chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: Driving home throat started to feel like something in it.; The right side of my neck my glands became swollen; Sore throat (r); Slight right ear ache.; My sinuses have also been bad but that is not new they are always like that; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 09Mar2021 at 15:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune hepatitis, thyroid cancer from past 20 years ago, reflux, sinus issues, and COVID-19 from Dec2020 to an unknown date. The patient had known allergies to contrast dye. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 09Mar2021 at 15:45, the patient was allergic to contrast dye, they made her stay for half-an-hour. Driving home her throat started to feel like something in it. The right side of her neck her glands became swollen, sore throat right (r), slight right ear ache. It had been a week and her glands were still swollen, slight ear ache and occasionally sore throat (r). The patient sinuses had also been bad but that was not new they were always like that. It was also reported that she already had COVID in December and did not feel that was the situation. The patient was not sure what to do or if she should get the next vaccine. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events throat started to feel like something in it, neck glands became swollen, sore throat (r), slight ear ache and bad sinus were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Nausea; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old 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 12Mar2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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. Concomitant medications included ALLEGRA and VITAMIN D. On 12Mar2021 at 10:15 the patient experienced nausea, sore left arm. 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 therapeutic measure for the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event nausea and sore left arm was resolved on an unknown date in Mar2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; Headache; Exhaustion; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 11:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had no known allergies to medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. 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 an unknown date in Mar2021, the patient experienced delayed reactions about a week later, vomiting, nausea, headache, exhaustion and general malaise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events delayed reactions about a week later, vomiting, nausea, headache, exhaustion, general malaise was resolved with sequelae on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6202), at the age of 66, via an unspecified route of administration, in the left arm, on Mar 3, 2021, single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoarthritis, type 2 diabetes mellitus, gastroesophageal reflux disease and other unspecified conditions (as reported). The patient has some unspecified allergies to medications, food or other products. 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. Concomitant medications not reported. On Mar 3, 2021, patient experienced extreme fatigue for three days (patient experienced lingering fatigue afterwards; as reported). The events did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of the event extreme fatigue resolved with sequelae on Mar 6, 2021. No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Sore swollen lymph node on neck.; Swollen lymph node on neck. Very painful.; Massive headache; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 12Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (ibs). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. 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 12Feb2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 08:00, the patient experienced sore swollen lymph node on neck. Very painful. Massive headache for the last 2 days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore swollen lymph node on neck, very painful and massive headache was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 84, via an unspecified route of administration, on Mar 13, 2021, at 11:00, single dose for COVID-19 immunisation. The medical history included diabetes, hypertension and penicillin allergy. 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. Concomitant medications not reported. On Mar 14, 2021, the area where the vaccine given on the patient was hard, red and hurt. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of the area where the area where the vaccine given on the patient was hard, red and hurt: not resolved (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Chills; Sweats; Body aches; Left arm hurts; Headache; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old unspecified gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 16:00 (at the age of 63-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 to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 14:00 the patient experienced chills, sweats, head and body aches and left arm hurts only the day after vaccination, left arm hurt was still there after 3 days also when reported by patient. Therapeutic measures were taken as a result of chills, sweats, head and body aches and left arm hurts and included treatment with paracetamol (TYLENOL)  reported by the patient that it helped. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, sweats, head and body aches was recovered on an unknown date in Mar2021 while left arm hurts was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 09:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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. Concomitant medication were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 19Feb2021 at 09:00 as a single dose for COVID-19 immunisation. On 13Mar2021 at 18:00, the patient experienced chills, headaches, and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, headaches, and body aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Rash papular, Skin exfoliation, Vaccination site erythema
Clinical narrative: Raised red patch that surrounded the injection site; Raised red patch that surrounded the injection site / At center of raised area there was a scaly area; At center of raised area there was a scaly area appox, a half inch long and and an 1/8" wide; A very small level of discomfort; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 04Mar2021 at 07:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included Trigeminal Neuralgia (TN), kidney damage, Transient Ischaemic Attack (TIA) and the patient reported that others would be on request. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the right arm on 08Feb2021 at 15:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 13:00, the patient experienced a raised red patch that surrounded the injection site, at the center of raised area there was a scaly area approximately a half inch long and and an 1/8" wide and had just a very small level of discomfort. The redness was gone and the scaly area was healing. 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 event raised red patch that surrounded the injection site was recovered on an unknown date in Mar2021 while scaly area and discomfort were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, SARS-CoV-2 antibody test
Clinical narrative: Metallic taste in your mouth/Icky taste; lips and her tongue was tingling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EN6200, expiry date: Unknown) via Intramuscular route of administration administered in left shoulder (Deltoid Left) on 20Feb2021 13:00 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. Medical history and Concomitant drugs were none. There was no family medical history relevant to Adverse event nothing relevant to the metallic taste, other issues. Prior vaccinations were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL9264, Expiry date: Unknown) via Intramuscular route of administration, administered in left shoulder on 30Jan2021 14:00 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. It was reported that on 28Feb2021 17:00 patient experienced Metallic taste, Tingling lips and tongue, Icky taste. Reporter did not have this problem before and all of sudden she had the second dose on 20Feb2021 and right after that had a metallic taste in her mouth and lips and her tongue was tingling and when she would eat food like salad, she had a terrible nasty taste. Reported queried that a metallic taste in your mouth is a side effect from the Pfizer vaccine. patient had both of them and started with the problem in the last few weeks. Don't see anything out there on the website for this side effect. Reporter stated her problem seems to be getting worse and she contacted her primary care physician on 12Mar2021 and her doctor saw that what she was experiencing was a side effect from the vaccine shot. Reporter also stated she had problems over the weekend with it and so she emailed her gastrointestinal doctor, and she said the problems that she was having was not from a gastrointestinal point of view and her doctor recommended that she should contact Pfizer to see what was going. Seriousness Criteria for events were Persistent. Patient underwent lab test and procedures which included on 22Dec2020 SARS-CoV-2 Antibody IgG- Positive, SARS-CoV-2 Antibody IgM- Positive. Patient visited physician office visit for the events. Patient did not receive any treatment for the events.  The outcome of the events was Recovering.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 11:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, eczema and known allergies to dust, cat, dog, pollen, grass and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and vitamins nos (DAILY MULTIVITAMIN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 17:00, the patient experienced large, warm, itchy red rash/spot at vaccination site, about 3 inches across. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large, warm, itchy red rash/spot at vaccination site, about 3 inches across were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Woke up next morning with noticeably extreme soreness, unable to lift left arm; Woke up with chills; Noticeable soreness started around 6 hours after the vaccine administration,/ Woke up next morning with noticeably extreme soreness, unable to lift left arm.; This is a spontaneous report from a contactable pharmacist, the patient. A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient previously 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 20Feb2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 14:00, around 6 hours after the vaccine administration the patient experienced noticeable soreness. On 13Mar2021 at 22:30, the patient woke up with chills. On 14Mar2021 (also reported as next morning) at 11:00, the patient woke up with noticeably extreme soreness and unable to lift left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events noticeable soreness started around 6 hours after the vaccine administration, woke up next morning with noticeably extreme soreness, unable to lift left arm which included treatment with 2 doses of acetaminophen (TYLENOL) 650 milligram on 13Mar2021 around 23:30 and on 14Mar2021 at 13:30 and symptoms reduced drastically by 22:00. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event woke up with chills was resolved on an unknown date in Mar2021; while that of the events noticeable soreness started around 6 hours after the vaccine administration, woke up next morning with noticeably extreme soreness, unable to lift left arm was resolved on 14Mar2021 at 22:00.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have developed sometimes severe pains in my legs after shot #2; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included COVID-19 (I'm a post-Covid 19 patient). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient developed sometimes severe pains in his legs after shot 2. The event outcome was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Chills; Severe arm pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 60-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. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 09Mar2021, the patient experienced fatigue, chills and severe arm pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills and severe arm pain at injection site were not resolved the time of this report  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 14Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 14Mar2021, after getting the first dose of vaccine in the morning, the patient experienced tinnitus in the evening. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 tinnitus was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Difficulty swallowing.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal 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 COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for seasonal allergy from an unknown date and unknown if ongoing. On an unknown date in Mar2021 the patient experienced swollen lymph nodes and difficulty swallowing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes and difficulty swallowing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old patient with unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 taken within two weeks were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 22Feb2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Mar2021 at 14:30, the patient experienced sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and fatigue was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6207), at the age of 55,  via an unspecified route of administration, in the right arm, on Mar 12, 2021, at 12:30, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On Mar 12, 2021 at 12:30, patient experienced ringing in ears, dizziness and fatigue. The events resulted in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of ringing in ears and fatigue recovered on an unknown date in 2021; while that of dizziness recovered on an unknown date in Mar 2021. No follow-up attempts needed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: Soft lump in right forearm; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (COMIRNATY; Lot Number: EN6208) via an unspecified route of administration in the right arm on 15Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Mar2021 at 10:00, the patient experienced soft lump in right forearm. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 event soft lump in right forearm was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration
Clinical narrative: Severe dizziness. That has lasted almost two weeks; Dose 1 on 18Feb2021 and Dose 2 on 02Mar2021; This is a spontaneous report from a contactable consumer, the patient. A 88-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 02Mar2021 at 11:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hashimotos disease, arthritis and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of 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 18Feb2021 at 14:00 (at the age of 88-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. On 07Mar2021 at 09:00, the patient experienced severe dizziness that has lasted almost two weeks. The event resulted in and emergency room/department or urgent care. Therapeutic measures were taken as a result of the dizziness which included treatment with diphenhydramine hydrochloride (BENADRYL) and tests (unspecified) was given. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe dizziness was recovered on an unknown in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling overwhelming fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 51-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 on 28Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and allergic to sulfa meds. 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 COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO), buspirone hydrochloride (BUSPAR) and irbesartan (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. On 01Mar2021, the patient stated that she felt overwhelming fatigue ever since the first dose. It started about 24 hours after and had not let up even now, 10 days later. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling overwhelming fatigue 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast tenderness, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; Redness around injection site; Tender breasts; Sore breasts; Sore, tender to touch in the armpit of right arm (Sidewhere injection took place); Swollen lymph node in the armpit area.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Mar2021 at 15:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included indoor or outdoor allergies, knee arthritis, back disorder, migraine and sinus disorder. The patient was not aware of any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cyanocobalamin (VITAMIN B12), iron (MANUFACTURER UNKNOWN), OTC allergy meds (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021, the patient experienced sore arm from time of shot to about 24 hours next day. redness around injection site for about 2 days, sore or tender breasts about 4 days.  About a week later, it was sore, tender to touch in the armpit of right arm (side where injection took place). That also came with swollen lymph node in the armpit area, began about a week from day of 1st shot and is still a bit tender the day of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, redness around injection site, sore or tender breasts, sore, tender to touch in the armpit of right arm and swollen lymph node in the armpit area was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Sore arm; Redness around injection site; Tender breasts; Sore breasts; Sore, tender to touch in the armpit of right arm (Sidewhere injection took place); Swollen lymph node in the armpit area.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Mar2021 at 15:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included indoor or outdoor allergies, knee arthritis, back disorder, migraine and sinus disorder. The patient was not aware of any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cyanocobalamin (VITAMIN B12), iron (MANUFACTURER UNKNOWN), OTC allergy meds (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021, the patient experienced sore arm from time of shot to about 24 hours next day. redness around injection site for about 2 days, sore or tender breasts about 4 days.  About a week later, it was sore, tender to touch in the armpit of right arm (side where injection took place). That also came with swollen lymph node in the armpit area, began about a week from day of 1st shot and is still a bit tender the day of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, redness around injection site, sore or tender breasts, sore, tender to touch in the armpit of right arm and swollen lymph node in the armpit area was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I experienced a severely tender, swollen lymph node in my armpit; I experienced a severely tender, swollen lymph node in my armpit; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included uncontrolled asthma, anxiety and celiac. The patient had known shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL) and montelukast sodium (SINGULAIR); all taken on an unknown date for an unknown indication and unknown if ongoing. On 13Mar2021, approximately 1 week after vaccine, the patient experienced a severely tender, swollen lymph node in armpit. It was the same arm as the injection site. The events resulted in doctor or other healthcare professional office/clinic visit. 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 the patient experienced a severely tender, swollen lymph node in the armpit was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Feeling abnormal, Head discomfort, Muscular weakness
Clinical narrative: fullness sensation in head associated with fullness in the ears Day 4; fullness sensation in head associated with fullness in the ears Day 4; dizziness; strange sensation in legs upon walking/ they seemed to be rubber like-very strange; I developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting; I developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting; Injection site pain lasted 3 days-not a big deal.; a strange sensation in head, no pain, associated with ringing in the ears; This is a spontaneous report from a contactable physician, the patient. A 65-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 05Mar2021 at 14:15 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD)- sporadic and allergy to bee sting. 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. On 05Mar2021 at 16:15, approximately one and half hours after injection, the patient developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting. The patient also experienced injection site pain that lasted 3 days. On 06Mar2021,  the following day, the supra tentorial symptoms were worse with a strange sensation in legs upon walking-that only occurred upon getting out of bed that day and spontaneously resolved after walking briefly, they seemed to be rubber like-very strange, no weakness or pain or numbness. On 09Mar2021, day 4, the patient was bothered by the nausea and dizziness and fullness sensation in head associated with fullness in the ears. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome for injection site pain was recovered on 08Mar2021, after 3 days. The clinical outcome of the event transient nausea, ringing in the ears, strange sensation in head, dizziness and strange sensation in legs upon walking-that only occurred upon getting out of bed that day and spontaneously resolved after walking briefly, they seemed to be rubber like-very strange, dizziness and fullness sensation in head associated with fullness in the ears was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus, Vaccination site pain
Clinical narrative: fullness sensation in head associated with fullness in the ears Day 4; fullness sensation in head associated with fullness in the ears Day 4; dizziness; strange sensation in legs upon walking/ they seemed to be rubber like-very strange; I developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting; I developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting; Injection site pain lasted 3 days-not a big deal.; a strange sensation in head, no pain, associated with ringing in the ears; This is a spontaneous report from a contactable physician, the patient. A 65-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 05Mar2021 at 14:15 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD)- sporadic and allergy to bee sting. 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. On 05Mar2021 at 16:15, approximately one and half hours after injection, the patient developed transient nausea, followed by a strange sensation in head, no pain, associated with ringing in the ears and subsequent nausea-no vomiting. The patient also experienced injection site pain that lasted 3 days. On 06Mar2021,  the following day, the supra tentorial symptoms were worse with a strange sensation in legs upon walking-that only occurred upon getting out of bed that day and spontaneously resolved after walking briefly, they seemed to be rubber like-very strange, no weakness or pain or numbness. On 09Mar2021, day 4, the patient was bothered by the nausea and dizziness and fullness sensation in head associated with fullness in the ears. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome for injection site pain was recovered on 08Mar2021, after 3 days. The clinical outcome of the event transient nausea, ringing in the ears, strange sensation in head, dizziness and strange sensation in legs upon walking-that only occurred upon getting out of bed that day and spontaneously resolved after walking briefly, they seemed to be rubber like-very strange, dizziness and fullness sensation in head associated with fullness in the ears was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.