chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lip haemorrhage, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Sore neck; Dry lips; Bleeding lips; Chapped lips; Sore eyes; Tired; Sore arm; Menstrual cramps; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included corneal transplant and sulfonamide allergy. Concomitant medication included birth control (unspecified). The patient previously took Codeine and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 17:00, the patient experienced fever, sore neck, dry/chapped/bleeding lips, gooey sore eyes, tired, sore arm and menstrual cramps (no menses). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with TYLENOL. The clinical outcome of the events fever, sore neck, dry lips, chapped lips, bleeding lips, sore eyes, tired, sore arm and menstrual cramps (no menses) was resolved on an unknown date in May2021  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Melanocytic naevus, Pruritus, Rash, Scar
Clinical narrative: I have some flat mole on underneath my breast a flat mole and they have always been there for years but all of sudden one or two of them start to range you know get bigger; I have a rash underline breast more underline left breast then the right; I start feeling this itching under my breast and it's progressive till like it is now; it left the big scars I don't now it's a red that's all I know. It's all red on under there now; it left the big scars I don't now it's a red that's all I know; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 28Jul2021, this case contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient).   A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0185) (at age of 84-years old) as dose 1, single and on 04Jun2021 (Batch/Lot Number: EW0187) (at age of 84-years old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN) and clopidogrel bisulfate (PLAVIX).  The patient had a rash underline breast more underline left breast then the right and she stated she never had any situation in her life like this and the only thing that she could pick it up to do with the shot the vaccine that she took, the vaccine could cause her any problem howsoever neither shot. The patient started sometime after she got a shot she started feeling this itching under her breast and it was progressive till like it was till the time of reporting and she used all kind of thing where she could fix it, that would make it go away but it did not go away. The only thing the patient thought of it could be because it was not from any kind of soap or any kind of detergent soap. The patient mentioned that it had not gone away and in fact it seemed to get little bit worse. It was stopped and left big scars, it was all red on under there till the time of reporting. The patient had some flat mole on underneath her breast, a flat mole and they have always been there for years but all sudden one or two of them had started to range and get bigger. The patient have not taken any treatment and just decided to call as she was reading the papers that she had to see if that could probably be one of the condition that she got after having a shot but since she did not have any pain or anything after she took the shot she did not think she could be able and would never have such a thing at all. The outcome of the events pruritus, erythema and scar was not recovered, while the outcome of other events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, My ears keep ringing for the past 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 13May2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received any other vaccines within four weeks prior to the vaccination. On 13May2021 at 12:00, the patient experienced tinnitus and her ears kept ringing for the past 36 hours. The patient looked it up, it seemed not many people have this reaction so she wanted to report it. No therapeutic measures were taken as a result of the reported event. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tinnitus, her ears kept ringing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 12May2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, two days after second shot, the patient experienced extreme dizziness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event extreme dizziness was recovered on 14May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on top of left hand; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07May2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included colecalciferol (VITAMIN D3) and menaquinone-7 (VITAMIN K2), both taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, 2 or 3 days after the second shot, the patient experienced itchy rash on top of left hand only, same side as the shot. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchy rash was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Racing heart: confirmed as her heart is beating fast; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, 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. Patient reported that, since she got the shot, she has had a racing heart (heart is beating fast) in the morning, when she wakes up. she was just curious as to what she could do about her racing heart. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate increased, Hypotension
Clinical narrative: Rapid heart beat; Upper back feeling funny; caller was asked regarding blood pressure as she previously stated 120/56.Caller confirms as 102/56, and that it was actually 102/56.; This is a spontaneous report from a contactable consumer or other non hcp(Patient). A 58-year old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)(At the age of 58 years old),via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included metformin,1000 mg, 2x/day for diabetes mellitus, atorvastatin 40 mg(she says long time she means 10 years), 1x/day taken for blood cholesterol increased, cetirizine ,10 mg, 1x/day(caller has been on for three years) taken for hypersensitivity, hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 20 mg, 2x/day ,taken for hypertension, gabapentin,900 mg, 3x/day (she has been on for over ten years) taken for surgery. On 18May2021 the patient experienced rapid heart beat , upper back feeling funny , and on an unknown date in 2021 caller was asked regarding blood pressure as she previously stated 120/56.caller confirms as 102/56, and that it was actually 102/56. Patient not visited to Emergency Room or Physician Office. Patient stated that Upper back feeling funny: caller states that it was not in her arm, just in her back but not in the arm or the shoulder. It was just on the left side kind of behind her breast. That started and she waited there for fifteen minutes and she kind of felt it then but when she got home that is when she really felt it. Even now, it is not painful but it is something like say something crawling maybe. It is just kind of staying the same, and it has not spread anywhere else.'Caller adds that the only other thing she noticed was not where the shot was at but like, how can she explain it, on the left side. Nothing is wrong with her arm, no numbness or anything. On the left part, left arm, upper back it was kind of feeling funny. Her left arm was where the vaccine was. The patient underwent lab tests and procedures which included blood pressure measurement: 102/56, body temperature: 97.5 on an unknown date in 2021.Treatment was not taken, she is just drinking her soda. The outcome of events experienced rapid heart beat , upper back feeling funny was not recovered and unknown for other event.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, SARS-CoV-2 antibody test, Swelling
Clinical narrative: the area is slightly swollen; Discomfort on my left arm pit; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 17May2021 09:15 as dose 2, single, and then 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 administered in Hospital. Medical history included none. The concomitant medications in 2 weeks were not reported. The patient reported, discomfort on her left arm pit (the area is slightly swollen) on 18May021 07:00. This happened on her first dose too. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 21Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Elevated heart rate; During one event I had to stop the workout to catch my breath; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporter's wife) that female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unknown date in 2021, the patient experienced elevated heart rate and during one event i had to stop the workout to catch my breath. Facility where the most recent COVID-19 vaccine was administered at doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received any other medications within 2 weeks of vaccination. The clinical outcome of both events were unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021598382 same reporter/AE/SD, different patients.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Swelling, Ultrasound scan, Vascular pain, Vein disorder
Clinical narrative: I got swollen veins at the back of my knee. It suddenly got swollen and painful. The veins were swollen pretty fast until I have to elevate it to slow it down/ veins have been throbbing; I got swollen veins at the back of my knee. It suddenly got swollen and painful; I also had some rising heart rate; I got swollen veins at the back of my knee; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0167), via an unspecified route of administration in left arm on 21May2021 (at the age of 32 years old) as single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. 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 not been tested for COVID-19. On 31May2021, patient experienced swollen veins at the back of her knee. It suddenly got swollen and painful. The veins were swollen pretty fast until she have to elevated it to slow it down. She also had some rising heart rate. She went to ER and had an ultrasound. It doesn't seem to be blood clot related, but the veins have been throbbing since. The patient underwent lab tests and procedures which included ultrasound scan: unknown on 31May2021 It doesn't seem to be blood clot related, but the veins have been throbbing since.  The events resulted in a visit to emergency room/department or urgent care. No hospitalization required. The reporter considered events as non-serious. The outcome of events was recovering.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: Nausea; Dry heaves; Headache; Extreme body aches; Fatigue; Chills; Fever started; Slight vertigo began; Still felt unwell until Tuesday when I felt like myself again; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injec-tion, Batch/Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 28May2021 14:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunization. Medical history included PKD, Anxiety, HBP from an unknown date and unknown if ongo-ing. Concomitant medication(s) included metoprolol succinate; citalopram; losartan and Vit. taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). The patient was not pregnant at the time of vaccination. The patient was previously received first dose of BNT162B2 (Lot number: EW0179), administered in Left arm on 07May2021 03:30 PM (at the age of 51-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. 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 not been tested for COVID-19. Patient had no known allergies. Reported, approximately 12 hours after injec-tion (3am on Saturday, 29May2021) chills and fever started, 4 hours later (7am) nausea and dry heaves started with headache and extreme body aches, and fatigue. By noon after the nausea and dry heaves stopped and slight vertigo began (29May2021). (1000mg of Tylenol was started and taken every 6 hours following until Tuesday morning at 7am.) Fever decreased to upper 99's -101, and chills were on and off and didn't completely go away until Monday morning (31May2021) when I woke up at approx. 7 am. Body aches and headache also continued until Monday morning. Still felt unwell until Tuesday when I felt like myself again on an unspecified date in 2021. Patient received 1000 mg of Tylenol was taken every 6 hours as treatment for all events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 99's-101 on 2021 (decreased to upper 99's-101). Therapeutic measures were taken as a result of chills, fever started, nausea, dry heaves, headache, extreme body aches, fatigue, slight vertigo began, still felt unwell until Tuesday when I felt like myself again. The outcome of events was recovered on an unspecified date in 2021, event nausea and dry heaves was recovered on 29May2021.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Retching, Vertigo
Clinical narrative: Nausea; Dry heaves; Headache; Extreme body aches; Fatigue; Chills; Fever started; Slight vertigo began; Still felt unwell until Tuesday when I felt like myself again; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injec-tion, Batch/Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 28May2021 14:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunization. Medical history included PKD, Anxiety, HBP from an unknown date and unknown if ongo-ing. Concomitant medication(s) included metoprolol succinate; citalopram; losartan and Vit. taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). The patient was not pregnant at the time of vaccination. The patient was previously received first dose of BNT162B2 (Lot number: EW0179), administered in Left arm on 07May2021 03:30 PM (at the age of 51-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. 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 not been tested for COVID-19. Patient had no known allergies. Reported, approximately 12 hours after injec-tion (3am on Saturday, 29May2021) chills and fever started, 4 hours later (7am) nausea and dry heaves started with headache and extreme body aches, and fatigue. By noon after the nausea and dry heaves stopped and slight vertigo began (29May2021). (1000mg of Tylenol was started and taken every 6 hours following until Tuesday morning at 7am.) Fever decreased to upper 99's -101, and chills were on and off and didn't completely go away until Monday morning (31May2021) when I woke up at approx. 7 am. Body aches and headache also continued until Monday morning. Still felt unwell until Tuesday when I felt like myself again on an unspecified date in 2021. Patient received 1000 mg of Tylenol was taken every 6 hours as treatment for all events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 99's-101 on 2021 (decreased to upper 99's-101). Therapeutic measures were taken as a result of chills, fever started, nausea, dry heaves, headache, extreme body aches, fatigue, slight vertigo began, still felt unwell until Tuesday when I felt like myself again. The outcome of events was recovered on an unspecified date in 2021, event nausea and dry heaves was recovered on 29May2021.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Testicular pain; This is a spontaneous report from a contactable consumer(patient). A 15-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0185), via an unspecified route of administration on 03Jun2021 at 17:30 (at the age of 15-years-old) into left arm as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0173), via an unspecified route of administration on 13May2021 at 17:30 pm into left arm as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021 at 12:30, the patient experienced Testicular pain. No treatment was received for the event. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Chest discomfort, Chills, Cough
Clinical narrative: vomiting; fever of 103; severe chills; my chest was on fire; severe cough; sore throat; body aches; headache; oxygen hovered at 88 for 18 hours; laryngitis; suffered severe exhausted.; i couldn't ever roll ever on my bed; i couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 intramuscular, administered in the left arm on 24Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia from 17Jan2009 and ongoing (antibiotics some hospitalisation), renal lithiasis prophylaxis from 01Sep2010 to 01Sep2010, headache from an unknown date and unknown if ongoing. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 24Mar2021, within 4 hours of first vaccine, I suffered severe exhausted. Within 6 hours, my chest was on fire with severe cough and sore throat, body aches, headache, fever of 103.  My oxygen hovered at 88 for 18 hours and my resting heart rate was 118.  This lasted for a full 18 hours and then very gradually subsided.  Oxygen came back up slowly and I was able to walk around my house for a few minutes on day 2.  By day 4, I was almost back to normal except for laryngitis, which lasted a full 7 days. The patient also reported shot received at 3:30 by 20:00 I was extremely tired. I woke up at 1:00 am with a fever of 103 degrees, severe chills that were so bad I bit my tongue. I also had a horrible cough and sore throat. I couldn't catch my breath. I couldn't ever roll over in my bed because I couldn't breath or catch my breath. Vomiting began at 4 am and lasted 1 hour. Oxygen level was 84 to 88 for 18 hours. Treatment for the events included unspecified nebulizer, paracetamol (TYLENOL), and cough syrup. The patient recovered from all the events.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate, Insomnia
Clinical narrative: vomiting; fever of 103; severe chills; my chest was on fire; severe cough; sore throat; body aches; headache; oxygen hovered at 88 for 18 hours; laryngitis; suffered severe exhausted.; i couldn't ever roll ever on my bed; i couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 intramuscular, administered in the left arm on 24Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia from 17Jan2009 and ongoing (antibiotics some hospitalisation), renal lithiasis prophylaxis from 01Sep2010 to 01Sep2010, headache from an unknown date and unknown if ongoing. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 24Mar2021, within 4 hours of first vaccine, I suffered severe exhausted. Within 6 hours, my chest was on fire with severe cough and sore throat, body aches, headache, fever of 103.  My oxygen hovered at 88 for 18 hours and my resting heart rate was 118.  This lasted for a full 18 hours and then very gradually subsided.  Oxygen came back up slowly and I was able to walk around my house for a few minutes on day 2.  By day 4, I was almost back to normal except for laryngitis, which lasted a full 7 days. The patient also reported shot received at 3:30 by 20:00 I was extremely tired. I woke up at 1:00 am with a fever of 103 degrees, severe chills that were so bad I bit my tongue. I also had a horrible cough and sore throat. I couldn't catch my breath. I couldn't ever roll over in my bed because I couldn't breath or catch my breath. Vomiting began at 4 am and lasted 1 hour. Oxygen level was 84 to 88 for 18 hours. Treatment for the events included unspecified nebulizer, paracetamol (TYLENOL), and cough syrup. The patient recovered from all the events.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Oropharyngeal pain, Oxygen consumption, Oxygen saturation decreased, Pain
Clinical narrative: vomiting; fever of 103; severe chills; my chest was on fire; severe cough; sore throat; body aches; headache; oxygen hovered at 88 for 18 hours; laryngitis; suffered severe exhausted.; i couldn't ever roll ever on my bed; i couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 intramuscular, administered in the left arm on 24Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia from 17Jan2009 and ongoing (antibiotics some hospitalisation), renal lithiasis prophylaxis from 01Sep2010 to 01Sep2010, headache from an unknown date and unknown if ongoing. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 24Mar2021, within 4 hours of first vaccine, I suffered severe exhausted. Within 6 hours, my chest was on fire with severe cough and sore throat, body aches, headache, fever of 103.  My oxygen hovered at 88 for 18 hours and my resting heart rate was 118.  This lasted for a full 18 hours and then very gradually subsided.  Oxygen came back up slowly and I was able to walk around my house for a few minutes on day 2.  By day 4, I was almost back to normal except for laryngitis, which lasted a full 7 days. The patient also reported shot received at 3:30 by 20:00 I was extremely tired. I woke up at 1:00 am with a fever of 103 degrees, severe chills that were so bad I bit my tongue. I also had a horrible cough and sore throat. I couldn't catch my breath. I couldn't ever roll over in my bed because I couldn't breath or catch my breath. Vomiting began at 4 am and lasted 1 hour. Oxygen level was 84 to 88 for 18 hours. Treatment for the events included unspecified nebulizer, paracetamol (TYLENOL), and cough syrup. The patient recovered from all the events.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting; fever of 103; severe chills; my chest was on fire; severe cough; sore throat; body aches; headache; oxygen hovered at 88 for 18 hours; laryngitis; suffered severe exhausted.; i couldn't ever roll ever on my bed; i couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 intramuscular, administered in the left arm on 24Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia from 17Jan2009 and ongoing (antibiotics some hospitalisation), renal lithiasis prophylaxis from 01Sep2010 to 01Sep2010, headache from an unknown date and unknown if ongoing. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 24Mar2021, within 4 hours of first vaccine, I suffered severe exhausted. Within 6 hours, my chest was on fire with severe cough and sore throat, body aches, headache, fever of 103.  My oxygen hovered at 88 for 18 hours and my resting heart rate was 118.  This lasted for a full 18 hours and then very gradually subsided.  Oxygen came back up slowly and I was able to walk around my house for a few minutes on day 2.  By day 4, I was almost back to normal except for laryngitis, which lasted a full 7 days. The patient also reported shot received at 3:30 by 20:00 I was extremely tired. I woke up at 1:00 am with a fever of 103 degrees, severe chills that were so bad I bit my tongue. I also had a horrible cough and sore throat. I couldn't catch my breath. I couldn't ever roll over in my bed because I couldn't breath or catch my breath. Vomiting began at 4 am and lasted 1 hour. Oxygen level was 84 to 88 for 18 hours. Treatment for the events included unspecified nebulizer, paracetamol (TYLENOL), and cough syrup. The patient recovered from all the events.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Extrasystoles, Heart rate irregular
Clinical narrative: Heart felt like it was skipping beats and heavy heart thumping.; Heart felt like it was skipping beats and heavy heart thumping.; 24-hour Holter monitor showed occasional PVCs and well as PACs; 24-hour Holter monitor showed occasional PVCs and well as PACs; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in arm right on 04May2021 at 13:30 pm as dose 2, single dose for covid-19 immunization (at the age of 53-years-old). Medical history included supraventricular tachycardia from an unknown date and unknown if ongoing and supraventricular tachycardia-ablation successful in Jan2019. Patient had not received any other vaccine in four weeks. Patient had no known allergies. Patient had no Covid prior vaccination and did not tested for covid post vaccination. Concomitant medication(s) included daily vitamin, fish oil and calcium all were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0164) via an unspecified route of administration, administered in left arm on 13Apr2021 at 01:30 pm, as single dose for COVID-19 immunization (at the age of 53-years-old). It was reported that after receiving the second dose of vaccine on 09May2021 the patient experienced heart felt like it was skipping beats and heavy heart thumping. 24-hour Holter monitor showed occasional PVCs (premature ventricular contractions) and well as PACs (premature atrial contraction). Normal EKG (electrocardiogram). Normal echocardiogram. Events resulted in doctor or other healthcare professional office/clinic visit. Patient had not received any treatment for the events.The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Heart felt like it was skipping beats and heavy heart thumping.; Heart felt like it was skipping beats and heavy heart thumping.; 24-hour Holter monitor showed occasional PVCs and well as PACs; 24-hour Holter monitor showed occasional PVCs and well as PACs; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in arm right on 04May2021 at 13:30 pm as dose 2, single dose for covid-19 immunization (at the age of 53-years-old). Medical history included supraventricular tachycardia from an unknown date and unknown if ongoing and supraventricular tachycardia-ablation successful in Jan2019. Patient had not received any other vaccine in four weeks. Patient had no known allergies. Patient had no Covid prior vaccination and did not tested for covid post vaccination. Concomitant medication(s) included daily vitamin, fish oil and calcium all were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0164) via an unspecified route of administration, administered in left arm on 13Apr2021 at 01:30 pm, as single dose for COVID-19 immunization (at the age of 53-years-old). It was reported that after receiving the second dose of vaccine on 09May2021 the patient experienced heart felt like it was skipping beats and heavy heart thumping. 24-hour Holter monitor showed occasional PVCs (premature ventricular contractions) and well as PACs (premature atrial contraction). Normal EKG (electrocardiogram). Normal echocardiogram. Events resulted in doctor or other healthcare professional office/clinic visit. Patient had not received any treatment for the events.The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, C-reactive protein increased, Gait inability, Immunology test
Clinical narrative: Horrible shoulder pain which was unbearable and moved throughout body; Horrible shoulder pain which was unbearable and moved throughout body; C reactive protein jumped to 8.6; Polymyalgia; Could not walk; This is a spontaneous report from a contactable consumer (the patient). This consumer reported similar events under the same suspect product for two patients. This is one of two reports.   A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 09Feb2021 10:15 (at the age of 67 years old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) on 18Jan2021 10:30 AM, administered in left arm, for COVID-19 immunization. The patient has no history of COVID prior vaccination. He was not COVID tested post vaccination. 1 month later on 01Mar2021, the patient experienced developed horrible shoulder pain which was unbearable and moved throughout body. C-reactive protein jumped to 8.6 and ended up with polymyalgia. The patient was treated with Prednisone. It was also reported that the patient could not walk until treated with steroids. The events required a visit to the physician's office. The patient underwent lab tests and procedures which included c-reactive protein: 8.6 on 01Mar2021, Immune tests: ok on Jun2021, Basic metabolic panel (BMP): ok on Jun2021 and sedimentation rate: ok on Jun2021. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677122 Same reporter and drug, similar event, different patient
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Myalgia, Pain, Red blood cell sedimentation rate
Clinical narrative: Horrible shoulder pain which was unbearable and moved throughout body; Horrible shoulder pain which was unbearable and moved throughout body; C reactive protein jumped to 8.6; Polymyalgia; Could not walk; This is a spontaneous report from a contactable consumer (the patient). This consumer reported similar events under the same suspect product for two patients. This is one of two reports.   A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 09Feb2021 10:15 (at the age of 67 years old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) on 18Jan2021 10:30 AM, administered in left arm, for COVID-19 immunization. The patient has no history of COVID prior vaccination. He was not COVID tested post vaccination. 1 month later on 01Mar2021, the patient experienced developed horrible shoulder pain which was unbearable and moved throughout body. C-reactive protein jumped to 8.6 and ended up with polymyalgia. The patient was treated with Prednisone. It was also reported that the patient could not walk until treated with steroids. The events required a visit to the physician's office. The patient underwent lab tests and procedures which included c-reactive protein: 8.6 on 01Mar2021, Immune tests: ok on Jun2021, Basic metabolic panel (BMP): ok on Jun2021 and sedimentation rate: ok on Jun2021. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677122 Same reporter and drug, similar event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood test, C-reactive protein, Neck pain
Clinical narrative: Shoulder pain; Sore under left arm (armpit); Neck are throbbing pain that moves around; This is a spontaneous report from two contactable consumers (the patient's husband and the patient herself). The consumers reported similar events for two patients. This is the second of two reports. This report is for the wife.  A 67-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via intramuscular route of administration in the left arm on 09Feb2021 at 10:15 (Batch/Lot Number: EL9263, at the age of 67-years-old at vaccination) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. Historical vaccine information included the patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an intramuscular route of administration in the left arm on 18Jan2021 at 10:30 (Batch/Lot Number: EL1283, at the age of 67-years-old at vaccination) as a single dose for COVID-19 immunisation. On 09Feb2021, the patient received the second dose of the BNT162B2 vaccine. The husband reported that 1 month later in Mar2021, his wife developed a horrible shoulder pain and "hers left the right side". In Mar2021, the shoulder started hurting and she was sore under left arm (armpit), and in the neck was a throbbing pain that moves around. On 28Jul2021, the patient reported that the shoulder pain was getting worse 3-4 weeks after vaccination. It was also reported that the right shoulder was better but left arm up through the neck had throbbing pain that moves around. She was sore under the left arm (armpit) but that was better. She was going for EMG (Electromyogram) in "Jul2022". Seriousness criteria was reported as persistent and significant disability and incapacity. The adverse events required a visit to the physician office.  The patient underwent lab tests and procedures which included blood test was okay in 2021, c-reactive protein was okay in Jun2021, red blood cell sedimentation rate was okay in Jun2021. The outcome of events shoulder pain and sore under left arm (armpit) was recovering. The outcome of event neck throbbing pain that moves around was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021676900 same reporters, drug, and event in different patients