chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site extravasation, Vaccination site haemorrhage
Clinical narrative: A vaccinator was vaccinating a client, and some fluid leaked out at injection site.; A vaccinator was vaccinating a client, and some fluid leaked out at injection site.; blood trickle down the arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 24 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Feb2022 (Lot number: 33030BD, Expiration Date: 31May2022) at the age of 24 years 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: INCORRECT DOSE ADMINISTERED (non-serious), VACCINATION SITE EXTRAVASATION (non-serious) all with onset 08Feb2022, outcome "unknown" and all described as "A vaccinator was vaccinating a client, and some fluid leaked out at injection site."; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 08Feb2022, outcome "unknown", described as "blood trickle down the arms".  Additional information: Reporter is a Physician Assistant, working at a vaccination site. A vaccinator was vaccinating a client, and some fluid leaked out at injection site. Unsure how much of the vaccine was actually administered. Asking that should we give another dose immediately. Patient was administered today (at the time of report, that is 08Feb2022). Physician assistant confirmed that not the entire dose of the purple cap Pfizer BioNTech covid-19 Vaccine has been administered to a patient. They estimate it to be about half or 3/4 of the dose only administered, after she pulled the needle out there is little bit of fluid and little bit of blood trickle down the arms. Reporter don't know how much actually got in but MA (further not clarified) told me after she pulled the needle out there is little bit of fluid and little bit of blood trickle down the arms. Reporter was thinking it was at least half the dose if not more actually got in, but just can't be sure and didn't see it.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities and updated event from injection site leaking to vaccination site extravasation.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Mammogram, Swelling, Ultrasound breast
Clinical narrative: armpit is swollen; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "armpit is swollen". The event "armpit is swollen" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that, Ever since, she feel like her armpit is swollen and is slightly bothersome. She have had a mammogram, three breast exams, and an ultrasound. None of which show any abnormalities. If she take Ibuprofen, the feeling in her armpit goes away. She was wondering...Is it possible that she w is still having a slight reaction from the vaccines even though it has been 5 months since booster. The doctor stated her lymph node was not swollen.  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: Body temperature, Headache, Incorrect dose administered, Injection site pain, Overdose
Clinical narrative: mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; The administration was of 0.2 mL but of an undiluted vial; mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; Mild fever 99 degree F; headaches; Pain at pt of injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Mar2022 13:00 (Lot number: FL0007) as dose 2, 0.2 ml, (tris) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prior Vaccinations: (Within 4 weeks), Manufacturer: Pfizer, Batch/ Lot#: FL0007, Route: In, Anatomical site of injection: LD, No. of previous doses: 0, Date: 03Feb2022), administration date: 03Feb2022, for covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose"; PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown", described as "The administration was of 0.2 mL but of an undiluted vial"; INJECTION SITE PAIN (non-serious) with onset 03Mar2022 21:00, outcome "recovered" (04Mar2022), described as "Pain at pt of injection"; PYREXIA (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "Mild fever 99 degree F"; HEADACHE (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, pyrexia, headache.  Additional information: Received call from nurse practitioner regarding the Pfizer Pediatric 5-11 COVID 19 vaccine. A nurse injected 0.2ml of the vaccine without diluent to a 07-year-old patient. Nurse would like to know what next steps are needed for patient. No further details provided.  Follow-up (18Mar2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported for a patient in response to HCP letter sent that included:  Updated information included: Reporter information, Patient name, Dosage regimen slider #1, recoded, Anatomical Location, Vaccine Facility Information, Historical Vaccine, Concomitant Therapy captured as None, Lab data, New AE [Injection site pain, Fever, Headache]  Follow-Up (23Mar2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Pyrexia
Clinical narrative: mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; The administration was of 0.2 mL but of an undiluted vial; mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; Mild fever 99 degree F; headaches; Pain at pt of injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Mar2022 13:00 (Lot number: FL0007) as dose 2, 0.2 ml, (tris) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prior Vaccinations: (Within 4 weeks), Manufacturer: Pfizer, Batch/ Lot#: FL0007, Route: In, Anatomical site of injection: LD, No. of previous doses: 0, Date: 03Feb2022), administration date: 03Feb2022, for covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose"; PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown", described as "The administration was of 0.2 mL but of an undiluted vial"; INJECTION SITE PAIN (non-serious) with onset 03Mar2022 21:00, outcome "recovered" (04Mar2022), described as "Pain at pt of injection"; PYREXIA (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "Mild fever 99 degree F"; HEADACHE (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, pyrexia, headache.  Additional information: Received call from nurse practitioner regarding the Pfizer Pediatric 5-11 COVID 19 vaccine. A nurse injected 0.2ml of the vaccine without diluent to a 07-year-old patient. Nurse would like to know what next steps are needed for patient. No further details provided.  Follow-up (18Mar2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported for a patient in response to HCP letter sent that included:  Updated information included: Reporter information, Patient name, Dosage regimen slider #1, recoded, Anatomical Location, Vaccine Facility Information, Historical Vaccine, Concomitant Therapy captured as None, Lab data, New AE [Injection site pain, Fever, Headache]  Follow-Up (23Mar2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild tiredness after the third 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: she and her husband are immunocompromised; "I am asthmatic" (unspecified if ongoing), notes: I am asthmatic. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "mild tiredness after the third dose".  Follow-up (25Feb2022): This is a spontaneous follow-up report received from a contactable consumer. This female consumer (Patient) reported that: Updated information included: RMH. New Event of "My doctor was upset that I got the Covid vaccine. I am asthmatic and almost died and he asked me why I got a third vaccine".   Follow-up (10Mar2022): The initial and follow-up case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 10Mar2022, this case now contains all required information to be considered valid. This is a spontaneous follow-up report from a contactable consumer. This female consumer (patient) reported in response to Non-HCP letter sent via telephonic follow-up activity which included that: Updated Information Included: New event "Tiredness".  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Nervous system disorder
Clinical narrative: have some type of neurological conditions on my hands; muscle spasm on my hands and my arms; all the way from my shoulders to the end of my finger tips are numb; all the way from my shoulders to the end of my finger tips are numb; have several spasms; second shot and now I am having numbness all over (voice overlapping) in my hand; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "neither one of those are working"; Neurontin, reaction(s): "neither one of those are working". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Numbness in feet", "numbness in my hand". The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "have some type of neurological conditions on my hands"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasm on my hands and my arms"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "all the way from my shoulders to the end of my finger tips are numb"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "have several spasms"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "second shot and now I am having numbness all over (voice overlapping) in my hand".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "Racing heart"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest pains". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pruritus
Clinical narrative: My head is itching really bad; Really bad taste in mouth like chewed aspirin whole time on med; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Aug2021 (Lot number: Fc3184) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid long haulers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Paxil, reaction(s): "Known allergies: Paxil". The following information was reported: PRURITUS (non-serious) with onset 05Mar2022, outcome "not recovered", described as "My head is itching really bad"; DYSGEUSIA (non-serious) with onset 05Mar2022, outcome "not recovered", described as "Really bad taste in mouth like chewed aspirin whole time on med". It was unknown if therapeutic measures were taken as a result of pruritus, dysgeusia.  Additional information: Anti-viral details was noted as product for COVID-19 treatment; brand noted as Pfizer; treatment start date noted as 04Mar2022; treatment stop date noted as 08Mar2022; lot number noted as Ft5407 and indication noted as treatment of covid-19. It was reported that patient's head was itching really bad. Did not start until started that medicine (unspecified). Really bad taste in mouth like chewed aspirin whole time on med was also noted.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nasal congestion
Clinical narrative: Headache; congestion; tiredness; swollen armpit lymph node on arm injection received.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2022 14:00 (Lot number: FK9895) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyrodism" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERDS" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; EZETIMIBE; VIT D3; VIT B12; VIT E [TOCOPHEROL]. Past drug history included: Hydrocodone, reaction(s): "Known Allergies: Hydrocodone". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FD8448, Location of injection: Arm Right), administration date: 06Sep2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Right), administration date: 06Aug2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "Headache"; NASAL CONGESTION (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "tiredness"; LYMPHADENOPATHY (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "swollen armpit lymph node on arm injection received.". Therapeutic measures were not taken as a result of headache, nasal congestion, fatigue, lymphadenopathy.  Additional information: Patient did not receive other vaccine in four weeks. Facility type vaccine was Pharmacy or Drug Store. Patient received other medications in two weeks were Estradiol, Ezetimibe, Vit D3, Vit B12, Vit E. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: he gets his second dose his arms pop all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "he gets his second dose his arms pop all the time".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleeds; 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 16 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 10Mar2022, outcome "unknown", described as "nosebleeds".  Additional information: Patient never had nosebleeds before   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, SARS-CoV-2 test, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, hot, swollen, hard lump around the injection site; Red, hot, swollen, hard lump around the injection site; Red, hot, swollen, hard lump around the injection site; Red, hot, swollen, hard lump around the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 (Lot number: 320308D) at the age of 9 years 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 Number: 1, Batch/Lot No: FH8028, Location of injection: Arm Right), administration date: 04Nov2021, for covid-19 immunisation. The following information was reported: ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MASS (non-serious) all with onset 30Nov2021, outcome "recovered" and all described as "Red, hot, swollen, hard lump around the injection site". The event "red, hot, swollen, hard lump around the injection site", "red, hot, swollen, hard lump around the injection site", "red, hot, swollen, hard lump around the injection site" and "red, hot, swollen, hard lump around the injection site" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of erythema, vaccination site warmth, vaccination site swelling, vaccination site mass.  It was reported that the patient did not have covid prior to vaccination. The patient was tested for covid post vaccination. The patient had no Known allergies and had no Other medical history. The patient did not have any vaccine in four weeks. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Pruritus, Swelling, Vaccination site rash
Clinical narrative: Red circle at the injection site that has grown larger everyday; Swollen; hot to the touch.; Hurts and itches at the same time; Hurts and itches at the same time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2022 16:00 (Lot number: FK9895) at the age of 48 years 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: 2, Batch/Lot No: FC8132, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Aug2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 02Aug2021, when the patient was 48 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 08Mar2022, outcome "unknown", described as "Red circle at the injection site that has grown larger everyday"; SWELLING (non-serious) with onset 08Mar2022, outcome "unknown", described as "Swollen"; FEELING HOT (non-serious) with onset 08Mar2022, outcome "unknown", described as "hot to the touch."; PAIN (non-serious), PRURITUS (non-serious) all with onset 08Mar2022, outcome "unknown" and all described as "Hurts and itches at the same time". The events "red circle at the injection site that has grown larger everyday", "swollen", "hot to the touch.", "hurts and itches at the same time" and "hurts and itches at the same time" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site rash, swelling, feeling hot, pain, pruritus. Additional Information: Prior vaccinations within 4 weeks were reported as none. COVID tested prior vaccination and tested post vaccination were reported as none. Treatment received for the events were reported as antibiotics. The patient reported that red circle at the injection site that has grown larger every day. Swollen, hot to the touch. Hurts and itches at the same time. The outside ring of the circle has gotten darker and redder and wider as more time goes by.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pyrexia
Clinical narrative: Fever of 102.9; Chills; Head in a fog; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2022 (Lot number: FK9729) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; VIT D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EN6203), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Mar2022, outcome "recovering", described as "Fever of 102.9"; CHILLS (non-serious) with onset 10Mar2022, outcome "recovering", described as "Chills"; FEELING ABNORMAL (non-serious) with onset 10Mar2022, outcome "recovering", described as "Head in a fog". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 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. List of any other medications the patient received within 2 weeks of vaccination: multi vitamin.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: If changes to menstruation with the girls could be like a reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  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: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), administration date: Dec2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), administration date: Dec2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "If changes to menstruation with the girls could be like a reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200398491 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: did not experience any adverse events after taking doses of the vaccine as compared with her sister who experienced fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (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: PYREXIA (non-serious), outcome "unknown", described as "did not experience any adverse events after taking doses of the vaccine as compared with her sister who experienced fever.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: changes in menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  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: Covid-19 vaccine (dose:1, Manufacturer Unknown , but mentioned her and her family got two doses of the vaccine last Dec.), administration date: Dec2021, for COVID-19 Immunization; Covid-19 vaccine (dose:2, Manufacturer Unknown , but mentioned her and her family got two doses of the vaccine last Dec.), administration date: Dec2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "changes in menstruation".  Additional information: Reporter's real concern though was asking if changes to menstruation with the girls could be like a reaction, for her two daughters. Reporter wanted to know if there were any reactions or any effects to any girls menstruation for a side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200398438 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Emphysema
Clinical narrative: emphysema; COPD; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 ( booster),single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation; Covid-19 vaccine (Dose 2), for Covid-19 immunisation.  The following information was reported: EMPHYSEMA (non-serious), outcome "unknown", described as "emphysema"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  Additional information: patient read in the paper that country is doing trials for a fourth vaccine of Covid for immunocompromised for people older than 65. She was immunocompromised and had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever over 103; body aches; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EK4176) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: EH9899), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever over 103"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 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.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test, Thyroid function test
Clinical narrative: Loosing hair was coming out everytime i combed it/Hair is so thin now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0182, Location of injection: Arm Right), administration date: 11Jun2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0173, Location of injection: Arm Left), administration date: 21May2021, when the patient was 66 years old, for COVID-19 Immunization.  The following information was reported: ALOPECIA (non-serious) with onset 31Dec2021, outcome "recovered with sequelae", described as "Loosing hair was coming out everytime i combed it/Hair is so thin now". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Within a day or 2 patient started loosing hair, which was coming out everytime she combed it. This lasted for about 5 weeks. Patient hair was so thin now, told cardiologist and sent her for thyroid test, which came back good. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Other medical history: Yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: Feeling fullness in tongue and cheeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-030422-5619.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; botulinum toxin type a haemagglutinin complex (DYSPORT), since 03Mar2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Mar2022, outcome "unknown", described as "Feeling fullness in tongue and cheeks". The action taken for botulinum toxin type a haemagglutinin complex was unknown.  Additional Information: Reference is made to the FDA Guidelines for Post-marketing Reporting of Adverse Drug Experiences (Docket No. withheld) dated Mar1992, requires "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." Female reports fullness in her tongue and inside of her cheeks. She denies any rash, shortness of breath or difficulty swallowing. Female reports that she has had Dysport in the past with another provider and did not experience any symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I was diagnosed with Alopecia by my Dermatologist after my hair stylist found a bald patch on my scalp.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 (Lot number: 30/55BA) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies Mint" (unspecified if ongoing), notes: known allergies Mint. Concomitant medication(s) included: SIMVASTATIN; ZINC; PROBIOTICS; COQ10 [UBIDECARENONE]; CALCIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8983, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 31Dec2021, outcome "not recovered", described as "I was diagnosed with Alopecia by my Dermatologist after my hair stylist found a bald patch on my scalp". The event "i was diagnosed with alopecia by my dermatologist after my hair stylist found a bald patch on my scalp." was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: Event was treated with injections in the scalp and prescription liquid. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Since receiving the booster, I am having constant joint pain. Even though I am 72, I teach 4 nights a week and am very active. Why only now since the booster do I have such constant joint pain?; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 16:00 (Lot number: 5682) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Citrus, reaction(s): "known allergies: citrus". Vaccination history included: Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine brand unknown=False,, vaccine administration date=30Jun2021,, vaccine administration time=09:30AM,, vaccine lot number=0198,, vaccine lot unknown=False,, vaccine dose number unknown=True,, vaccine dose number unknown reason=UNKNOWN,, vaccine location=Left arm), administration date: 30Jun2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine brand unknown=False,, vaccine administration date=21Jul2021,, vaccine administration time=09:00AM, vaccine lot number=7484,, vaccine lot unknown=False,, vaccine dose number unknown=True,, vaccine dose number unknown reason=UNKNOWN,, vaccine location=Right arm), administration date: 21Jul2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Since receiving the booster, I am having constant joint pain. Even though I am 72, I teach 4 nights a week and am very active. Why only now since the booster do I have such constant joint pain?". Therapeutic measures were not taken as a result of arthralgia.  Additional information: Reported that since receiving the booster, patient had constant joint pain. Even though patient was 72, she teach 4 nights a week and was very active. Why only now since the booster did, she had such constant joint pain? How can she remedy this? She did not take any other meds other than a blood pressure pill, 10 mg, every second day. Please advise sooner rather than later. Patient had known allergies: cillins, citrus, and numerous others.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Endometriosis, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Change in menstrual cycle; Increase in severity of endometriosis symptoms; Increase in severity of endometriosis symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 19Jul2021, outcome "recovering", described as "Change in menstrual cycle"; ENDOMETRIOSIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 19Jul2021, outcome "recovering" and all described as "Increase in severity of endometriosis symptoms". The events "change in menstrual cycle", "increase in severity of endometriosis symptoms" and "increase in severity of endometriosis symptoms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of menstrual disorder, endometriosis, condition aggravated.  Additional information: The reporter was reported about covid vaccine. The patient was reported and AE reported and Female and no had Pregnant. The patient Dose received: 2 and Product: COVID 19 its Pfizer brand. The lot not provided. The Administration date: 02Aug2021 11:00 AM at Vaccine location: Left arm and The previous dose history unknown. The Previous dose administration time: 11:00 AM and dose number: 1 .The Previous dose vaccine location: Left arm Facility type vaccine: Pharmacy or Drug Store and no other vaccine in four weeks. The reporter was reported about Adverse event: Change in menstrual cycle Increase in severity of endometriosis symptoms and adverse event start date: 19Jul2021. The AE resulted in: [Doctor or other healthcare professional office/clinic visit] and patient recovered: Recovering. The treatment was unknown and no covid prior vaccination. The covid tested post vaccination and covid test type post vaccination: Nasal Swab results was Negative . The related history had  known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: experienced symptoms afterwards like a flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient in her 60's 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: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer" ), administration date: Dec2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "experienced symptoms afterwards like a flu". Additional Information: The reporter stated that the patient and her family received the 2 doses of the vaccine back in Dec and they already got the booster dose. Caller said that she is the only one who experienced symptoms afterwards like a flu. She would like to know if there are any cases with girls' periods being affected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Movement disorder, Muscle twitching, Neurological symptom, Oxygen saturation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "had breathing issues" (unspecified if ongoing), notes: Dates for had breathing issues: (From: Unspecified To: Unspecified). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization) with onset 25Jan2022, outcome "unknown", described as "acute respiratory failure"; PNEUMONIA (medically significant) with onset 23Dec2021, outcome "recovered with sequelae" (03Jan2022), described as "Pneumonia"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "could not get out of bed"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "stated that she has put on some weight since all of this started happening"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "hands are doing these twitchy things"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "something neurological going on". The patient was hospitalized for acute respiratory failure (start date: 25Jan2022, discharge date: 31Jan2022, hospitalization duration: 6 day(s)). The events "acute respiratory failure" and "pneumonia" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (23Jan2022) low; weight: (unspecified date) put on. Therapeutic measures were taken as a result of pneumonia. On 23Dec2021, patient was started on oxygen. She saw her doctor on 03Jan2022 and was put on antibiotics and steroids due to pneumonia. She went back home and had been off work the entire time. On 25Jan2022 that she went to the ER and was told that she was in respiratory failure. Her health dropped off so much she could not get out of bed and had to have her son come dress her. She does not know if the oxygen will permanent. She was hospitalized for acute respiratory failure and was diagnosed with pneumonia on 23Dec2021 but was not hospitalized and only went to the ER. She had breathing issues that started earlier on from that date. She did not recover from pneumonia and her condition was getting worst so she called her doctor back and asked for some more steroids and antibiotics. The lot number for bnt162b2 was not provided and will be requested during follow up.