chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: extreme tiredness/feeling really tired; headache/the headache is quite bad; chills/had some chills, more chills; some arm soreness; I cannot sleep all that day; Coming down with allergies; This is a spontaneous report received from contactable (patient) reported for herself. A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Mar2021 (age at vaccination was 74 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypertension and diabetic from an unknown date. Concomitant medications included insulin glargine (LANTUS) taken for an unspecified indication, insulin aspart (NOVOLOG) taken for blood glucose fluctuation (as needed, when her blood sugar level was more than 150), hydrochlorothiazide, triamterene (DYAZIDE) taken for an unspecified indication, amlodipine besilate (NORVASC) taken for an unspecified indication, metoprolol succinate (TOPROL) taken for an unspecified indication and atorvastatin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM9809, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 74 years) as dose 1, single for COVID-19 immunization. The patient received the second dose of the Pfizer-Biontech COVID-19 vaccine last Thursday and on an unspecified date, the side effects started probably about 7 o'clock, her symptoms getting started and until like the next day was very mild. On an unspecified date, the patient experienced some arm soreness and tiredness that lasted all day long but then she was fine until yesterday evening, when she experienced extreme tiredness, headache and chill, which were continuing. Going to tired and she could not sleep all that day, the next day and did not do anything the whole weekend so she did not require much activity but yesterday she just started from very, yesterday evening, afternoon she started feeling really tired and had some chills, more chills, just really tired. It was better today. It continued with the headache and today the headache was quite bad so she did not know. She asked if that could be still the symptoms from the vaccine or not or related, maybe she was coming down with allergies or something like that. Because the symptoms really got worse to her yesterday and she asked if that was normal. Her concern was headache, chills and tiredness, she knew they were side effects, she just wanted to know if they would be cured. She had used Tylenol to treat the headache and stated that helped. She asked if it was normal to still be having tiredness, headache and chills that continued. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cough, Dizziness, Eye discharge
Clinical narrative: This is a spontaneous report received from a received from a contactable consumer patient reported for herself via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 04Mar2021 14:00 (at the age of 74 years old) as a dose 1 single for COVID-19 immunization. Patient medical history included FLU Vaccine from unspecified start and stop date (She and her father both always got a light case of the flu after receiving the flu vaccine). Patient had family history of Her father has passed away, Father reacts to the flu vaccine. Patient had not received any concomitant medications. Patient was not administered with any other additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced arm hurting and aching, very tired, chills, dizzy. On 05Mar2021 patient experienced low grade fever, strange stomach like pressure, bloated and cough. Patient stated that, she had side effects on the 1st vaccine shot that her friends didn't have until their 2nd Pfizer vaccine dose. Patient stated that her second vaccination was on 24Mar2021 and had been to her doctor and she had right eye discharge and upper respiratory symptoms on 08Mar2021. She was on antibiotics. Patient was visited to physician or ER (emergency room) for the events reported. Outcome of events right eye discharge, very tired, a strange sensation in her stomach like pressure or bloated like, cough was not recovered, and upper respiratory symptoms was unknown. Outcome of arm was hurting and aching, chills, dizziness, had a low-grade temperature was recovered on 07Mar2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Respiratory disorder
Clinical narrative: This is a spontaneous report received from a received from a contactable consumer patient reported for herself via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 04Mar2021 14:00 (at the age of 74 years old) as a dose 1 single for COVID-19 immunization. Patient medical history included FLU Vaccine from unspecified start and stop date (She and her father both always got a light case of the flu after receiving the flu vaccine). Patient had family history of Her father has passed away, Father reacts to the flu vaccine. Patient had not received any concomitant medications. Patient was not administered with any other additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced arm hurting and aching, very tired, chills, dizzy. On 05Mar2021 patient experienced low grade fever, strange stomach like pressure, bloated and cough. Patient stated that, she had side effects on the 1st vaccine shot that her friends didn't have until their 2nd Pfizer vaccine dose. Patient stated that her second vaccination was on 24Mar2021 and had been to her doctor and she had right eye discharge and upper respiratory symptoms on 08Mar2021. She was on antibiotics. Patient was visited to physician or ER (emergency room) for the events reported. Outcome of events right eye discharge, very tired, a strange sensation in her stomach like pressure or bloated like, cough was not recovered, and upper respiratory symptoms was unknown. Outcome of arm was hurting and aching, chills, dizziness, had a low-grade temperature was recovered on 07Mar2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Hypersensitivity, Ocular hyperaemia
Clinical narrative: Woke up with one eye red; HCP diagnosed as allergy/conjunctivitis; HCP diagnosed as allergy/conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6200) via an unspecified route of administration, on an 21Feb2021 at around 11:30 (age at the time of vaccination was 68-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have prior vaccinations within 4 weeks or any AE(s) following prior vaccinations. In 2021, the patient experienced, HCP diagnosed as allergy/conjunctivitis. On 23Feb2021, the patient experienced Woke up with one eye red. Caller reported that she has had two doses of the pfizer covid 19 vaccine. Caller reported she had the first dose on 21Feb2021 and later woke up with one eye red. HCP diagnosed as allergy/conjunctivitis. Caller stated she had the second dose on Sunday and woke up this morning, 16Mar2021 with redness in the same eye. Caller stated she got the vaccine in the left arm and the redness is in the left eye. Caller wanted to know if this is a reported side effect. Treatment: Caller stated had not taken anything for treatment. Caller then stated she has over the counter dry eye drops and the eye doctor said she could use that. Outcome of Woke up with one eye red was recovered on 26Feb2021, while the outcome of HCP diagnosed as allergy/conjunctivitis was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at 17:00 (at the age of 67-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure and heart racing. The concomitant medication(s) included irbesartan (AVAPRO) 300 mg orally once a day taken for blood pressure measurement orally taking for three or fours years, and glimepiride (GLIMEPRID) 4 mg orally twice a day taken for diabetes mellitus orally taking for ten years (both ongoing). The patient had not received any other vaccination within four weeks. On 24Feb2021, the patient reported she doesn't remember much about the day of the vaccination after the shot because they didn't get home until 08:00 pm. Adds that day she think she had pain in her left arm and shoulder. The next day on 25Feb2021, she had a headache that was not bad and she had it for a day or two; she had chills and felt feverish that night/ little bit feverish. Adds she didn't took her temperature so she doesn't know if she had a fever and she didn't take anything for it. The next morning, on 26Feb2021, she still had the chills and felt feverish for a day or so then that went away. On 28Feb202, Sunday night she noticed her heart rate going fast; it has been worse especially at night and there was a loud thumping in her ears. This lasted nearly a week. The patient reported that she went to see her primary care but the doctor didn't think the thumping had to do with the vaccine and said maybe the patient had inflammation on her ear previously and could not hear the thumping so she can hear better now. The doctor gave her Flonase nasal spray for her ears but she only took it twice. The heart racing has gotten better and better and has finally gone away. It lasted for five or six days until last Monday. She still has the headache, but the thumping was gone. The patient was scheduled for the next dose of the vaccine on 17Mar2021 and was asking by having these symptoms should she get the next dose of the vaccine. The patient's any AE(s) required a visit to physician saw a doctor but no hospitalization for loud thumping in her ears. The outcome of the headache not recovered, and pain left arm and shoulder, chills, little bit feverish was recovered on 26Feb2021, and loud thumping in her ears and heart racing recovered on 08Mar2021. Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at 17:00 (at the age of 67-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure and heart racing. The concomitant medication(s) included irbesartan (AVAPRO) 300 mg orally once a day taken for blood pressure measurement orally taking for three or fours years, and glimepiride (GLIMEPRID) 4 mg orally twice a day taken for diabetes mellitus orally taking for ten years (both ongoing). The patient had not received any other vaccination within four weeks. On 24Feb2021, the patient reported she doesn't remember much about the day of the vaccination after the shot because they didn't get home until 08:00 pm. Adds that day she think she had pain in her left arm and shoulder. The next day on 25Feb2021, she had a headache that was not bad and she had it for a day or two; she had chills and felt feverish that night/ little bit feverish. Adds she didn't took her temperature so she doesn't know if she had a fever and she didn't take anything for it. The next morning, on 26Feb2021, she still had the chills and felt feverish for a day or so then that went away. On 28Feb202, Sunday night she noticed her heart rate going fast; it has been worse especially at night and there was a loud thumping in her ears. This lasted nearly a week. The patient reported that she went to see her primary care but the doctor didn't think the thumping had to do with the vaccine and said maybe the patient had inflammation on her ear previously and could not hear the thumping so she can hear better now. The doctor gave her Flonase nasal spray for her ears but she only took it twice. The heart racing has gotten better and better and has finally gone away. It lasted for five or six days until last Monday. She still has the headache, but the thumping was gone. The patient was scheduled for the next dose of the vaccine on 17Mar2021 and was asking by having these symptoms should she get the next dose of the vaccine. The patient's any AE(s) required a visit to physician saw a doctor but no hospitalization for loud thumping in her ears. The outcome of the headache not recovered, and pain left arm and shoulder, chills, little bit feverish was recovered on 26Feb2021, and loud thumping in her ears and heart racing recovered on 08Mar2021. Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: has a rash on his upper back; feels a little bit itchy on his upper back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-years-old male patient reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205, NDC number, Expiration date: unknown), via an unspecified route of administration on 15Mar2021 (age at vaccination was 64-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient took covid-19 vaccine for prevention for covid-19 virus and doesn't want to die. Medical history included high blood pressure, high cholesterol and allergic to aspirin; all from an unknown date and unknown if ongoing. Concomitant medications included atenolol 25 mg and losartan 100 mg, both taken for high blood pressure and rosuvastatin 5 mg taken for high cholesterol; all start and stop date were not reported. Report stated as, the patient had the first dose of the PFIZER-BIONTECH COVID-19 VACCINE 15Mar2021 - After 24 hours he developed rashes on his upper back - He described the rashes itchy - reported the side effect - Asking how long will the rashes last and if this is a reported case. Additional context reported as, the patient got first shot of COVID-19 vaccine yesterday, 15Mar2021. This afternoon, on 16Mar2021, the patient feels a little bit itchy on his upper back. Told his wife to check. Wife stated patient has a rash on his upper back. Admission to the hospital due to event was reported as unknown. The patient was concerned about second dose and wanted to know if it is ok for him to take it. The patient saw his doctor every six months and had no lab work since covid-19 vaccine. Treatment received was reported as unknown. No investigation assessment was reported. Outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Lacrimation increased, Pruritus, Rhinorrhoea
Clinical narrative: she was experiencing itchiness all over the body; cough; runny eyes; runny nose; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported for himself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wanted to report symptoms that she experienced after taking the 1st dose last 02Feb2021. She was experiencing itchiness all over the body, cough, runny eyes, and runny nose. She was advised not to continue to take the 2nd dose of the vaccine due to these symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm sore; slight fever the next day; bouts of fatigue over the next two weeks; This is a spontaneous report from a non-contactable consumer (patient herself). An unspecified aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 patient medical history includes Multiple sclerosis, Allergy, food intolerance. The concomitant medications were not reported. It was stated that events took place after use of product. On an unspecified date, the patient experienced arm sore, slight fever the next day and bouts of fatigue over the next two weeks. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Back pain, Decreased appetite, Lethargy
Clinical narrative: body aches; Ongoing "intense dreams"; pain (especially in lower back/hips); thrashing at night over the next two weeks; loss of appetite; lethargic on the next day; sore arm; fever; pain (especially in lower back/hips); This is a spontaneous report received from a contactable female consumer (patient). A female of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included multiple sclerosis, allergies, food intolerances. The patient was on an immunomodulator medication. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced sore arm, fever, loss of appetite, body aches and pain (especially in lower back/hips), and lethargic on the next day, ongoing intense dreams and thrashing at night over the next two weeks. The outcome of events was unknown.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: body aches; Ongoing "intense dreams"; pain (especially in lower back/hips); thrashing at night over the next two weeks; loss of appetite; lethargic on the next day; sore arm; fever; pain (especially in lower back/hips); This is a spontaneous report received from a contactable female consumer (patient). A female of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included multiple sclerosis, allergies, food intolerances. The patient was on an immunomodulator medication. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced sore arm, fever, loss of appetite, body aches and pain (especially in lower back/hips), and lethargic on the next day, ongoing intense dreams and thrashing at night over the next two weeks. The outcome of events was unknown.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: allergic reaction; face swollen; This is a spontaneous report from a non-contactable consumer (patient). A female unspecified age of patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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. On an unspecified date, the patient experienced allergic reaction and had face swollen after the 2nd dose. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Sneezing
Clinical narrative: she is currently experiencing aching, runny nose, and a lot of sneezing; she is currently experiencing aching, runny nose, and a lot of sneezing; she is currently experiencing aching, runny nose, and a lot of sneezing; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: Not reported) dose 2, via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was experiencing aching, runny nose, and a lot of sneezing on Mar2021. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swollen lymph nodes on the left side of neck/and swelling of armpit; swollen lymph nodes on the left side of neck/and swelling of armpit; This is a spontaneous report from a contactable consumer from Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 12Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date of Mar2021, the patient had experienced swollen lymph nodes on the left side of neck/and swelling of armpit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever; Aches; Fatigue; Chills; Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 at 11:45 hours as dose 2, single (at the age of 61-years-old) for COVID-19 immunisation. Medical history included papillary thyroid cancer from an unknown date and unknown if ongoing. Patient was not allergic to medications, food and other products. Historical vaccine included patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, administered in left arm on 26Feb2021 at 12:00 hours as dose 1, single (at the age of 61-years-old) for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (Synthroid) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, at 06:00 hours, patient experienced low-grade fever, aches, chills, fatigue and nosebleed. The adverse event did not result in doctor or other healthcare professional office or clinic or emergency room visit. Therapeutic measures taken for all the events and treatment included Advil and Tylenol. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Neck mass, SARS-CoV-2 test
Clinical narrative: got big lumps on his neck; began to feel ill; This is a spontaneous report from a contactable consumer (patient's relative). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 12Feb2021 as (at the age of 77-years-old) dose 1, single for COVID-19 immunization. Medical history included blood pressure measurement and pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  List of any other medications the patient received within 2 weeks of vaccination was blood pressure and pain medication.  No known allergies reported. Prior to vaccination the patient did nod diagnosed with COVID-19. On 16Feb2021 the patient experienced got big lumps on his neck and began to feel ill. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test (no result was reported). No treatment received for the adverse event. The clinical course reported as follows, the reporter stated that four or five days after the first job his father got big lumps on his neck and began to feel ill, he went to the doctor and they weren't too worried about it. The adverse event result in doctor or other healthcare professional office/clinic visits. The outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hair disorder, Pain, Swelling, Weight, Weight increased
Clinical narrative: overnight he gained over 25 pounds; lot of pain on his body and problems; his hair hurts; swelled up; This is a spontaneous report from a contactable consumer or other non HCP. A 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration on 09Mar2021 (at the age of 84-Years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient experienced overnight he gained over 25 pounds, lot of pain and problems on his body, his hair hurts and swelled up on an unspecified date. Adverse event gained over 25 pounds was considered as serious with seriousness criteria of medically significant and remaining event were considered as non-serious. Adverse events was resulted in emergency room visit. The patient underwent lab tests and procedures which included weight: 25 lbs. on an unspecified date. Therapeutic measures were taken as a result of overnight he gained over 25 pounds, lot of pain on his body, his hair hurts and swelled up included IV fluids. The outcome of the events were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased
Clinical narrative: My heart was beating and fluttering so fast I was quite alarmed. It did stop a couple of seconds cans later I have been experiencing light fluttering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram ambulatory, Eyelid function disorder, Eyelid irritation, Facial pain
Clinical narrative: 1.  The reaction began about 2 minutes after taking her first dose. It started as a painful numbness in the arm in which she was injected. Slowly this painful numbness decreased in intensity to the point she is now able to sublimate it away, except for a persistent moderate intensity pain in the left pinky and ring fingers.  2. About an hour after the injection the left side of her face also became afflicted with the same numbness. About two hours later her face hurt less and less and it has also decreased to the point of her being able to slowly sublimate it away. At present her main concern is that her left upper eye lid closes and it takes a conscious effort on her part to keep it open, preferring to keep it closed because it is more comfortable that way.  3. As the painful numbness receded in her left arm she began to develop an intermittent pain in the middle of her chest as if it were a heart attack. She has seen a variety of doctors and their advice is mixed and confusing. At the moment she is being seen by a cardiologist and is temporarily wearing a Holter monitor to keep track of her heart and eliminate any possibility of its complication. (She feels no radiating pain in her left arm.)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity
Clinical narrative: 1.  The reaction began about 2 minutes after taking her first dose. It started as a painful numbness in the arm in which she was injected. Slowly this painful numbness decreased in intensity to the point she is now able to sublimate it away, except for a persistent moderate intensity pain in the left pinky and ring fingers.  2. About an hour after the injection the left side of her face also became afflicted with the same numbness. About two hours later her face hurt less and less and it has also decreased to the point of her being able to slowly sublimate it away. At present her main concern is that her left upper eye lid closes and it takes a conscious effort on her part to keep it open, preferring to keep it closed because it is more comfortable that way.  3. As the painful numbness receded in her left arm she began to develop an intermittent pain in the middle of her chest as if it were a heart attack. She has seen a variety of doctors and their advice is mixed and confusing. At the moment she is being seen by a cardiologist and is temporarily wearing a Holter monitor to keep track of her heart and eliminate any possibility of its complication. (She feels no radiating pain in her left arm.)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Chills, Headache, Lethargy
Clinical narrative: generalized weakness, body aches, headaches, chills, lethargy x4 days. most significant symptom was mental disconnect; difficulty finding words, difficulty completing tasks r/t mental barriers
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mental impairment, Pain
Clinical narrative: generalized weakness, body aches, headaches, chills, lethargy x4 days. most significant symptom was mental disconnect; difficulty finding words, difficulty completing tasks r/t mental barriers
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Tachycardia, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: Refer pt to ER due to tachycardia and anxiety.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle aches,  chills, fever,
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: PATIENT HAS STATED RASH SPREADS FROM EXTREMITIES UP TO THE COLLARBONE. PHARMACY HAS ADVISED TO TAKE BENADRYL, PATIENT HAS ONLY TRIED CETIRIZINE FOR THE LAST COUPLE OF DAYS. REACTION DID NOT START UNTIL A WEEK AFTE VACCINATION DATE
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dermatitis allergic, Vaccination site pain
Clinical narrative: Injection site arm pain that lasted for 36 hours.; Joint pain and got worse in the next 24hours; As with first dose, skin allergic reactions that by now healed reappeared 1 day after the shot.; This is a spontaneous report from a contactable consumer, the patient.  A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in left arm on 07Mar2021 at 10:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation and experienced vaccination site pain and allergic skin reactions.Medical history included hashimotos thyroiditis and over active immune system. Concomitant medications included 50 mcg of levothyroxine (MANUFACTURER UNKNOWN) and 150mg of flucanazole (DIFLUCAN), both for an unknown indication, from unknown duration and unknown if ongoing. The patient was allergic to adhesive bandages, lemon grass and pea plant but not peas.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 28Mar2021, at 12:30, the patient had experienced vaccination site pain, which lasted for 36 hours and joint pain, which was felt few hours after the shot was given. Joint pain got worse in the next 24hours at which point pain medication was needed. The patient had also reported that as with first dose, skin allergic reactions that by then healed, reappeared one day after the shot. Therapeutic measures were taken as the result of adverse events, which included treatment with continued skin rash control for allergic skin rash and unknown point pain medication for joint pain. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, joint pain were recovered in Unknown date in Mar2021 and allergic skin rash was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration (age at vaccination 40 years) on 05Apr2021 as a single dose in arm for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced a big ball of a lump under her armpit of the arm at the vaccination site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of big ball of a lump under armpit was unknown. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Updated age at Vaccination and updated event code from "Lymphadenopathy " to "vaccination site mass"
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Illness
Clinical narrative: Fever of 104.5; Chills; Nausea; Joint pain; She really is very miserable; She is ill; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 60-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. The patient experienced fever of 104.5, chills, nausea, joint pain, she really is very miserable, she is ill on 02Apr2021 and I don't know what to do. Reporter stated, "I really do not know, I am just reading from the paper that she was given at the time of the vaccine. So I do not know the LOT#. I do not have her vaccination card .  The patient underwent lab tests and procedures which included body temperature: 104.5 on 02Apr2021. The outcome of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 104.5; Chills; Nausea; Joint pain; She really is very miserable; She is ill; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 60-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. The patient experienced fever of 104.5, chills, nausea, joint pain, she really is very miserable, she is ill on 02Apr2021 and I don't know what to do. Reporter stated, "I really do not know, I am just reading from the paper that she was given at the time of the vaccine. So I do not know the LOT#. I do not have her vaccination card .  The patient underwent lab tests and procedures which included body temperature: 104.5 on 02Apr2021. The outcome of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 30-years-old female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 10Apr2021 16:45 (at the age of 30-years-old) as single dose for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing Other medical history: Endometriosis. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication from 12Mar2021 to 12Mar2021; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. On 11Apr2021 14:30, the patient experienced vaginal bleeding. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Electrocardiogram, Hypertension, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration in arm left on 05Apr2021 at 09:45 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypertension and asthma. The known allergies of the patient was reported as mild allergy to apples, carrots, nuts. The concomitant medications of the patient included clarithromycin (CLARITIN [CLARITHROMYCIN]), escitalopram (ESCITALOPRAM), omeprazole (PROTONIX [OMEPRAZOLE]), losartan (LOSARTAN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took albuterol sulfate and experienced adverse reaction. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 06Apr2021 at 20:00, the patient experienced 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm and blood pressure was high. The patient stated the next morning he felt fine and had resumed normal activity. His cardiologist did and exam and said it was not an arterial issue and agreed it may have been a reaction to the vaccine. His blood pressure spiked up to almost the high/9Os.  The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included Nitroglycerin brought pressure to 120/80s but it went back up to 140 afterward (blood pressure measurement): 120/80s on 06Apr2021, blood pressure measurement: 140s/90s on 06Apr2021, blood pressure measurement: spiked up to almost the high/90s on 06Apr2021, EKGs: normal on 06Apr2021, troponin tests: normal on 06Apr2021, x-ray: normal on 06Apr2021 and Nasal swab sars-cov-2 test: negative on 07Apr2021. Therapeutic measures were taken as a result of events that included patient took aprazolam, and a glass of red wine, it did not subside and nitroglycerin in hospital. The patient recovered from 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm on an unspecified date in 2021 and the outcome of the event blood pressure was high 140s/90s was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration in arm left on 05Apr2021 at 09:45 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypertension and asthma. The known allergies of the patient was reported as mild allergy to apples, carrots, nuts. The concomitant medications of the patient included clarithromycin (CLARITIN [CLARITHROMYCIN]), escitalopram (ESCITALOPRAM), omeprazole (PROTONIX [OMEPRAZOLE]), losartan (LOSARTAN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took albuterol sulfate and experienced adverse reaction. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 06Apr2021 at 20:00, the patient experienced 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm and blood pressure was high. The patient stated the next morning he felt fine and had resumed normal activity. His cardiologist did and exam and said it was not an arterial issue and agreed it may have been a reaction to the vaccine. His blood pressure spiked up to almost the high/9Os.  The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included Nitroglycerin brought pressure to 120/80s but it went back up to 140 afterward (blood pressure measurement): 120/80s on 06Apr2021, blood pressure measurement: 140s/90s on 06Apr2021, blood pressure measurement: spiked up to almost the high/90s on 06Apr2021, EKGs: normal on 06Apr2021, troponin tests: normal on 06Apr2021, x-ray: normal on 06Apr2021 and Nasal swab sars-cov-2 test: negative on 07Apr2021. Therapeutic measures were taken as a result of events that included patient took aprazolam, and a glass of red wine, it did not subside and nitroglycerin in hospital. The patient recovered from 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm on an unspecified date in 2021 and the outcome of the event blood pressure was high 140s/90s was reported as unknown. No follow-up attempts are possible. No further information is expected.