chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Neuralgic amyotrophy, Pain, Paraesthesia, Winged scapula
Clinical narrative: Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; tingling/numbness throughout her left hand and some in forearm; tingling/numbness throughout her left hand and some in forearm; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Intermittent discomfort in forearm; winging of her left scapula; weakness of serrates anterior; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration in the right arm on 06Jan2021 07:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, raynaud's symptom, orthopedic surgeries. Concomitant medication included levothyroxine (unknown manufacturer). The patient previously took aspirin and gabapentin and experienced drug hypersensitivity. On 18Jan2021 13:00 the patient experienced tingling/numbness throughout her left hand and some in forearm, sudden onset of pretty severe diffuse pain 1.5-2 days later (Jan2021) in left shoulder, axilla, anterior chest wall, persistent and consistent significant pain that does not change with position, ROM, or much with palpation, intermittent discomfort in forearm, evolving into the progressive weakness phase with significant winging of her left scapula and weakness of serrates anterior. Events resulted in emergency room visit and physician office visit. The events were evaluated by an MD who has given the patient a tentative diagnosis of Neuralgic Amyotrophy. Seeing a neurologist on 02Jan2021. The outcome of the events was not recovered. The patient received mediation to manage pain. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Dizziness, Pyrexia
Clinical narrative: Dizzy; Loss of smell and some taste; Loss of smell and some taste; Fever at 101.4 Fahrenheit; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El9262) at single dose, in the left arm, on 20Jan2021 at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was none. No allergies to medications, food, or other products were reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (ZUBSOLV) from an unspecified date (within 2 weeks of vaccination), for an unknown indication. On 23Jan2021, at 03:00 PM, the patient experienced dizzy, loss of smell and some taste and fever at 101.4 Fahrenheit. Treatment was required (unspecified). Physician Office Visit required. Clinical outcome of the events was recovering at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Receive a cortisone shot on his wrist for his inflammation; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called in because he received his first shot of the vaccine last 21Jan2021 and about to receive his second shot on 11Feb2021. He was asking if it's okay to receive a cortisone shot on his wrist for his inflammation before taking the second shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Pain
Clinical narrative: felt sore, hot and cold along with fatigue; felt sore, hot and cold along with fatigue; felt sore, hot and cold along with fatigue; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose  for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient  felt sore, hot and cold along with fatigue on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Cough, Dyspnoea
Clinical narrative: Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital.  Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital.  Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: having some arm soreness at the injection site after getting the vaccine; This is a spontaneous report from a consumer (patient). An 84-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient experienced arm soreness at the injection site after getting the vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Slight fever (99.4); Fatigue; Aches; shoulder where shot was administered ached; This is a spontaneous report from a contactable consumer reported for himself.   A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route at left arm on 26Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included Covid-19 infection. Since the vaccination the patient has not been tested for COVID-19. Concomitant medications were not reported. On 26Jan2021 at 20:00 the patient experienced slight fever (99.4),fFatigue, ache and shoulder where shot was administered ached. The outcome of the events was recovered on unknown date. The patient did not receive any treatment.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient).  This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 26Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included arthritis, blood pressure and allergies. Relevant concomitant medications included atorvastatin, furosemide and metoprolol. On 27Jan2021, the patient woke up in the morning the room was spinning and she was so dizzy she couldn't even get up. She remained dizzy for quite a while - she was not sure if she should receive the next dose. She also had nausea. The patient was not treated for the events. Pre and post vaccination COVID tests were not performed. The patient had recovered from the events on unknown date in 2021.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: I had continuous headaches pain scale 5 and SOB where Ive needed to use an inhaler.; I had continuous headaches pain scale 5 and SOB where Ive needed to use an inhaler.; This is a spontaneous report from a contactable  other HCP reporting for herself.    A 45-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine  , intramuscular in the left arm on 11Jan2021 15:30 at SINGLE DOSE for covid-19 immunisation .  Medical history included thyroid disorder and  rubber sensitivity (Allergy: Latex).  The patient  had continuous headaches pain scale 5 and Shortness of Breath (SOB) on 12Jan2021 12:00 with outcome of recovered with sequelae. The patient received Tylenol  and an inhaler as treatment of the events.  Lot number information have been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rotator cuff syndrome
Clinical narrative: rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; This is a spontaneous report from a contactable consumer reported for herself.   A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL8982 via intramuscular route at right deltoid on 26Jan2021 16:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. On unknown date the patient experienced rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain as recommended by her HCP. The patient was unable to remember if she took an Aleve before or after she received the vaccine. She would like to know if this will interact with the vaccine. The outcome of the events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm; This is a spontaneous report from a contactable consumer (patient) A 46-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL8982, in Hospital, via an unspecified route of administration in right arm, on 18Jan2021 (at 46 years of age) at single dose for COVID-19 immunization. Medical history included seasonal allergy (pollen) and allergy to cats, both from an unknown date. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included Vitamin D3 and Multi vitamins. On 27Jan2021 the patient experienced swollen lymph node under left arm. No treatment was administered for the event. The patient was recovering from the reported event at the time of the report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore muscles in left arm where injected; This is a spontaneous report from a contactable consumer. A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiration date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (METFORMIN), spironolactone (SPIRONOLACTONE), ethinylestradiol, norethisterone acetate (JUNEL), and escitalopram (ESCITALOPRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscles in left arm where injected on 26Jan2021 at 19:00. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the event. The event resolved on an unknown date in Jan2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphonia, Fatigue, Feeling abnormal, Headache
Clinical narrative: sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient).   This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oropharyngeal pain
Clinical narrative: sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient).   This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: friend came down with COVID; friend came down with COVID; This is a spontaneous report from a contactable consumer (reporting for friend). A 86-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date not reported) (at the age of 86-years-old), via an unspecified route of administration on 14Jan2021 as a single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that on 21Jan2021 she "came down with COVID."  The clinical outcome of the events COVID was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and information about lot/batch number cannot be obtained. .No follow up attempts are possible.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in upper and lower extremities/bilateral upper and lower extremity changes, strength and dexterity changes; numbness and tingling in upper and lower extremities; dexterity issues/bilateral upper and lower extremity changes, strength and dexterity changes; intermittent dull occipital headaches; This is a spontaneous report from a contactable Nurse (patient)  This 36-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose for covid-19 immunization .The patient medical history was not reported.  The patient's concomitant medications were not reported.  She received the first dose of the Pfizer vaccine on 7th Jan and after 2 weeks, she started experiencing numbness and tingling in upper and lower extremities and dexterity issues, caller stated its progressive issue to the point that its interfering with her daily actives.On 21Jan she recognized bilateral upper and lower extremity changes, strength and dexterity changes, intermittent dull occipital headaches. She Wanted to know if those symptoms are in line for reported symptoms with part one. Is scheduled for her second one today and was unable to get appointment with her doctor until tomorrow. Stated that she has reservations about having the second one.The events were reported as non serious.Outcome of the event was unkown
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got a positive covid result; got a positive covid result; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported on the 17th or 18th she was sick and got a positive covid result on Jan2021. The patient underwent lab tests and procedures which included covid: positive on Jan2021. The event outcome was unknown.  Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site indentation
Clinical narrative: Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Peripheral swelling, Vaccination site pain
Clinical narrative: Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: mouth pain; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization.  The patient medical history included root canal procedure on 27Jan2021.  The patient's concomitant medications were not reported.  The patient experienced mouth pain on an unspecified date. Therapeutic measures were taken as a result of mouth pain and included treatment with ibuprofen 800 mg. The patient outcome of the event was unknown.  The information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose, Wrong technique in product usage process
Clinical narrative: Some of the vaccine leaked out of my arm/solution trickled down the arm with blood; Some of the vaccine leaked out of my arm/solution trickled down the arm with blood; shot me with the same needle twice/nurse reinserted the same needle to administer the rest of the dose; She concerned she didn't have enough of the medicine her; This is a spontaneous report from a contactable consumer.   A 66-years-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL9263 on 28Jan2021 12:30 at SINGLE  DOSE for covid-19 immunization.The patient received the first Covid-19 vaccine on 07Jan2021 (lot number for first dose as EL3646) and her arm got stiff, had a little nausea and a little headache. Didn't get sick to her stomach, but she ate a lot.The patient reported that when she get her second dose some of the vaccine leaked out of her arm/solution trickled down the arm with blood ; she felt like it didn't go in properly ;She shot me with the same needle twice to administer the rest of the dose.She concerned she didn't have enough of the medicine her.Outcome of the event was not recovered. .
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This is a spontaneous report from a contactable Nurse (patient's herself).  This female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route, on 11Jan2021 at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jan2021, the patient developed bladder infection. She was taking nitrofurantoin (MACRODANTIN) 100 mg twice a day (once in the morning, and once at bedtime) from last Sunday (24Jan2021) for bladder infection. The patient was scheduled to receive the second dose on 01Feb2021, and she wanted to know if it will interfere with the second dose of the vaccine. The outcome of the event was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling on the left side of her face below her eye and lower half of her face/facial tingling on the left side of her face; This is a spontaneous report from a contactable Consumer (patient) A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose in her left arm for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 28Jan2021 patient noticed facial tingling on the left side of her face below her eye and lower half of her face. The final outcome of the event was unknown.Patient would like to know if her symptoms were normal and would like to know what she should do about her symptoms. She wanted to know if she should be worried about that and if it was a known side effect. information on the batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness
Clinical narrative: decrease appetite; feeling "sicky", not throwing up; This is a spontaneous report from a contactable consumer reported for her mother.   A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on unknown date in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021 the patient experienced feeling "sicky", not throwing up and decrease appetite. The outcome of the events was recovering. The patient received treatment with zofran.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: nausea; Inappetence; fatigue; headache; brief chills; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications in two weeks prior to the vaccination included atorvastatin (LIPITOR), sertraline hydrochloride (ZOLOFT), fish oil, multi-vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 27Jan2021 at 06:30PM patient experienced nausea, inappetance, fatigue, headache, brief chills. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from the events on unknown date.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever 102.5 fahrenheit/fever from 99.4 to 102.5 Fahrenheit; Headache; Chills; This is a spontaneous report from a contactable consumer (patient)  A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL9262) on 27Jan2021 at 17:00 at single dose in Right arm for COVID-19 immunization.  Medical history included migraine from 2016 (reported as from 5 years).  Concomitant medication included propranolol. Previously, on 06Jan2021 at 19:00 patient received the first dose of the vaccine (lot EL1685) at single dose  in left arm for COVID-19 immunization and he had no effects to report. On 17Dec2020 patient received Flu vaccine for immunization.On 28Jan2021 at 17:00 the patient experienced fever 102.5 Fahrenheit/ fever from 99.4 to 102.5 Fahrenheit; on 28Jan2021 he also had headache and chills. No treatment given for fever; patient has taken three 650 mg Tylenol, one every few hours, but his headache was still the same. Final outcome of all the events was reported as not recovered. Patient asked if the temperature 102.5 was normal or should go to the hospital.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: antibodies are still negative; This is a spontaneous report from patient.   A female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route, the first dose on unknown date and the second one on 20Jan2021 both at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Jan2021 the patient had a blood drawn and her antibodies were still negative. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Product use issue, Taste disorder
Clinical narrative: Weird taste; extremely tired; other_vaccine_same_date_vaccine_date=28Jan2021; other_vaccine_same_date_vaccine_date=28Jan2021; This is a spontaneous report from a contactable consumer who reported for the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:30 at single dose for COVID-19 immunisation. The patient was vaccinated at Health  facility. Age at vaccination was 79 years. On the same date (28Jan2021) the patient receive another Pfizer vaccine for immunization. It was reported the patient receive other Pfizer vaccines within 4 weeks prior to the COVID vaccine in Jan2021. On 28Jan2021 at 17:15 the patient experienced weird taste and was extremely tired. No treatment was received for the adverse events. The events had resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Contactable Nurse. This Nurse reported for a 94-year-old female patient (consumer's grandmother). A 94-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 at single dose of second dose, on 29Dec2020 at single dose of first dose for covid-19 immunisation. Medical history included dementia, hip fracture from 19Nov2020 the patient was admitted for a broken hip on 19Nov2020, on 16Jan2021, she had a fall in the rehab facility. No Prior Vaccinations (within 4 weeks). Concomitant medication included levofloxacin (LOVENOX [LEVOFLOXACIN]) to 18Jan2021 and restarted in Jan2021, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced tested positive for covid-19 on 28Jan2021. The patient was swabbed for the COVID-19 PCR test on 26Jan2021, her results came back as positive. She had a rapid COVID-19 test on 28Jan2021 that came back positive as well. The patient underwent lab tests and procedures which included chest x-ray: unknown results on 28Jan2021, COVID-19 PCR test: positive on 26Jan2021, COVID-19 Rapid Test: negative on 19Nov2020, COVID-19 Rapid Test: positive on 28Jan2021. The patient was asymptomatic. She had no fever, lungs sounded clear. The event outcome was unknown.  No follow-up attempts are possible; Information on Lot/Batch number can not be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Severe headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm on 26Jan2021 at 03:30 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 27Jan2021 patient experienced severe headache and chills. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from the events on unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Secretion discharge
Clinical narrative: Normal muscle pain; Feeling unwell a little; Has secretion of mucus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first shot of the vaccine last 16Jan2021 and her second shot of the vaccine is scheduled on 06Feb2021. She claims that after the vaccine, she is experiencing the normal muscle pain, feeling unwell a little, and has secretion of mucus. She is asking if it's okay to take the 2nd shot with these types of symptoms. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Left knee joint pain; This is a spontaneous report from a contactable consumer reported for herself. This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left arm on 27Jan2021 09:00 for Covid-19 immunisation. Medical history none. Concomitant medications were not reported. The patient experienced left knee joint pain on 28Jan2021 18:30 with outcome of not recovered. No treatment required. The vaccine was administered at clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Skin burning sensation
Clinical narrative: Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient).   A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering.  The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Lethargy, Pain
Clinical narrative: Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Contusion, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Bruise; Covid antibody test and it came back negative; some bleeding that soaked the bandage; some significant soreness and stated that the injection site is still sore if he presses on it; a very cold sensation at the injection site; felt a chill on his arm; This is a spontaneous report from a contactable Consumer(patient). A 71-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, Expiry Date: May2021), intramuscularly on 15Jan2021 at 0.3 mL, single, left arm for covid-19 vaccination. Medical history and concomitant medications reported as none. There was some/fair amount of bleeding that soaked/saturated the bandage after the shot and a bruise developed that was 3 inches around and was there for 10 days and he still had the bruise. He said that there was also a cold sensation at the injection site when it was administered and he felt a chill on his arm. He said that he was calling because he wanted to make sure the first dose was effective. He said that his 2nd dose was due next week. The bleeding resolved within the hour and soaked the band aid itself. He said that it was not persistent bleeding it was just immediately after the injection. He also had some significant soreness at the injection site and stated that the injection site was still sore if he presses on it.  He never bothered to look at his arm and stated that he noticed the bruise was there about 8 days later. It might have been there prior to that, but he did not know. He had blood work done on the 25Jan2021 and asked for a Covid antibody test and it came back negative. The patient asked should there be a positive antibody test at this point? The patient asked did this mean he didn't develop immunity? The bruise had diminished but still there. The soreness was still there. The soreness was not sore if pressure was not put on it and was never sore if he laid on it. The patient was asking if Pfizer considered the vaccine to be viable. He was not on a blood thinner. Onset date of events "some bleeding that soaked the bandage" was 15Jan2021, of bruise was unknown, "some significant soreness and stated that the injection site is still sore if he presses on it" was 15Jan2021, "a very cold sensation at the injection site" was 15Jan2021. The outcome of event "some bleeding that soaked the bandage" was recovered on 15Jan2021, of bruise and "some significant soreness and stated that the injection site is still sore if he presses on it" was recovering, of other events was unknown.