chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 3 days after 1 shot developed shingles sytarted getting better with medication and topical meds 3 days after 2nd shot it flared up again; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 61-years-old) as a single dose and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure but controlled. The patient had no known allergies to medications food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, 3 days after first shot, the patient developed shingles which started getting better with medication and topical medications, 3 days after 2nd shot it flared up again. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with valtrex and gabapentin. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event 3 days after first shot developed shingles started getting better with medication and topical meds and again 3 days after 2nd shot it flared up was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevated BP for 12 hours beginning 24 hours after receiving injection.  Generally BP 120/75. Ran 150/90 to 162/101 from 10 am to 10 pm.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 26Mar2021 at 10:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol, thyroid, osteoporosis and mild reactions for penicillin. Concomitant medications included lisinopril dihydrate (LISINOPRIL), levothyroxine (MANUFACTURER UNKNOWN), lovastatin (MANUFACTURER UNKNOWN) and alendronate sodium (ALENDRONATE); all for unknown indication from an unknown date. The patient previously received blue dye for unknown indication on an unknown date for 2 weeks and experienced elevated BP. The patient previously received macrobid (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 05Mar2021 at 11:30 (at the age of 68-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 10:00, the patient experienced elevated BP for 12 hours beginning 24 hours after receiving injection. Generally, BP 120/75. Ran 150/90 to 162/101 from 10 am to 10 pm. The patient previously experienced elevated BP as a reaction to maintenance meds with blue dye after taking them for 2plus weeks. This was unanticipated, more immediate and extensive. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event Elevated BP was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: lymph glands under left arm were quite swollen and sore; fever; chills; sore arm at the injection site; Felt tired and crappy; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 03Apr2021 at 09:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient did not have an allergy to any medications, food, or other products. Concomitant medications were unspecified and received within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not experience any side effect with the first dose. On 04Apr2021 at 06:30, the patient woke up with fever, chills, and sore arm at the injection site and felt tired and crappy, then felt better around midnight. On 05Apr2021, when the patient woke up, the patient reported that the lymph glands under the left arm were quite swollen and sore on the same vaccinated arm and lasted for 3 days. On 08Apr2021, the patient was all fine on day 4. 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 the events which included treatment with acetaminophen 500mg (MANUFACTURER UNKNOWN) on 04Apr2021; 1 tablet taken and the fever went away for a while, repeated as needed and unknown if still ongoing. The clinical outcome of the events fever, chills, sore arm at the injection site, felt tired and crappy, lymph glands under the left arm were quite swollen and sore, were recovered on 08Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Painful Lymph nodes near armpit and collarbone; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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 an unknown date in 2021, the patient experienced painful lymph nodes near armpit and collarbone. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event painful lymph nodes near armpit and collarbone was recovered with sequelae on an unknown date.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: 13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via unspecified route of administration in the right arm on 07Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via unspecified route of administration in the right arm on 28Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to unspecified products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021, 13 days after each vaccine, the patient experienced swollen tongue, gums, cheek and lips. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen tongue, gums, cheek and lips was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Sinusitis
Clinical narrative: Chest congestion within 10 minutes needing to clear with cough.; Chest congestion within 10 minutes needing to clear with cough.; Then sinus swelling lasted for around 26 hour.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 01Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfa and many side effects to other medications, soaps and cleaners. The patient had known allergies to erythromycin but no food allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), curcuma longa rhizome (TURMERIC) and omeprazole (GENERIC PRILOSEC); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 10:45, within 10 minutes of vaccination, the patient experienced chest congestion needing to clear with cough which lasted for hour in half and sinus swelling that lasted for around 26 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest congestion needing to clear with cough which lasted for hour in half was recovered on 01Apr2021; while that of the sinus swelling that lasted for around 26 hours was recovered on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Soreness at the injection site; Indigestion; Vomiting; Nausea; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 09Apr2021 at 10:00 (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. 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 18:00, the patient experienced soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue. 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 events. The clinical outcome of the events soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Soreness at the injection site; Indigestion; Vomiting; Nausea; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 09Apr2021 at 10:00 (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. 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 18:00, the patient experienced soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue. 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 events. The clinical outcome of the events soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 40, via an unspecified route of administration, left arm, on Apr 7, 2021, at 08:45, single dose, for COVID-19 immunisation. Medical history not reported. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 8, 2021, at 14:00, day after receiving the first dose, patient experienced tinnitus. The patient did not receive any treatment for the event. The events did not result in doctor, other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the tinnitus: not recovered. No follow-up attempts needed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: My menstrual cycle was different than normal; I had terrible cramping which is very abnormal for me, and instead of having a normal period, I just had spotting the days of my period.; I had terrible cramping which is very abnormal for me, and instead of having a normal period, I just had spotting the days of my period.; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known 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 vaccination. On 02Apr2021, the patient experienced her menstrual cycle different than normal. The patient had terrible cramping which was very abnormal for her, and instead of having a normal period, she just had spotting the days of her period. The patient typically always had normal menstrual cycles and this was the only thing that had changed. The patient was on zero medications and not pregnant. 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 events. The clinical outcome of the events menstrual cycle was different than normal, had terrible cramping which was very abnormal, and instead of having a normal period, just had spotting the days of period was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder discomfort, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Headacke; Dizzyness; Nasua; Loss of bladder control; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 66-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 07Apr2021 at 17:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes, heart failure and COPD. The patient did not have any allergies to medications, food, or other products. Concomitant medications were 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 05:00, the patient experienced headacke, dizzyness, nasua, throwing up and loss of bladder control. 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. The clinical outcome of the events headache, dizziness, nausea, throwing up and loss of bladder control were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eye swelling, Headache, Hypoaesthesia, Pallor
Clinical narrative: After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; face swelled up; After the shot:12 minutes - minor headache; After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:45 AM as single dose (at the age of 43-year-old) for covid-19 immunisation. The patient's medical history included allergic reaction to the fruit, pears (had a severe allergic reaction after eating a long time ago, 10-15 years ago). Concomitant medications included pre-natal vitamins within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. As per report it was reported that, on 12Apr2021 at 09:00, after the shot, 15 minutes later face swelled up, 12 minutes later patient experienced minor headache. After 30 minutes patient experienced swollen throat/throat swelled up, shaking legs, pale colour, medicine taste in mouth (patient was administered 2 pills of benadryl). Next day on 13Apr2021 area around the eyes was swollen and also itchy/numb nose. Patient was given Benadryl at the clinic (location of the vaccination). Patient took 1 pill of Cetirizine Hydrochloride 10mg. Therapeutic measures were taken as a result of the events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling face, Tremor
Clinical narrative: After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; face swelled up; After the shot:12 minutes - minor headache; After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:45 AM as single dose (at the age of 43-year-old) for covid-19 immunisation. The patient's medical history included allergic reaction to the fruit, pears (had a severe allergic reaction after eating a long time ago, 10-15 years ago). Concomitant medications included pre-natal vitamins within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. As per report it was reported that, on 12Apr2021 at 09:00, after the shot, 15 minutes later face swelled up, 12 minutes later patient experienced minor headache. After 30 minutes patient experienced swollen throat/throat swelled up, shaking legs, pale colour, medicine taste in mouth (patient was administered 2 pills of benadryl). Next day on 13Apr2021 area around the eyes was swollen and also itchy/numb nose. Patient was given Benadryl at the clinic (location of the vaccination). Patient took 1 pill of Cetirizine Hydrochloride 10mg. Therapeutic measures were taken as a result of the events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Nipple pain
Clinical narrative: Sharp pain in right breast/nipple; Sharp pain in right breast/nipple; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, hypothyroidism, fibromyalgia and COVID-19. The patient was allergic to penicillin. Concomitant medications included piroxicam (PAXIL), levothyroxine sodium (LEVOTHYROXIN), vitamin d nos (MANUFACTURER UNKNOWN) and cobamamide (VITAMIN B12); from an unknown date and for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00, the patient experienced sharp pain in right breast/nipple entire day after receiving vaccine. This was the opposite side from where the patient received the shot. 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 events. The clinical outcome of the events sharp pain in right breast/nipple were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate abnormal, Myalgia
Clinical narrative: Blurred vision; Abnormal heart beat; Light headed/ occasional dizziness; Severe headache; Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 09Apr2021 at 14:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD) and mushrooms (food allergy). Concomitant medications included CRESTOR, 81 mg ASPRIN and 100 mg COQ10 for unknown indication from unknown dates. The patient previously took LEVAQUIN for unknown indication and experienced drug allergy on 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. The patient vaccinated Friday pm (09Apr2021). On 10Apr2021 at 09:00 (Saturday morning), the patient experienced severe headache, muscle aches, blurred vision, abnormal heart beat as indicated by BP machine. Constant for about 24 hours. Extreme fatigue and light headed/occasional dizziness continue into Tuesday (4 days later). All symptoms improving slowly. Therapeutic measures were not taken as a result of these events. The adverse 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 events severe headache, muscle aches, blurred vision, abnormal heart beat, extreme fatigue and light headed/occasional dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; Abnormal heart beat; Light headed/ occasional dizziness; Severe headache; Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 09Apr2021 at 14:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD) and mushrooms (food allergy). Concomitant medications included CRESTOR, 81 mg ASPRIN and 100 mg COQ10 for unknown indication from unknown dates. The patient previously took LEVAQUIN for unknown indication and experienced drug allergy on 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. The patient vaccinated Friday pm (09Apr2021). On 10Apr2021 at 09:00 (Saturday morning), the patient experienced severe headache, muscle aches, blurred vision, abnormal heart beat as indicated by BP machine. Constant for about 24 hours. Extreme fatigue and light headed/occasional dizziness continue into Tuesday (4 days later). All symptoms improving slowly. Therapeutic measures were not taken as a result of these events. The adverse 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 events severe headache, muscle aches, blurred vision, abnormal heart beat, extreme fatigue and light headed/occasional dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Memory impairment, Mental fatigue, Parosmia
Clinical narrative: Extreme mental fatigue; Forgetfulness; Metallic taste in mouth; Metallic smell in nose; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 12:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and non-steroidal anti-inflammatory drug allergy (NSAID). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), progesterone (PROGESTIN)/ estrogen nos (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) all for unspecified indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00 the patient experienced extreme mental fatigue, forgetfulness, metallic taste in mouth and metallic smell in nose. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme mental fatigue, forgetfulness, metallic taste in mouth and metallic smell in nose were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm - same arm where the vaccine was administered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 12Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) for unknown indication on an unknown date and unknown if ongoing. 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 right arm on 23Mar2021 at 14:15 (at the age of 40-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 13Apr2021 at 07:00, the patient experienced sore arm - same arm where the vaccine was administered. No therapeutic measures were taken as a result of the event. The clinical outcome of the event sore arm - same arm where the vaccine was administered was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dermatitis, Headache, Hot flush, Rash
Clinical narrative: full body rash; inflammation/skin is very inflamed; chills; hit flashes; huge headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo, premature ovarian failure (POF), eyebrow loss and low thyroid. The patient had no known allergies. The patient received unspecidied thyroid medication and estrogen patch 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 06Apr2021 at 22:00, 12 hours after the shot, the patient had chills that wouldn't go away, then hit flashes, then a huge headache. On 12Apr2021, 6 days after the shot, the patient developed a full body rash and inflammation. But currently (at the time of this report) the patient has had a body rash for 3 days and her skin was very inflamed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, hit flashes, huge headache, full body rash, inflammation/skin was very inflamed were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: bursitis in right elbow, right heal, and left foot. about 1-2 weeks apart; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Feb2021(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and heart attack in 2017. The patient previously had almonds and experienced allergy to nuts. The patient previously had beer and experienced alcohol intolerance. The patient previously took cefuroxime axetil [CEFTIN] for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included apixaban (ELIQUIS) and metoprolol (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. 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 an unknown date in Feb2021, the patient experienced bursitis in right elbow, right heal, and  left foot about one-two weeks apart. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bursitis in right elbow, right heal, and  left foot, about one-two weeks apart and included treatment with prednisone. The clinical outcome of the event bursitis in right elbow, right heal, and  left foot about one-two weeks apart. was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Woke up with a headache; Body aches; Temperature/Temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit; Extremely fatigued; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 18:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, anxiety, acid reflux and non-alcoholic liver disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN) and "Vi"; all from unknown dates for unknown indications and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 20Feb2021 at 20:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously took tetracycline and codeine and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 16Mar2021, about 12 hours after the second dose, the patient woke up with a headache, body aches and a temperature. The patient reported that the temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit before returning to normal. The patient reported that the headache lasted for 3 days and was very intense for the first 2 days. The patient was also extremely fatigued for 3 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events extremely fatigued, temperature fluctuated and headache. Therapeutic measures were taken as a result of body aches and included treatment with ADVIL. The clinical outcome of the events headache and extremely fatigued was resolved on 19Apr2021. The clinical outcome of the events temperature/ temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit was resolved on 17Apr2021 at 18:30. The clinical outcome of the event body aches was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bruxism, Facial pain, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, largest on left side collar bone; Lymph nodes painful to the touch; Visible swelling under skin; Jaw muscle cramps; Clenching; Facial soreness; Fatigue; Body wide muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 07Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, suspected hypophosphatasia, chronic migraines, peptic ulcers, IBS (irritable bowel syndrome), hiatal hernia and bone lesions. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) glucosamine hydrochloride; methylsulfonylmethane (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021, the patient experienced swollen lymph nodes which were painful to the touch, the largest on the left side collar bone with a visible swelling under the skin. On 10Apr2021, the patient also experienced jaw muscle cramps and clenching which lead to facial soreness, fatigue and he also had body wide muscle soreness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes which were painful to the touch, visible swelling under skin, jaw muscle cramps, facial soreness, fatigue and body wide muscle soreness were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Swelling
Clinical narrative: Swollen lymph nodes, largest on left side collar bone; Lymph nodes painful to the touch; Visible swelling under skin; Jaw muscle cramps; Clenching; Facial soreness; Fatigue; Body wide muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 07Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, suspected hypophosphatasia, chronic migraines, peptic ulcers, IBS (irritable bowel syndrome), hiatal hernia and bone lesions. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) glucosamine hydrochloride; methylsulfonylmethane (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021, the patient experienced swollen lymph nodes which were painful to the touch, the largest on the left side collar bone with a visible swelling under the skin. On 10Apr2021, the patient also experienced jaw muscle cramps and clenching which lead to facial soreness, fatigue and he also had body wide muscle soreness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes which were painful to the touch, visible swelling under skin, jaw muscle cramps, facial soreness, fatigue and body wide muscle soreness were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 58-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 12Apr2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. As per the patient's knowledge, she had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient experienced sore arm and body aches. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and body aches was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: maculopapular rash; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 28Mar2021 at 10:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 the patient experienced maculopapular rash which persisting for over 10 days. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event maculopapular rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown 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. Medical history and concomitant medications were 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced diarrhea. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event diarrhea was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.