chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymerase chain reaction, Pyrexia
Clinical narrative: soreness in my arm, bone in my under arm; soreness in my arm, bone in my under arm; right side of my breast is swollen; body ache; Fever; I just don''t feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 31Jan2022 (Lot number: FH8027) at the age of 46 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Polycystic disease" (unspecified if ongoing), notes: Verbatim: polycystic disease; "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: NORVASC taken for blood pressure measurement; LOZOL taken for blood pressure measurement; HCTZ taken for blood pressure measurement. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose number : Unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), BONE PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "soreness in my arm, bone in my under arm"; BREAST SWELLING (non-serious) with onset 2022, outcome "unknown", described as "right side of my breast is swollen"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "I just don''t feel good". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, bone pain, breast swelling, pain, pyrexia, feeling abnormal.  Additional Information: It was reported that the patient took the Pfizer booster on Monday, was having like soreness in her arm, bone in her under arm, right side of her breast was swollen, she was having body ache, she was having fever,she just didn't feel good. It was further reported that she just had her blood work done. she got the blood work done, everything was fine. They did the PCR testing and it was negative, she was fine beside those things. she had Tylenol, she was taking, every 6 hours. There was no Prior vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: experiencing a lot of itching; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2022 (Lot number: FL3197) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; LOSARTAN; SIMVASTATIN; METHIMAZOLE taken for thyroid disorder. The following information was reported: PRURITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "experiencing a lot of itching"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "Rash". Therapeutic measures were taken as a result of pruritus, rash.  Additional information: Today, patient took an allergy pill (Further clarification unknown, hence suspect captured conservatively as unspecified medication). Patient put a little Cortisone (Suspect captured as per verbatim; further not clarified hence Pfizer not checked) cream on it but the itching is still there and now the rashes.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Expired product administered, Feeling abnormal, Pain
Clinical narrative: when she pulls it out, it made a popping sound; Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired; Feeling funny; I can feel like a soreness in my chest; My chest, I just don''t feel right; Coughing up little bit of phlegm; Whole body feels sore; There is a lump, little lump where she gave the shot; 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 (COMIRNATY), administration date 01Feb2022 (Batch/Lot number: unknown, Expiration Date: Sep2021) 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: PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "when she pulls it out, it made a popping sound"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling funny"; CHEST PAIN (non-serious), outcome "unknown", described as "I can feel like a soreness in my chest"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "My chest, I just don''t feel right"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Coughing up little bit of phlegm"; PAIN (non-serious), outcome "unknown", described as "Whole body feels sore"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "There is a lump, little lump where she gave the shot".  Additional information: Consumer stated, Well I am trying to tell you an experience. I am asking you a question because when they gave me my vaccination two days ago, the Health Department people came to my house and the bottle said Sep2021, that is 6 months ago (date not clarified, hence not captured in tab). So, I do not know if it was expired or what and I am also feeling funny now. I got it two days ago, my chest, I just don't feel right. Is that supposed to happen? I can feel like a soreness in my chest which I did not have before in my chest area, I am coughing up little bit of phlegm which I did not have before. Are these things supposed to happen? My whole body feels sore and there is a lump, little lump where she gave the shot and when she pulls it out, it made a popping sound. Is that supposed to happen? Those are my questions. Product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Productive cough, Vaccination site mass
Clinical narrative: when she pulls it out, it made a popping sound; Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired; Feeling funny; I can feel like a soreness in my chest; My chest, I just don''t feel right; Coughing up little bit of phlegm; Whole body feels sore; There is a lump, little lump where she gave the shot; 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 (COMIRNATY), administration date 01Feb2022 (Batch/Lot number: unknown, Expiration Date: Sep2021) 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: PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "when she pulls it out, it made a popping sound"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling funny"; CHEST PAIN (non-serious), outcome "unknown", described as "I can feel like a soreness in my chest"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "My chest, I just don''t feel right"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Coughing up little bit of phlegm"; PAIN (non-serious), outcome "unknown", described as "Whole body feels sore"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "There is a lump, little lump where she gave the shot".  Additional information: Consumer stated, Well I am trying to tell you an experience. I am asking you a question because when they gave me my vaccination two days ago, the Health Department people came to my house and the bottle said Sep2021, that is 6 months ago (date not clarified, hence not captured in tab). So, I do not know if it was expired or what and I am also feeling funny now. I got it two days ago, my chest, I just don't feel right. Is that supposed to happen? I can feel like a soreness in my chest which I did not have before in my chest area, I am coughing up little bit of phlegm which I did not have before. Are these things supposed to happen? My whole body feels sore and there is a lump, little lump where she gave the shot and when she pulls it out, it made a popping sound. Is that supposed to happen? Those are my questions. Product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: 24 hours later after injection started feeling achy; upset stomach; felt feverish; sweating; chilled; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 18:30 (Lot number: 33036BD) at the age of 45 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Thyroid problem" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot number:Er8731,, prev dose lot unknown:False,, prev dose administration date:22Apr2021, prev dose number:2,, prev dose vaccine location:Right arm), administration date: 22Apr2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot number:SR8733, prev dose lot unknown:False,, prev dose administration date:10Apr2021, prev dose number:1, prev dose vaccine location:Left arm), administration date: 10Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "24 hours later after injection started feeling achy"; ABDOMINAL DISCOMFORT (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "upset stomach"; PYREXIA (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "felt feverish"; HYPERHIDROSIS (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "sweating"; CHILLS (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "chilled". The events "24 hours later after injection started feeling achy", "upset stomach", "felt feverish", "sweating" and "chilled" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, abdominal discomfort, pyrexia, hyperhidrosis, chills.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200204856 same patient and drug, different event separated in time
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Felt wiped out; 100 degrees Fahrenheit body temperature; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left(at unknown time in late afternoon), administration date 23Mar2021 (Lot number: ED7534) at the age of 63 years as dose 1, single and administered in arm left,(at unknown time in late afternoon) administration date 13Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles vaccine (Verbatim: other vaccines in the past like the shingles vaccine), for Immunization; Flu vaccine (Verbatim: had flu vaccines in the last 5-10 years which he did not have those regular side effects), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "Felt wiped out"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "100 degrees Fahrenheit body temperature". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: He additionally mentioned later in report having had what he referred to as regular side effects with the first two doses of Pfizer Covid Vaccine which he further described as being that he felt wiped out and 100 degrees Fahrenheit body temperature. He had these with both of the first two doses. He recovered completely from events after about 2-3 days. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: a slight temperature after the first shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 09Jan2021 15:00 (Lot number: EL1283) 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: PYREXIA (non-serious), outcome "unknown", described as "a slight temperature after the first shot". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Small red bumps; skin rash; itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 18:30 (Lot number: 33036BD) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 01Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: RASH PAPULAR (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "Small red bumps"; RASH (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "skin rash"; PRURITUS (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "itchy". Therapeutic measures were not taken as a result of rash papular, rash, pruritus.  Additional information: It was reported that no other vaccine in fourweeks. No treatment for the events. No covid prior vaccination. Patient was not tested covid post vaccination. Patient had No Known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Extreme fatigue; full body aches; chills; high fever; joint pain; extreme nausea; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2022 10:15 (Lot number: FJ1614) at the age of 21 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TDAP, administration date 18Jan2022; NEXPLANON. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0158, Location of injection: Arm Right), administration date: 15Apr2021, when the patient was 20 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 20 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "Extreme fatigue"; PAIN (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "full body aches"; CHILLS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "high fever"; ARTHRALGIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "extreme nausea"; DIZZINESS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "dizziness".  Additional information: Day of shot: Extreme fatigue leading to full body aches and chills, high fever, joint pain, extreme nausea and dizziness. Day after: full body aches and pain, joint pain, fatigue, dizziness. Patient had no known allergies. Patient had no COVID prior vaccination and was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme fatigue; full body aches; chills; high fever; joint pain; extreme nausea; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2022 10:15 (Lot number: FJ1614) at the age of 21 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TDAP, administration date 18Jan2022; NEXPLANON. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0158, Location of injection: Arm Right), administration date: 15Apr2021, when the patient was 20 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 20 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "Extreme fatigue"; PAIN (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "full body aches"; CHILLS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "high fever"; ARTHRALGIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "extreme nausea"; DIZZINESS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "dizziness".  Additional information: Day of shot: Extreme fatigue leading to full body aches and chills, high fever, joint pain, extreme nausea and dizziness. Day after: full body aches and pain, joint pain, fatigue, dizziness. Patient had no known allergies. Patient had no COVID prior vaccination and was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Local site pain; lymphadenopathy/swelling in axilla going all the way down to left breast.; arthralgias; fatigue; fever; swelling in axilla going all the way down to left breast.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FE3592) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 08Jan2021, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: EK5730, Location of injection: Arm Left), administration date: 21Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Local site pain"; LYMPHADENOPATHY (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "lymphadenopathy/swelling in axilla going all the way down to left breast."; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "arthralgias"; FATIGUE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fatigue"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; SWELLING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "swelling in axilla going all the way down to left breast.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, lymphadenopathy, arthralgia, fatigue, pyrexia, swelling.  Additional information: Facility type vaccine: Hospital. Known allergies: No. Other vaccine in four weeks: No. Other medications in two weeks: no. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment with Tylenol, ibuprofen.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Local site pain; lymphadenopathy/swelling in axilla going all the way down to left breast.; arthralgias; fatigue; fever; swelling in axilla going all the way down to left breast.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FE3592) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 08Jan2021, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: EK5730, Location of injection: Arm Left), administration date: 21Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Local site pain"; LYMPHADENOPATHY (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "lymphadenopathy/swelling in axilla going all the way down to left breast."; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "arthralgias"; FATIGUE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fatigue"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; SWELLING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "swelling in axilla going all the way down to left breast.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, lymphadenopathy, arthralgia, fatigue, pyrexia, swelling.  Additional information: Facility type vaccine: Hospital. Known allergies: No. Other vaccine in four weeks: No. Other medications in two weeks: no. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment with Tylenol, ibuprofen.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Blood creatine phosphokinase, C-reactive protein, COVID-19, Chest pain
Clinical narrative: RECEIVED JOHNSON JOHNSON VACCINE ON 8/29/2021. FOLLOW UP WITH BOOSTER MODERNA AS RECOMMENDED BY PHARMACIST ON 1/5/22. HANDWRITTEN  LOT NUMBER IS NOT CLEAR ON MY CARD. I TOOK A RAT HOME TEST THE DAY BEFORE MY BOOSTER TO CONFIRM I WAS NEGATIVE. GOT BOOSTER ON 1/5/22 AND WAS SICKLY AND POSITIVE THE NEXT DAY.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Full blood count, Laboratory test, Lipids
Clinical narrative: RECEIVED JOHNSON JOHNSON VACCINE ON 8/29/2021. FOLLOW UP WITH BOOSTER MODERNA AS RECOMMENDED BY PHARMACIST ON 1/5/22. HANDWRITTEN  LOT NUMBER IS NOT CLEAR ON MY CARD. I TOOK A RAT HOME TEST THE DAY BEFORE MY BOOSTER TO CONFIRM I WAS NEGATIVE. GOT BOOSTER ON 1/5/22 AND WAS SICKLY AND POSITIVE THE NEXT DAY.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pericarditis, Pneumonia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: RECEIVED JOHNSON JOHNSON VACCINE ON 8/29/2021. FOLLOW UP WITH BOOSTER MODERNA AS RECOMMENDED BY PHARMACIST ON 1/5/22. HANDWRITTEN  LOT NUMBER IS NOT CLEAR ON MY CARD. I TOOK A RAT HOME TEST THE DAY BEFORE MY BOOSTER TO CONFIRM I WAS NEGATIVE. GOT BOOSTER ON 1/5/22 AND WAS SICKLY AND POSITIVE THE NEXT DAY.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: RECEIVED JOHNSON JOHNSON VACCINE ON 8/29/2021. FOLLOW UP WITH BOOSTER MODERNA AS RECOMMENDED BY PHARMACIST ON 1/5/22. HANDWRITTEN  LOT NUMBER IS NOT CLEAR ON MY CARD. I TOOK A RAT HOME TEST THE DAY BEFORE MY BOOSTER TO CONFIRM I WAS NEGATIVE. GOT BOOSTER ON 1/5/22 AND WAS SICKLY AND POSITIVE THE NEXT DAY.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Condition aggravated, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: Though I have had 3 DVT's over the last 4 years, approximately 6 weeks after the Pfizer booster, I began to experience pain and swelling that I suspected was a DVT in my left leg. Testing revealed 3 clots in my left leg. In the past they were always single DVT's or evidence of a DVT. I am now on a anti coagulant, and likely for life.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Though I have had 3 DVT's over the last 4 years, approximately 6 weeks after the Pfizer booster, I began to experience pain and swelling that I suspected was a DVT in my left leg. Testing revealed 3 clots in my left leg. In the past they were always single DVT's or evidence of a DVT. I am now on a anti coagulant, and likely for life.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction/I started to get symptoms, I say about 20 minutes later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2022 (Batch/Lot number: unknown) at the age of 24 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 04Feb2022, outcome "unknown", described as "Allergic reaction/I started to get symptoms, I say about 20 minutes later". Therapeutic measures were taken as a result of hypersensitivity.  Additional Information:The patient herself reported that her appointment was at 3 'O' Clock but she just running a little late so she would say more precise may be 03:15 (3.15 PM) 04Feb2022, she got the vaccine on her left and at about 03:30, she started to get symptoms as an allergic reaction, about 20 minutes later. She took some Antihistamine and some Tylenol as treatment medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: He doesn't stop sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2022 (Lot number: FR5618) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation. The following information was reported: SNEEZING (non-serious) with onset Feb2022, outcome "unknown", described as "He doesn't stop sneezing". Therapeutic measures were not taken as a result of sneezing. Additional information: Vaccination facility details Hospital  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever for 2 days (100 F); body ache; Headache; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 (Lot number: FJ5682) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (COVID 19, Pfizer, lot number=EW0168, administration date=11Jun2021, dose number=2, vaccine location=Right arm), administration date: 11Jun2021, when the patient was 13 years old, for Covid-19 immunization; Bnt162b2 (COVID 19, Pfizer, lot number=EW0173, administration date=21May2021, dose number=1, vaccine location=Left arm), administration date: 21May2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "Fever for 2 days (100 F)"; PAIN (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "body ache"; HEADACHE (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "Headache"; FATIGUE (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain, headache, fatigue.  Additional information: Patient had received treatment for events was Tylenol. No covid prior vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; all 3 shots had same effect.. sore arm with in a few hours. 18 hour later body aches, nausua and low grade fever; nausua; low grade fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 12:15 (Lot number: er8737) at the age of 60 years as dose 1, single, administered in arm left, administration date 22Apr2021 12:15 (Lot number: er8737) as dose 2, single and administered in arm left, administration date 06Feb2022 13:15 (Lot number: fl3198) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination: Yes. Concomitant medication(s) included: TESTOSTERONE; CHLORTAB [CHLORPHENAMINE MALEATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]. The following information was reported: PAIN (non-serious), outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "all 3 shots had same effect.. sore arm with in a few hours. 18 hour later body aches, nausua and low grade fever"; NAUSEA (non-serious), outcome "recovering", described as "nausua"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever". Therapeutic measures were not taken as a result of pain, pain in extremity, nausea, pyrexia.  Additional information: The patient did receive other vaccine in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. After receiving dose 3, on 07Feb2022 06:00 patient experienced sore arm with in a few hours. 18 hour later body aches, nausea and low grade fever. All 3 shots had same effect. . No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats, Pain, Pyrexia
Clinical narrative: pain at the injection site; swelling at the injection site; redness at the injection site; had chills; night sweats; fever; headache; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 14:00 (Lot number: FJ1614) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant; "Insulin resistant" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant. Concomitant medication(s) included: DROSPIRENONE; ETHINYL ESTRADIOL; METFORMIN; SYNTHROID. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 17Jan2022, outcome "recovering", described as "swelling at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Jan2022, outcome "recovering", described as "redness at the injection site"; CHILLS (non-serious) with onset 17Jan2022, outcome "recovering", described as "had chills"; NIGHT SWEATS (non-serious) with onset 17Jan2022, outcome "recovering", described as "night sweats"; PYREXIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 17Jan2022, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "Body aches". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, chills, night sweats, pyrexia, headache, pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; redness at the injection site; had chills; night sweats; fever; headache; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 14:00 (Lot number: FJ1614) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant; "Insulin resistant" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant. Concomitant medication(s) included: DROSPIRENONE; ETHINYL ESTRADIOL; METFORMIN; SYNTHROID. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 17Jan2022, outcome "recovering", described as "swelling at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Jan2022, outcome "recovering", described as "redness at the injection site"; CHILLS (non-serious) with onset 17Jan2022, outcome "recovering", described as "had chills"; NIGHT SWEATS (non-serious) with onset 17Jan2022, outcome "recovering", described as "night sweats"; PYREXIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 17Jan2022, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "Body aches". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, chills, night sweats, pyrexia, headache, pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine; My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to shell fish" (unspecified if ongoing), notes: known allergies: allergic to shell fish. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), PYREXIA (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine". The patient underwent the following laboratory tests and procedures: body temperature: (May2021) 38.5 c. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications in two weeks. The reporter said son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine. He took Tylenol and slept about 12 hours. He felt better after the rest. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Pyrexia, Urticaria
Clinical narrative: Hives; Chest tightness; Pulse elevated; Low grade fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Hives"; CHEST DISCOMFORT (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Chest tightness"; HEART RATE INCREASED (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Pulse elevated"; PYREXIA (non-serious) with onset 25Jan2022 07:00, outcome "not recovered", described as "Low grade fever". The events "hives", "chest tightness", "pulse elevated" and "low grade fever" were 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 urticaria, chest discomfort, heart rate increased, pyrexia.  Additional information: No known allergies reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient received within 2 weeks of vaccination. Since the vaccination, patient has not been tested for COVID-19. Patient had hives chest tightness pulse elevated for over 2 weeks low grade fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; had an itch in the upper arm; 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 received bnt162b2 (BNT162B2) (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 (Dose number Unknown, Manufacturer unknown), for Covid-19 Immunization.  The following information was reported: RASH (non-serious), outcome "unknown", described as "rash"; PRURITUS (non-serious), outcome "unknown", described as "had an itch in the upper arm".  Additional information: Her friend had a booster shot and had an itch in the upper arm, also she had a rash 2 and a half weeks later after her booster shot, and wondered if anyone else had it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itch in the upper arm; rash; 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 received bnt162b2 (BNT162B2) (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 (Manufacturer unknown), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itch in the upper arm"; RASH (non-serious), outcome "unknown", described as "rash".  Additional information: Verbatim and Event Description: Caller # heard on the radio that Pfizer is putting a list for the Covid therapeutics, she had bought Ivermectin in a feed store. Her friend had a booster shot and had an itch in the upper arm, also she had a rash 2 and a half weeks later after her booster shot, and wondered if anyone else had it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.