chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Heart rate, Hyperhidrosis, Pyrexia
Clinical narrative: 102 fever; SOB; sweats; chills; This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm right on 11Feb2021 at 15:45 (at the age of 69-year-old) (Lot Number: EL3302) as dose 1, single for covid-19 immunisation. Medical history included congestive heart failure (CHF) (20 years), chronic lymphocytic leukemia (CLL) (25 year) and SARS-CoV-2 test positive on 15Dec2020. Concomitant medications included apixaban (ELIQUIS), simvastatin, sacubitril valsartan sodium hydrate (ENTRESTO) and furosemide. On 12Feb2021 at 06:00, the patient experienced 102 fever, shortness of breath (sob), heart rate (hr) about 90-100, sweats and chills for last 3 days and improving slowly. It was reported that the patient was tests positive nasal swab COVID on 15Dec2020. The patient was mildly sick 2-3 weeks. She was much more fit and did not feel well for a day or two (slight fever, too, CHF and CLL, WBC of 80,000 for 25 years). It was reported that the patient did not experienced arm pain. The patient was wondering if patient need the second dose with such a strong booster reaction. Hard on his heart. The outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, White blood cell count
Clinical narrative: 102 fever; SOB; sweats; chills; This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm right on 11Feb2021 at 15:45 (at the age of 69-year-old) (Lot Number: EL3302) as dose 1, single for covid-19 immunisation. Medical history included congestive heart failure (CHF) (20 years), chronic lymphocytic leukemia (CLL) (25 year) and SARS-CoV-2 test positive on 15Dec2020. Concomitant medications included apixaban (ELIQUIS), simvastatin, sacubitril valsartan sodium hydrate (ENTRESTO) and furosemide. On 12Feb2021 at 06:00, the patient experienced 102 fever, shortness of breath (sob), heart rate (hr) about 90-100, sweats and chills for last 3 days and improving slowly. It was reported that the patient was tests positive nasal swab COVID on 15Dec2020. The patient was mildly sick 2-3 weeks. She was much more fit and did not feel well for a day or two (slight fever, too, CHF and CLL, WBC of 80,000 for 25 years). It was reported that the patient did not experienced arm pain. The patient was wondering if patient need the second dose with such a strong booster reaction. Hard on his heart. The outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Hand tingled in the right arm that the vaccine was put in in under 5 minutes of getting it.; The next day, just my arm hurt; Within 20/25 minutes of waking up I began having a light chest pain; chills; cold; body aches; Head hurt; Very tired; This is a spontaneous report from a contactable consumer or other Non-health care professional. A 35-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9267), via an unspecified route of administration, in right arm (at the age of 35-year-old) on 11Feb2021 14:00 as dose 1, single for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing and was reported as none. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was 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. The patient did not receive any other medications in two weeks prior to the vaccination. On 11Feb2021 14:15 the patient experienced hand tingled in the right arm that the vaccine was put in in under 5 minutes of getting it. Then, whole arm was tingling and later the whole arm hurt and tingled. Later that evening it was very cold. On the next day, just her arm hurt, and she felt great. Within 20/25 minutes of waking up she began having a light chest pain. It lingered all day. Later began with chills, cold and body aches. Just got worse throughout the day. Head hurt off and on all day for a few seconds and then would go away. Very tired. Arm hurt bad. The patient did not receive treatment. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Hand tingled in the right arm that the vaccine was put in in under 5 minutes of getting it.; The next day, just my arm hurt; Within 20/25 minutes of waking up I began having a light chest pain; chills; cold; body aches; Head hurt; Very tired; This is a spontaneous report from a contactable consumer or other Non-health care professional. A 35-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9267), via an unspecified route of administration, in right arm (at the age of 35-year-old) on 11Feb2021 14:00 as dose 1, single for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing and was reported as none. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was 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. The patient did not receive any other medications in two weeks prior to the vaccination. On 11Feb2021 14:15 the patient experienced hand tingled in the right arm that the vaccine was put in in under 5 minutes of getting it. Then, whole arm was tingling and later the whole arm hurt and tingled. Later that evening it was very cold. On the next day, just her arm hurt, and she felt great. Within 20/25 minutes of waking up she began having a light chest pain. It lingered all day. Later began with chills, cold and body aches. Just got worse throughout the day. Head hurt off and on all day for a few seconds and then would go away. Very tired. Arm hurt bad. The patient did not receive treatment. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Slight tingling of the tongue; This is a spontaneous report from the Pfizer-sponsored program from contactable nurse reported for a patient (Husband). A 72-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EM9810, at the age of vaccination 72 years) as dose 1, single for covid-19 immunization.The patient Medical history included diabetes mellitus, hypertension, supraventricular tachycardia. The Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken 1 DF, twice aday (1 tablet, twice a day/ 50/1000) for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken 1000 iU, daily for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken 81 mg for an unspecified indication, start and stop date were not reported; glipizide (GLIPIZIDE) taken 10 mg, twice a day for an unspecified indi-cation, start and stop date were not reported; lisinopril (LISINOPRIL) taken 20 mg, daily  for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken 100 ug, daily for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken 25 mg, daily for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken 40 mg, once a day for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken 50 mg once aday for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken 10 mg once a day for an unspecified indication, start and stop date were not reported.  The patient experienced slight tingling of the tongue on 02Feb2021. A nurse reported that her husband got his first Covid vaccine and immediately when he got it, he had slight tingling of the tongue that did go away eventually. He is due for get the second shot and we are wondering if he should get that. Lab work: Nurse stated, he had lab work for his diabetes but that was probably a month ago. No treatment was received. The event outcome was recovered on unspecified date.   No follow up attempts are possible. No further information is expected
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired and very weak; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3247; Expiration Date: May2021) as dose number unknown, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included that she had pacemaker and breast cancer. Concomitant medications included letrozole once a day and olmesartan medoxomil (BENICAR) 20mg, oral, once a day due to pacemaker and Letrozole. The patient stated that she was 83 years of old, second of all her doctor wants her to take it because she had breast cancer. The patient was very tired and very weak on 22Jan2021. The patient experienced few days of runny nose, headache and she bad day on 25Jan2021. The patient stated that last day she had experienced was 25Jan2021 and since then she had been fine but all of a sudden on Saturday the 06Feb2021, she started having like muscle pain on her arm, the one she got the shot and Saturday, Sunday and today. Last night she put some kind of cream for the muscle pain relief and little bit better this morning. She enquired if that was normal to have pain after almost so many days after the vaccine. The outcome of the event runny nose, I had a bad day, headache, very tired and very weak was recovered while the outcome of Muscle pain on my arm was recovering.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: To delete the event "Off label use in unapproved indication", added breast cancer in the medical history, removed the indication breast cancer for drug bnt162b2 and added COVID-19 immunisation and deleted At Risk classification.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired and very weak; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3247; Expiration Date: May2021) as dose number unknown, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included that she had pacemaker and breast cancer. Concomitant medications included letrozole once a day and olmesartan medoxomil (BENICAR) 20mg, oral, once a day due to pacemaker and Letrozole. The patient stated that she was 83 years of old, second of all her doctor wants her to take it because she had breast cancer. The patient was very tired and very weak on 22Jan2021. The patient experienced few days of runny nose, headache and she bad day on 25Jan2021. The patient stated that last day she had experienced was 25Jan2021 and since then she had been fine but all of a sudden on Saturday the 06Feb2021, she started having like muscle pain on her arm, the one she got the shot and Saturday, Sunday and today. Last night she put some kind of cream for the muscle pain relief and little bit better this morning. She enquired if that was normal to have pain after almost so many days after the vaccine. The outcome of the event runny nose, I had a bad day, headache, very tired and very weak was recovered while the outcome of Muscle pain on my arm was recovering.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: To delete the event "Off label use in unapproved indication", added breast cancer in the medical history, removed the indication breast cancer for drug bnt162b2 and added COVID-19 immunisation and deleted At Risk classification.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: My face is tingling.; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 31-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, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Left arm on 19Feb2021 at 18:45 (31-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included depression, anxiety and Known allergies to Paxil, Levaquin , codeine and penicillin. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported and Women's multivitamin. The patient did not have covid prior to the vaccination and post vaccination. The patient experienced face tingling on 20Feb2021 at 04:30 Am. No treatment received for the event. The outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: tightness in chest; upper back discomfort; tingling in right leg from calf to toes; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 71-years-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 10Feb2021 12:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alendronate sodium, calcium, colecalciferol (D3) taken for an and eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication, start and stop date were not reported. The patient previously took statins and experienced drug hypersensitivity, aspirin (acetylsalicylic acid) and experienced drug hypersensitivity. No vaccination to covid prior and not covid tested post vaccination. The patient experienced tingling in right leg from calf to toes on 10Feb2021, tightness in chest and upper back discomfort on 10Feb2021 19:00. No treatment received for events. The outcome of the events tightness in chest and upper back discomfort was resolved on 10Feb2021 21:00 and other event tingling in right leg from calf to toes resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Pain in extremity, Pyrexia
Clinical narrative: chest pain, heart so heavy can hardly breathe; chest pain, heart so heavy can hardly breathe; Fever; serious headaches, which whole body hurts and in pain; body aches; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 (14:00-15:00, as reported), (at the age of 33-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. Patient took first done of bnt162b2 (Lot Number/Expiry Date: EL1283, unable to provide expiry) in Arm Left on 23Jan2021 for covid-19 immunization. On 09Feb2021 03:00, the patient experienced chest pain, heart so heavy can hardly breathe, fever, serious headaches, which whole body hurts and in pain and body aches. No emergency room and physician office visit. Outcome of the events was not recovered.   Additional Context: Caller reports, the second shot yesterday and has come down with side effects so bad and she can't go to the emergency room due to no insurance. Received the second shot 08Feb. Has had fever, chest pain with heart so heavy she can barely breathe, body so hot, serious headaches, which whole body hurting and in pain, body aches that all started at 3am this morning. No further details provided. Unable to provide NDC, expiry, or dose for second Covid vaccine. No other vaccines given the same day. 4 weeks prior did get the first Covid vaccine, 23Jan and provides a lot number of EL1283. Mentions with that one it was in same arm and she had side effects, but not as much as this second one. Had light headache, nausea, pain in left hand. Again, mentions second vaccine much worse. No history of problems with vaccines in past. No further details provided. Mentions she has already missed work and looking to see what Pfizer can do to help her with side effects, looking for medical advice. Talks about a form she saw with help for medical care. Recommended caller for further medical advice to seek medical care, Pfizer is unable to provide medical advice. No further details provided.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingle; This is a spontaneous report from a contactable consumer. A 50-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration on left arm on 02Feb2021 at 03:00PM as single dose (Age at Vaccination: 50 years) for COVID-19 immunization. The patient medical history included drug allergy, food allergy and allergies to other products: insect bites: kissing bug and nickel. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no covid prior vaccination and had no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 02Feb2021 03:00 PM, the patient experienced within about a minute bottom lip of the patient started to tingle and lasted for about 15 minutes. The patient inquired is tingling an allergic reaction. No treatment was received. The outcome of the event was resolved.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: whole left side just itches.; I was sitting at my desk and all of a sudden the whole left side of my face started tingling badly and burning.; I was sitting at my desk and all of a sudden the whole left side of my face started tingling badly and burning.; Then from there my ear kind of went numb and thenI got light headed and dizzy; Then from there my ear kind of went numb and thenI got light headed and dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 16Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included shingles (had about 5 months prior to). Concomitant medication was not reported. On 16Feb2021 (after about 5 hours of vaccination), patient was sitting at desk and all of a sudden the whole left side of face started tingling badly and burning. Then from there ear kind of went numb and then got lightheaded and dizzy. On 19Feb2021, patient had whole left side just itches. So, patient went and got on the bed for a little bit. Then the next day was ok, not a 100% but fine now. Patient almost went to the emergency room. Patient wanted to know whether the vaccine was triggering the virus in people that have had shingles. Patient face start tingling and burning badly, ears got numb right on the side where had shingles. While patient was sitting and talking, whole left side just itches, like the start of shingles but it was all the way down left side. It was on my left fingertip too. Like shingles. Just like left side, that's the side where got shot in and that was the side had the shingles on. So that was patient concerned because shingles was a virus and wonders if there was something in the vaccine. It was not as severe today as the day that when got the vaccine. Patient was concerned about taking the second dose. If had a harder time with the second dose, would be scared to death and if do not get the second shot because of this, at least have some in. So, if patient gets COVID, would not have it as bad. The outcome for event whole left side just itches was unknown and for all events was recovering.   Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: My oxygen saturation also fell to a low of 93 when it's usually 96-97; shortness of breath; chest pressure; my resting pulse surged to 98 to 114 over the next 3 hours. My resting pulse is usually 75; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EN6200), via an unspecified route in the left arm on 27Feb2021 at 15:30, as a single dose for covid-19 immunization. Patient medical history included polycythemia vera and known allergies to NSAIDS, citrus, caffeine. Patient concomitant medications included irbesartan, atorvastatin, omeprazole and acetylsalicylic acid (BABY ASPIRIN). Patient historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EL9261), in the left arm on 06Feb2021 at 15:30, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 28Feb2021 at 12:15, approximately 20 hours after my 2nd Covid vaccine shot, patient experienced chest pressure, shortness of breath and resting pulse surged to 98 to 114 over the next 3 hours, his resting pulse is usually 75. Her oxygen saturation also fell to a low of 93 when it's usually 96-97. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included resting pulse surged to 98 to 114 his resting pulse is usually 75 and oxygen saturation also fell to a low of 93 when it's usually 96-97 on 28Feb2021. The clinical outcome of the events was recovering as by 42 hours after the shot, patient was pretty much back to normal although he had some lingering chest pressure and resting pulse was now in the low 80's.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal
Clinical narrative: My oxygen saturation also fell to a low of 93 when it's usually 96-97; shortness of breath; chest pressure; my resting pulse surged to 98 to 114 over the next 3 hours. My resting pulse is usually 75; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EN6200), via an unspecified route in the left arm on 27Feb2021 at 15:30, as a single dose for covid-19 immunization. Patient medical history included polycythemia vera and known allergies to NSAIDS, citrus, caffeine. Patient concomitant medications included irbesartan, atorvastatin, omeprazole and acetylsalicylic acid (BABY ASPIRIN). Patient historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EL9261), in the left arm on 06Feb2021 at 15:30, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 28Feb2021 at 12:15, approximately 20 hours after my 2nd Covid vaccine shot, patient experienced chest pressure, shortness of breath and resting pulse surged to 98 to 114 over the next 3 hours, his resting pulse is usually 75. Her oxygen saturation also fell to a low of 93 when it's usually 96-97. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included resting pulse surged to 98 to 114 his resting pulse is usually 75 and oxygen saturation also fell to a low of 93 when it's usually 96-97 on 28Feb2021. The clinical outcome of the events was recovering as by 42 hours after the shot, patient was pretty much back to normal although he had some lingering chest pressure and resting pulse was now in the low 80's.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: Tingling/strong tingling in the arms, legs, and around mouth; Short breath; Fast heartbeat during midnight or early morning; it weakened her up; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 16:30 (Age at vaccination: 62-year-old) as single dose, for covid-19 immunization. Medical history included thyroid replace medicine from an unknown date and unknown if ongoing. Concomitant medication included ergocalciferol (VIT D), levothyroxine sodium (LEVOTHYROXINE SODIUM), calcium (CALCIUM) and unspecified medications all taken for an unspecified indication, start and stop date were not reported. and It was reported that a few minutes after the first dose she felt some tingling and the next day it was rather severe and it weakened her up, this never happened before, she went to ER and everything seemed okay. After the second dose, she developed muscle weakness and severe tingling, she is not sure if it is related to the vaccine, but she has felt this almost every other day, she was weak because of the tingling, it is limiting and has been there for some time, on the face. The tingling increased at night. She went again to ER the day before yesterday, the doctor found everything was normal except the potassium, which was at 3.4 (limit 3.5) and she thinks it may not be related. After that, she started taking potassium supply tablets but they did not help. Patient wanted to know how many days after the vaccine was the fatigue reported. Upon date 01Mar2021 it was reported that patent stated, Muscle weakness, muscle tingling on face and my arms, sometimes face, most of the time it was limbs. She want to get some advice on what is going on there. Also reported after the vaccination, she feel muscle weakness. Upon date 13Mar2021 it was reported that wake-up by strong tingling in the arms, legs, and around mouth with short breath and fast heartbeat during midnight or early morning, and the tingling last during the day. First event occurred the night after 1st dose; then after the 2nd dose, the episodes occurred almost every other day (sometimes, every day). Occasionally there was strong muscle ache in the arms and legs. She was still having those symptoms. She could not sleep for most of the nights due to these episodes. she can not live normally since the vaccination. Patient was not tested for covid post vaccination. Adverse event resulted in physician office visit or ER visit. Outcomes for the event was reported as not resolved.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238818 same reporter/patient/drug, different events/vaccine dose
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site vesicles, Neoplasm skin
Clinical narrative: Lump on my arm; Pea sized blister filled with fluid near the injection site; This is a spontaneous report received from a contactable consumer (patient). A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 25Feb2021 at 14:00 as DOSE 1, SINGLE for covid-19 immunization. Vaccine facility was reported as pharmacy or drug store. Medical history included hypertension, diabetes and two stents in arteries from an unknown date and unknown if ongoing. Concomitant medications included losartan 100 mg, amlodipine 5 mg and hydrochlorothiazide: all taken for an unspecified indication, start and stop date were not reported. Patient was not aware of any allergies. Other vaccine in four weeks was reported as no. Prior vaccination and post vaccination patient was not tested for covid. Patient reported as soon as vaccine was administered (25Feb2021 at 14:00) the technician said that he saw a lump on my arm. He said my body reacted to the vaccine very quickly. Noticed when he got home that there was a pea sized blister filled with fluid near the injection site. It had been 5 days and the blister was still on arm. The patient was concerned that he had not received the full dose of this vaccine. The patient could not find any other documentation of this being a side affect. The patient was not treated for the events. The events did not result in emergency room/ physician office visit. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Paraesthesia, Spinal pain
Clinical narrative: Had tingling in back of head/felt tingling in right bicep; felt shooting pain in left knee replacement; weakness; felt pain in C5 cervical area; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:45 (at the age of 67 years) as dose 1, single for covid-19 immunisation.Medical history included ehlers-danlos syndrome, arthritis, osteoarthritis, Morphine, Prednisone, Cephalexin, Keflex, Cortisone, Sulfa drug hypersensitivity. Concomitant medications included lisinopril, paracetamol (TYLENOL), celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 02Mar2021 15:30 patient experienced tingling in back of head immediately, felt tingling in right bicep where patient had a large rotator tear, felt shooting pain in left knee replacement- felt pain in C5 cervical area- everywhere patient currently having issues patient felt immediate tingling and/or pain. Patient had an Autoimmune disease -Ehlers Danlos and the doctor said patient could get the vaccine with no problem. Once patient left the clinic, stopped at grocery store and felt weakness in lower back and legs but just kept moving. Patient stated It's been 3 hours and having lots of joint pain already. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling hand and face.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiry date were not reported) via unspecified route of administration, administered in left arm on 26Feb2021 15:15 (at age of 42-year-old) as single dose, for COVID-19 immunization. Patient medical history includes high blood pressure and known allergies to Phenagen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient concomitant medications include Lisinopril. The patient's past drug event included "Phenagen" and experienced allergies. On 26Feb2021 15:45 (30 mins after vaccination), patient experienced tingling hand and face. Patient did not receive any treatment for event. The outcome of event was resolved, on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Breast pain, Insomnia, Mobility decreased
Clinical narrative: pain traveled below underarm into right breast, still remaining in right back; pain traveled below underarm into right breast, still remaining in right back; totally incapacitated; felt like there was a foot embedded in the right back/pain was excruciating; difficult to find a position to sleep; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left upper arm, on 27Feb2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, diabetes, high blood pressure, thyroid, pregnancy from 1985 to 1986 (last menstrual period (LMP) reported as 21Aug1985), sulfa allergy, and angiotensin-converting enzyme (ACE) inhibitor allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tofacitinib citrate (XELJANZ), metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and imipramine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced felt like there was a foot embedded in the right back/pain was excruciating and difficult to find a position to sleep on 28Feb2021 at 22:00 and pain traveled below underarm into right breast, still remaining in right back and totally incapacitated on 01Mar2021. The clinical course was reported as follows: The patient woke up the next morning after vaccination feeling like there was a foot embedded in her right back and the pain was excruciating to the point that she was moaning out in pain. The patient reached out to her primary care physician, who told her to give it 36 hours. That same night, the patient found it difficult to find a position to sleep and ended up on her left side. When she woke up the following morning, the pain had traveled below the underarm into her right breast, along with still remaining in the right back. She was still in excruciating pain and totally incapacitated. She stated she could not imagine experiencing this same reaction from a second dose. The patient did not receive any treatment as a result of the events. The clinical outcome of felt like there was a foot embedded in the right back/pain was excruciating, difficult to find a position to sleep, pain traveled below underarm into right breast, still remaining in right back, and totally incapacitated was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in left arm on 28Jan2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (Lot number: Not reported) in left arm on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced some kind of tingling in left arm and on the side of left breast and that the sensation is sensitive, tender, and tingly on an unknown date after second dose of vaccine. It was reported patient wanted to know if this is a commonly reported AE, and how long it would last since it's been ongoing for 5 weeks since her 2nd dose. Also, the patient read about abnormal mammograms and swollen lymph nodes that have been a result of vaccination, and her symptoms seem to be where her lymph nodes are, but she does not report any swelling in the area. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: patient noticed that her tongue and mouth were tingling; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received first dose of BNT162B2 (Pfizer- BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 01Mar2021 (Monday), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, Wednesday evening the patient noticed that her tongue and mouth were tingling. She denied any swelling in her mouth and tongue. She had not spoken with her HCP yet. She wants to know if this is a known side effect of the Pfizer COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: After my 2nd shot I had tingling in my thumb; This is a spontaneous report from a contactable consumer (reporting herself). This 43-Year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration in right arm on 03Feb2021 at 10:00 (age at the time of vaccination was 43 years old) as single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had unspecified allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks of COVID vaccination. The patient did not experience COVID-19 prior to vaccination. The patient received other unspecified medication in two weeks of vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL0142), via an unspecified route of administration in right arm on 13Jan2021 at 10:00 as single dose for COVID-19 immunization. On 03Feb2021 at 10:00, After the second shot, the patient had tingling in her thumb and on her first two fingers (like finger fell asleep) and had very little feeling. This was lasted about for 2 and half hours. The patient did not received any treatment for the event. On 26Feb2021, the patient tested negative for COVID test. On 04Mar2021, the patient again tested for COVID and the result was pending. The outcome of the event was resolved.  No follow-ups are possible. No further information is required.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: tingling/slight numbness on tongue and roof of inside of mouth; tingling/slight numbness on tongue and roof of inside of mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6205 and expiration date was not reported), dose 1 via intramuscular route on 04Mar2021 at 10:45 (at the age of 59-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. Concomitant medications (other medications in two weeks) included rosuvastatin calcium (CRESTOR) and acetylsalicylic acid (BABY ASPIRIN); loratadine (CLARITIN) and fluticasone propionate (FLONASE), both taken for allergies; Airborne Imun system suppl, and Multi Vitamin Suppl. The patient previously took Shringx dose 1 on 04Feb2021 (other vaccine in four weeks) for unspecified indication. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. On 04Mar2021 at 17:00, the patient experienced tingling/slight numbness on tongue and roof of inside of mouth. The clinical course of the event was reported as: tingling/slight numbness on tongue and roof of inside of mouth; symptoms started approximately 7hours after getting Pfizer COVID vaccine for 1st dose. Then gradually decreased into next day with slight symptoms still present 30hours after 1st dose. The patient did not lose taste. He inquired had anyone else reported this symptom and was this something he should be concerned about. The patient did not receive treatment for reported events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt tired; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 16:00 as (At the age of 76-years) DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal, patient Was on blood pressure medication for many years. After losing 20 pounds did not need it anymore, blood cholesterol abnormal from an unknown date and unknown if ongoing Take Crestor 10 mg for cholesterol (total around160). Patient had no Known allergies except latex band aids. Concomitant medication included vitamin d3 and rosuvastatin calcium (CRESTOR). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and post vaccination. It was reported that After the first shot patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired. As treatment patient received Benicar 40 mg and Lorazapam.5 mg, Zicam. The patient underwent lab tests and procedures which included blood pressure measurement: rise on Feb2021 slight rise in blood pressure and pulse, heart rate: rise on Feb2021 slight rise in blood pressure and pulse. On an unspecified date in 2021, the events was resolved with sequelae.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Cough, Dyspnoea
Clinical narrative: shortness of breath; tightness in throat; sore throat; chills; cough; fatigue; runny nose; chest congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EZ9262, via an unspecified route of administration, in arm left on 06Feb2021 at 09:30 (at 72-years age), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 1284, 72-years-old at the time of vaccination), via an unspecified route of administration, in arm left on 16Jan2021 as single for covid-19 immunisation and experienced redness and swelling at injection site no other side effects. On 07Feb2021 the patient underwent blood test, chest X-RAY and electrocardiogram which resulted normal. On 07Feb2021, the patient experienced shortness of breath, tightness in throat, sore throat, chills, cough, fatigue, runny nose. Adverse events required visit to emergency room. On an unknown date in Feb2021 she experienced chest congestion. Patient took cough medicine for mucus and chest congestion vicks on chest and heat pad and did not receive any treatment for all other events. Outcome was unknown for chest congestion and was resolved with sequel on 09Feb2021 for all other events.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Lower respiratory tract congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: shortness of breath; tightness in throat; sore throat; chills; cough; fatigue; runny nose; chest congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EZ9262, via an unspecified route of administration, in arm left on 06Feb2021 at 09:30 (at 72-years age), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 1284, 72-years-old at the time of vaccination), via an unspecified route of administration, in arm left on 16Jan2021 as single for covid-19 immunisation and experienced redness and swelling at injection site no other side effects. On 07Feb2021 the patient underwent blood test, chest X-RAY and electrocardiogram which resulted normal. On 07Feb2021, the patient experienced shortness of breath, tightness in throat, sore throat, chills, cough, fatigue, runny nose. Adverse events required visit to emergency room. On an unknown date in Feb2021 she experienced chest congestion. Patient took cough medicine for mucus and chest congestion vicks on chest and heat pad and did not receive any treatment for all other events. Outcome was unknown for chest congestion and was resolved with sequel on 09Feb2021 for all other events.  No follow-up attempts are possible. No further information is expected.