chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Pain in extremity
Clinical narrative: Anxiety/mental related; Lightheaded; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955), via an unspecified route of administration in the left arm on 16Mar2021 at 02:30 PM (at the age of 23 years), as a single first dose for COVID-19 immunisation. The patient was allergic to Penicillin, Sulfa drugs, Cefalexin, walnuts and pecans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Zoloft (Sertraline) and Estarylla (Ethinyl Estradiol and Norgestimate). The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 16Mar2021 at 02:45 PM (directly following the vaccination), the patient experienced light headedness, and she thought it was mostly anxiety/mental related and not vaccine related as she was nervous; fully recovered after 10 minutes or deep breaths and drinking Gatorade. Four hours later, she experienced sore arm. Therapeutic measures taken for the adverse events was unknown. The clinical outcome of events lightheaded, anxiety/mental related, nervous were fully recovered, and sore arm was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm is sore; slight fatigue; slight fever; Body is achy all over; Headache; Bruising at the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no EL3247) dose number 1via an unspecified route of administration on the left arm on 23Feb2021 at 02:30 and second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no: EN6203) on 16Mar2021 at 02:30 (at the age of 52-year-old) via an unspecified route of administration on right arm as a single dose for COVID-19 immunisation . Medical history included thyroid disease. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Synthroid, Centrum, Magnesium, Vitamin C  since an unknown date for unknown indications and Vitamin C was taken daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 the patient experienced arm sore, bruising at the site of injection, body ache all over, slight fever, headache and slight fatigue. Therapeutic measures taken for the reported events included Advil from an unknown date. The Clinical outcome of the events arm was sore, bruising at the site of injection, body was achy all over, slight fever, headache and slight fatigue was recovering. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Arm is sore; slight fatigue; slight fever; Body is achy all over; Headache; Bruising at the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no EL3247) dose number 1via an unspecified route of administration on the left arm on 23Feb2021 at 02:30 and second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no: EN6203) on 16Mar2021 at 02:30 (at the age of 52-year-old) via an unspecified route of administration on right arm as a single dose for COVID-19 immunisation . Medical history included thyroid disease. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Synthroid, Centrum, Magnesium, Vitamin C  since an unknown date for unknown indications and Vitamin C was taken daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 the patient experienced arm sore, bruising at the site of injection, body ache all over, slight fever, headache and slight fatigue. Therapeutic measures taken for the reported events included Advil from an unknown date. The Clinical outcome of the events arm was sore, bruising at the site of injection, body was achy all over, slight fever, headache and slight fatigue was recovering. No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fairly significant injection site pain; This is a spontaneous report from a contactable patient. A 33-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot/batch number: EM9809), via an unspecified route of administration on the left arm on 16Mar2021 at 13:30PM (age at vaccination was 33-year-old) for COVID-19 immunisation. His medical history and concomitant medication were not reported. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, he had not tested for COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unreported date, she experienced injection site pain after 12 plus hours of vaccination. The patient did not receive any treatment for this event. At the time of report, the clinical outcome of the event injection site pain was recovering. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: sore, stiff shoulder; sore, stiff shoulder; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient (also reported as 50 months) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) as a first dose, single on 16Mar2021 at 11:00 Am in the right arm for COVID-19 immunization at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Medical history was not reported. Concomitant medication includes atorvastatin (LIPITOR) and lisinopril within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 23:00, the patient experienced sore, stiff shoulder and 12 hours after vaccine fever and chills lasting 6 hours. No treatment received for the adverse event. Outcome of the events fever and chills was reported as recovered on 17-MAR-2021 05:00, outcome of events sore, stiff shoulder was recovered on an unspecified in Mar2021.   No follow-up attempts are possible; no further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: low fever of 100 degrees; Achie; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199) dose number 1, via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history of the patient included asthma and COVID-19. The patient was allergic to medications clarithromycin (MACROBID) and amoxicillin; clavulanic acid (AUGMENTIN, also reported as Augmentent). Prior to the vaccination, the patient was diagnosed with COVID-19. On 03Feb2021, the patient underwent nasal swab test resulted in negative. Since the vaccination, the patient has been tested for COVID-19 (result not specified). Concomitant medications included fexofenadine, pseudoephedrine hydrochloride (ALLEGRA-D), levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (BENADRYL), and Melatonin (also reported as melatonin bri, MANUFACTURER UNKNOWN) received within 2 weeks of vaccination all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 10:00, the patient experienced ache, fatigue, and low fever of 100 degrees (units unspecified). No therapeutic response for the result of the events. The clinical outcome of the events ache, fatigue and low fever of 100 degrees was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: dizziness; heart palpitations or racing heartbeat; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no EN6208), via unspecified route of administration in the right arm (at the age of 31-years -old) on 17Mar2021 at 12:15 as a single dose, for COVID-19 Immunisation. Patient received vaccination in pharmacy/ drug store. Patient had medical history of Shellfish, amp, avocado allergy and Factor 5 Leiden Mutation. The patient's concomitant medications were reported as gabapentin, magnesium, paracetamol (ACETAMINOPHEN), flo gummies. Patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 14:30 the patient experienced heart palpitations/racing heartbeat and dizziness. The patient did not receive any treatment for the events. The clinical outcomes of the events heart palpitations/racing heartbeat and dizziness were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Pain
Clinical narrative: 101.4 temp; Headache; Achy; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6201, Dose number: 2) via an unspecified route, administration in the left arm on 17Mar2021 at 13:00 as 2nd dose single for COVID-19 immunization. Medical history and concomitant were not reported. The patient previously received BNT162B2 (lot: EL9264) in the arm on 22Feb2021 as a first dose for COVID-19 immunisation. The patient had 101.4 (unspecified units) body temperature increased, headache and achy on 17Mar2021 14:00. It was unknown whether the patient received therapeutic measures for the event. The clinical outcome of body temperature increased, headache and ache were unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Joint stiffness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: arm and neck immobility; Inflammatory flareups; knee pain; my neck and shoulder stiffened; Joint stiffness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 5318; DOSE NUMBER: 1) via unspecified route of administration in the left arm on 22Feb2021 at 16:15 (at the age of 45-year-old) as 1st dose single for COVID-19 immunisation. Medical history of the patient included Herpes simplex type 2 (hsv-2) and bulging disks. The patient had gluten sensitivity, yeast and onion allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested with COVID-19. Concomitant medications were reported as using other medication in 2 weeks. The patient had not received any other vaccine 4 weeks prior to vaccination. On 23Feb2021, the patient had inflammatory flare ups, neck and shoulder stiffened, knee pain and joint stiffening, arm and neck immobility. Events resulted Doctor or other healthcare professional office/clinic visit. The patient received chiropractic adjustment, massage and physical treatment (PT) for the event. The outcome of the events inflammatory flare ups, neck and shoulder stiffness, knee pain and joint stiffening, arm and neck immobility was recovering. No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over the body, arm, back and neck; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6208, NDC and UPC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm on Friday (at the age of 52-years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took COVID-19 shot on Friday, and today afternoon around 12:30 got hives all over the body, arm, back and neck. Patient visited the doctor and suggested not to get the second shot. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for Injection, Lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation . The patient's medical history and concomitant medications were not reported. On an unspecified date, after about 3 hours of vaccination, the patient experienced mild cases of hives. Patient wanted to know, if that was common and if patient can still receive second dose. The clinical outcome of the event was unknown.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Tongue rough
Clinical narrative: Two minutes after receiving shot tongue began burning and feeling rough.; Two minutes after receiving shot tongue began burning and feeling rough.; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female (unknown age) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: Unknown) via an unspecified route of administration in left arm on 10Mar2021 at 18:45, as an unknown dose, single for COVID-19 Immunisation. The patient's medical history included Celiac disease, endometriosis, Raynaud's, supraventricular tachycardia (SVT). The patient was allergic to Bactrim, Latex, Erythromycin. The concomitant medications included Pristine, Cartia, Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On10Mar2021 at 18:47, two minutes after receiving shot, tongue began burning and felt rough. Symptoms mostly subsided within 30 minutes, some burning feeling along perimeter of tongue lasted for another 24 hours. On 10Mar2021 the event of tongue rough was resolved. On 11Mar2021, tongue burning was resolved. The clinical outcome of the events tongue rough and tongue burning was resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Have Diarrhea; This is a spontaneous report from a contactable non health care professional (Patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6Z04), via unknown route of administrated in left arm on 12Mar2021 (at the age of 25-years-old) as a single dose for Covid-19 immunisation. Patient received vaccine at public health Clinic/veterans administration facility. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. The patient lab tests were not reported. Patient was not enrolled in the clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced diarrhea on 14Mar2021. Treatment was not received for the event diarrhea. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. The clinical outcome of the event diarrhea was not resolving. Prior to vaccination the patient was not diagnosed with COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Flushing, Headache, Pharyngeal swelling, Pruritus
Clinical narrative: Flushing red and hot; Throat swelling; Itching; Severe headache; Left ear pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 17MAR2021 (at the age of 58-years-old) at 10:00, as dose number one, single dose for COVID-19 immunisation. The patient had allergies to unknown medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included cortisone injection into foot on 26MAR2021 for an unknown indication and Tylenol for an unknown indication on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17MAR2021 at 10:15, the patient experienced itching ,left ear pain, severe headache, throat swelling, flushing red and hot. The patient visited emergency room for the reported adverse event. Therapeutic treatment received for  itching ,left ear pain, severe headache, throat swelling, flushing red and hot were Antihistamines and steroids via intravenous route of administration. The clinical outcome of itching, left ear pain, severe headache, throat swelling, flushing red were recovering on an unknown date. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: reports hives under chin; This is a spontaneous case received from a contactable female consumer (patient). A female patient of unspecified age received first dose bnt162b2 (Pfizer's COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 22Feb2021 date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hives under chin after administration of the first dose. She wanted to know if this was normal side effects. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Neck pain, Peripheral swelling
Clinical narrative: Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: UNKNOWN), via unspecified route of administration on 02Mar2021 at 09:30 (at the age of 57-years-old) as unknown single for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included other medication used in 2 weeks. The patient did not have any allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced armpit pain, shoulder pain, swelling arm, pain neck and breast pain on 02Mar2021 at 15:00. No therapeutic measures were taken for armpit pain, shoulder pain, swelling arm, pain neck and breast pain. Outcome of event of armpit pain, shoulder pain, swelling arm, pain neck and breast pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Headache, Pain, Vaccination site pain, Vision blurred
Clinical narrative: slight sporadic blurriness of vision.; slight headache; Soreness at site of administration; full body aches; soreness at site of administration, full body aches; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female the received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45(at the age of 49-years-old), as a second single dose for COVID-19 immunisation. No significant medical history included. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included vitamins D (MANUFACTURER UNKNOWN) and Vitamin B3 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if its ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (Lot number: EL3247), in the left arm on 23Feb2021 at 09:45AM (at the age of 49-years-old), as a first single dose for COVID-19 immunisation and experienced general but mild full body aches, Soreness and tenderness at the injection site. On 16Mar2021, the patient was experienced soreness at site of administration, full body aches, slight headache, slight sporadic blurriness of vision. The patient did not receive any treatment for all the events. The clinical outcome of vaccination site pain, general body pain, slight headache, slight sporadic blurriness of vision was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient with unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) through an unspecified route of administration and an unknown anatomical site on 15Mar2021 at 14:00 (at an unknown age) as second dose for COVID-19 Immunisation. The patient past drug history included first dose of BNT162B2 on an unspecified date, unspecified route of administration and an unknown anatomical site for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. It was also unknown whether the patient had been tested for COVID-19 since the vaccination. It was unknown whether the patient received any other vaccines within 4 weeks prior to vaccine. On 16Mar2021, the patient experienced high fever and was unwell all the day after vaccination. It was unknown whether the patient received therapeutic measures for the events. The clinical outcome of the events high fever and unwell were recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Fever; rash began on right arm and traveled to upper torso down to about belly button; This is a spontaneous report from received from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (lot number: EN6200) via unspecified route of administration on the left arm on 15Mar2021 at 15:30 (age at vaccination was 34-year-old) for COVID-19 immunisation. There was none medical history. Concomitant medication included sertraline hydrochloride (ZOLOFT) 50mg daily. Her historical vaccine included first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (lot/batch no: EN6200) via unspecified route of administration on the left arm on 22Feb2021 at 15:30 for COVID-19 immunization. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19 or not and since the vaccination, she had not been tested positive for COVID-19 as well. She did not have any allergies to medications, food, or other product and she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She has received recent COVID-19 vaccine administered in the Public Health Clinic/Veterans Administration facility. On 16Mar2021, she experienced fever and rash which began in the right arm and travelled to upper torso down to about belly button. Adverse event results in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient did not test for COVID-19. It was not reported if any therapeutic measures were taken to treat these events. The clinical outcomes of the event fever and rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 03Mar2021 at the age of 45-year-old female as a single dose for COVID-19 vaccination. The patient's medical history, concomitant medications and allergies to medications, food and other products were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The facility where the most recent COVID-19 vaccine administered was other. On 12Mar2021, the patient experienced rash in neck area. The rash resembles red spots with itching and burning sensation. It started as small patch and is spreading even on the fourth day of the rash start. The treatment received for the events were unknown. The clinical outcome of events were unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Vomiting; Headaches; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received BNT162B2(Phizer- BioNTech/EP7534) (lot no: Unknown) solution via injection via an unspecified route of administration for Covid 19 immunisation on 15Mar2021. The patient's medical history included Chronic obstructive pulmonary disease (Copd), depression, anxiety, post-traumatic stress disorder (ptsd)and bipolar 1. The patient's past drug history included Bactrim which had caused drug allergy. The patient was not pregnant at the time of vaccination and has not had symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, the patient experienced Nausea, headaches, vomiting and sore arm. No therapeutic measures were taken for the reported events. The clinical outcome of the events was unknown at the time of reporting. No follow up attempts are needed, information about batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palatal swelling, Swollen tongue
Clinical narrative: swelling of tongue; swelling of roof of mouth; This is a spontaneous report from a contactable pharmacist, the patient. A 62-years-old adult non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) via an unspecified route of administration in the left arm on 17Mar2021 at 09:45 (at the age 62-years-old) as single dose for COVID-19 immunisation. Medical history included back surgery and chronic pain. The patient was allergic to latex, papaya, trees, grasses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem (AMBIEN), pravastatin (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), vitamins, bupropion (MANUFACTURER UNKNOWN). Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient experienced swelling of roof of the mouth and tongue. Therapeutic measures included self-treatment with diphenhydramine (Benadryl). The patient felt much better 8 hours after taking the diphenhydramine. The clinical outcome of the events swelling of roof of the mouth and tongue was reported as recovering.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: extreme rash; itching especially on palm of hands, knees, thighs, back; This is a spontaneous report received from a contactable Consumer, Pharmacist. A non-pregnant female patient of unspecified age, received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: Unknown) at an unspecified dose Via unspecified route of administration on left arm on 10Mar2021 at 09:45 AM (at an age of 59-year-old at vaccination) as second dose single for COVID-19 immunisation. The medical history and concomitant medication of the patient was not reported. The past drug history of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: unknown) at an unspecified dose Via unspecified route of administration on left arm on 11Feb2021 at 09:30 AM for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has not tested for COVID-19 since having the vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. On 16Mar2021, the patient experienced extreme rash and itching especially on palm of hands, knees, thighs, back. No therapeutic measures were taken for the events. The patient did not have any allergies to medications, food, or other products. The outcome for the events of extreme rash and itching especially on palm of hands, knees, thighs, back was reported as not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Soreness at injection site; Body aches; Tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 AM (at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not receiving any concomitant medications. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021, the patient had soreness at injection site, felt tired and had body aches. The patient did not receive any treatment for the adverse events. The clinical outcome of soreness at injection site, tired and body aches was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Weight increased
Clinical narrative: BMI of 107 to 118; Fever of 101; Shortness of breath; This is a spontaneous report received from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration to left arm on 12Mar2021 (at the age of 39 years old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma and penicillin allergy. Concomitant medications included Motrin 800, Allegra, and Clindamycin for an unknown indication and taken prior to the two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021, the patient experienced shortness of breath the next day of vaccination and still 4 days later, BMI (Body mass index) of 107 to 118 and fever of 101. No treatment was received for the events. The clinical outcome of the events shortness of breath, BMI of 107 to 118 and fever of 101 was not resolving. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pruritus
Clinical narrative: extremely itchy all over torso, arms, arm pits, palms, face and head; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) from unspecified route administered in left arm on 26Feb2021 at 03:30 PM (at the age of vaccination 54 years) for COVID-19 immunisation. Medical history included breast cancer, fibromyalgia, autonomic neuropathy, peripheral neuropathy and paraneoplastic disorder. The patient had allergies with Penicillin, vancomycin, amoxicillin and nitrofurantoin. The concomitant drugs received by the patient were oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) (MANUFACTURER UNKNOWN), milnacipran hydrochloride (SAVELLA) (MANUFACTURER UNKNOWN), gabapentin (NEURONTIN) (MANUFACTURER UNKNOWN) and bifidobacterium lactis (PROBIOTIC) (MANUFACTURER UNKNOWN) for unknown indication from unknown start date. The patient experienced as extremely itchy all over torso, arms, arm pits, palms, face and head on 03Mar2021 (no rash or hives as reported). The patient underwent PCR test having report result as negative. The patient received Benadryl as therapeutic measures for event itching. The clinical outcome of the event itchy was ongoing (at the time of reporting patient has unbearably itchy everywhere even after 19 days of 1st shot, and face was itchy all day). Prior to vaccination patient was not diagnosed with COVID-19 and Since the vaccination has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Feeling abnormal
Clinical narrative: tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeling chills; body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204; expiration date: Jun2021), via an unspecified route of administration in shoulder on 05Mar2021 (at 67-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient started feeling bad on Monday 08Mar2021, 3 to 4 days later. After she was feeling bad the whole week, she tested positive on the 12Mar2021. The patient got all the symptoms what people said, it's like having the COVID and she lost taste and smell, she had feeling chills, body ache, headache and all that. So, week later she went for a test COVID test and she tested Positive and the test was on 12Mar2021. Her second shot was due on 26Mar2021. Feeling bad was reported as worsened from 09Mar2021. The outcome of event feeling bad was not recovered. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeling chills; body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204; expiration date: Jun2021), via an unspecified route of administration in shoulder on 05Mar2021 (at 67-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient started feeling bad on Monday 08Mar2021, 3 to 4 days later. After she was feeling bad the whole week, she tested positive on the 12Mar2021. The patient got all the symptoms what people said, it's like having the COVID and she lost taste and smell, she had feeling chills, body ache, headache and all that. So, week later she went for a test COVID test and she tested Positive and the test was on 12Mar2021. Her second shot was due on 26Mar2021. Feeling bad was reported as worsened from 09Mar2021. The outcome of event feeling bad was not recovered. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Illness
Clinical narrative: getting sick; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient received both injection of suspect vaccine and she got sick after the second injection. The patient reported having antibody testing done afterwards that showed negative for IgM antibodies and positive for IgG antibodies. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The person experienced hives after; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) (non-pregnant at the time of vaccination) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior and since the vaccination. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the person experienced hives on 17Mar2021 with outcome of recovered. It was reported that the reporter became aware of the adverse event on 20Mar2021 and reported the event on 20Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Had hives; This is a spontaneous report from a contactable consumer or other non hcp who reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that first time she had dose 1 of vaccine and had hives, the EMT gave benadryl. She asked if she should get the second dose. The clinical outcome of the events was unknown.  It was unknown if the reporter was a health care professional. It was unknown if the reporter the prescribing HCP.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Headache, Insomnia, Pruritus, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.