chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival blister, Gingival pain, Noninfective gingivitis
Clinical narrative: blisters on mygumline; large sores on my gums and inbetween some teeth; painful; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown,) via an unspecified route of administration in the left arm on 08Mar2021 at 08:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included carotid artery dissection in 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 09 Mar2021, the patient noticed blisters on the gum line. The blisters continued and got more worse and severe as the weeks passed. On an unknown date in Mar2021, the patient had large sores on the gums and in between some teeth. The gum sores were not painful in the beginning but were very painful and irritating at the time of this report. The patients tongue, under the tongue, inner cheeks, and the roof of the mouth were clear of blisters. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events blisters, sores gum and gum pain were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left side of my body, especially my face and head, felt numb after getting the vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730); via an unspecified route of administration in the left arm on 25Mar2021 (at the age 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of known allergies to penicillin. The concomitant medications included colchicine (MITIGARE), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), ascorbic acid; retinol; tocopherol (OCUVITE), vitamin b (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021, the patient experienced numbness on the left-side of body, especially on face and head. The patient did not receive any treatment for reported events. 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. The clinical outcome of event numbness on the left-side of the body, especially on face and head was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain; Malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-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. On 24Mar2021 at 22:15, the patient experienced headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs. The patient received treatment for event fever 100.6 with acetaminophen(TYLENOL). It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes of events headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs were resolving at the time of the report.   No follow-up attempts possible. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Restless legs syndrome, Vaccination site pain
Clinical narrative: Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain; Malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-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. On 24Mar2021 at 22:15, the patient experienced headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs. The patient received treatment for event fever 100.6 with acetaminophen(TYLENOL). It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes of events headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs were resolving at the time of the report.   No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Headache, Neck pain, Pain in extremity
Clinical narrative: Headache; face/neck pain; Neck pain; sore arm; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history included high cholesterol and hypothyroidism (low thyroid). Concomitant medications included progesterone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient has known allergy to hydrocodone and it makes her itchy. Prior to vaccination, patient had not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 18:00 (night at vaccination day), the patient had sore arm and was tired. On 23Mar2021 (second day), the patient was fine but, in the evening, experienced headache with torso and face/neck pain and was fine the third day. Therapeutic measures were taken as a result of the events which included over the counter medication TYLENOL. 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 painful arm, tiredness was resolved on 23Mar2021, whereas for events headache, facial pain, neck pain and pain were resolved on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Visual brightness
Clinical narrative: Woke up with a huge left blood shot eye; Everything was so bright; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730), via an unspecified route of administration in the left arm on 22Mar2021 at 17:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, laser surgery for a detached retina one and half years ago and allergy to latex gloves. 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 received unspecified concomitant medications within two weeks of vaccination. The patient previously received oxycodone; aspirin (PERCODAN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 22:00, the patient was watching television, and all of a sudden, she had to turn off the television and lights because everything was so bright and the patient went to bed. On 23Mar2021 at 06:30, the patient woke up with a huge left blood shot eye. It was reported that the patient had never experienced a blood shot eye before, and this was the eye she had laser surgery for a detached retina one and half years ago. The patient had just gone to retina doctor two weeks prior to the vaccine and her eye was doing great. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events everything was so bright and woke up with a huge left blood shot eye. The clinical outcomes of the events everything was so bright and woke up with a huge left blood shot eye were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Sinus congestion
Clinical narrative: Slight fever of 99.8 the evening of the shot; Sinus congestion; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6199) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history included irregular heartbeat. The patient previously had drug allergy while taking diclofenac sodium (MANUFACTURER UNKNOWN). Concomitant medications included mirtazepine (REMERON), metoprolol (MANUFACTURER UNKNOWN) and krill oil (MANUFACTURER UNKNOWN) all used for an unknown indication and were started on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient had sinus congestion almost immediately and on the same day in the evening at 19:00, the patient had a slight fever of 99.8 (units unspecified). 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 adverse events. The clinical outcomes of the events fever and sinus congestion were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: 3 weeks early and heavy period; 3 weeks early and heavy period; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in left arm on 23Mar2021 at 11:45 (at age of 24 years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in left arm on 04Mar2021 at 09:00 (at age of 24 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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 25Mar2020 at 12:00 after the vaccination, the patient reported she experienced 3 weeks early and heavy period. No therapeutic measures were taken 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 the event 3 weeks early and heavy period was recovered on an unknown date in Mar 2021.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Minor left arm pain; low grade fever of 99.2F the next day; Nausea for most of the next day; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via unspecified route of administration in the left arm on 24Mar2021 at 08:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. No known allergies were reported. 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 had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via unspecified route of administration in the left arm on 04Mar2021 at 07:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 (reported as next day of vaccination), the patient had experienced minor left arm pain, low grade fever of 99.2-degree F and nausea. 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 reported events. The clinical outcomes of the events mild left arm pain, low grade fever and nausea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot no: EM9809) via an unspecified route on her left arm on 19Mar2021, at 14:00 as a dose2, single for COVID-19 immunisation (at the age of 32-Years-old). The patient did not have any medical history. Patient did not have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EM9808) via an unspecified route of administration on her left arm on 26Feb2021, as a dose 1, single for COVID-19 immunisation (vaccinated at 32years old). On 19Mar2021, after approximately 6.5 hours following second vaccination the patient had sudden and acute back pain. The patient stated that the pain was located primarily on left side in the middle back, although there were some sharp pains on the right side (middle) and left lower back, sharp pains would come and go intermittently, multiple times in the first 24 hours and then about twice a day for the following three days, pain was lingered on day 4 though that was mostly a sore ache. 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 events. The clinical outcome of acute back pain was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.  DSU Amendment (02July2021): This follow-up report is being submitted to amend previously reported information included 1. Patient country added in patient tab 2. Relevant Med History "None" deleted since Historical Vaccine captured 3. "a contactable patient" updated as "a non-contactable patient" in narrative.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Gastrointestinal pain, Influenza like illness, Myalgia
Clinical narrative: vaccination site swelling; muscle pain; Nauseous; near syncope; joint pain; Dizziness; Felt like I had the flu but with worse pain and without any upper respiratory symptoms; random pain throughout body.; Pain in the gut; vaccination site arm pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, hyperlipidemia, herpes 1 and 2. The patient was allergic to morphine, hydrocodone, jalapenos and kiwi skin. Concomitant medications included beta blocker (unspecified), statin (unspecified), valacyclovir (MANUFACTURER UNKNOWN) from an unknown date taken for herpes simplex type 1 and 2. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 12:30, the patient experienced pain at the injection site (vaccination site pain) arm pain started about an hour after injection. On 25Mar2021, the patient experienced swelling at injection site so bad she could not move her arm (vaccination site swelling); and on 25Mar2021, the patient experienced  muscle pain and joint pain were bad enough to keep from doing regular activities, random pain throughout body such as in her gut. Nauseous when the patient attempted physical activity. Felt like the patient had the flu but with worse pain and without any upper respiratory symptoms. Pain kept the patient up at night. The patient also experienced dizziness and near syncope. Arm pain started about an hour after injection, other symptoms started second day and lasted until she woke up on 3rd day. The patient did not receive any treatment for the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of vaccination site pain, vaccination site swelling, muscle pain, joint pain, pain, nauseous, flu, dizziness and near syncope was resolved on 26Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Presyncope, Vaccination site pain, Vaccination site swelling
Clinical narrative: vaccination site swelling; muscle pain; Nauseous; near syncope; joint pain; Dizziness; Felt like I had the flu but with worse pain and without any upper respiratory symptoms; random pain throughout body.; Pain in the gut; vaccination site arm pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, hyperlipidemia, herpes 1 and 2. The patient was allergic to morphine, hydrocodone, jalapenos and kiwi skin. Concomitant medications included beta blocker (unspecified), statin (unspecified), valacyclovir (MANUFACTURER UNKNOWN) from an unknown date taken for herpes simplex type 1 and 2. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 12:30, the patient experienced pain at the injection site (vaccination site pain) arm pain started about an hour after injection. On 25Mar2021, the patient experienced swelling at injection site so bad she could not move her arm (vaccination site swelling); and on 25Mar2021, the patient experienced  muscle pain and joint pain were bad enough to keep from doing regular activities, random pain throughout body such as in her gut. Nauseous when the patient attempted physical activity. Felt like the patient had the flu but with worse pain and without any upper respiratory symptoms. Pain kept the patient up at night. The patient also experienced dizziness and near syncope. Arm pain started about an hour after injection, other symptoms started second day and lasted until she woke up on 3rd day. The patient did not receive any treatment for the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of vaccination site pain, vaccination site swelling, muscle pain, joint pain, pain, nauseous, flu, dizziness and near syncope was resolved on 26Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A week after 2nd dose, I broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter or length on arms,legs, back, chest.; This is a spontaneous report received from a contactable consumer, the patient. An 82-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the right arm on 13Mar2021 at 09:30 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Medical history included occasional sciatica and some hearing loss. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the right arm on an unspecified date in Feb2021 at 09:30 (at the age of 82-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. On 21Mar2021 at 17:00, the patient broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter of length on arms, legs, back and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with BENADRYL and calamine lotion (MANUFACTURER UNKNOWN). The clinical outcome of welts was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: 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: ER8730) via an unspecified route of administration in left arm on 25Mar2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 25Mar2021 at 15.45, the patient experienced red and swollen at injection site with localized pain, a hard lump at injection site, and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The clinical outcome of the event vaccination site lump, vaccination site pain, vaccination site swelling, vaccination site erythema and low-grade fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 48-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 left arm on 26Mar2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history was reported as no. The patient had no known allergies. The concomitant medications included celecoxib (CELEXA), cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), acetylsalicylic acid; paracetamol; caffeine; salicylamide (EXCEDRIN) all for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The vaccine was administered at the doctors office or urgent care. On 26Mar2021 at 10:15, the patient experienced extremely dry mouth within 10 minutes of vaccine and severe chills. The events had not resulted 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 adverse events. The clinical outcome of the events extremely dry mouth and severe chills was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tremor
Clinical narrative: Muscle pain; tremor; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration on the left arm on 24Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of receiving the second dose COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. 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 as a single dose for COVID-19 immunisation. The patient experienced muscle pain and tremor on 24Mar2021 at 22:00. 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 event muscle pain and tremor was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unspecified date, 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 for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced fatigue on an unspecified date. The patient did not receive any treatment for the reported event fatigue. The clinical outcome of event fatigue was resolving at the time of this report. No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: 9Concomitant medications were reported as yes. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FN6205) via an unspecified route of administration in right arm on 03March2021 at 12:45 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had reported no allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 25Mar2021 at 07:30, the patient experienced nausea and joint pain. 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 reported events. The clinical outcomes for the events nausea and joint pain were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer, patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (age at vaccination was 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any known allergies. The concomitant medications included fesoterodine fumarate (TOVIAZ) and loratadine (CLARITIN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 46-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four 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 tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced exhaustion. The patient did not receive any treatment for the reported 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 exhaustion was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body pain; Sore arm; Fever 101.6; This is a spontaneous report from a contactable company representative, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, 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 concomitant medications 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 on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient had sore arm, body pain and fever 101.6. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events sore arm, body pain and fever 101.6. The clinical outcomes of the events sore arm, body pain and fever 101.6 were 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: Arthralgia, Body temperature, Myalgia, Pyrexia, Saliva altered
Clinical narrative: A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC) 5mg and magnesium 400 (MANUFACTURER UNKNOWN) (unit unspecified) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 (at an age of 61-year-old) at 11:30, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 13:30 (immediately after vaccination), the patient experienced change in saliva flow. On 26Mar2021 at 06:30 (in the next morning), the patient experienced 103.1 F temperature, muscle ache and joint ache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events changes in saliva flow, 103.1 F temperature, muscle ache and joint ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Oropharyngeal pain
Clinical narrative: Saw throat; I had no voice for 12 days.; Voice came back hoarse; This is a spontaneous report received from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Feb2021 at 15:30 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), heart disorder. The patient had a history of known allergies. The patient had received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines 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 04Feb2021, the patient experienced saw throat. It was reported that the patient had a saw throat for 4 days then she had no voice for 12 days. The patient's voice came back hoarse and was still that way. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken included speech therapy. The clinical outcome of the event saw throat and hoarse voice was not resolved while that of loss of voice was resolved on an unknown date. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Migraine, Pain, SARS-CoV-2 test
Clinical narrative: Intense migraine day after (3/24); Joint and body pains day after (3/24); Joint and body pains day after (3/24); Minor fatigue immediately following(3/23), extreme fatigue day after(3/24), lingering fatigue following 2days (3/25-26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia, raynaud's and attention deficit hyperactivity disorder (ADHD). Concomitant medications included duloxetine hydrochloride (CYMBALTA), testosterone cypionate (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 12:15, the patient experienced minor fatigue immediately following vaccination and had tightness, soreness and pain in injection site day of and 3 days following. On 24Mar2021, the patient experienced extreme fatigue, intense migraine, joint and body pains. On 25Mar2021, the patient had lingering fatigue for next 2 days. The patient underwent lab tests and procedures, which included COVID test (nasal swab) on 04Feb2021 and tested negative. 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 fatigue, tightness and pain at the injection site was recovered on 26Mar2021 and of the intense migraine, joint pains and body pains was recovering at the time of this report.   No follow-up attempts are needed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness, Vaccination site pain
Clinical narrative: Intense migraine day after (3/24); Joint and body pains day after (3/24); Joint and body pains day after (3/24); Minor fatigue immediately following(3/23), extreme fatigue day after(3/24), lingering fatigue following 2days (3/25-26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia, raynaud's and attention deficit hyperactivity disorder (ADHD). Concomitant medications included duloxetine hydrochloride (CYMBALTA), testosterone cypionate (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 12:15, the patient experienced minor fatigue immediately following vaccination and had tightness, soreness and pain in injection site day of and 3 days following. On 24Mar2021, the patient experienced extreme fatigue, intense migraine, joint and body pains. On 25Mar2021, the patient had lingering fatigue for next 2 days. The patient underwent lab tests and procedures, which included COVID test (nasal swab) on 04Feb2021 and tested negative. 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 fatigue, tightness and pain at the injection site was recovered on 26Mar2021 and of the intense migraine, joint pains and body pains was recovering at the time of this report.   No follow-up attempts are needed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Upper lip spasm; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old male patient 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 04Mar2021 at 08:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indications from unspecified dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had tested positive for 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 14Mar2021, the patient experienced lip spasm which started about two weeks after having had received the vaccine. Therapeutic measures and treatment were not taken for the adverse event lip spasm. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lip spasm was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling of lymph nodes in Left armpit.  Very sore to touch.; Swelling of lymph nodes in Left armpit.  Very sore to touch.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination. Since having the vaccine the patient had not undergone a COVID-19 test. The patient experienced swelling of lymph nodes in left armpit which were very sore to touch on 23Mar2021 at 20:00. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken as a result of the adverse events. The clinical outcome of the event swollen lymph nodes and the lymph node pain were not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting.; This is a spontaneous report from a contactable consumer, the parent. A 19-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 25Mar2021 at 14:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history reported as asthma. Concomitant medication included LEXIPRO. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 07:00, the patient experienced vomiting. The adverse event 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 reported events. The clinical outcome of the event vomiting was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.