chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: My left arm is still swollen; The muscle is extremely soar to move at times; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received 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 the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to dura bond. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, the patient experienced left arm was still swollen and muscle was extremely soar. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of swollen arm and muscle soreness was not recovered at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 02Apr2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer. An adult female patient (unknown if pregnant), of unspecified age, received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. The patient's medical history: unknown. Prior to vaccination, it was unknown whether patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether patient tested for COVID-19. It was unknown whether patient received any other vaccines within four weeks prior to the vaccination. Concomitant medication within 2 weeks of vaccination: unknown. On an unknown date after the vaccination, patient did not feel well. The clinical course as follows: On Apr 9, 2021, the reporter was at a small gathering and met a prior coworker (the patient). Later, patient took the Pfizer COVID-19 vaccine. The reporter called on Apr 9, 2021 to report the event but couldn't reach a live person to document the event. The reporter called again on Apr 10, 2021 and received instruction to report via the website. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event (did not feel well) was unknown at the time of the report. No follow-up attempts possible. Information about batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Added information that it was unknown if patient was pregnant, and vaccine facility information updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I felt was a little numbness going down the vein that's my wrist and went away; This is a spontaneous report received from contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch number: HR2659903, lot number: EN6206), via an unspecified route of administration in left arm on 13Mar2021 as single for COVID-19 immunisation. The patient's medical history included dry palm. Concomitant medications were not reported. On an unknown date, the patient experienced "I felt was a little numbness going down the vein that's my wrist and went away". She was all concerned about her husband than for herself, so having those she meant she had dry palm that was how it was. She was due for second dose on that Saturday. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Palpitations, Pyrexia
Clinical narrative: Chills; Fever; Body aches; Heart palpitations; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 20:00 the patient experienced chills, fever, body aches, heart palpitations and dizziness. No therapeutic measures were 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 the events chills, fever, body aches, heart palpitations and dizziness were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I have a series of cold sores appearing on my lip. Have had these before in the past but not more than one. Having several suddenly. Could just be a coincidence but felt it should be mentioned.; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (at the age of 34-years-old)(Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ceclor and experienced Known allergies. It was reporter that on 10Apr2021 23:00 patient experienced a series of cold sores appearing on his lip. He previously had these before in the past but it was not more than that. It was several suddenly. He also says that could just be a coincidence but felt it should be mentioned. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that she was not tested positive for covid 19 prior and post vaccination. The outcome of the event was resolving/recovering.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Full body rash; Full body rash and itchy; This is a spontaneous report from a contactable consumer, the patient. A 45-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 left arm on 09Apr2021 at 08:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. Concomitant medications included atorvastatin calcium (ATORVASTIN) and diltiazem (MANUFACTURER UNKNOWN) both for an unknown indications, from unspecified dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 22:30, the patient experienced full body rash and itchy. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures was taken as a result of the events. The clinical outcome of the events full body rash and itchy was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: Loss of appetite; Extremely nausea; Diarrhea; Headache all the time; This is a spontaneous report from a contactable consumer, the patient. A 43-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 19Mar2021 at 18:15 (at the age of 43-years-old) and 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 09Apr2021 (at the age of 43-years-old), both as a single dose for COVID-19 immunisation. Medical history included asthma, bipolar, depression, and anxiety. The patient had known allergies to medications (unspecified). The patient did not receive any medication within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 19:00, the patient experienced "extremely nausea", loss of appetite, diarrhea and headache all the time between shots 1 and 2. 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. The clinical outcome of the events extremely nausea, loss of appetite, diarrhea and headache was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Headache; tiredness; body aches; arm soreness at shot site; arm soreness at shot site and through arm and shoulder; arm soreness at shot site and through arm and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL), escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate (TUMS) and mefenamic acid (ADVIL), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 11:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 05:00, the patient experienced headache, tiredness, body aches, arm soreness at shot site and through arm and shoulder. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, tiredness, body aches, arm soreness at shot site and through arm and shoulder were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; tiredness; body aches; arm soreness at shot site; arm soreness at shot site and through arm and shoulder; arm soreness at shot site and through arm and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL), escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate (TUMS) and mefenamic acid (ADVIL), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 11:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 05:00, the patient experienced headache, tiredness, body aches, arm soreness at shot site and through arm and shoulder. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, tiredness, body aches, arm soreness at shot site and through arm and shoulder were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Ear pain
Clinical narrative: 101.9/100.6 F fever; chills; loss of appetite; hips/ankle/neck severe joint pain.; Headaches; Ear ache; Jaw ache; Muscle pain; Left shoulder pain; Dry nose; Weakness at shot administration site; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL), birth control pill and calcium carbonate, magnesium carbonate 1500mg (TUMS) all taken for unknown indications from an unknown date. The patient previously took hydro-morphone and experienced allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 17:30. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 03:30, the patient experienced fever of 101.9deg/100.6deg F, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose. On 10Apr2021 patient underwent lab tests which include body temperature and the result was 101.9 /100.6 degrees F. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal dryness, Pain, Pyrexia
Clinical narrative: 101.9/100.6 F fever; chills; loss of appetite; hips/ankle/neck severe joint pain.; Headaches; Ear ache; Jaw ache; Muscle pain; Left shoulder pain; Dry nose; Weakness at shot administration site; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL), birth control pill and calcium carbonate, magnesium carbonate 1500mg (TUMS) all taken for unknown indications from an unknown date. The patient previously took hydro-morphone and experienced allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 17:30. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 03:30, the patient experienced fever of 101.9deg/100.6deg F, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose. On 10Apr2021 patient underwent lab tests which include body temperature and the result was 101.9 /100.6 degrees F. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 101.9/100.6 F fever; chills; loss of appetite; hips/ankle/neck severe joint pain.; Headaches; Ear ache; Jaw ache; Muscle pain; Left shoulder pain; Dry nose; Weakness at shot administration site; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL), birth control pill and calcium carbonate, magnesium carbonate 1500mg (TUMS) all taken for unknown indications from an unknown date. The patient previously took hydro-morphone and experienced allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 17:30. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 03:30, the patient experienced fever of 101.9deg/100.6deg F, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose. On 10Apr2021 patient underwent lab tests which include body temperature and the result was 101.9 /100.6 degrees F. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, loss of appetite, hips/ankle/neck severe joint pain, headaches, earache and jaw aches, muscle pain and weakness at shot administration site along with left shoulder pain and dry nose was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue
Clinical narrative: tired; weak; coughing; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included heart condition. The patient did not have a history of allergies to any food or medications or other products. The patient received unspecified medications within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021, after nine days of vaccination the patient experienced still tired, weak and coughing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events tired, weak and coughing was not recovered at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Left arm is throbbing; rash around injection site.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 16:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications within two weeks prior to vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 6:00, the patient experienced left-arm throbbing and rash around the injection site. The clinical course was reported as follows: Left-arm was throbbing even after 30 hours post-injection and 3 diameter rash around the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events left arm is throbbing and the rash around the injection site was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: strong tingling sensation in left leg; also had nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-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 16Mar2021 at 11:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and radiographic stroke since an unspecified dates. The patient did not have any allergies to food, medications, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), statins (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN) for an unknown indications since an unspecified dates within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:00, the patient had strong tingling sensation in her left leg for about two hours. It felt like the patient had sat on her leg and it "went to sleep" - but she had not. The patient also had nausea. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events strong tingling sensation in left leg was resolved on 17Mar2021 at 17:00, whereas the event nausea resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hyperhidrosis, Pain, Vomiting
Clinical narrative: "Woke up to body aches"; chills; "my whole body was sweating bullets"; "I threw up water and stomach acid"; "I got really cold"; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 10Apr2021 at 07:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, obsessive-compulsive disorder, agoraphobia and mood disorder. Concomitant medications included 8-tetrahydrocannabinol (MANUFACTURER UNKNOWN); taken for unknown indication on an unknown date. The patient previously took Geodon, Gabapentin, Remeron and Oxcarbazepine and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 07:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 13:00, the patient slept 12 hours, that was normal. Woke up to body aches, chills, her whole body was sweating bullets and she threw up water and stomach acid, then she got really cold. The patient did not receive any treatment for the events. The clinical outcome of the events "woke up to body aches", chills, "whole body was sweating bullets", "threw up water and stomach acid" and "got really cold" was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Fever; Chills; Weakness; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 74-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm left on 06Apr2021 12:00 (Lot Number: ER8732, Expiration Date: Jul2021) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, illness from 05Dec2020 to Feb2021 until the middle of February. Caller confirms she was never tested for Covid. Caller confirms that she was sick and because it was the middle of the winter, she toughed it out. Caller states that she was never tested for Covid, but she believes she may have had it at that time. There were no vaccines with in four weeks. Concomitant medications included oral levothyroxine sodium (SYNTHROID) 88 mcg every other day and 100mcg every other day, once a day taken for hypothyroidism, start and stop date were not reported; ibuprofen sodium (IBUPROFEN [IBUPROFEN SODIUM]) taken for an unspecified indication, start and stop date were not reported. Caller states that she was not medically minded but reports that she takes thyroid medication and Ibuprofen sometimes. Caller states on the day of the vaccine, she did not take Ibuprofen, but took one after for the fever. Caller states she does not like medication and was not a pill popper. On 06Apr2021 at 19:00, the patient experienced fever, chills and weakness. Caller states that she had a reaction to her first shot. Fever at 7 pm, along with chills and weakness, it lasted 27.5 hours and at 10:30 last night, it lifted away. Caller states she woke up a little weak and as the day goes on, she was getting better. Therapeutic measures were taken as a result of fever with ibuprofen. The outcome with events pyrexia and chills was recovered on 07Apr2021, outcome of event weakness was recovering.  No follow up attempts needed. No further information is excepted.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever - already 3 days; This is a spontaneous report from a contactable consumer, the patient. A 33-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 08Apr2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any 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 18Mar2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 21:30, the patient experienced high fever - already 3 days. 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 event. The clinical outcome of the event high fever - already 3 days was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear discomfort, Facial discomfort, Musculoskeletal discomfort, Neck pain
Clinical narrative: neck, ear and facial pressure; neck, ear and facial pressure; neck, ear and facial pressure; Pain on left side; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient did not take any concomitant medication. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 36-year-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 tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, several hours after getting the vaccine the patient experienced left arm, shoulder and neck were sore. On 28Mar2021, couple of days after the vaccine, the patient neck, ear and facial pressure and pain on my left side, which continued for several days. The patient took painkillers to control it. It was finally calming down two weeks after the vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment himself with pain killers. The clinical outcome of the events left arm, shoulder and neck were sore, neck, ear and facial pressure and pain on my left side was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: neck, ear and facial pressure; neck, ear and facial pressure; neck, ear and facial pressure; Pain on left side; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient did not take any concomitant medication. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 36-year-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 tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, several hours after getting the vaccine the patient experienced left arm, shoulder and neck were sore. On 28Mar2021, couple of days after the vaccine, the patient neck, ear and facial pressure and pain on my left side, which continued for several days. The patient took painkillers to control it. It was finally calming down two weeks after the vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment himself with pain killers. The clinical outcome of the events left arm, shoulder and neck were sore, neck, ear and facial pressure and pain on my left side was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair falling out in clumps over the last 2 weeks; This is a spontaneous report from a contactable other health care professional, the patient. A 50-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 left arm on 20Mar2021 at 10:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 09:00, the patient experienced hair falling out in clumps and which continued to occur over the last 2 weeks (at the time of this report). 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 event. The clinical outcome of the event hair falling out in clumps was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Fatigue, Nausea, Pain
Clinical narrative: Earache; Body aches; Nausea; Vomiting; Fatigue; fever of 100; 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: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. The patient had history of known allergies to sulfa. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date (at the age of 54-years-old) as a single dose for COVID-19 immunisation. She also received amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:00, the patient experienced earache, nausea, vomiting, fatigue, body aches, and fever of 100. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of earache, nausea, vomiting, fatigue, body aches and fever were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Earache; Body aches; Nausea; Vomiting; Fatigue; fever of 100; 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: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. The patient had history of known allergies to sulfa. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date (at the age of 54-years-old) as a single dose for COVID-19 immunisation. She also received amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:00, the patient experienced earache, nausea, vomiting, fatigue, body aches, and fever of 100. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of earache, nausea, vomiting, fatigue, body aches and fever were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 64-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 right arm on 06Apr2021 at 12:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. 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. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 02:00, the patient experienced dizzy. Therapeutic measures were not taken as a result of 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 of the event dizzy was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: After having received the second dose within 12 hours began to have a reoccurrence of a shingles attack on the lower right half side of back.; This is a spontaneous report from a contactable consumer, the patient. A 63-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 right arm on 09Apr2021 at 13:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles and allergy to metal staple. Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 01:00, within 12 hours after receiving the second dose the patient experienced a reoccurrence of a shingles attack on the lower right half side of back. The patient had shingles before but knew from past experience it was a result of a stressful experience. The patient had a prescription for valeted and was ok. The event 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 event. The clinical outcome of the event reoccurrence of a shingles attack on the lower right half side of back was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: Chills; Achiness/soreness all over body; Low energy/very tired; Low energy/very tired; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 06:00, the patient experienced chills, achiness/soreness all over body and low energy/very tired. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, achiness/soreness all over body and low energy/very tired were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Elevated heart rate about 20 bpm for 2 hours. I thought it was anxiety.; Mild sore arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 19:15 (at the age of 46-year-old), at dose 1, single for COVID-19 immunisation. Medical history included brain tumor, Respiratory tract congestion (undiagnosed constant congestion) and cough from congestion. The patient had allergy to band-aid adhesive (Known allergies: Bandaid adhesive). The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced mild sore arm. On 19Mar2021 at 19:15, immediately after the first shot, the patient experienced elevated heart rate about 20 bpm for 2 hours. The patient thought it was anxiety. 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. On 19Mar2021 at 19:15, the patient underwent lab test and procedure which included heart rate and the result was elevated heart rate about 20 bpm. The clinical outcome of elevated heart rate was recovered on 19Mar2021 at 21:15. The clinical outcome of mild sore arm was unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival swelling, Oral pain
Clinical narrative: Mouth sore; Swelling of gums; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 00:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take other medication in two weeks of vaccination. The patient previously received naproxen sodium (ALEVE) 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. On 10Apr2021 at 00:00 4 days after shot the patient experienced mouth sore and swelling of gums. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mouth sore and swelling of gums was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.