chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Chills; Congestion; Dry cough; Sour muscles; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PR8735) via an unspecified route of administration in the right arm on 27Apr2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and atorvastatin calcium (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. 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 27Apr2021 at 12:45, the patient experienced headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: Headache; Chills; Congestion; Dry cough; Sour muscles; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PR8735) via an unspecified route of administration in the right arm on 27Apr2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and atorvastatin calcium (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. 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 27Apr2021 at 12:45, the patient experienced headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Pruritus, Sleep deficit
Clinical narrative: she is miserable; she is totally depressed because of this; has gotten very little sleep because she is up all night scratching; itchy all over, on her legs, arms, trunk, neck, front side, you got it; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The caller said that she has had a miserable month and she keeps thinking that it was going to get better. She had her second Pfizer COVID vaccine, and the first dose did not give her any complications at all, it was smooth and easy. The same night that she got her second dose she started with itchy all over, on her legs, arms, trunk, neck, front side, you got it. She cannot live with it anymore. She wakes up every day thinking that it will be better. She just wants someone to know that she was miserable. She wants Pfizer to reach out to her on if they can help her or anyone else going through this miserable experience. Caller asked, how can she make it go away. So basically, she was stuck in limbo. Basically, live with it and be done. Sorry, she does not mean to sound condescending but until someone was able to walk in her shoes they would not understand. She has had this since 02Apr2021. Every day she wakes up and prays it goes away, but it has just intensified. She was sorry that she ever took this drug. She thinks she would have had a better time with COVID than with this. She said she was thankful of this agent's time, but she was totally depressed because of this and it was not this agent's fault but until you can walk in her shoes and feel what she has felt then you might would understand. She has stuck it out and stuck it out and has hoped for it to go away. She has gotten very little sleep because she was up all-night scratching. It was such a bad thing; she would not wish this on anyone. The outcome of itchy was not resolved and sleep deprivation, depressed mood, feeling miserable was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Pain, Pain in extremity
Clinical narrative: numbness from the knee down running into her ankle along with some swelling; numbness from the knee down running into her ankle along with some swelling; Severe pain; It went all up into her thigh, and your pain from her thigh went down to her ankle; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; It went all up into her thigh, and your pain from her thigh went down to her ankle; This is a spontaneous report from contactable consumer reported for a female patient (reporter's wife). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot number: EW0164, Expiration date: Unknown), via an unspecified route on 20Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021 (the next day), patient experienced numbness from the knee down running into her ankle along with some swelling and then it seems to moving upward. It went all up into her thigh, and pain from her thigh went down to her ankle, now it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet. It was a severe pain, so trying to see it's kind of in relation to her COVID- shot. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: numbness from the knee down running into her ankle along with some swelling; numbness from the knee down running into her ankle along with some swelling; Severe pain; It went all up into her thigh, and your pain from her thigh went down to her ankle; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet; It went all up into her thigh, and your pain from her thigh went down to her ankle; This is a spontaneous report from contactable consumer reported for a female patient (reporter's wife). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot number: EW0164, Expiration date: Unknown), via an unspecified route on 20Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021 (the next day), patient experienced numbness from the knee down running into her ankle along with some swelling and then it seems to moving upward. It went all up into her thigh, and pain from her thigh went down to her ankle, now it's kind of up in her hip and hip down to her ankle and she gets some swelling in her feet. It was a severe pain, so trying to see it's kind of in relation to her COVID- shot. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Pain inside the armpit (not able to locate it by touching the area); This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 28Apr2021 at 17:30 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN); all taken from unknown date for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 07Apr2021 at 17:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Apr2021 at 20:00 the patient experienced pain inside the armpit (not able to locate it by touching the area). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No therapeutic measures were taken as a result of the event. The clinical outcome of the event pain inside the armpit (not able to locate it by touching the area) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills; Body aches; Headache; Night sweats; Dizziness; Upset stomach; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, colecalciferol, cyanocobalamin, retinol palmitate, choline bitartrate, inositol, calcium pantothenate, zinc citrate, potassium iodide, dl-alpha tocopheryl acetate (VITAMINS). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration 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 vaccine within four weeks prior to the COVID-19 vaccine. On 16Apr2021 at 21:00, the patient experienced chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue were resolved on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain
Clinical narrative: Chills; Body aches; Headache; Night sweats; Dizziness; Upset stomach; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, colecalciferol, cyanocobalamin, retinol palmitate, choline bitartrate, inositol, calcium pantothenate, zinc citrate, potassium iodide, dl-alpha tocopheryl acetate (VITAMINS). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration 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 vaccine within four weeks prior to the COVID-19 vaccine. On 16Apr2021 at 21:00, the patient experienced chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue were resolved on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost sense of taste 3 hours after vaccine and it hasn't returned as of today> 4/30/21; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 16:45, 3 hours after vaccine, the patient lost sense of taste and it had not returned as of the present day, on 30Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost sense of taste was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electric shock sensation
Clinical narrative: Burning sensation intermittently on 3 occasions inside left arm; Burning sensation intermittently on 3 occasions inside left arm. It felt like an electric shock or jolt.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: En6200), via an unspecified route of administration in left arm on 23Mar2021 at 13:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. No other medications received in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 18:00, the patient experienced burning sensation intermittently on 3 occasions inside left arm and it felt like an electric shock or jolt. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The clinical outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment received), events were recovered in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heartbeat and that is what I witnessed when I was sitting and waiting for 5 to 10 minutes; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, "I was reading on the website about the Pfizer vaccine (unspecified vaccine) and I noticed that it says certain things about the fast heartbeat and that is what I witnessed when I was sitting and waiting for 5 to 10 minutes or whatever and I notice that so. I'm schedule to go for my second shot and I kind of worried about going, so with this fast heart beat I don't think I should go for the second vaccine." Onset date of the event was unknown. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymph node swelling under left armpit/breast area.  The swelling was big (size of a small breast so looked like I had 3 breasts), painful and lasted for a week.; Lymph node swelling under left armpit/breast area. The swelling was big (size of a small breast so looked like I had 3 breasts), painful and lasted for a week.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient 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 22Apr2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available. The patient had no known allergies to medications, food, or other products. The patient had received dietary supplements on an unknown date for unknown indication within two weeks of vaccination. 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 23Apr2021 at 06:00, the patient experienced lymph node swelling under left armpit/breast area. The swelling was big (size of a small breast so looked like the patient had three breasts), painful and lasted for a week. Therapeutic measures were taken as a result of pain and included treatment with Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event lymph node swelling under left armpit/breast area; the swelling was big (size of a small breast so looked like the patient had three breasts), painful and lasted for a week was resolved on an unknown date in Apr2021 .   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Fatigue, Feeding disorder, Pyrexia
Clinical narrative: High Fever; Vomiting; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; get tired; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that,  A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced Vomiting and high fever, getting weak, tired and patient couldn't eat or drink. His job was sending him notice and he was asking to get a paper to stay home because of his adverse events. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: High Fever; Vomiting; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; get tired; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that,  A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced Vomiting and high fever, getting weak, tired and patient couldn't eat or drink. His job was sending him notice and he was asking to get a paper to stay home because of his adverse events. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Swelling
Clinical narrative: had major swelling in my armpit. Hurts and is lumpy; had major swelling in my armpit. Hurts and is lumpy; had major swelling in my armpit. Hurts and is lumpy; This is a spontaneous report from a contactable other healthcare professional. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and allergy to penicillin  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced major swelling in armpit, hurts and was lumpy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event major swelling in armpit, hurts and was lumpy was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 01May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) for unknown indication on unknown date 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 right arm on 10Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced back pain. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event back pain was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Substantial loss of appetite within 2-3 days of second injection; This is a spontaneous report from a contactable consumer, the patient. A 35-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 arm left on 23Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included bupropion (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and oral contraceptive nos (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously took duloxetine hydrochloride (CYMBALTA) and cefaclor (CECLOR) on unknown dates and experienced allergy. On an unknown date in Apr2021, within 2-3 days of second injection, the patient experienced substantial loss of appetite and was present at 8 days after second injection (at the time of report). The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event substantial loss of appetite was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Had first case of shingles ever; This is a spontaneous report from a contactable nurse, the patient. A 83-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 left arm on 12Apr2021 at 12:00 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included a fib. The patient had no known allergies. Concomitant medications included zolpidem tartrate (AMBEIN) 5 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Previously patient 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 2021, as a single dose for COVID-19 immunisation. On 19Apr2021 at 07:00, the patient developed first case of shingles ever. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with Valtrex started from an unknown date.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Paraesthesia, Peripheral swelling
Clinical narrative: Tingle in hands and feet; Headache; Chills; Fatigue; Swelling in arm; Pain in arm where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 38-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 on 29Apr2021 at 18:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and avocado. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 19:00, the patient experienced tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, the patient underwent Nasal Swab and the result was negative. The clinical outcome of the events tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Tingle in hands and feet; Headache; Chills; Fatigue; Swelling in arm; Pain in arm where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 38-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 on 29Apr2021 at 18:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and avocado. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 19:00, the patient experienced tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, the patient underwent Nasal Swab and the result was negative. The clinical outcome of the events tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Muscular weakness
Clinical narrative: I felt like a numbness in my arm; numbness went to my left foot and then it went to my right foot; Feel like more weak; my left hand and then kind of the nerves in the right hand too, they just feel like numb and weak; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old female patient received bnt162b2 (Pfizer COVID 19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in upper arm on 09Apr2021 (at 25-years-old) (Batch/Lot Number: EW0153, expiration date: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patients medical history included acne from an unknown date and unknown if ongoing. Concomitant medication included minocycline 500 mg, once a day, taken for acne from an unspecified start date and ongoing. Patient stated, I was calling to report a possible side effect, so I felt like a numbness in my arm like a week after I got it the first dose (on an unknown date in Apr2021) and then the numbness went to my left foot and then it went to my right foot so it its feel like more weak lately than my left hand and then kind of the nerves in the right hand too they just feel like numb and weak. While paraphrasing the concern patient stated, the right arm, I mean the right hand and then the right foot. Scheduled date of the second shot: patient stated, I was supposed to get it today but they said I can go back in 3 weeks to get it, but I didn't get it. About event outcome, patient stated, they improved that does I don't feel as much but I have been still feeling. The patient underwent lab tests and procedures which included lab work which showed everything was clear on (laboratory Test: Consumer stated, Yes, I went to get lab work done and everything was clear) on an unspecified date. Patient did not receive any treatment for the events. Reporter seriousness for the events was unspecified. The outcome of the events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (39.7 degrees Centigrade); This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 17Apr2021 at 11:30 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 10:00, after about 18 hours after vaccination, the patient developed fever (39.7 degrees centigrade) that lasted about two days. On the second day, fever and temperature was much reduced. After two days, the fever was completely cleared. The event did not result in doctor 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (39.7 degrees centigrade) was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia
Clinical narrative: Metal taste in throat; after ate lunch tightness in stomach area about half hour after shot lingered off and on for a couple ofdays; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 23Apr2021 at 10:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 11:00 right after vaccination, the patient had metal taste in throat which went away after couple of hours and when ate lunch tightness in stomach area about half hour after shot which lingered off and on for a couple of days. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events metal taste in throat was recovered on 23Apr2021 and tightness in stomach area about half hour after shot which lingered off and on for a couple of days was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected. .
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: High fever; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on an unknown date (at the age of 28-year-old) as a dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on an unknown date (at the age of 28-year-old) as a dose 1, single 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 have COVID-19 test. On an unknown date, the patient experienced high fever and chills, on and off for 20 hours 10 hours after receiving the vaccine. Lab data included body temperature of result high fever on an unknown date. The clinical outcome of the event high fever and chills was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient initial added in first name field.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Headache; restlessness; nausea; brain fog; sore throat; malaise; felt much like the early stages of a cold; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient 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 30Apr2021 at 16:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, irritable bowel syndrome, polycystic ovarian syndrome, adenomyosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ondansetron (ZOFRAN), promethazine (MANUFACTURER UNKNOWN), bismuth subsalicylate (PEPTO-BISMOL), paracetamol (TYLENOL) and ibuprofen (ADVIL); all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness, mainly recovered after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness was resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Restlessness, Vaccination site pain
Clinical narrative: Headache; restlessness; nausea; brain fog; sore throat; malaise; felt much like the early stages of a cold; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient 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 30Apr2021 at 16:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, irritable bowel syndrome, polycystic ovarian syndrome, adenomyosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ondansetron (ZOFRAN), promethazine (MANUFACTURER UNKNOWN), bismuth subsalicylate (PEPTO-BISMOL), paracetamol (TYLENOL) and ibuprofen (ADVIL); all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness, mainly recovered after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness was resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Massive migraines lasting hours at least 3 or 4 times a week.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included dupilumab (DUPIXENT), escitalopram oxalate (LEXAPRO) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the  left arm on 19Mar2021 at 17:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 10Apr2021, the patient experienced massive migraines which lasted for hours at least 3 or 4 times a week. She used to have migraines only 2 or 3 times a year. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of massive migraines and included treatment with Sumatriptan (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event massive migraines was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin warm
Clinical narrative: left thumb pain, soreness; Left thumb warm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ewo162) via an unspecified route of administration on an unknown date in Apr2021 at 04:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE), multi vitamin (MANUFACTURE UNKNOWN) and benazepril hydrochloride (Benazepril) from an unknown date for unknown indication and unknown if ongoing. The patient previously had no known allergy. On an unknown date in 2021, the patient experienced left thumb pain, soreness and warm. The events 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left thumb pain, soreness and warm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.