chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Feeling abnormal
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0167), at the age of 70, via an unspecified route of administration, left arm, on May 18, 2021, single dose, for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included antibiotics (unspecified) for unknown indication from unknown start date and unknown if ongoing. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jun 23, 2021, patient's breast started hurting. She also experienced hurting under arm pit and overall feeling bad (still present at the time of this report). No therapeutic measures taken as a result of the events. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of patient's breast started hurting, hurting under arm pit, overall feeling bad not recovered at the time of this report. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Feeling of slow motion; Fever; Chills; Upset stomach; Headache; severe injection site pain, swelling, and redness; severe injection site pain, swelling, and redness; severe injection site pain, swelling, and redness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jun2021 at 09:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder, hypothyroidism and irritable bowel syndrome. Concomitant medications included levothyroxine sodium (SYNTHROID), dicycloverine hydrochloride (DICYCLOMINE HYDROCHLORIDE), duloxetine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to food, medications, or other products. On 29Jun2021 at 09:15, the patient had feeling of slow motion and experienced fever, chills, upset stomach, headache, severe injection site pain, swelling, and redness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feeling of slow-motion fever, chills, upset stomach, headache, severe injection site pain, swelling, and redness was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Feeling of slow motion; Fever; Chills; Upset stomach; Headache; severe injection site pain, swelling, and redness; severe injection site pain, swelling, and redness; severe injection site pain, swelling, and redness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jun2021 at 09:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder, hypothyroidism and irritable bowel syndrome. Concomitant medications included levothyroxine sodium (SYNTHROID), dicycloverine hydrochloride (DICYCLOMINE HYDROCHLORIDE), duloxetine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to food, medications, or other products. On 29Jun2021 at 09:15, the patient had feeling of slow motion and experienced fever, chills, upset stomach, headache, severe injection site pain, swelling, and redness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feeling of slow-motion fever, chills, upset stomach, headache, severe injection site pain, swelling, and redness was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea; Vomiting; headache; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jun2021 at 12:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and asthma.  The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 12:00, as a single dose for COVID-19 immunisation. On 29Jun2021, the patient experienced nausea, vomiting, headache, fever, chills, body aches and fatigue. Therapeutic measures were not taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea, vomiting, headache, fever, chills, body aches and fatigue were resolving at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; headache; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jun2021 at 12:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and asthma.  The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 12:00, as a single dose for COVID-19 immunisation. On 29Jun2021, the patient experienced nausea, vomiting, headache, fever, chills, body aches and fatigue. Therapeutic measures were not taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea, vomiting, headache, fever, chills, body aches and fatigue were resolving at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: major lip swelling; sore throat; muscle pain; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, one week after the vaccination, the patient experienced a delayed reaction of major lip swelling (the patient had lip filler), sore throat, muscle pain and slight fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events major lip swelling, sore throat, muscle pain and slight fever were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Pyrexia
Clinical narrative: disorientation; High fever/fever 101F; substantial chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) Dose 2 intramuscular, administered in the left arm on 29Jun2021 at 14:00 (at the age of 56 years-old)  as a single dose for COVID-19 immunisation. Medical history included ongoing hypothyroidism, and ongoing blood cholesterol increased High CHL. Concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism from an unspecified start date and ongoing; atorvastatin for blood cholesterol increased from an unspecified start date and ongoing. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 on 08Jun2021 at 14:00 (Lot Number: EW0191) via intramuscular in the left arm for COVID-19 immunisation. The patient experienced substantial chills (disability) on 29Jun2021 at 22:00, disorientation (medically significant) on 30Jun2021, and high fever /fever 101F (non-serious) on 29Jun2021 at 22:00.  No adverse event until 12 hours after Dose 2 of bnt162b2, which included significant chills. Need to place pillow between knees to prevent injury. Fever is 101 F for 20 hrs. Disorientation was significant. The patient underwent lab tests and procedures which included body temperature: 101F on 29Jun2021.  The patient recovered from the event, High fever/fever 101F on 30Jun2021, and from substantial chills on an unknown date. The outcome of the event, disorientation was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 2 small patches of hair loss from the back/alopecia; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 15May2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21May2021, after receiving the first dose, there were 2 small patches of hair loss from the back, we noticed that within one week. The doctor stated that it was alopecia, the patient never had that and patch of hair loss was very evident now. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event 2 small patches of hair loss from the back/alopecia was not recovered at the time of this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching or jerking of feet and hands; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 06Mar2021 at 07:00 as a single dose for COVID-19 immunisation. Medical history included latex allergy. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced twitching or jerking of feet and hands. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event twitching or jerking of feet and hands was not recovered at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: For about two weeks after the shot I felt a needle like sensation in my left arm. The feeling returns every 2-3 weeks.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the arm left on 07Apr2021 at 18:30(at the age of 36-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0179) via an unspecified route of administration in the arm left on 28Apr2021 at 18:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included probiotics (unspecified) from an unknown date for an unknown indication. On 28Apr2021, for about two weeks after the first dose, the patient felt a needle like sensation in the left arm. The feeling returned every 2-3 weeks. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event needle like sensation in the left arm was unknown at the time of this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 11Jun2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient did not know about any known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 21May2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced back lower pain and stomach upset since he vaccinated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events back lower pain and stomach upset was unknown at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Low grade fever ranging from 99.0 to 100.6 for one week so far.; Mild sore throat - still ongoing; Left arm pain; Ear ache in right ear; Fatigue that lasted 48 hours afterinjection; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23Jun2021 at 14:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, inflammatory bowel disease, known allergies to sulfa antibiotics, penicillin, contrast dye(iodine), latex, coconut oil, more. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took clarithromycin (BIAXIN), clindamycin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unspecified indication on unknown dates and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 23Jun2021, the patient experienced low grade fever ranging from 99.0 to 100.6 (units unspecified) for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing, left arm pain, injection site pain and fatigue that lasted 48 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever ranging from 99.0 to 100.6 for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing left arm pain, injection site pain was not recovered at the time of this report and of the event fatigue that lasted 48 hours after injection was recovered on 25Jun2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever ranging from 99.0 to 100.6 for one week so far.; Mild sore throat - still ongoing; Left arm pain; Ear ache in right ear; Fatigue that lasted 48 hours afterinjection; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23Jun2021 at 14:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, inflammatory bowel disease, known allergies to sulfa antibiotics, penicillin, contrast dye(iodine), latex, coconut oil, more. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took clarithromycin (BIAXIN), clindamycin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unspecified indication on unknown dates and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 23Jun2021, the patient experienced low grade fever ranging from 99.0 to 100.6 (units unspecified) for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing, left arm pain, injection site pain and fatigue that lasted 48 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever ranging from 99.0 to 100.6 for one week so far, mild sore throat still ongoing, ear ache in right ear, not constant but occasional and ongoing left arm pain, injection site pain was not recovered at the time of this report and of the event fatigue that lasted 48 hours after injection was recovered on 25Jun2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: ear fullness, bilateral; bilateral tinnitus; This is a spontaneous report from a contactable physician. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via intramuscular route of administration in the right arm on 22Jan2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jan2021, within 24 hours of vaccine, the patient experienced bilateral ear fullness and then bilateral tinnitus which had persisted. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events bilateral ear fullness and bilateral tinnitus were not resolved at the time of this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Difficulty staying awake; Muscle and joint pain especially in the legs and back; Muscle and joint pain especially in the legs and back; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jun2021 at 16:45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jun2021 at 07:00, the patient experienced muscle and joint pain especially in the legs and back, nausea, chills, fatigue, and difficulty staying awake. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events difficulty staying awake, muscle pain and joint pain especially in the legs and back, nausea, chills, and fatigue were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow-up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Difficulty staying awake; Muscle and joint pain especially in the legs and back; Muscle and joint pain especially in the legs and back; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jun2021 at 16:45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jun2021 at 07:00, the patient experienced muscle and joint pain especially in the legs and back, nausea, chills, fatigue, and difficulty staying awake. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events difficulty staying awake, muscle pain and joint pain especially in the legs and back, nausea, chills, and fatigue were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Left side of my breast was hurting; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0191) via an unspecified route of administration in the left arm on 29May2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. The patient took blood pressure medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the left arm in 2021 at 13:15 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 22Jun2021 at 14:30, the patient noticed that left side of her breast was hurting. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side of her breast was hurting was recovered at the time of this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body ache; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 29Jun2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 26May2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. On 30Jun2021, the patient experienced body ache, fatigue and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, fatigue and headache were recovering at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: I have been having my menstrual cycle every 30 days from the day I know my self. But after the first doze of vaccination, I had 5 days earlier and very heavy.; I have been having my menstrual cycle every 30 days from the day I know my self. But after the first doze of vaccination, I had 5 days earlier and very heavy.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient medical history was not reported. The patient had no covid prior vaccination. There were no concomitant medications. The patient did not receive any other other vaccine in four weeks and did not receive any other medications in two weeks. The patient has been having menstrual cycle every 30 days from the day she knew herself. But after the first doze of vaccination, she had 5 days earlier and very heavy. The patient did not receive any treatment for the event. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 12:00 AM. The patient had not tested covid post vaccination. Outcome of the events was recovered.  Information about the Lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Left Arm Site Injection was swollen 8 days after injection.; Left Arm Site Injection was with Pain 8 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma and ibs (irritable bowel syndrome). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included travoprost (MANUFACTURER UNKNOWN), timolol maleate, brimonidine tartrate (COMBIGAN), dorzolamide (MANUFACTURER UNKNOWN), glucosamine sulfate (BIOFLEX) and Multi vitamins; all from an unknown date for unknown indications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Jun2021 at 14:00, 8 days after injection, the patient experienced left arm site injection was swollen with pain. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left arm site injection was swollen with pain was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling persistent 5+days; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0180) via an unspecified route of administration in the right arm on 24Jun2021 at 16:45 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included allergy to fire ants. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified birth control medications within two weeks of vaccination. On 26Jun2021 at 04:00, the patient experienced facial swelling which persisted for more than 5 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of facial swelling and included treatment with Benadryl on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial swelling was not resolved at the time of this report.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Tiredness; Muscle pain; Chills; Joint pain; Fever; Feeling ill; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient received of unknown gender the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Jun2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient underwent lab tests and procedures, which included nasal swab test on 04Aug2020 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 30Jun2021 the patient experienced tiredness, muscle pain, chills, joint pain, fever and feeling ill. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date in 2021 and the result was negative. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, fever and feeling ill was unknown at the time of this report.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tiredness; Muscle pain; Chills; Joint pain; Fever; Feeling ill; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient received of unknown gender the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Jun2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient underwent lab tests and procedures, which included nasal swab test on 04Aug2020 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 30Jun2021 the patient experienced tiredness, muscle pain, chills, joint pain, fever and feeling ill. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date in 2021 and the result was negative. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, fever and feeling ill was unknown at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Mechanical urticaria, Urticaria chronic
Clinical narrative: My entire body felt like I was on fire.; One month after my second dose, I developed hives all over my body that have not gone away with any treatment/ Chronic hives; dermatographia; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0173), intramuscular, administered in left arm on 06May2021 as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8779) on 08Apr2021 for COVID-19 immunisation. The facility type vaccine was Pharmacy or Drug store. Vaccine was not administered at Military Facility. The patient had no other vaccine in four weeks. On 04Jun2021 (one month after her second dose), the patient developed hives all over her body that have not gone away with any treatment. Her allergy healthcare provider told her it was due to the vaccine. She have never been so uncomfortable in her life, and it has been constant for the past three weeks with no relief. Every day she wake up with new hives all over her body and face. She have spent an obscene amount of money trying to manage this now. First day, she stated developing hives on my ears. This spread to her entire face and body for over a month. She was diagnosed with dermatographia caused by the vaccine by her doctor. Any heat, pressure, a slightest friction caused me to break out in hives. She was on 3 types of antihistamines a day, nothing worked. Only steroids bought relief for a period of 5 days, but she chose not to continue because of issues prednisone can cause long term. Her entire body felt like she was on fire on an unspecified date. Events chronic hives and dermatographia resulted in doctor or other healthcare professional office/clinic and physician office visit. Therapeutic measures were taken as a result of chronic hives and dermatographia and included treatment with steroids and doxepin. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events chronic hives and dermatographia was recovered with sequel on 07Jul2021, and the outcome of the event burning sensation was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder, Overdose
Clinical narrative: Dose 1 and Dose 2 on same date (23Dec2020 13:00); Dose 1 and Dose 2 on same date (23Dec2020 13:00); I had totally regular periods until I got the vaccine, then NOTHING to date. Menstrual cycle disruption.; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 23Dec2020 13:00 (at the age of 52-years-old) in Arm Right, as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 23Dec2020 13:00 (at the age of 52-years-old) in Arm Right, as dose 2, single for COVID-19 immunization. The patient Medical history included , migraine from an unknown date and unknown if ongoing. Concomitant medications included topiramate (TOPIRAMATE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccinations within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19. On 03Jan2021, the patient experienced she had totally regular periods until she got the vaccine, then nothing to date menstrual cycle disruption and Dose 1 and Dose 2 on same date (23Dec2020 13:00). The patient did not received treatment for the adverse event. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: My left arm is stiff and sore.; My left arm is stiff and sore. It hurts to raise it like a chicken wing.; My left arm is stiff and sore. It hurts to raise it like a chicken wing.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the arm left on 12Feb2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vilazodone hydrochloride (VIIBRYD) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9261) via an unspecified route of administration in the arm left on an unknown date in Jan2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient's left arm was stiff and sore. It hurt to raise it like a chicken wing. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm was stiff and sore. It hurts to raise it like a chicken wing was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: persistent rash that changes locations; This is a spontaneous report from a contactable consumer. A adult non-pregnant female patient of unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on Jun2021 (Batch/Lot number: Not provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. 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. It was unknown, Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, patient did not test for COVID-19. The patient experienced persistent rash that changes locations on an unspecified date in Jun2021. Patient visited the physician office for the event. Patient did not receive any treatment for the event. The event was not serious, no life threatening, no prolonged hospitalization, no disabling and no Congenital anomaly/birth defect. Outcome of event was not recovered.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperaesthesia, Inflammation, Migraine, Neck pain
Clinical narrative: Consecutive migraines; pain in neck; pain in shoulders; Sensitivity to touch in neck and shoulders; inflammation in neck and shoulders; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jun2021 at 18:00 (at the age of 48-years-old)  as a single dose for COVID-19 immunisation. Other medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 18:00  (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 26Jun2021 at 11:00, the patient experienced consecutive migraines with pain in neck and shoulders, sensitivity to touch and inflammation in neck and shoulders. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events of consecutive migraines with pain in neck and shoulders, sensitivity to touch and inflammation in neck and shoulders and included treatment with muscle relaxer and migraine meditation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of consecutive migraines, pain in neck and shoulders, sensitivity to touch and inflammation in neck and shoulders was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches.; Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches.; There is a lump on the site; Injection site has been swollen, red, and warm to touch. It's about 3inches  4 inches. There is a lump on the site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU0181) via an unspecified route of administration on an unknown date (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the injection site was swollen, red, and warm to touch. It was about 3 inches x 4 inches. There was a lump on the site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event injection site was swollen, red, and warm to touch, lump on the site was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.