chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: One day after the injection, experiencing tinnitus in left ear only; Dose received 3/ dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 40-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 12:00 (Lot number: 33030BD) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: DAILY BIRTH CONTROL PILL, VITAMIN D3, VITAMIN C and M. Vaccination history included:  BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0150, Route of administration: Unspecified, Anatomical location: Left arm, Vaccine Administration Time: 12:00), administration date: 02Apr2021, when the patient was 40 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0171,Route of administration: Unspecified, Anatomical location: Left arm, Vaccine Administration Time: 12:00), administration date: 23Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 12:00, outcome "unknown", described as "Dose received 3/ dose number=3"; TINNITUS (non-serious) with onset 30Nov2021 at 00:00, outcome "not recovered", described as "One day after the injection the patient experienced tinnitus in her left ear only". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Hyperhidrosis, Immunisation
Clinical narrative: Swelling and pain in left arm pit; Swelling and pain in left arm pit; Serious arm pain first 24 hours; Extreme fatigue; Sweating/chills; Sweating/chills; Received 3rd dose of BNT162B2 Pfizer vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 15:45 (Lot number: 330308D) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "Hypercholesterolemia" (unspecified if ongoing). Concomitant medications included: BIRTH CONTROL; CITALOPRAM; ZYRTEC and PRAVASTATIN. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: EW0162, Anatomical Location: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 16Apr2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8730, Anatomical Location: Left arm, Administration time: 16:00, Route of administration: unspecified), administration date: 28Mar2021, both when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 15:45, outcome "unknown", described as "received 3rd dose of BNT162B2 Pfizer vaccine"; SWELLING (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), HYPERHIDROSIS (non-serious) and CHILLS (non-serious), all with onset 30Nov2021, outcome "not recovered", and all described as "swelling and pain in left arm pit, serious arm pain first 24 hours, extreme fatigue, sweating and chills". Therapeutic measures were not taken as a result of swelling, axillary pain, pain in extremity, fatigue, hyperhidrosis and chills.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Swelling and pain in left arm pit; Swelling and pain in left arm pit; Serious arm pain first 24 hours; Extreme fatigue; Sweating/chills; Sweating/chills; Received 3rd dose of BNT162B2 Pfizer vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 15:45 (Lot number: 330308D) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "Hypercholesterolemia" (unspecified if ongoing). Concomitant medications included: BIRTH CONTROL; CITALOPRAM; ZYRTEC and PRAVASTATIN. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: EW0162, Anatomical Location: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 16Apr2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8730, Anatomical Location: Left arm, Administration time: 16:00, Route of administration: unspecified), administration date: 28Mar2021, both when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 15:45, outcome "unknown", described as "received 3rd dose of BNT162B2 Pfizer vaccine"; SWELLING (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), HYPERHIDROSIS (non-serious) and CHILLS (non-serious), all with onset 30Nov2021, outcome "not recovered", and all described as "swelling and pain in left arm pit, serious arm pain first 24 hours, extreme fatigue, sweating and chills". Therapeutic measures were not taken as a result of swelling, axillary pain, pain in extremity, fatigue, hyperhidrosis and chills.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: A parent on his daughter's robotics team passed away from Covid today; A parent on his daughter's robotics team passed away from Covid today; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death), outcome "fatal" and all described as "A parent on his daughter's robotics team passed away from Covid today". The deceased was fully vaccinated. The patient date of death was unknown. The reported cause of death was covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment of event COVID-19 infection post- BNT162B2 Vaccine,however its causal role cannot be excluded due to lack of efficacy  .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate ; Reported Cause(s) of Death: passed away from Covid
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gastric disorder, Illness
Clinical narrative: sick to her stomach; feeling dizzy; she's really really sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received first dose of  bnt162b2 (BNT162B2, Batch/Lot number: unknown) administration date 25Feb2021 as DOSE 1, SINGLE dose for covid-19 immunization. Relevant medical history included: "gall bladder trouble" (unspecified if ongoing); "mental illness" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "asthma" (unspecified if ongoing); "heavy smoker" (unspecified if ongoing). Concomitant medication(s) included: HALDOL. The following information was reported: GASTRIC DISORDER (non-serious), outcome "unknown", described as "sick to her stomach"; DIZZINESS (non-serious), outcome "unknown", described as "feeling dizzy"; ILLNESS (non-serious), outcome "unknown", described as "she's really sick". Therapeutic measures were taken as a result of gastric disorder, dizziness, illness.  Additional Information: Caller stated she was asking questions regarding her daughter medical conditions. Caller stated her daughter received her first Pfizer COVID-19 vaccination on last Thursday (25FEB2021). Caller reported that her daughter is a heavy smoker. Caller mentioned that her daughter had other underlying medical conditions. Caller stated her daughter has emphysema and asthma. Caller reported to that her daughter has a mental condition. Caller stated her daughter is on Haldol. Caller reported that her daughter has taken Dramamine secondary to feeling dizzy and sick to her stomach after taking the vaccine. Caller implied she was really sick. Due to these symptoms, caller stated that they were hesitant of her taking the second vaccination. Caller stated her daughter had gall bladder trouble. Caller asked will this vaccine effect the gall bladder. Caller asked was there any information regarding her daughter medical conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: both sides of my groin were hurting when walking; 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 83 year-old male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 83 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 (1st dose), administration date: 13Jan2021, when the patient was 83 years old, for Covid-19 Immunisation. The following information was reported: GROIN PAIN (non-serious), outcome "not recovered", described as "both sides of my groin were hurting when walking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: malaise and feeling bad the day after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 88-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 88 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), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "malaise and feeling bad the day after receiving the vaccine".  Additional information: The patient stated that the patient reports a general feeling of unwell and feels horrible. Caller states the patient saw another provider 25Feb and 26Feb in which they believed the patient was experiencing serum sickness. The physician that saw her on 25Feb and 26Feb gave her a shot of steroids and prescribed her a Medrol dose pack. Caller states that the patient reports feeling much better the day after receiving the shot of steroids.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; 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 NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: was very tired.; she experienced dizziness; imbalance "my balance was off"; 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.  An 88-year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: fatigue with onset 17Feb2021, outcome "unknown", described as "was very tired."; dizziness with onset 17Feb2021, outcome "unknown", described as "she experienced dizziness"; balance disorder with onset 17Feb2021, outcome "unknown", described as "imbalance "my balance was off""; headache with onset 17Feb2021, outcome "unknown", described as "headache".  Additional information: consumer agreed to be contacted later, if possible after 5:00 PM, declined to file a report online on website name) 2 hours after the 1st COVID-19 vaccine, she experienced dizziness, imbalance "my balance was off", headache and was very tired. I was that way for 2 or 3 days. Patient is 88-years old. The first dose was administered 12 days ago, her next vaccination is scheduled for 11Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: experiencing back pain that feels like its in her muscles; 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), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL; LIDOCAINE. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization.  The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "experiencing back pain that feels like its in her muscles".  Additional information: It was reported as second dose of the Pfizer vaccine on 09Feb2021 and was now experiencing back pain that feels like its in her muscles.She has been using lidocaine patches and tylenol. She does not have a history of back pain.The patient questioned if that was a reported side effect and that it would last forever. The patient reported that if there was anything the patient could take for the pain and what would the doctor give the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: sore arm (at injection site); body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 10:30 AM (Lot number: EL3247) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperlipidemia and idiopathic peripheral neuropathy" (unspecified if ongoing), notes: Hyperlipidemia and idiopathic peripheral neuropathy; "Hyperlipidemia and idiopathic peripheral neuropathy" (unspecified if ongoing), notes: Hyperlipidemia and idiopathic peripheral neuropathy. Concomitant medication(s) included: LIPITOR [ATORVASTATIN] (20mg); AMITRIPTYLINE (25mg). The following information was reported: INJECTION SITE PAIN (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "sore arm (at injection site)"; PAIN (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of injection site pain, pain, headache.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: both elbows were uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66-years-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown)  administered in arm left, administration date 23Jan2021 as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "facial neuritis" (unspecified if ongoing), notes: facial neuritis, 12 years ago; "breast cancer" (unspecified if ongoing), notes: 7 years ago. The patient's concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious), outcome "unknown", described as "both elbows were uncomfortable".  Additional Information: Caller stated that she would like to report an adverse event. She stated her mother received the first dose of the Pfizer COVID vaccine on 23Jan2021 in her left arm and both elbows were uncomfortable. Caller states 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then. Caller states her grandmother had strokes in the past and she just wanted to share that family history in relation to nerves. Caller states 7 years ago her mother had breast cancer and her nerves were hurt after treatment of cancer and she went to the hospital and the doctor said everything was okay no problems and she never had problems after having facial neuritis. The patient was scheduled for dose 2 on 20Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site itching; injection site redness; injection site swelling; injection site warmth; injection site tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression and anxiety" (unspecified if ongoing); "Depression and anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing); "adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (Dose 1, single at 10:00, administered on Left arm, Lot number: EL9264), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "headache", "fatigue". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site itching"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site swelling"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site warmth"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site tenderness". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pain.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site itching; injection site redness; injection site swelling; injection site warmth; injection site tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression and anxiety" (unspecified if ongoing); "Depression and anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing); "adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (Dose 1, single at 10:00, administered on Left arm, Lot number: EL9264), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "headache", "fatigue". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site itching"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site swelling"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site warmth"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site tenderness". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pain.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site itching; injection site redness; injection site swelling; injection site warmth; injection site tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression and anxiety" (unspecified if ongoing); "Depression and anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing); "adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (Dose 1, single at 10:00, administered on Left arm, Lot number: EL9264), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "headache", "fatigue". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site itching"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site swelling"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site warmth"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site tenderness". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pain.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: covid arm/ red spot; covid arm/ itchy; covid arm/ swollen; covid arm/ hot; covid arm/ tender; covid arm/ firm to touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "possible allergies to dairy" (unspecified if ongoing); "possible allergies to adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL9264, vaccine location: left arm), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "Headache", "fatigue". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ red spot"; VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ itchy"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ swollen"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ hot"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ tender"; VACCINATION SITE INDURATION (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ firm to touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site swelling, vaccination site warmth, vaccination site pain, vaccination site induration.  Additional Information: Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: covid arm/ red spot; covid arm/ itchy; covid arm/ swollen; covid arm/ hot; covid arm/ tender; covid arm/ firm to touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "possible allergies to dairy" (unspecified if ongoing); "possible allergies to adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL9264, vaccine location: left arm), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "Headache", "fatigue". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ red spot"; VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ itchy"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ swollen"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ hot"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ tender"; VACCINATION SITE INDURATION (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ firm to touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site swelling, vaccination site warmth, vaccination site pain, vaccination site induration.  Additional Information: Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: covid arm/ red spot; covid arm/ itchy; covid arm/ swollen; covid arm/ hot; covid arm/ tender; covid arm/ firm to touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "possible allergies to dairy" (unspecified if ongoing); "possible allergies to adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL9264, vaccine location: left arm), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "Headache", "fatigue". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ red spot"; VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ itchy"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ swollen"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ hot"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ tender"; VACCINATION SITE INDURATION (non-serious) with onset 28Feb2021, outcome "not recovered", described as "covid arm/ firm to touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site swelling, vaccination site warmth, vaccination site pain, vaccination site induration.  Additional Information: Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: felt hot at night, fatigue for 24+ hours.; felt hot at night, fatigue for 24+ hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EL3302) at the age of 83 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 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: still experiencing), administration date: 16Jan2021, for COVID-19 IMMUNISATION, reaction(s): "stroke-like symptom"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for COVID-19 Immnunisation, reaction(s): "left arm droop"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for COVID-19 Immunisation, reaction(s): "no feeling on left side"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for Covid-19 Immunisation, reaction(s): "Loss of mobility in left arm", "Droop on left side of face". The following information was reported: FEELING HOT (non-serious), FATIGUE (non-serious) all with onset 06Feb2021, outcome "recovered" (07Feb2021) and all described as "felt hot at night, fatigue for 24+ hours.".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: her husband is going to the dentist to have a tooth pulled out as an emergency and she asked if that is okay; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 24Feb2021 (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 immunisation. The following information was reported: TOOTH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "her husband is going to the dentist to have a tooth pulled out as an emergency and she asked if that is okay".  Additional information: The patient was the reporter's husband and was asking if they should still wear a mask while around her pregnant daughter and when her husband comes back from the dentist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain in his left shoulder; pain in his left shoulder/ not in the injection site but muscles around it; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date Jan2021 (Lot number: EL9265) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 01Feb2021, outcome "not recovered", described as "pain in his left shoulder"; VACCINATION SITE PAIN (non-serious) with onset 01Feb2021, outcome "not recovered", described as "pain in his left shoulder/ not in the injection site but muscles around it". Therapeutic measures were not taken as a result of arthralgia, vaccination site pain.  Additional information: The patient has no known allergies. He did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. He also received the second dose of BNT162B2, administered in the left arm, administration date 20Feb2021 13:00 (Lot number: EN6201) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: very bad dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "very bad dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: a slight throb at the injection site; Mild body aches that only started 27 hours after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 09:30 (Lot number: EM9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "hpn" (unspecified if ongoing); "allergy to bromine in pools as skin irritant" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; BISOPROLOL; OMEGA 3 PLUS [FISH OIL]. Past drug history included: Ibuprofen, reaction(s): "allergies". Vaccination history included: Bnt162b2 (dose 1, single, Lot number: EN6202, Administration time: 12:45 PM, Vaccine location: Left arm), administration date: 08Feb2021, when the patient was 76 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Mar2021 12:30, outcome "unknown", described as "a slight throb at the injection site"; PAIN (non-serious) with onset 02Mar2021 12:30, outcome "unknown", described as "Mild body aches that only started 27 hours after injection". Therapeutic measures were not taken as a result of vaccination site pain, pain.  Additional Information: The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medication included "Micro Dail". Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling began at the injection site/Caller got pretty good swelling right where the injection site is; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Medical Information Team. The reporter is the patient.  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 02Mar2021 at 14:00 (Lot number: EL3247) at the age of 73 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (first dose, Lot: FL3302), for COVID-19 Immunisation, reaction: "No adverse effect".  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 02Mar2021, outcome "not recovered", described as "swelling began at the injection site/Caller got pretty good swelling right where the injection site is".   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/hurting a little bit in his arm; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 01Mar2021 (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, single), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/hurting a little bit in his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Hyperhidrosis
Clinical narrative: sharp stomach pain/really sharp stomach pains; back pain/back pains intermittently; sweating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 01Mar2021 14:30 (Batch/Lot number: unknown) at the age of 29 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION taken for depression, start date: Dec2020 (ongoing); VIENVA taken for contraception, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose 1; Dose: 0.3mL injection to the left arm at 14:30), administration date: 10Feb2021, when the patient was 29 years old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "not recovered", described as "sharp stomach pain/really sharp stomach pains"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "back pain/back pains intermittently"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The reporter was the patient's husband. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on the same day of vaccination. The events come and go but usually occur early in the mornings at around 04:00. The events did not result in an emergency room/physician office visit or hospitalization. No relevant tests were performed. The reporter would like to know if there are any recommendations on what to do to lessen the symptoms (remedies or anything to make her feel better).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Pain in extremity, Somnolence
Clinical narrative: sleepy very very sleepy; sore arm; extreme fatigue and tiredness; irritating right now; 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), administration date 12Feb2021 (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 (First shot on 22Jan 2021 after which they experienced a sore arm), administration date 22Jan2021, for Covid-19 immunisation. The following information was reported SOMNOLENCE (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; FATIGUE (non-serious), outcome unknown; IRRITABILITY (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-2021224012 same reporter, drug, dose, event, and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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), administration date 25Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (dose 1, single), administration date: 05Jan2021, for covid-19 immunization, reaction(s): "lethargy", "fatigue".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.   Additional information: Vaccinator was "cold and not friendly" with her 2nd dose and caller stated that she was worried that she did not vaccinate her." Caller placed husband, MD HCP , on the phone to received HCP information.  Follow up activities closed: No Follow Up attempts were possible; Information about batch no/ lot no. could not be obtained.