chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: bleeding gums; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration at left arm on 16Dec2020 at 02:00 at a single dose for COVID-19 immunization. The patient did not have covid prior vaccination, and no covid test done post vaccination. The patient has no known allergies to medications, food, or other products. The patient has no other medical history. The patient did not receive any other vaccine in four weeks. Concomitant medication included marijuana (MARIJUANA CANDY).  The patient noted bleeding gums 2 days later on 18Dec2020 at 06:30. It was not usual for her. It was just blood streaked spit with brushing teeth. The patient did not receive treatment for the reported event. The outcome of the event was unknown. The event was not considered serious.  No follow-up attempts are possible; information about lot/batch number has been requested. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling and hives at the site of injection (left arm). Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collar; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); heart palpitations; weakness; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EH9899) intramuscularly at the left arm on 16Dec2020 12:45 at a single dose for covid-19 immunisation. Medical history included migraine from an unknown date.  The patient's concomitant medications were not reported. On 16Dec2020 15:45, the patient experienced Pain, redness, swelling and hives at the site of injection (left arm). It was further reported that the pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck and left collarbone. The patient also experienced weakness, dizziness and heart palpitations on 16Dec2020 15:45. The events were reported as non-serious. The patient did not receive treatment for the reported events. Outcome of events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site urticaria, Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: Pain, redness, swelling and hives at the site of injection (left arm). Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collar; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); heart palpitations; weakness; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EH9899) intramuscularly at the left arm on 16Dec2020 12:45 at a single dose for covid-19 immunisation. Medical history included migraine from an unknown date.  The patient's concomitant medications were not reported. On 16Dec2020 15:45, the patient experienced Pain, redness, swelling and hives at the site of injection (left arm). It was further reported that the pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck and left collarbone. The patient also experienced weakness, dizziness and heart palpitations on 16Dec2020 15:45. The events were reported as non-serious. The patient did not receive treatment for the reported events. Outcome of events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pain, redness, swelling and hives at the site of injection (left arm). Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collar; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); heart palpitations; weakness; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EH9899) intramuscularly at the left arm on 16Dec2020 12:45 at a single dose for covid-19 immunisation. Medical history included migraine from an unknown date.  The patient's concomitant medications were not reported. On 16Dec2020 15:45, the patient experienced Pain, redness, swelling and hives at the site of injection (left arm). It was further reported that the pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck and left collarbone. The patient also experienced weakness, dizziness and heart palpitations on 16Dec2020 15:45. The events were reported as non-serious. The patient did not receive treatment for the reported events. Outcome of events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: injection site pain 8 hours post injection. Fever 100.1 overnight with body aches and chills, headache; injection site pain 8 hours post injection. Fever 100.1 overnight with body aches and chills, headache; injection site pain 8 hours post injection. Fever 100.1 overnight with body aches and chills, headache; injection site pain 8 hours post injection. Fever 100.1 overnight with body aches and chills, headache; injection site pain 8 hours post injection. Fever 100.1 overnight with body aches and chills, headache; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685), via an unspecified route of administration in right arm on 17Dec2020 11:00 at a single dose for immunization, administered in the hospital. Medical history included allergies to Penicillin, crustaceans. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included herbal remedies: Guanyin Pearls, Shu Gan Tang. The patient experienced injection site pain 8 hours post injection, fever of 100.1 overnight with body aches, chills and headache on 17Dec2020 07:00. The outcome of the events was recovering. The events did not caused hospitalization. Since the vaccination, the patient has not been tested for COVID-19.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm pain for 24 hours; This is a spontaneous report received from a non-contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 17Dec2020 09:00, at single dose, for COVID-19 immunization. The patient has no medical history and has no known allergy. Concomitant medication included lansoprazole. The patient experienced left arm pain for 24 hours on 17Dec2020 12:00. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The event was reported as non-serious. The outcome of the event was recovered on 18Dec2020 12:00.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: waxing and waning redness and intense itching of both palms; waxing and waning redness and intense itching of both palms; This is a spontaneous report from a  non-contactable consumer. A 63-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EH9899), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for immunization, administered in the hospital. Medical history included seasonal allergies (dust, mold, juniper pollen), allergies to erythromycin, coconut, blueberries, banana, cocoamidopropyl betaine in anything (shampoo, toothpaste, soap). The patient was not diagnosed of COVID 19 prior to vaccination. Concomitant medication included multivitamins, ergocalciferol (VIT D), ascorbic acid (VIT C), and zn [zinc] (ZN [ZINC]). On  16Dec2020 11:30, about 18 hours after injection, developed waxing and waning redness and intense itching of both palms. This lasted for about 6 hours. The patient reported that she never had this before following a vaccine. Never had this before related to any food or seasonal allergy reaction. The patient was concerned about getting the second injection of the series. The patient's BMI was 30. The patient was not tested for covid 19 after the vaccination. The outcome of the events was recovered on 16Dec2020. The events was considered non-serious. There was no treatment for the reported events.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Sore throat; nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), intramuscular on the right arm on 15Dec2020 17:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. On 15Dec2020 19:30, the patient experienced sore throat and nausea. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling mouth; This is a spontaneous report from a contactable physician.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced tingling mouth in Dec2020. The event happened during the observation period after the vaccine was administered. The reporter thinks that the patient just panicked and overreacted and doesn't think they had a reaction. The patient did go the emergency room (ER) and was discharged the same day. The outcome of tingling mouth was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: chills; low-grade temperature; dizziness; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 17Dec2020 at 07:45 (at the age of 25-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. It was unknown if prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included cetirizine hydrochloride (ZYRTEC) and progesterone;estrogens (MANUFACTURER UNKNOWN) oral contraceptives. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, low-grade temperature, and dizziness on 17Dec2020 at 08:45. The events were reported as non-serious. The events were reported to have occurred within 90 minutes of vaccination. The patient underwent lab tests and procedures, which included temperature: low-grade on 17Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, low-grade temperature, and dizziness was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular on right arm on 16Dec2020 (08:45 PM) at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, hypertension, and COVID-19. Concomitant medications were not reported. It was reported that prior vaccination, patient diagnosed with COVID-19. No known allergies. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, fever, and headache on 17Dec2020 (09:00 AM). There was no treatment received for the reported adverse events. The outcome of events was recovering. This case is reported as non-serious.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Hypoaesthesia oral
Clinical narrative: Tongue numbness and sensitive; Tongue numbness and sensitive; This is a spontaneous report from a contactable nurse (patient) and a physician. A 31-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on17Dec2020 13:30 at a single dose on right arm as COVID-19 vaccine. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. On 17Dec2020, she received the vaccine and an hour after getting it, her tongue went numb and became sensitive (tongue numbness and sensitive on 17Dec2020 14:00). Today, it was not as numb feeling but was still sensitive. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was noted as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no expiry date for the vaccine. The card she has, only has the received date: 17Dec2020 and when to return for the second dose: 07Jan2021. She had submitted a claim about the side effects experienced but it wasn't clear what would happen next. The patient inquired if someone would reach out to her and would there be a follow-up. She wanted to know what the process would be regarding reporting. The outcome of the event 'numbness of tongue' was recovering while 'sensitive tongue' was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: fever; Malaise; chills; muscle and joint aches; muscle and joint aches; extreme fatigue; nausea; headache; both arms started itching on lower arm, not at site/the face and scalp started itching; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiration date unknown), dose number 1, intramuscularly on 16Dec2020 10:00 at a single dose for COVID-19 immunisation. Medical history included Hashimotos Thyroiditis, MDD (major depressive disorder), and acne. Concomitant medications included zinc, ergocalciferol (VIT D), venlafaxine, levothyroxine sodium (SYNTHROID), and spironolactone. The patient had vaccine at 10 AM. At 11 AM, both arms started itching on lower arm, not at site; injection arm was worse than non injection arm. At 11:45, the face and scalp started itching. By noon, all symptoms had resolved. The patient did not medicate. Two days post vaccine, on 18Dec2020, the patient had all symptoms on warning sheet: fever, malaise, chills, muscle and joint aches, extreme fatigue, nausea and headache. The outcome of the event was recovered for itching and not recovered for the other events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia
Clinical narrative: fever; Malaise; chills; muscle and joint aches; muscle and joint aches; extreme fatigue; nausea; headache; both arms started itching on lower arm, not at site/the face and scalp started itching; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiration date unknown), dose number 1, intramuscularly on 16Dec2020 10:00 at a single dose for COVID-19 immunisation. Medical history included Hashimotos Thyroiditis, MDD (major depressive disorder), and acne. Concomitant medications included zinc, ergocalciferol (VIT D), venlafaxine, levothyroxine sodium (SYNTHROID), and spironolactone. The patient had vaccine at 10 AM. At 11 AM, both arms started itching on lower arm, not at site; injection arm was worse than non injection arm. At 11:45, the face and scalp started itching. By noon, all symptoms had resolved. The patient did not medicate. Two days post vaccine, on 18Dec2020, the patient had all symptoms on warning sheet: fever, malaise, chills, muscle and joint aches, extreme fatigue, nausea and headache. The outcome of the event was recovered for itching and not recovered for the other events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; I have slight fever 99.6; Muscle ache; This is a spontaneous report from a contactable healthcare professional, the patient.  A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK55730), via an unspecified route of administration on 17Dec2020 at 13:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization.  Medical history included high blood pressure, lupus, stroke, and diabetes.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN).  On 17Dec2020, soon after receiving the vaccine, the patient experienced a big headache, almost like a migraine headache; slight fever of 99.6 (no units provided), and muscle ache. The clinical outcomes of slight fever of 99.6 and muscle ache were unknown; while that of the big headache, like a migraine was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: HCP caller is complaining of a fever after vaccine got wed; Chills; felt tired; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 16Dec2020 at a single dose for Covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient called to report on the COVID vaccine, and explains that she received the vaccine on Wednesday, 16Dec2020 around 2:30pm. She received the vaccine at work. It was administered in the left upper arm. The following morning (17Dec2020) around 2am she woke up with chills and a fever that lasted all day yesterday, so she didn't go to work. She was running a fever of about 99.7-100.0 on 17Dec2020 and that was with alternating Advil and Tylenol. She felt tired and so she rested the whole day. The patient explained that she thought it would go away after a day but today she woke up at 5am with chills. She didn't take her temperature at that time but took some medication. Then on 18Dec2020 at 9am, she woke up with chills again and she still was at 100.8. She called to see how long does the fever last after the vaccine. Outcome of the events fever and chills was not recovered and for fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient developed a delayed onset rash 12 hours after getting vaccine and has no resolved in 3 days; This is a spontaneous report from a contactable pharmacist.   A female patient in their 40's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a delayed onset rash 12 hours after getting vaccine and has no resolved in 3 days. The outcome of the events was not recovered.   Information on the Batch/Lot number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: lips/mouth swelling; lips/mouth swelling; tingling sensation in throat and on tongue; tingling sensation in throat and on tongue; This is a spontaneous report from a contactable other healthcare professional (HCP, also the patient).  A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 17Dec2020 10:45 at single dose for COVID-19 immunization. The patient's medical history included asthma, hashimoto's thyroiditis, depression, anxiety, seasonal allergies, known allergies: latex, banana. Concomitant medication included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), trazodone, alprazolam (XANAX), fexofenadine hydrochloride (ALLEGRA), salbutamol (ALBUTEROL) (as needed), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), zinc, all reported as other medications in two weeks. No other vaccine in four weeks. The patient previously took codeine and experienced drug alergy (known allergies). The facility type of vaccine was hospital. No COVID prior vaccination and no COVID tested post vacccination. The patient was not pregnant at the time of vaccination. On 17Dec2020 11:00, the patient experienced "lips/mouth swelling tingling sensation in throat and on tongue". Therapeutic measures were taken as a result of "lips/mouth swelling tingling sensation in throat and on tongue" included over the counter (OTC) Benadryl. The outcome of the event "lips/mouth swelling tingling sensation in throat and on tongue" was recovered (assumed in Dec2020).  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Chest pain
Clinical narrative: pretty strong chest pain; heart pain; some kind of back pain, behind her heart; This is a spontaneous report from contactable consumer (reporting for her daughter).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 at 10:00 AM at a single dose for COVID-19 immunization.  The patient's medical history were not reported.  Concomitant medications included unspecified bipolar medications.  The patient experienced pretty strong chest pain on 18Dec2020 at 07:00 and heart pain and some kind of back pain, behind her heart in Dec2020.  The pretty strong chest pain lasted about 10 minutes and then went away.  The outcome of pretty strong chest pain was recovered on 18Dec2020 and of some kind of back pain, behind her heart and heart pain was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain
Clinical narrative: headache; achy; weak; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 14:00 at single dose on the left arm as COVID-19 vaccine. Medical history included allergies to penicillin; allergies, ITP. Concomitant medication was noted as other vaccine in four weeks reported as allergy shots on 08Dec2020 (advance ENT). The patient also had other medications in two weeks such as zinc 50mg, 5000 Vit D, venlafaxine 225, levothyroxine sodium (SYNTHROID) 100, spironolactone 100. The patient experienced headache, achy, and weak, all on 17Dec2020 21:00. Treatment was not received for the adverse events. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular from 16Dec2020 22:00 at a single dose on the left arm as COVID-19 vaccine. Medical history included ulcerative colitis. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination (no other vaccine in four weeks and no other medications in two weeks). The patient experienced pain at injection site on 16Dec2020 23:00. Treatment was not received for the adverse event. The patient had no Covid prior vaccination and did not have Covid tested post vaccination. The event was assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bifrontal headache; This is a spontaneous report from a contactable consumer and contactable physician.  A 56-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration at left arm on 17Dec2020 at 15:15 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient previously took cephalexine and experienced allergies. On 18Dec2020 at 06:00, the patient experienced bifrontal headache. The patient outcome of the event was recovered. Therapeutic measures were taken as a result of bifrontal headache and included treatment with MIDRIN.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Scratchy Throat; tongue swelling; This is a spontaneous report from a contactable consumer (patient himself). A 36-year-old male patient received bnt162b2 (BNT162B2, lot no. and expiry date were not reported), via an unspecified route of administration on 18Dec2020 05:30 at single dose for Covid-19 immunisation. The patient had no known allergies. There were no medical history and concomitant medications. No other medications the patient received within 2 weeks of vaccination. The patient experienced scratchy throat and tongue swelling on 18Dec2020 (06:00 PM). The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included Benadryl. The outcome of the events was not recovered.    Information about Lot/batch no has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Swelling at injection site; headache; slight nausea; pain at injection site; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, first dose via an unspecified route of administration on 17Dec2020 13:00, in left arm at single dose for immunization. The patient's medical history was not reported. Concomitant medication included emtricitabine, tenofovir disoproxil fumarate (TRUVADA). The patient was vaccinated in the hospital. No other vaccine was receive in four weeks. The patient experienced swelling at injection site, headache, slight nausea and pain at injection site on 17Dec2020 18:00. No treatment was given to the patient for the events. The patient had no COVID prior to vaccination and no COVID test post vaccination. The events was reported as non serious. The patient has no known allergies. The outcome of the events was recovering.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Slight headache; sore throat; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date unknown) dose number 1 via an unspecified route of administration on the left arm on 18Dec2020 11:15 for COVID-19 immunization. Medical history included polycythemia vera, high BP, and GERD (gastrooesophageal reflux disease). Concomitant medications included omeprazole, aspirin [acetylsalicylic acid], hydroxyurea, tapentadol hydrochloride (NUCYNTA), and amlodipine besilate (NORVASC). The patient experienced slight headache and sore throat on 18Dec2020 12:15. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling; sore; swollen; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 55-year-old female patient (no pregnancy) received first dose of bnt162b2, intramuscularly at site of left arm at 11:15 on 18Dec2020 at single dose for COVID-19 immunization. Medical history included atrophied kidney, high BP, high cholesterol and allergies to medications, food, or other products. Concomitant medication included atorvastatin calcium (LIPITOR) and benazepril hydrochloride (LOTENSIN). The patient experienced arm swelling, sore, and swollen at 18:00 on 18Dec2020. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Foggy feeling; headache; body aches; low grade fever; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient (no pregnancy) received bnt162b2, via an unspecified route of administration at site of right arm at 15:45 on 14Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced foggy feeling, headache, body aches and low grade fever at 12:00 on 18Dec2020. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site; mild diffuse myalgias; fatigue the following day; This is a spontaneous report from a contactable physician. This 30-year-old male physician (patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), via intramuscular on 16Dec2020 15:30 in arm left at single dose for covid-19 immunization. Medical history included exercise-induced asthma and allergies: certain types of deodorant. The patient's concomitant medications were not reported. The patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced soreness at injection site, mild diffuse myalgias and fatigue the following day on 17Dec2020 07:00. All events were reported as non-serious. Outcome of events were recovered in Dec2020. The patient received the treatment-ibuprofen for events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: Flushed red skin upper torso and face; Flushed red skin upper torso and face; This is a spontaneous report from a contactable nurse (patient herself). A 55-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 08:00 am in left arm at single dose for covid-19 immunization. Medical history included chronic migraines and allergies: shellfish. Concomitant medication included famotidine, memantine and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patent previously took pethidine hydrochloride (DEMEROL) and experienced allergies.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced flushed red skin upper torso and face on 18Dec2020 13:00 with outcome of recovering. No treatment was received for flushed red skin upper torso and face.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fever; body aches; nausea; vomiting; severe fatigue; headache; abdominal pain; site pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# Ek5730), via an unspecified route of administration on 16Dec2020 16:15 in right arm at single dose for covid-19 immunization. Medical history included asthma, hypothyroidism, hyperlipidemia, allergies: codeine and sulfa. Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medication included levothyroxine within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, body aches, nausea, vomiting, severe fatigue, headache, abdominal pain and site pain on 17Dec2020 04:00 with outcome of recovering. All events were reported as non-serious. The patient received the treatment ondansetron (ZOFRAN) for events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever; body aches; nausea; vomiting; severe fatigue; headache; abdominal pain; site pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# Ek5730), via an unspecified route of administration on 16Dec2020 16:15 in right arm at single dose for covid-19 immunization. Medical history included asthma, hypothyroidism, hyperlipidemia, allergies: codeine and sulfa. Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medication included levothyroxine within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, body aches, nausea, vomiting, severe fatigue, headache, abdominal pain and site pain on 17Dec2020 04:00 with outcome of recovering. All events were reported as non-serious. The patient received the treatment ondansetron (ZOFRAN) for events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Flushing, Hyperhidrosis, Oropharyngeal discomfort, Sensation of foreign body
Clinical narrative: sensation in throat/a menthol cough drop stuck in the throat; flushed; diaphoretic; burning into my chest; some random hives; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received first dose of bnt162b2 (lot number: EL0140), via an unspecified route of administration at site of left arm at 11:30 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included Oral Allergy Syndrome, ADHD (attention deficit hyperactivity disorder), multiple food allergies, and allergies: PCN, Ceclor and Lovenox multiple. Concomitant medication included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Within minutes after vaccination, the patient became flushed and diaphoretic followed by a sensation in her throat, it felt that she had a menthol cough drop stuck in the throat and the burning into her chest. Once the medics administered IV Benadryl, the sensation in her throat went away. She was in the emergency room for about 3 hours and had some random hives throughout the rest of the evening. She had anaphylaxis previously to avocado and to an allergy shot. This was definitely nothing close to anaphylaxis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: sensation in throat/a menthol cough drop stuck in the throat; flushed; diaphoretic; burning into my chest; some random hives; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received first dose of bnt162b2 (lot number: EL0140), via an unspecified route of administration at site of left arm at 11:30 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included Oral Allergy Syndrome, ADHD (attention deficit hyperactivity disorder), multiple food allergies, and allergies: PCN, Ceclor and Lovenox multiple. Concomitant medication included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Within minutes after vaccination, the patient became flushed and diaphoretic followed by a sensation in her throat, it felt that she had a menthol cough drop stuck in the throat and the burning into her chest. Once the medics administered IV Benadryl, the sensation in her throat went away. She was in the emergency room for about 3 hours and had some random hives throughout the rest of the evening. She had anaphylaxis previously to avocado and to an allergy shot. This was definitely nothing close to anaphylaxis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscles aches; really tired; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received bnt162b2, via an unspecified route of administration at site of right arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history included lung surgery from 2019. There were no concomitant medications. The patient experienced muscles aches, really tired on 17Dec2020. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: top of her left arm was swollen; she had pain all down the left side of her body, the whole left side; This is a spontaneous report from a contactable consumer (Patient).  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 17Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got the shot in her left arm and the top of her left arm was swollen, she had pain all down the left side of her body, the whole left side in Dec2020. The patient only took paracetamol (TYLENOL) for treatment. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine; Felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A 33-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine in 200. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort
Clinical narrative: little discomfort felt in the deltoid from the shot; This is a spontaneous report from a non-contactable consumer (patient, Pfizer employee). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date in 2020 at a single dose in deltoid for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced little discomfort felt in the deltoid from the shot on an unspecified date. The outcome of event was unknown.    No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received the first dose of 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 medications were not reported. The patient  experienced sore arm, feeling foggy, headaches but better the next day on an unspecified date with outcome of recovering.  No follow-up attempts are possible ; information about lot/Batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Metabolic function test normal
Clinical narrative: Severe dizziness; This is a spontaneous report from a contactable Physician reporting for herself.  A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced severe dizziness on 18Dec2020 with outcome of recovering. No treatment was performed. The patient underwent CMP test on 07Dec2020 and it was normal.