chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: N/V; N/V; lightheaded; abdominal discomfort; general weakness; SOB; increased high blood pressure and heart rate; increased high blood pressure and heart rate; This is a spontaneous report from a contactable HCP consumer. This HCP consumer (patient) reported that:  A 47-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW01150 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 06Apr2021 12:00 AM (age at vaccination was 47-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food, or other products: penicillin and iodide. Medical history included Migraine and high lipid panel from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination was omega-3-acid ethyl ester (LOVAZA), rosuvastatin calcium (CRESTOR), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534, and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 16Mar2021 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. On 12Apr2021 15:00 the patient experienced N/V, lightheaded, dizzy, abdominal discomfort, general weakness, SOB, increased high blood pressure and heart rate, weakness. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 12Jan2021 by nasal Swab. Treatment received for the events was unknown. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: N/V; N/V; lightheaded; abdominal discomfort; general weakness; SOB; increased high blood pressure and heart rate; increased high blood pressure and heart rate; This is a spontaneous report from a contactable HCP consumer. This HCP consumer (patient) reported that:  A 47-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW01150 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 06Apr2021 12:00 AM (age at vaccination was 47-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food, or other products: penicillin and iodide. Medical history included Migraine and high lipid panel from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination was omega-3-acid ethyl ester (LOVAZA), rosuvastatin calcium (CRESTOR), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534, and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 16Mar2021 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. On 12Apr2021 15:00 the patient experienced N/V, lightheaded, dizzy, abdominal discomfort, general weakness, SOB, increased high blood pressure and heart rate, weakness. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 12Jan2021 by nasal Swab. Treatment received for the events was unknown. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pharyngeal swelling, Rash
Clinical narrative: body rash; slight throat swelling; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received (BNT162B2, formulation: Solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 12Apr2021 16:45 (age at vaccination 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included Known allergies to crawfish, hay fever, Allergy pollen all from an unknown date and unknown if ongoing. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cefalexin (CEPHALEXINE), Vitamin D Complex taken for an unspecified indication, start and stop date were not reported. the patient received multivitamin within 2 weeks of vaccination. It was reported that the patient was not a pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced diarrhoea on 13Apr2021, body rash on an unspecified date, slight throat swelling on 14Apr2021. The patient did not receive treatment for the events. The clinical outcome of the event Diarrhea was recovering and for slight throat swellingit was recovered in Apr2021, for body rash recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: a little painful; had redness/ has a "big red circle; has a "big red circle", it is bigger than before; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She took the second dose of the Pfizer COVID-19 vaccine on Friday. She said it was a little painful and she had redness. She now has a "big red circle", it was bigger than before. Is this an allergic reaction. Any reports of this and how long was it supposed to last. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on both of his arms; This is a spontaneous report received from medical information team. A contactable male reporter (patient) reported for himself that a 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 at 16:30 (at the age of 62-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Other Products and patient History was reported as none. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) and event following prior vaccinations were none. The patient experienced rash on both of his arms on 31Mar2021. Reporter was asking if he should get the second vaccine dose if he is still experiencing a side effect from the first? Reporter reported that he received his first vaccine dose and 1 week later he started getting a rash on both arms and nowhere else. He reported that he wasn't concerned and thought it would go away but now he was scheduled to get his second dose and it still hasn't gone away and he doesn't know what to do.  He asked Is it ok to get my second dose if I still have a rash? He said, I had a side effect after the first dose of the vaccine.  Should I get the second dose? Event was reported as ongoing. Further reporter said that he doesn't know if it was a severe reaction. He developed a rash on both of his arms. It was not his entire body, just both arms. He is scheduled to get the second dose today, but the rash hasn't gone away. He didn't know if that would be concerning or not in regard to getting the second dose. Reporter clarified product as Pfizer COVID19 Vaccine. The rash on both of his arms started around 31Mar2021. Reporter clarified that would like to speak to USMI about rashes after the vaccine and what that means for the second dose. He has not received any treatment for the rash. He has not had to go to the Emergency room or to a physician's office. Reporter seriousness for the event was unspecified. PQC was not present. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Tremor, Vaccination site pain
Clinical narrative: her hands felt shaky; pain at the injection site; right side chest pain; This is a spontaneous report from a contactable consumer. A 52-year-old female consumer (patient) reported for herself via Medical information team. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, the patient experienced her hands felt shaky, pain at the injection site and right-side chest pain. The reporter asked if the symptoms have been reported. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: pinching and feeling kind of itchy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 Immunisation. Patient medical history include exposed to someone who tested positive for COVID-19. Patient concomitant medications were not reported. Patient previously received flu shot and experienced pinching and feeling kind of itchy. Caller reported that she would like to know how protected she is against COVID-19 after receiving the first dose of the Pfizer BioNTech COVID-19 vaccine on 31Mar2021. She states that she was recently exposed to someone who tested positive for COVID-19 but reports that she herself has not been tested for COVID-19.Caller also mentions that after receiving the flu shot in the past, she experienced "pinching" and feeling "kind of itchy" but states that this is a normal thing for her and also stated that it happened after she received the Pfizer COVID-19 vaccine as well. In response to her enquired that there reported there is no information on efficacy after just one dose of the vaccine at this time and explained how the two doses work. Caller states that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 31Mar2021 and is scheduled to receive her second dose on 17Apr2021. She wants to know if it is okay for her to get it at this date because it would be sooner than the 21 days, or if she should attempt to reschedule it to be closer to 21 days. Enquired about getting the second dose earlier and later than the recommended 21 days. The Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: some rash in the neck area; This is a spontaneous report received from a contactable consumer (Patient's wife) reporting for husband (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that her husband received the first dose of the Pfizer covid vaccine on Thursday, April 8th and after that he had some rash in the neck area on an unspecified date in 2021. She said that was unlikely related to the vaccine but she would like to know if he can take Benadryl or Claritin. She was recommended to consult their physician prior to taking the medication. The reporter mentions that she has heard that some people get fever after the second dose of the Pfizer covid vaccine and she wanted to know if it was ok to take acetaminophen if that was to happen to her husband. She was recommended to consult a physician prior to the taking of the medication. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: blew his nose and it was full of blood; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A 70-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: unknown), via an unspecified route of administration on 13Apr2021 11:10(at the age of 70-years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The reporter stated that she and her husband, just had their first Pfizer covid vaccine at 11:10 this morning and at about 2:45 on 13Apr2021, her husband was eating and he blew his nose and it was full of blood. After a couple of blows, it stopped. Case assessed as non-serious by reporter. Could this be related to the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Fatigue, Malaise
Clinical narrative: feeling unwell with 1 degree higher than the normal body temperature; tiredness; fever/1 degree higher than the normal body temperature; bruising of the injection site(left arm); cheek was rosy/Reddened Cheeks; nausea and chills for 4 days; nausea and chills for 4 days; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot says ER8734 or ER873Y (unspecified), Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 as dose 1, single (at the age of 77-year-old) for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (States she has been diabetic for about 5 years. Says it in well controlled); ongoing high blood pressure (States was diagnosed a couple of years ago); ongoing anxiety. Past drug includes flu vaccine on an unspecified date for immunization and experienced Redness and Soreness after flu vaccine, sometimes. Concomitant medications included losartan potassium taken for hypertension (States she has been on this medication for years. In the last few months her doctor increased it from 25mg to 50mg), glimepiride taken for diabetes and pioglitazone hcl taken for diabetes. No history of all previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not have any prior vaccinations within 4 weeks. The patient experienced bruising of the injection site (left arm), feeling unwell with 1 degree higher than the normal body temperature, tiredness, cheek was rosy, nausea and chills for 4 days. She took Tylenol to manage the fever. Asking if she should really have these symptoms after getting the 1st dose since others say that it should be on the 2nd dose. 2nd dose was scheduled on 27Apr2021. Says the site became bruised; about the size of a dime. Says it is starting to turn yellow now. Nausea, Chills and Reddened Cheeks lasted about 5 days; then states she has it just a little bit today. One degree fever lasted on and off for 2 days. States today is the first day she is not tired; she feels fine. Caller states she has an appointment with her doctor on 22Apr2021. Says she sees him monthly to refill her anxiety medication. Therapeutic measures were taken as a result of event fever. The outcome of events bruising of the injection site (left arm) and cheek was rosy/Reddened Cheeks was Recovering; for Feeling unwell, fever, nausea and chills was recovered on unknown date of Apr2021, tiredness recovered on 13Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site bruising
Clinical narrative: feeling unwell with 1 degree higher than the normal body temperature; tiredness; fever/1 degree higher than the normal body temperature; bruising of the injection site(left arm); cheek was rosy/Reddened Cheeks; nausea and chills for 4 days; nausea and chills for 4 days; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot says ER8734 or ER873Y (unspecified), Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 as dose 1, single (at the age of 77-year-old) for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (States she has been diabetic for about 5 years. Says it in well controlled); ongoing high blood pressure (States was diagnosed a couple of years ago); ongoing anxiety. Past drug includes flu vaccine on an unspecified date for immunization and experienced Redness and Soreness after flu vaccine, sometimes. Concomitant medications included losartan potassium taken for hypertension (States she has been on this medication for years. In the last few months her doctor increased it from 25mg to 50mg), glimepiride taken for diabetes and pioglitazone hcl taken for diabetes. No history of all previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not have any prior vaccinations within 4 weeks. The patient experienced bruising of the injection site (left arm), feeling unwell with 1 degree higher than the normal body temperature, tiredness, cheek was rosy, nausea and chills for 4 days. She took Tylenol to manage the fever. Asking if she should really have these symptoms after getting the 1st dose since others say that it should be on the 2nd dose. 2nd dose was scheduled on 27Apr2021. Says the site became bruised; about the size of a dime. Says it is starting to turn yellow now. Nausea, Chills and Reddened Cheeks lasted about 5 days; then states she has it just a little bit today. One degree fever lasted on and off for 2 days. States today is the first day she is not tired; she feels fine. Caller states she has an appointment with her doctor on 22Apr2021. Says she sees him monthly to refill her anxiety medication. Therapeutic measures were taken as a result of event fever. The outcome of events bruising of the injection site (left arm) and cheek was rosy/Reddened Cheeks was Recovering; for Feeling unwell, fever, nausea and chills was recovered on unknown date of Apr2021, tiredness recovered on 13Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: pruritic rash; This is a spontaneous report from a contactable other-health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pruritic rash. Reporter requesting if this was a severe allergic reaction and patient did not have hives, no wheezing, no angioedema and no anaphylaxis and asks, since the symptoms did not present in a few minutes would this be considered a severe allergic reaction, and also can this patient receive second dose under supervision or should she not receive it at all. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she has been feeling much better after receiving both doses; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 05Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included neoplasm malignant, feeling abnormal, white blood cell count increased and arthralgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 15Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, she normally felt unwell for the past 10 years and has chronically high WBC count but she has been feeling much better after receiving both doses mentioned on an unspecified date. She also had a past medical history of bad knees and steroids shots to the knees which her doctors said might be the cause of the elevated WBCs. She has also been told that it might be bone marrow cancer. She was calling to report the good side effects of the vaccine. She heard that vaccine can help to treat cancer. She would like to report this as a positive adverse effect. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/ batch number can not be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: couldn't swallow normally; I could only breath easily with mouth open; This is a spontaneous report from a contactable consumer (patient) reported herself. A 60-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: not provided), via an unknown route of administration in right arm on 14Mar2021 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization at pharmacy. The patient's medical history included high blood pressure. No Known allergies. She was not allergic to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks. On 14Mar2021, half hour after taking the shot, the patient felt that she could not swallow normally and thus felt she could only breath easily with mouth open. The sensation lasted about 30 min. But drinking water helped. She continues to have these episodes intermittently. She started taking allergy pills and nose allergy medicine. She decided not to take the second shot after consulting with her doctor. The doctor told to get the shot at the hospital. It was scary to think that this symptom could become worse with a second shot. She continues to have this sensation once a day about 4times a week. The patient did not result to visit emergency room and physician office. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was unknown if COVID tested post vaccination. No treatment received for event. The outcome of the events was recovered with sequel.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My cheek, my left cheek seems a little bit swollen; This is a spontaneous report from a contactable consumer. A 50-years-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine: Solution for injection for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as dose number unknown, single for covid-19 immunisation. No medical history. Concomitant medication included iron (IRON) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On an unspecified date patient experienced my cheek, my left cheek seems a little bit swollen. Consumer stated, I had the Pfizer vaccine (Covid Vaccine) yesterday afternoon in Massachusetts, and I am experiencing like my cheek, my left cheek seems a little bit swollen, is that normal. I am just little bit nervous, so I am making sure that everything is okay. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Joint stiffness, Joint swelling
Clinical narrative: nausea; fever; chills; swollen/stiff/sore joints (esp. fingers); swollen/stiff/sore joints (esp. fingers); swollen/stiff/sore joints (esp. fingers); painful swelling in left armpit; painful swelling in left armpit; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: FD0168, Expiration date were not provided), via an unspecified route of administration in left arm on 08Apr2021 04:00 PM (Age at vaccination: 42-years) as dose 2, Single for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history included asthma. The patient had no known allergies. Patient concomitant medications included ZOLOFT (sertraline hydrochloride), vitamin B12, CLARITINE (loratadine) and other medications in Two weeks: PROZAC (Fluoxetine), all for unknown indication and start and stop date were unknown. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Batch no/Expiration date were not provided) via an unspecified route of administration in left arm on 18Mar2021 14:30 PM (age at vaccination 42-years-old) as dose 1, single for COVID-19 immunization. On 09Apr2021 09:15 AM the patient experienced nausea, fever, chills, swollen/stiff/sore joints (esp. fingers) and painful swelling in left armpit. The patient did not receive any treatment. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. The outcome of all the events was recovering except for chills which was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Swelling
Clinical narrative: nausea; fever; chills; swollen/stiff/sore joints (esp. fingers); swollen/stiff/sore joints (esp. fingers); swollen/stiff/sore joints (esp. fingers); painful swelling in left armpit; painful swelling in left armpit; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: FD0168, Expiration date were not provided), via an unspecified route of administration in left arm on 08Apr2021 04:00 PM (Age at vaccination: 42-years) as dose 2, Single for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history included asthma. The patient had no known allergies. Patient concomitant medications included ZOLOFT (sertraline hydrochloride), vitamin B12, CLARITINE (loratadine) and other medications in Two weeks: PROZAC (Fluoxetine), all for unknown indication and start and stop date were unknown. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Batch no/Expiration date were not provided) via an unspecified route of administration in left arm on 18Mar2021 14:30 PM (age at vaccination 42-years-old) as dose 1, single for COVID-19 immunization. On 09Apr2021 09:15 AM the patient experienced nausea, fever, chills, swollen/stiff/sore joints (esp. fingers) and painful swelling in left armpit. The patient did not receive any treatment. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. The outcome of all the events was recovering except for chills which was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: rash on my arm; My fingers/hands turned an orangey color- looked like COViD fingers; This is a spontaneous report from a non-contactable consumer (patient). A 5-decade-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The medical history included deep vein thrombosis suspected from COVID infection from February of 2020. On Xarelto being treated for clot right now. The concomitant medication(s) included rivaroxaban (XARELTO) taken for clot right now. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported her fingers/hands turned an orangey Color- looked like COVID fingers and she got a rash on her arm on an unspecified date in 2021. Patient was not diagnosed with Covid-19 prior to vaccination and patient not tested for Covid-19 since vaccination. Patient did not receive any treatment for AE. The outcome of event recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Oropharyngeal pain, Pyrexia
Clinical narrative: sick; fever; cough; sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing Low Thyroid, blood cholesterol increased from an unknown date and unknown if ongoing High cholesterol, type 2 diabetes mellitus from an unknown date and unknown if ongoing Type 2 diabetes mellitus. Concomitant medications included metformin (METFORMIN) taken for type 2 diabetes mellitus, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported; ezetimibe (EZETIMIBE) taken for blood cholesterol increased, start and stop date were not reported; glimepiride (GLIMEPIRIDE) taken for type 2 diabetes mellitus, start and stop date were not reported; enalapril (ENALAPRIL) taken for hypertension, start and stop date were not reported; estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause, start and stop date were not reported; insulin detemir (LEVEMIR) taken for type 2 diabetes mellitus, start and stop date were not reported. The patient stated that on 22Mar2021 she took vaccine, and two days later on 24Mar2021 the patient experienced being sick with fever, cough and sore throat. She was not hospitalised but was on bed. It was given that it looked like EN6208 for lot no but (Further not clarified hence not captured in tab). The outcome of the events was unknown. No follow up attempts are needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pain, Pruritus, Pyrexia
Clinical narrative: Had body pain; Bleeding nose; Fever; Itchy body and my lips were also itching badly; This is a spontaneous report from a contactable consumer (Patient). A 46 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8737), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included diabetes. The patient Concomitant medications included METFORMIN taken for diabetes mellitus from an unknown date. On an unspecified date, the patient experienced Had body pain, Bleeding nose, Fever, Itchy body and my lips were also itching badly. It was reported that I just received the dose of Pfizer on Saturday after that I had body pain but somehow I am having nose bleeding also and like I had a fever, itchy body and my lips were also itching badly. It's actually I wanted to go to ER but it's not like continuously it start to bleed and then it stops and then it starts again and I didn't want to go to the ER because this pandemic is going on. From your end will I get any information did this happen like to any other patients. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations
Clinical narrative: Dizziness; heart palpitations; shortness of breath; headache; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, expiration date: not reported), dose 1 via an unspecified route of administration on 27Mar2021 15:00 (age at vaccination: 26 Years) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, 13 days after the vaccination, the patient experienced dizziness, heart palpitations, headache, shortness of breath. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The outcome for events was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Inflammation, Malaise, Pain
Clinical narrative: inflammation under her armpit; it hurts to touch between the side of her right breast and right under the armpit; she feels swelling when touching under her arm; feels unwell; weakness; body aches; She also had pain under her right arm; pain under her right arm; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunization and experienced arm pain, on the third day she had almost no discomfort. The second dose was on Saturday 10Apr2021, she had no arm pain on that day, but quite some pain on Sunday (next day) on 11Apr2021 just like when she got the first dose, and at night she also had pain under her right arm on 11Apr2021. By Monday, she had inflammation under her armpit, it hurted to touch between the side of her right breast and right under the armpit on 12Apr2021. She was taking ibuprofen, she felt swelling when touching under her arm, and she also felt unwell, weakness and body aches since Sunday (11Apr2021). In the middle of the night she had to take 2 Ibuprofens to soothe the pain. Patient received treatment as ibuprofen for the adverse events reported. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Tenderness
Clinical narrative: inflammation under her armpit; it hurts to touch between the side of her right breast and right under the armpit; she feels swelling when touching under her arm; feels unwell; weakness; body aches; She also had pain under her right arm; pain under her right arm; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunization and experienced arm pain, on the third day she had almost no discomfort. The second dose was on Saturday 10Apr2021, she had no arm pain on that day, but quite some pain on Sunday (next day) on 11Apr2021 just like when she got the first dose, and at night she also had pain under her right arm on 11Apr2021. By Monday, she had inflammation under her armpit, it hurted to touch between the side of her right breast and right under the armpit on 12Apr2021. She was taking ibuprofen, she felt swelling when touching under her arm, and she also felt unwell, weakness and body aches since Sunday (11Apr2021). In the middle of the night she had to take 2 Ibuprofens to soothe the pain. Patient received treatment as ibuprofen for the adverse events reported. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: tiredness; headache; muscle pain; a low grade fever; arm swollen at injection site; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunisation in workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. It was unknown if patient received other vaccine in four weeks and any other medications in two weeks. On 13Apr2021, same day of vaccination, the patient experienced tiredness, headache, muscle pain, and thought she had a low-grade fever at night and also arm swollen at injection site. The explicit consent was yes. On 14Apr2021 patient was taking the day off. The patient not tested for COVID-19 post vaccination. It was unknown if patient received treatment. As per reporter understanding, the patient became aware of the symptoms on the 14th. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Paraesthesia, Pruritus
Clinical narrative: vision was blurry; face was tingly; torso area began to itch but no sign of hives; cough a wheezing kind of cough for a day; loss of appetite; diarrhea; This is a spontaneous report received from a contactable consumer or other non HCP (Patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that following dose 1 of the Covid vaccine (date unspecified), after about 20 minutes, patient vision was blurry and face was tingly, felt puffy although it was not actually puffy. This went away after approx. an hour. Within a couple hours torso area began to itch but no sign of hives. On an unknown date, the patient had cough a wheezing kind of cough for a day, had a loss of appetite and diarrhea for three days following. It was reported that CDC website labels this as a non-severe allergic reaction and suggests not to get dose 2. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: vision was blurry; face was tingly; torso area began to itch but no sign of hives; cough a wheezing kind of cough for a day; loss of appetite; diarrhea; This is a spontaneous report received from a contactable consumer or other non HCP (Patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that following dose 1 of the Covid vaccine (date unspecified), after about 20 minutes, patient vision was blurry and face was tingly, felt puffy although it was not actually puffy. This went away after approx. an hour. Within a couple hours torso area began to itch but no sign of hives. On an unknown date, the patient had cough a wheezing kind of cough for a day, had a loss of appetite and diarrhea for three days following. It was reported that CDC website labels this as a non-severe allergic reaction and suggests not to get dose 2. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: slight fever; Chill; severe sore muscle and joints; severe sore muscle and joints; super achy; felt like I had been run over by a truck; flu like symptoms; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 10:54, dose 2, single for COVID-19 immunisation. Medical history included ongoing birth control. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267) administered via an unspecified route of administration in the left arm on 12Feb2021 at 10:54, dose 1, single for COVID-19 immunisation and experienced soreness at injection site, lymph nodes left arm pit very sore, fatigue, red swollen injection site, swollen under left arm lymph nodes, sore arm, muscle + joints, lymph nodes left arm pit very sore. The patient did not receive other vaccines prior to COVID-19 vaccine. On 06Mar2021, the patient experienced fatigue, flu like symptoms. On 06Mar2021 at 02:00, the patient woke up in the morning and felt like she had been run over by a truck, super achy, severe muscle, joints, slight fever chills which lasted for 2 days. The patient took Ibuprofen and Advil for the events. The events were reported as non-serious. The outcome of the events fatigue and flu like symptoms recovered on an unspecified date and the outcome of other events was recovered on 08Mar2021.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195717 Same reporter/patient /product, different dose and similar events
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: slight fever; Chill; severe sore muscle and joints; severe sore muscle and joints; super achy; felt like I had been run over by a truck; flu like symptoms; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 10:54, dose 2, single for COVID-19 immunisation. Medical history included ongoing birth control. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267) administered via an unspecified route of administration in the left arm on 12Feb2021 at 10:54, dose 1, single for COVID-19 immunisation and experienced soreness at injection site, lymph nodes left arm pit very sore, fatigue, red swollen injection site, swollen under left arm lymph nodes, sore arm, muscle + joints, lymph nodes left arm pit very sore. The patient did not receive other vaccines prior to COVID-19 vaccine. On 06Mar2021, the patient experienced fatigue, flu like symptoms. On 06Mar2021 at 02:00, the patient woke up in the morning and felt like she had been run over by a truck, super achy, severe muscle, joints, slight fever chills which lasted for 2 days. The patient took Ibuprofen and Advil for the events. The events were reported as non-serious. The outcome of the events fatigue and flu like symptoms recovered on an unspecified date and the outcome of other events was recovered on 08Mar2021.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195717 Same reporter/patient /product, different dose and similar events