chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Pain, Pyrexia, Swelling face
Clinical narrative: had numbness in both hands for 2 days; had a lighter weight facial fillers that swelled and were painful (around the eyes but not on the lip fillers); had a lighter weight facial fillers that swelled and were painful (around the eyes but not on the lip fillers); fever; This is a spontaneous report from a non-contactable consumer or other non-hcp. A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, following the second dose, the patient had numbness in both hands for 2 days and on day 2, the patient had fever. On an unspecified date, the patient had a lighter weight facial filler that swelled and were painful (around the eyes but not on the lip fillers). The eyes had a mix of JUVEDERM products which spontaneously resolved after 1 day with a subjective loss in overall volume. The outcome of the events hypoaesthesia, pyrexia, swelling face, pain was unknown. No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Restless legs syndrome, Tinnitus
Clinical narrative: Ringing in ears; Restless leg syndrome on right side; Joint discomfort; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: enp6955) via an unspecified route of administration in the right arm on 31Mar2021 at 16:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included pudendal neuralgia. The patient had no known allergies to food, medications or other products. Concomitant medications included pain medications (unspecified) for an unknown indication started from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 66-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 01Apr2021 the patient experienced ringing in ears, restless leg syndrome on right side and joint discomfort. It was unknown whether therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears, restless leg syndrome on right side and joint discomfort was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smell Smokey car fumes most of the time. It does come and go but more at the moment.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD), COVID-19 and latex allergy. Concomitant medications were not reported. The patient previously took famotidine (MANUFACTURER UNKNOWN) and dexamethasone (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. 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. On 08Apr2021 at 16:30, the patient "smelled smokey car fumes most of the time. It did come and go but more at the moment. Began a few hours after injection". 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 event. The clinical outcome of the event "smelled smokey car fumes most of the time" was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Pain in extremity
Clinical narrative: I felt fatigue a couple of hours after receiving the shot; approximately 7 hours after receiving the shot, my arm started getting sore; I also experienced some pain in my neck; I also experienced some pain in my neck and left leg - on a scale of 1-10 the pain was about a 2, so nothing serious; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 11:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies to medications, food or other products. 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. On 12Apr2021 at 15:00, a couple of hours after receiving the shot, the patient experienced fatigue and approximately 7 hours after receiving the shot, her arm started getting sore. She also experienced some pain in her neck and left leg. It was reported by the patient that on a scale of 1 to 10 the pain was about a 2, so there was nothing serious. 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. The clinical outcome of the events fatigue started couple of hours after receiving the shot, arm started getting sore, pain in her neck and left leg were all recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Extreme swelling in the armpit lymph node; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8729) via an unspecified route of administration in the left arm on 10Apr2021 at 14:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced extreme swelling in the armpit lymph node. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with unspecified pain medication and warm compress to try and reduce swelling but there had been little to no change. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme swelling in the armpit lymph node was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Numbness in left arm and neck; Vice grip feeling around heart; Injection site pain; Headache; Nausea; Muscle pain; Extreme tiredness; 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: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included spondylolisthesis. The patient had allergies to medications (not specified). Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) both for unknown indications from an unknown date and unknown if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 10:15, the patient experienced injection site pain, headache, nausea, vice grip feeling around heart, numbness in left arm and neck, muscle pain and extreme tiredness. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site pain, headache, nausea, vice grip feeling around heart, numbness in left arm and neck, muscle pain and extreme tiredness was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Numbness in left arm and neck; Vice grip feeling around heart; Injection site pain; Headache; Nausea; Muscle pain; Extreme tiredness; 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: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included spondylolisthesis. The patient had allergies to medications (not specified). Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) both for unknown indications from an unknown date and unknown if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 10:15, the patient experienced injection site pain, headache, nausea, vice grip feeling around heart, numbness in left arm and neck, muscle pain and extreme tiredness. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site pain, headache, nausea, vice grip feeling around heart, numbness in left arm and neck, muscle pain and extreme tiredness was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: high fever of 101.3; felt very exhausted; chills; muscle pain; joint pain; This is a spontaneous report from Pfizer program from a contactable consumer reported for a male patient. A male patient of an unspecified age received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Verbatim and Event Description: The caller, said that she received her first dose of the Moderna vaccine 2 days ago. The caller was calling in for her husband who received his Pfizer Covid-19 Vaccine. The caller said that her husband experienced a high fever of 101.3, felt very exhausted, chills, muscle, and joint pain on an unspecified date. Medical Information (Were any medical questions addressed by this program forwarded/referred to Medical Information) was yes. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: I had pain radiate down the back of my left leg. It started at my buttocks and ran down into my foot, then quit.; Fifteen minutes after my shot, on the arm of the injection, I developed numbness in two of my fingers on my right hand.; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN5318) via an unspecified route of administration in the arm right on 26Mar2021 at 08:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, hypothyroidism, ovarian cancer stage III survivor, penicillin allergy and sulfonamide allergy. Concomitant medications included lisinopril dihydrate (LISINOPRIL) and levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date. The patient previously received epinephrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 COVID-19 vaccine. On 26Mar2021 at 9:00 fifteen minutes after the shot on the arm of the injection, the patient developed numbness in two fingers of right hand. The numbness lasted six hours. Also, an hour after the shot at 09:45, the patient had pain radiating down the back of left leg that started at buttocks and ran down into foot, then quit. The events 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 events. The clinical outcome of the events numbness in two of fingers on right hand, pain radiate down the back of left leg and pain started at buttocks and ran down into foot then quit was recovered on 26Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Headache, Heart rate irregular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9267), at the age of 78, via an unspecified route of administration, right arm, on Feb 22, 2021, at 13:15, single dose, for COVID-19 immunisation. Medical history included glaucoma from an unknown date. The patient allergic to latex and shrimp; all from an unknown date. Concomitant medications included warfarin, metoprolol and Crestor (rosuvastatin calcium); all for an unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9265), at the age of 78, via an unspecified route of administration in the right arm on Feb 1, 2021, at 13:15, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 08:00, patient experienced bad stomach cramps for one day, irregular heart beat for 3 days; then severe headache for the next 4 days; and a sore right shoulder the entire time. 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 bad stomach cramps for one day recovered on Apr 7, 2021; irregular heart beat for 3 days recovered on Apr 9, 2021; severe headache for the next 4 days recovered on Apr 10, 2021; and a sore right shoulder entire time recovered on an unknown date in Apr 2021. No follow-up attempts needed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Left arm pain from wrist through shoulder to upper left side of back.; Left arm pain from wrist through shoulder to upper left side of back.; Swollen & painful lymph nodes under left arm towards left breast and left side below arm; Swollen & painful lymph nodes under left arm towards left breast and left side below arm; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021, as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole (ESOMEPRAZOLE) and ibuprofen (MANUFACTURER UNKNOWN); all taken for unknown indications since anunknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed not with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 20Mar2021 as a single dose for COVID-19 immunisation. On 11Apr2021 at 19:00,  the patient reported that she felt pain in the left arm from wrist through shoulder to upper left side of back and swollen & painful lymph nodes under left arm towards her left breast and left side below her arm. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event left arm pain from wrist through shoulder to upper left side of back, swollen lymph nodes and painful lymph nodes under the left arm were not recovered at the time of this report.  No follow-up attempts are possible; No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: I have the sensation that I am leaning forward and I feel like I have to hold my balance backwards in order to stand up straight; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, neuropathy, borderline diabetes and asthma. The patient did not receive any concomitant medications. The patient previously took clindamycin (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 09:00, the patient experienced sensation that she was leaning forward and she felt like she had to hold her balance backwards in order to stand up straight (balance difficulty). No therapeutic measures were taken as a result of the reported events. The clinical outcome of balance difficulty was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue
Clinical narrative: Fatigue; diarrhea; weakness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 at 18:00(at the age of 19-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 12Apr2021 at 13:00, the patient experienced fatigue, diarrhea and weakness. The events 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 events. The clinical outcome of the events fatigue, diarrhea and weakness were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Confusional state, Feeling abnormal, Headache
Clinical narrative: Rapid heart beat; weakness; headache; burning sensation in arm; redness at vaccination site; confusion; brain fog; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient had known allergies which included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. 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 12Apr2021 at 14:00, the patient experienced rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vaccination site erythema
Clinical narrative: Rapid heart beat; weakness; headache; burning sensation in arm; redness at vaccination site; confusion; brain fog; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient had known allergies which included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. 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 12Apr2021 at 14:00, the patient experienced rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasopharyngitis, Paraesthesia
Clinical narrative: Fingers on left hand numb; Cold; Tingling; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 13:45 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), narcolepsy, aneurysm cerebral, penicillin allergy and COVID-19; all from unknown dates. Concomitant medication were not reported. The patient previously received gentamicin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. 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 13Apr2021 at 07:00, the patient woke up morning after with fingers on left hand numb, tingling and cold. It was unknown if the patient received any therapeutic measures for the reported events. 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 events fingers on left hand numb, tingling and cold were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: A red, itchy, slightly raised rash allover legs and torso; A red, itchy, slightly raised rash allover legs and torso; slightly raised rash all over my legs and torso; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in right arm on 01Apr2021 at 12:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included ADHD, female pattern baldness (hair loss), and obesity. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), minoxidil (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), melatonin (MELATOL), and vitamins nos (MULTIVITAMIN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced a red, itchy, slightly raised rash all over legs and torso, that became worse when scratched or overheat. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 06Apr2021, the patient underwent COVID-19 virus test  (Nasal Swab) and the result was negative. On 13Apr2021, the patient underwent COVID-19 virus test (Nasal Swab) and the result was pending. The clinical outcome of the events red, itchy, slightly raised rash all over legs and torso, that became worse when scratched or overheat was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore upper arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to any medications, food or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 20:00, the patient experienced sore upper arm at injection site. 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 event. The clinical outcome of the event sore upper arm at injection site was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: raise swelling at injection sight.; Swelling traveled from collarbone -shoulder - down arm into the hand; Jabbing pain/throbbing pain; tingling of hand; numbness of hand; Red at injection sight.; This is a spontaneous report from a non-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: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had unspecified allergies to medications, food, or other products. 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 patient did not receive any concomitant medication within two weeks of vaccination. On 19Mar2021, the patient experienced red raise swelling at injection sight, swelling traveled from collarbone -shoulder - down arm into the hand, jabbing pain/throbbing pain, tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included chiropractic visits for nerve damage. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red raise swelling at injection sight, swelling traveled from collarbone -shoulder - down arm into the hand, jabbing pain/throbbing pain, tingling and numbness was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: raise swelling at injection sight.; Swelling traveled from collarbone -shoulder - down arm into the hand; Jabbing pain/throbbing pain; tingling of hand; numbness of hand; Red at injection sight.; This is a spontaneous report from a non-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: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had unspecified allergies to medications, food, or other products. 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 patient did not receive any concomitant medication within two weeks of vaccination. On 19Mar2021, the patient experienced red raise swelling at injection sight, swelling traveled from collarbone -shoulder - down arm into the hand, jabbing pain/throbbing pain, tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included chiropractic visits for nerve damage. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red raise swelling at injection sight, swelling traveled from collarbone -shoulder - down arm into the hand, jabbing pain/throbbing pain, tingling and numbness was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea,; headache; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 12Apr2021 at 17:00(at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not received within two weeks of the COVID vaccine. The patient previously took  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955) via an unspecified route of administration in the right arm on 22Mar2021 at 17:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After the second dose on 13Apr2021 at 09:00 the patient experienced nausea and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events.  The clinical outcome of the events nausea and headache was recovering, at this time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; 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: UNKNOWN) via an unspecified route of administration in the right  arm on 12Apr2021 at 16:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. 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 12Apr2021 at 22:00 the patient experienced tinnitus. The events 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 adverse  event. The clinical outcome of the event tinnitus was recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received medication (UNSPECIFIED) within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. 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 08Apr2021 the patient experienced arm soreness. No therapeutic measures were taken as a result of the reported event.  The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm soreness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: nausea on and off.; nausea on and off.; Sore arm; Fatigue; Headache; Muscle soreness entire body; Metal taste in mouth immediately after injection still have it four days later.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 at 08:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 12.00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient previously took erythromycin (MANUFACTURER UNKNOWN), prochlorperazine maleate (COMPAZINE) and DEMERIT; all on unknown dates for unspecified indications and experienced drug allergy. 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 10Apr2021 at 08:00, the patient experienced metal taste in mouth immediately after injection still had it four days later. On 10Apr2021 at 12:00, the patient experienced normal side effects sore arm, fatigue, headache, muscle soreness entire body and nausea on and off. 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 metal taste in mouth immediately after injection still have it four days later, normal side effects sore arm, fatigue, headache, muscle soreness entire body and nausea on and off were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: nausea on and off.; nausea on and off.; Sore arm; Fatigue; Headache; Muscle soreness entire body; Metal taste in mouth immediately after injection still have it four days later.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 at 08:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 12.00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient previously took erythromycin (MANUFACTURER UNKNOWN), prochlorperazine maleate (COMPAZINE) and DEMERIT; all on unknown dates for unspecified indications and experienced drug allergy. 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 10Apr2021 at 08:00, the patient experienced metal taste in mouth immediately after injection still had it four days later. On 10Apr2021 at 12:00, the patient experienced normal side effects sore arm, fatigue, headache, muscle soreness entire body and nausea on and off. 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 metal taste in mouth immediately after injection still have it four days later, normal side effects sore arm, fatigue, headache, muscle soreness entire body and nausea on and off were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Headache; fever; joint pain; This is a spontaneous report received from contactable consumer via Pfizer sponsor program. A 46-year-old female patient received bnt162b2 (COVID-19 Vaccine, Solution for injection), via an unspecified route of administration in Sep2020 (at the age of 46-year-old) at dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that after receiving what would eventually be revealed as the actual vaccine during a clinical trial that started Sep2020, she experienced fever, joint pain, body aches, and headache. Patient reported that, "when I started getting my first shot, I had a systemic reaction- fever, joint pain. My body wasn't feeling great. I had done research, so I knew it could happen. It wasn't great to have a fever, it's one thing to learn about it (ahead of time), another thing to experience in your body." "When we got unblinded. I was not quite as surprised. I was so happy, but I had suspicious because how I felt when I got the shots. Body aches, headaches. The mind is very powerful and the placebo effect exists, but I could not cause a fever. It was a huge relief to know that yes, I had gotten (the vaccine)." Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: could not move arm without severe pain; could not move arm without severe pain; soreness 10 days after shot; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 29Mar2021 at 13:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included hyper tension. Concomitant medications included eplerenone (MANUFACTURER UNKNOWN), minoxidil (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all for unspecified indications from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies to medications, food or other products. On 08Apr2021 at 15:00, the patient started getting soreness 10 days after shot. On 09Apr2021, on 11th day, the patient could not move arm without severe pain. The patient called doctor who said to take tylenol and use hot compresses. The patient felt much better after 4 days and had easy movement, still a little sore. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included tylenol and hot compresses. The clinical outcome of the events, soreness and could not move the arm without severe pain was recovering at the time of report. The clinical outcome of the event soreness 10 days after shot was recovered on an unknown date of Apr2021.    No follow-up attempts are needed. No further information is expected.