chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 36-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 09Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to tetracycline. 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. On 09Mar2021 at 18:00, the patient experienced neck pain, muscle stiffness on back of the head, not able to sleep, fatigue and headache. The therapeutic measure was taken as a result of events and included the treatment with methocarbamol. The clinical outcome for the events neck pain, muscle stiffness on back of the head, not able to sleep, fatigue and headache were not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 69-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 18Mar2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included SYNTHROID for unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient receive any treatment for the event.  The clinical outcome of the heart palpitations was not resolved at the time of reporting.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route in the left arm on 01Mar2021(at the age of 36 years-old) as a single dose for COVID-19 immunisation. Medical history included SLE, Von Willebrands type 1, hellp syndrome, elevated liver enzymes. Concomitant medications included hydroxychloroquine (PLAQUENIL) 1 tablet daily, for unknown indication within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 02Mar2021, the patient experienced burning sensation. The patient did not feel pain but was unable to correlate to eating, sleeping, activity, etc. The patient reported burning sensation was continually occurring multiple times a day only on left side of body, mainly upper back down through legs- both front and back side. The patient reported occasional burning sensation in left arm from injection site down. The patient was receiving treatment with medical team at clinic. The clinical outcome burning sensation was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: 101 fever; Body aches; Severe headache all lasted 24 hours headache; Severe stiff neck; Vertigo that was still linger; Could barely walk, talk or stand; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EA6201) via an unspecified route in the left arm on 10Feb2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patients medical history included migraines, depression. The patient had received other medications within 2 weeks prior to the COVID-19 vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route in the left arm on 20Jan2021 at 16:45 as a single dose for COVID-19 immunisation. The patient previously penicillin for unknown indication and experienced an allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 11Feb2021 at 04:00, the patient experienced 101 fever, body aches, severe headache all lasted 24 hours headache, severe stiff neck and vertigo that was still linger. During the 14 days after the vaccine the patient could barely walk, talk or stand. The patient never had vertigo before and this was the worst she ever felt. Her whole world shut down during that time. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vertigo and Medicine was given for vertigo. The clinical outcome of the  body aches, severe stiff neck, vertigo, could barely walk, talk or stand, 101 fever and severe headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 101 fever; Body aches; Severe headache all lasted 24 hours headache; Severe stiff neck; Vertigo that was still linger; Could barely walk, talk or stand; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EA6201) via an unspecified route in the left arm on 10Feb2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patients medical history included migraines, depression. The patient had received other medications within 2 weeks prior to the COVID-19 vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route in the left arm on 20Jan2021 at 16:45 as a single dose for COVID-19 immunisation. The patient previously penicillin for unknown indication and experienced an allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 11Feb2021 at 04:00, the patient experienced 101 fever, body aches, severe headache all lasted 24 hours headache, severe stiff neck and vertigo that was still linger. During the 14 days after the vaccine the patient could barely walk, talk or stand. The patient never had vertigo before and this was the worst she ever felt. Her whole world shut down during that time. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vertigo and Medicine was given for vertigo. The clinical outcome of the  body aches, severe stiff neck, vertigo, could barely walk, talk or stand, 101 fever and severe headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry throat, Fatigue, Headache
Clinical narrative: Dry throat; chills; Very bad headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route administration in the left arm on 17Mar2021 at 13:30 (at the age of 59-years-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. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included unspecified vitamins (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 at 15:30, the patient had experienced dry throat, chills, very bad headache and tiredness. It was unknown if therapeutic measures were taken for the events. Adverse events did not result in doctor or other healthcare professional office or clinic visits, emergency room or department, or urgent care. The clinical outcome of the events dry throat, chills, very bad headache and tiredness was unknown.   Information about lot/batch number cannot be obtained. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Lymph nodes and glands in armpit, breast and arm have been inconstant pain; This is a spontaneous report from a contactable consumer, the patient. A 35-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 left arm on 18Mar2021 at 16:00 (at the age of 35 years) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer (full thyroidectomy) and the patient was allergic to almonds. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication and unknown if ongoing. The patient had known drug allergy with PERCOCET. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Jan2021 at 15:00, the patient experienced lymph nodes and glands in arm pit, breast and arm in constant pain for 24 hours after the shot. Therapeutic measures were not taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lymph nodes and glands in arm pit, breast and arm in constant pain was not resolved at the time of this report. Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweat; Body ache; Vomiting; Diarrhea; Chills; Fever; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 1115 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, high cholesterol and deaf. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 1400, the patient experienced vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache. The patient did not receive any treatment for the reported events. The clinical outcome of the events vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache was resolving at the time of this report.   No follow-up attempts possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Sweat; Body ache; Vomiting; Diarrhea; Chills; Fever; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 1115 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, high cholesterol and deaf. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 1400, the patient experienced vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache. The patient did not receive any treatment for the reported events. The clinical outcome of the events vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache was resolving at the time of this report.   No follow-up attempts possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstruating two weeks early; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route in the left arm on 17Mar2021 (at age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included graves disease and allergy to wheat, hazelnut and shrimps. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and propylthiouracil (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient started menstruating two weeks early and did not really have an explanation. The patient had not received any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for irregular period was recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vital signs measurement
Clinical narrative: Patient complained of dizziness at 11:13 after receiving first dose.; This is a spontaneous report received from a contactable pharmacist. A 44-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200) via intramuscular route of administration in the left arm on 22Feb2021 (at the age of 44-years-old) for COVID-19 immunisation. The patients medical history included dizziness. Concomitant medication was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19 and unknown if patient was tested for COVID-19, since the vaccination. On 22Feb2021 at 11:13, after receiving first dose the patient experienced dizziness, patient had history of dizziness not on medications. The patient vital signs were normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment taken as a result of reported event included drinking of water 8 oz of water at 11:15, then another 8 oz at 11:29. The clinical outcome of the event dizziness was recovered on 22Feb2021 at 11:40 at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: pain in the back of neck; pain in left shoulder blade, 1 day later pain also in right shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, 2 days after injection, the patient experienced pain in left shoulder blade and 1 day later pain also occurred in right shoulder blade. On 19Mar2021, 3 days later, the patient experienced pain in the back of neck. It was reported that the pain in shoulders subsided. It was unknown if the patient received treatment for the reported events. The clinical outcome of the event pain in left shoulder blade and also in right shoulder blade was recovered on an unknown date in Mar2021. The clinical outcome of the event pain in the back of neck was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; fatigue; Weakness; Pain; This is a spontaneous report from a non-contactable pharmacist. An adult male patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as a single dose for COVID-19 immunisation. Medical history included migraine and seasonal allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. On an unspecified date in Mar2021, the patient experienced fever, chill, weakness, fatigue and pain. It was unknown if the patient had tested positive for COVID-19, prior to vaccination. Since the vaccination, it was unknown whether the patient had tested positive for COVID-19. It was unknown if the patient receive treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, chills, fatigue, weakness and pain was recovered after 3 days on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: significant swelling (may be tennis ball size) in my shoulder area; lymph node, but seemed furtherdown my neck than that. It wastender to touch and sore; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021, at 10:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication within two weeks of vaccination included trinessa (MANUFACTURER UNKNOWN) and claritin (MANUFACTURER UNKNOWN), both for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, at 18:00, the patient had significant swelling (maybe tennis ball size) in her shoulder area on the side of the vaccination. It was reported that maybe a lymph node, but seemed further down her neck than that which was tender to touch and sore. Therapeutics measures included iced the area for events swelling arm and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swelling arm and swollen lymph nodes was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain
Clinical narrative: Falling sensation; Dizziness; Nausea; Felt a slight soreness at thevaccination site; This is a spontaneous report received from a contactable consumer, the patient. A 73-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the left arm on 15Mar2021 at 16:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and had prostate surgery for medium-risk prostate cancer over 10 years ago (unspecified date). The patient had no chronic health conditions and no signs of cancer have ever been present since his surgery (at the time of this report). The patient had no allergies to medications, food, or other products. The patient was not taking any concomitant medication. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient had not received any medication within 2 weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6201 6121) via an unspecified route of administration in the left arm on 22Feb2021 at 12:15(at the age of 73-years-old) as a single dose for COVID-19 immunisation.  The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 18:15, the patient experienced falling sensation (about a minute), dizziness (about an hour) and nausea (about an hour) felt a slight soreness at the vaccination site (about 36 hours). It was reported that, about 90 minutes after receiving his second dose of the vaccine, the patient had been driving his car for about a half hour and was experiencing no problems at all. The patient pulled the car over so his wife and he could switch driving duties, and when he got out of the car, he experienced a dizziness where he felt as though he was falling. The falling sensation continued and the patient almost fell down but his wife caught him, the sensation continued quite powerfully for about a minute. The patient got into the passenger seat, where he felt very mild nausea for about an hour, but then there was no further dizziness or nausea of any kind. The patient also felt a slight soreness at the vaccination site starting about a day after the vaccine and lasting about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the adverse events. The clinical outcome of falling sensation (about a minute), dizziness (about an hour) and nausea (about an hour) were recovered on 15Mar2021, while that of felt a slight soreness at the vaccination site (about 36 hours) was recovered on 17Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Headaches; Fever; Arm discomfort; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 32 years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other medications within two weeks of vaccination. On 20Mar2021, the patient experienced arm discomfort. On 21Mar2021, at 20:00, the patient experienced chills, body aches, headaches and fever. It was unknown if the patient received treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of arm discomfort, headache and general body pain was resolved on an unknown date in Mar2021. The clinical outcome of the events chills and fever was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Stomatitis, Tooth erosion
Clinical narrative: Roof of mouth enflamed; raw like road rash especially behind upper front teeth but also toward the back and the pallet.; Separately, Random pain spots ie, ball of left foot, left psoas area muscle.; This is a spontaneous report from a contactable consumer, the patient. A 63-years old female non pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (Lot number: EP6955) via the left arm on 16Mar2021 as a single dose for Covid-19 immunisation. The patients medical history includes no/possible fibromyalgia. Concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE [Lot number: EL9261] via the left arm on 21Feb2021 as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced events of roof of mouth enflamed, raw like road rash especially behind upper front teeth but also toward the back and the pallet. The patient also reported separately, random pain spots ie, ball of left foot, left psoas area muscle. The patient did not receive any treatment for the reported events. The clinical outcome of the events roof of mouth enflamed, raw like road rash especially behind upper front teeth but also toward the back and the pallet and separately, Random pain spots ie, ball of left foot, left psoas area muscle was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; pain; This is a spontaneous report from a non-contactable pharmacist. A male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route of administration on Mar2021 as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unknown route of administration on an unknown date, for COVID-19 immunisation. Concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced fever, pain and chills for two days. The patient received paracetamol (TYLENOL) as treatment medication for the events fever, pain and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, pain and chills was resolved on an unknown date in Mar2021(also reported as resolved in three days). No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER2613], via an unspecified route of administration in left arm on 22Mar2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021 at 11:15, the patient experienced sore arm. The event 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 event. The clinical outcome of the event sore arm was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Pyrexia, Sleep disorder
Clinical narrative: This is a spontaneous report received from a contactable health care professional. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via an unspecified route of administration on 15Feb2021 (at the age of 26 years), for COVID-19 immunisation. No medical history was reported. Concomitant medication received within 2 weeks of vaccination included vit-D (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration in her left arm on 25Jan2021 at 09:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 15Feb2021 at 12:00, the patient was fatigued and at 19:00, the patient was asleep and woke up at 11:00 with a fever of 103 and feeling freezing cold until about 12:00 following day fever persisted going up to 104, the patient had terrible chills and just overall felt like she was freezing cold. the fever finally broke the following day but still stayed higher than usual and she was fatigued for about 3 days following. She slept an abnormal amount. Patient received tylenol for chills, fever and feeling cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes for the events fatigue, insomnia, pyrexia, nasopharyngitis and chills was recovered at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lip pruritus, Rash, Tongue pruritus
Clinical narrative: Hives; Rash; Chills; Fatigue; Itchy tongue; Itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medication included metformin 1000 mg/day from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced hives, rash, chills, fatigue, itchy tongue and lips. The patient was treated for the hives, rash, chills, fatigue, itchy tongue and lips with BENADRYL. The adverse events resulted in a visit to doctors or other healthcare professional office/clinic visit. The clinical outcome of the hives, rash, chills, fatigue, itchy tongue and lips was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Rash; Chills; Fatigue; Itchy tongue; Itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medication included metformin 1000 mg/day from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced hives, rash, chills, fatigue, itchy tongue and lips. The patient was treated for the hives, rash, chills, fatigue, itchy tongue and lips with BENADRYL. The adverse events resulted in a visit to doctors or other healthcare professional office/clinic visit. The clinical outcome of the hives, rash, chills, fatigue, itchy tongue and lips was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Subcutaneous abscess
Clinical narrative: 2 days after taking 1st dose ofvaccine, patient woke up with a lumpunder his armpit in the arm that wasinjected; Pocket of fluid in the armpit that spread towards the breast area.; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm on 10Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was 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 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 (2 days after taking the first dose of vaccine), the patient woke up with a lump under his armpit in the arm that was injected. There was also a pocket of fluid in the armpit that spread towards the breast area. The patient was concerned to take the 2nd dose. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of axillary lump and axillary abscess were recovered with sequalae on an unspecified date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Dizziness; Body ache; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 29-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 arm left on an unknown date in Mar2021 at 17:00(at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included IBS (as reported) and GAD (as reported). Concomitant medications were not reported. The patient previously received cefalexin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. 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 experienced dizziness, chills, fever and body aches 12Mar2021 at 18:00. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, pyrexia, ache and dizziness were recovered on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea
Clinical narrative: Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male 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 19Mar2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CRESTOR and SYNTHROID, both for unknown indication from unknown dates. The patient did not had allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 16:30, the patient experienced an extremely strong headache for three days, nausea, weakness and some dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea, weakness and dizziness was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Vaccination site pain
Clinical narrative: Discovered raw type sore under left breast on day 3,; Injection site sore and achy; chills some on the next day; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included none other than just a little high blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril-hctz (MANUFACTURER UNKNOWN) 20-25 Mg Tab (1 Daily) and omeprazol (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route in the left arm on 27Feb2021 at 12:00(at the age of 74-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced injection site sore and achy (vaccination site pain), and some chills on the next day, also discovered raw type sore under left breast on day 3. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the injection site sore and achy, chills, and breast pain was resolved with sequelae (recovered with lasting effects) on an unknown date.   No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on the left collar area; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration on 23Feb2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Medical history and concomitant medication were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported no allergies to medications, food, or other products. On 17Mar2021, the patient experienced there was swelling on her left collar area was sensitive to touch. 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 treatment for the event. The clinical outcome of swelling was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Low grade fever; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration at right arm on 20Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and asthma. The patient did not have allergies to medications, food, or other products. Concomitant medications included Synthroid, vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and cannabidiol (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 15:00, the patient experienced fatigue, low grade fever and arm pain. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events fatigue, low grade fever and arm pain were resolving.   Information about lot number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: tiredness; headache; muscle pain; chills; fever; nausea; swollen nodes; feeling totally unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the left arm on 13Mar2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 14Mar2021 at 00:00, the patient experienced tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell for at least 9 days so far. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: tiredness; headache; muscle pain; chills; fever; nausea; swollen nodes; feeling totally unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the left arm on 13Mar2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 14Mar2021 at 00:00, the patient experienced tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell for at least 9 days so far. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.