This is a spontaneous follow up report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): -PFIZER INC-202101573857 (Pfizer).   Updated information: Identification of the country where the drug was obtained: , Country of authorization/application:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dilated cardiomyopathy" (unspecified if ongoing), notes: heart condition called dilated cardiomyopathy that he before the shots which was 20 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 02Feb2021, outcome "recovered" (02Feb2021), described as "had a bad headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: Mild arm pain; Age: 10 years; Age: 10 years; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 06Nov2021 (Lot number: FK%127) as dose 1, single and intramuscular, administered in arm left, administration date 27Nov2021 10:45 (Lot number: FK5127) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 06Nov2021, outcome "unknown" and all described as "Age: 10 years"; PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 18:00, outcome "unknown", described as "Mild arm pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: A 10-year-old patient (off label use, product use in unapproved population) received DOSE 1 on 06Nov2021 and experienced had mild arm pain same day 06Nov2021 at 18:00 and received ice pack as treatment but event not resolved. On 27Nov2021 at 10:45 AM, he received DOSE 2 and again experienced mild arm pain on 27Nov2021 at 09:00 PM and received no treatment for the same and outcome was unknown. Any other medications the patient received within 2 weeks of vaccination included multivitamins and seasonal influenza. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient had no covid prior vaccination. Covid not tested post vaccination. Event did not cause hospitalization.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer/patient or other non-HCP (005570). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunization. The patient reported, "I am Pfizer fully vaccinated and had the booster as well. I now have tinnitus (ringing in ears)," with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: age 8 had mild injection site pain; mild injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "recovering", described as "mild injection site pain"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 06Oct2021, outcome "unknown", described as "age 8 had mild injection site pain".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chest pain, Dyspnoea, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent. A 11-year-old male patient received bnt162b2, administered in arm right, administration date 09Nov2021 15:30 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 09Nov2021 15:45 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 09Nov2021 15:30, outcome "unknown", described as "Caller states she has 2 kids that got their Pfizer Covid shots and flu shots (11 Years old)"; CHEST PAIN (non-serious) with onset 09Nov2021 21:00, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset 09Nov2021 21:00, outcome "unknown", described as "he said he has to stop doing something to catch his breath". Patient had not received any vaccine within 4 weeks prior to vaccinations. There was no relevant test. There were no adverse event following prior vaccinations. Reporter seriousness for both events were unspecified. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: Received his booster dose on 09Nov2021; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "Received his booster dose on 09Nov2021"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Headache".   Additional information: Caller says "I know you're not suppose to take over the counter medications like Advil before vaccination. Is it acceptable to take for a headache afterwards?".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site vesicles
Clinical narrative: A blister popped up near the site; patient received booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 11:15 (Lot number: FE3592) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "chronic pain disorder" (unspecified if ongoing). Family history included: "odd reactions to about everything" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot No-EN6207, Route: Injected into left arm), administration date: 16Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot No-ER8729, Route: Injected into left arm), administration date: 06Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Nov2021 11:15, outcome "unknown", described as "patient received booster dose"; VACCINATION SITE VESICLES (non-serious) with onset 09Nov2021, outcome "not recovered", described as "A blister popped up near the site".  Additional information: A blister popped up near the site (on same arm, left arm, same side as administration), but not sure if it was exactly where injection was given. It was rather nasty. It was only about less than the width of her pinky finger, very small. Hasn't gotten any bigger. Blister was on the left arm. Started to get smaller. She had been really careful not to burst it. She woke up and had scratched in herself in her sleep and it hurt like heck enough to wake her up. Part of the blister burst and was drying out. She had chronic pain disease prior to vaccination and a couple other things, but nothing that would cause the blister. NDC number and expiry date were reported as unknown. No investigation assessment was reported. She worked as a research assistant with behavioural pharmacology. Knows that some of the rare side effects that happen don't necessarily get listed if they fall under a certain percentage point. She is the kind of person that gets the rare side effects. Additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, relevant tests were reported as none. The adverse events did not require visit to emergency room or physician office. Vaccine wise pretty normal. Outside of that, family has odd reactions to about everything, but not vaccines.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Immunisation
Clinical narrative: Got her Pfizer covid vaccine booster; Has bruising on her toes on the opposite side of her body that the vaccine was given on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Got her Pfizer covid vaccine booster"; CONTUSION (non-serious) with onset Nov2021, outcome "unknown", described as "Has bruising on her toes on the opposite side of her body that the vaccine was given on". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Nov2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that included: event details, seriousness.  Follow-up (16Nov2021): 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.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: they got their booster vaccine; The person told me they got a rash all down both sides of their neck and onto their shoulders the day they got their booster vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Oct2021, outcome "unknown", described as "they got their booster vaccine"; RASH (non-serious) with onset 17Oct2021, outcome "recovered" (2021), described as "The person told me they got a rash all down both sides of their neck and onto their shoulders the day they got their booster vaccine.".  Additional information: Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown patient been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Immunisation, Lymphadenopathy, Swelling
Clinical narrative: lymph nodes swollen under left arm to middle of chest; Dose 3; Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before; Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101572685 (PFIZER).  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 14:00 (Lot number: FE3592, Expiration Date: 30Nov2021) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, diagnosed since he was a kid. Concomitant medication(s) included: SINGULAIR taken for asthma. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6205, Expiration: 30Jun2021), administration date: 09Mar2021, when the patient was 46 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot: ER2613, Expiration: 31Jul2021), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 14:00, outcome "unknown", described as "Dose 3"; LYMPHADENOPATHY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "lymph nodes swollen under left arm to middle of chest"; BRONCHITIS (non-serious), SWELLING (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No AEs following prior vaccinations. The events did not result in emergency room or physician office visit. The reporter assessed the events as non serious. No other vaccines was administered on same day as suspect.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling face
Clinical narrative: swelling under her cheekbones on her face; she received the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Aug2021 (Lot number: FC3182) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, Covid-19 First dose: , Lot: EL9265, Expiry date: 31May2021, Dose Unknown, injection in the left arm for all 3 doses.), administration date: 05Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Caller said that with the first dose she had nothing"; Bnt162b2 (Covid-19 Second dose :, Lot: EN6203, Expiry: 30Jun2021, Dose Unknown, injection in the left arm for all 3 doses. , Caller said that with the first dose she had nothing. With the second dose, after about 12 hours she got sick for 12 hours. It was very odd. Part of her body was hot and part was cold. She had ice packs on part of her body and heating pads on the other parts. After 12 hours it was gone. It was nuts.), administration date: 26Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "she got sick for 12 hours", "Part of her body was hot and part was cold", "Part of her body was hot and part was cold", "It was very odd/It was nuts.". The following information was reported: IMMUNISATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "she received the booster dose"; SWELLING FACE (non-serious) with onset Oct2021, outcome "not recovered", described as "swelling under her cheekbones on her face".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in emergency room or physician office visit. The reporter assessed the events as non serious. Relevant tests was reported as none. No additional vaccine was administered on same day as suspect. Patient experienced facial swelling under her check bone after the booster dose. it did not started right away and " it was not horrible" but now she has it under both check bone. it was under one check bone before. The patient said that she had her Botox, but she had the swelling prior to going. She said that after the 3rd Covid-19 shot it got worse.   Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaccination site bruising, Vaccination site rash
Clinical narrative: Arm has a strange rash/bruise at site of injection; Arm has a strange rash/bruise at site of injection; Current age-7; Current age-7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 13Nov2021, outcome "not recovered" and all described as "Arm has a strange rash/bruise at site of injection"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 08Nov2021, outcome "unknown" and all described as "Current age-7". Therapeutic measures were not taken as a result of vaccination site bruising, vaccination site rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Known allergies reported as NKNDA. The patient had not received any other vaccine within 4 weeks and not received any other medications in two weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:00 (Lot number: EW0173) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Dec2020, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Jan2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "Dose Number: 1 23Dec2020, Dose Number: 2 10Jan2021". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4"; IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: Results of tests and procedures for investigation of the patient: (Test: Nasal Swab, Result: Negative). 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 been tested for COVID-19.  Follow-Up (17Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Mobility decreased, Peripheral swelling, Swelling
Clinical narrative: Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine; Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine; my left side chest has swollen; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 11:30 (Lot number: Ph8020) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 16:30), administration date: 28May2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 11May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious) all with onset 14Nov2021 16:30, outcome "unknown" and all described as "Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine"; SWELLING (non-serious) with onset 14Nov2021 16:30, outcome "unknown", described as "my left side chest has swollen"; IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "Dose Number: 3". Therapeutic measures were not taken as a result of peripheral swelling, mobility decreased, swelling.  Additional information: No known allergies was reported. Events required no prolonged hospitalization. The patient had not received any other vaccine within four weeks prior to the COVID vaccine. The patient was not tested for Covid-19 since vaccination. Device date was reported as 14Nov2021.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspepsia, Illness, Immunisation, Malaise
Clinical narrative: booster shot; She had a little pain after the booster shot; she is in pain; swelling/ I was swell, swollen; I have got sick; My stomach that has got the burning on; couldn't move; She is weak; I am not well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; PAIN (non-serious), outcome "not recovered", described as "She had a little pain after the booster shot; she is in pain"; SWELLING (non-serious), outcome "unknown", described as "swelling/ I was swell, swollen"; ILLNESS (non-serious), outcome "unknown", described as "I have got sick"; DYSPEPSIA (non-serious), outcome "unknown", described as "My stomach that has got the burning on"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "couldn't move"; ASTHENIA (non-serious), outcome "unknown", described as "She is weak"; MALAISE (non-serious), outcome "unknown", described as "I am not well".   Additional information: The reporter stated that, patient was not well, (not clear), got sick, was swell/ swollen, could not move and the stomach that had got the burning on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Swelling
Clinical narrative: booster shot; She had a little pain after the booster shot; she is in pain; swelling/ I was swell, swollen; I have got sick; My stomach that has got the burning on; couldn't move; She is weak; I am not well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; PAIN (non-serious), outcome "not recovered", described as "She had a little pain after the booster shot; she is in pain"; SWELLING (non-serious), outcome "unknown", described as "swelling/ I was swell, swollen"; ILLNESS (non-serious), outcome "unknown", described as "I have got sick"; DYSPEPSIA (non-serious), outcome "unknown", described as "My stomach that has got the burning on"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "couldn't move"; ASTHENIA (non-serious), outcome "unknown", described as "She is weak"; MALAISE (non-serious), outcome "unknown", described as "I am not well".   Additional information: The reporter stated that, patient was not well, (not clear), got sick, was swell/ swollen, could not move and the stomach that had got the burning on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Illness, Immunisation
Clinical narrative: booster; She has been sick for a couple of days; Where she got the shot is just burning hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; ILLNESS (non-serious) with onset 2021, outcome "recovering", described as "She has been sick for a couple of days"; BURNING SENSATION (non-serious) with onset 2021, outcome "not recovered", described as "Where she got the shot is just burning hot". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: This consumer (patient husband) reported for a female patient(reporter's wife).  Follow-up (16Nov2021): 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.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Nov 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient "got the booster shot" and experienced diarrhea, onset Nov 14, 2021, with outcome of unknown. Additional information: Report not related to a study or program. The patient got the booster shot on Friday and today started feeling some side effect. The patient does not know if related, but just today started with diarrhea. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vomiting
Clinical narrative: 7 yo f began vomiting 6 hrs after first pediatric comirnaty dose; 7 yo f began vomiting 6 hrs after first pediatric comirnaty dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 2021, outcome "unknown" and all described as "7 yo f began vomiting 6 hrs after first pediatric comirnaty dose".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Erythema, Headache, Immunisation, Joint swelling
Clinical narrative: booster; it hurts to move my arm; Slight headache; Nausea; My shoulders been red and swollen; My shoulders been red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FE3592) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for hypertension; MONTELUKAST; SYMBICORT. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 12Nov2021, outcome "unknown", described as "it hurts to move my arm"; HEADACHE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Slight headache"; NAUSEA (non-serious) with onset 12Nov2021, outcome "unknown", described as "Nausea"; JOINT SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "unknown" and all described as "My shoulders been red and swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, nausea, joint swelling, erythema.  Additional information: The patient stated she was reading her paper work and it said if she had any reactions she should call Pfizer Drug Safety. She got her shot about 09:30 on Friday morning at her medical Center and her shoulders been red and swollen since then, sometime it hurts to move her arm. She had a slight headache and little bit of nausea. Treatment, she stated she put some ice on it and took an allergy pill.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: booster; it hurts to move my arm; Slight headache; Nausea; My shoulders been red and swollen; My shoulders been red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FE3592) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for hypertension; MONTELUKAST; SYMBICORT. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 12Nov2021, outcome "unknown", described as "it hurts to move my arm"; HEADACHE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Slight headache"; NAUSEA (non-serious) with onset 12Nov2021, outcome "unknown", described as "Nausea"; JOINT SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "unknown" and all described as "My shoulders been red and swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, nausea, joint swelling, erythema.  Additional information: The patient stated she was reading her paper work and it said if she had any reactions she should call Pfizer Drug Safety. She got her shot about 09:30 on Friday morning at her medical Center and her shoulders been red and swollen since then, sometime it hurts to move her arm. She had a slight headache and little bit of nausea. Treatment, she stated she put some ice on it and took an allergy pill.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Lymphadenopathy, Malaise, Off label use
Clinical narrative: General malaise; swollen lymph node under left armpit; Joint pain in legs; other vaccine same date: Flu shot; other vaccine same date: Flu shot; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 11Nov2021 14:30 (Lot number: FG3527) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 33 years old, for COVID-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "other vaccine same date: Flu shot"; IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Dose number 3"; MALAISE (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "General malaise"; LYMPHADENOPATHY (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "swollen lymph node under left armpit"; ARTHRALGIA (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "Joint pain in legs". Therapeutic measures were not taken as a result of malaise, lymphadenopathy, arthralgia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: General malaise; swollen lymph node under left armpit; Joint pain in legs; other vaccine same date: Flu shot; other vaccine same date: Flu shot; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 11Nov2021 14:30 (Lot number: FG3527) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 33 years old, for COVID-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "other vaccine same date: Flu shot"; IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Dose number 3"; MALAISE (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "General malaise"; LYMPHADENOPATHY (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "swollen lymph node under left armpit"; ARTHRALGIA (non-serious) with onset 12Nov2021 07:00, outcome "recovered" (Nov2021), described as "Joint pain in legs". Therapeutic measures were not taken as a result of malaise, lymphadenopathy, arthralgia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Immunisation
Clinical narrative: Booster; Nose bleeds; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single (Primary Immunization series complete but unknown manufacturer)), administration date: Apr2021, for Covid-19 immunization; Covid-19 vaccine (dose 2, single (Primary Immunization series complete but unknown manufacturer)), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (non-serious) with onset Nov2021, outcome "unknown", described as "Nose bleeds". Additional information: The patient had nosebleed 2 days after the booster dose, really bad. The patient does not know if the vaccine caused this nosebleed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site rash
Clinical narrative: Red Rash from injection site covering bicep; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Dose brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION SITE RASH (non-serious) with onset 13Nov2021, outcome "unknown", described as "Red Rash from injection site covering bicep". Therapeutic measures were not taken as a result of vaccination site rash. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Device date was 15Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.