chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Pain
Clinical narrative: Hot/cold; Body aches; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 22Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 09:00, the patient experienced headache, body aches, hot/cold, fatigue. 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 headache, body aches, hot/cold, fatigue was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and 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. 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 31Mar2021 at 11:45 (at the age of 51-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 vaccination. On 23Apr2021, the patient experienced arm pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain and fatigue were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Feeling of pins and needles in toes and fingers; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not take any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 about a week after the first dose, the patient experienced feeling of pins and needles in toes and fingers for 2 weeks which started about a week after the first dose. The patient was unsure if to take the second dose of vaccination which was scheduled the next day otherwise felt fine. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event feeling of pins and needles in toes and fingers was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: 6 days after receiving vaccine, noticed a lump below my right collarbone. Diagnostic ultrasound is scheduled for 30Apr2021.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL0162) via an unspecified route of administration in the arm left on 15Apr2021 at 16:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The medical history included impaired fasting glucose, obesity, allergy to nuts and stone fruit. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included bupropion (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. On 21Apr2021 at 15:00, 6 days after receiving vaccine, the patient noticed a lump below her right collarbone. The patient reported that diagnostic ultrasound was scheduled on 30Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump below right collarbone was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: I had tingling of my tongue and lips.; I had numbness of my tongue and lips.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 17:00 (at the age of 30-years-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration on 02Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included a known allergy to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Mar2021 at 17:00, the patient experienced tingling and numbness of her tongue and lips. She took a double dose of diphenhydramine (BENADRYL) shortly after and the symptoms resolved within 4 hours. The patient reported that the second dose was taken on 02Apr2021 (also reported as 4 /2/21) and she had the same reaction but took diphenhydramine (BENADRYL) immediately before shot and the reaction lasted only for two and a half hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with double dose of diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling and numbness of tongue and lips were resolved on 12Mar2021 at 21:00.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain, Paraesthesia
Clinical narrative: tingling sensation in both arm; muscle spasm; body aches/sharp needle like pain; headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 04Apr2021 at 14:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 04Apr2021 at 16:00 about 2 hours after the second dose, patient started having headaches and body aches, muscles spam, sharp needle like pain. On 09Apr2021, 5 days later, patient begin to feel tingling sensation in both arms particularly in the palms. He did not think much of these since they were not severed. But now he was concerning that the symptoms were not going away even 3 weeks later(at the time of reporting). The tingling sensations, the needle like pain and occasional headache. He was asking whether this Could be a sign that he was developing a blood clot? He was praying that he will be well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, body aches/sharp needle like pain, muscle spasm and tingling sensation in both arm were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: had a marked increase in depression; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included major depressive disorder (MDD), generalised anxiety disorder (GAD), post-traumatic stress disorder (PTSD), cervical cancer, multiple/recurrent lung infections and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (CLARITIN) and ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE), both from unknown dates for unknown indications and unknown if ongoing. On 11Apr2021 at 08:00, for the next three days following the vaccination, the patient had a marked increase in depression. On 14Apr2021 morning, the patient woke feeling balanced. The patient reported that it was a dramatic difference, like a switch. However, the depression did come back the following week with even greater intensity. The patient believed that the first bout of depression was directly related to the vaccination, but was not certain if the second bout of depression correlates to the vaccine. Also, the patient was concerned to receive the second vaccine dose for fear of increased depression at an even greater rate. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event marked increase in depression for the next three days following the vaccination that came back the following week with even greater intensity was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test
Clinical narrative: Menstrual cycle is late; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 17Apr2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 27Mar2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced menstrual cycle was late. Had taken 4 pregnancy tests, all negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent Pregnancy Test and the result was negative. Patient stated to have undergone four pregnancy tests, all of them were negative. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle was late. Had taken 4 pregnancy tests, all negative was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Insomnia, Paraesthesia
Clinical narrative: Tingling/pins and needles feeling in both hands and arms; Lightheadedness when standing up; Feeling spaced out; Unable to sleep first night after vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm right on 24Apr2021 at 08:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included Henoch-Schonlein Purpura, anxiety, depression and ADHD (Attention deficit Hyperactive Disorder) and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications included ursodeoxycholic acid (ACTIGALL), omeprazole (PRILOSEC), famotidine (PEPCID), melatonin (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication from an unknown date. The patient previously took diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) in the left arm on 27Mar2021 at 11:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr 2021, first night after the vaccine the patient was unable to sleep. On 25Apr2021 at 11:00, the patient experienced Tingling/ pins and needles feeling in both hands and arms, light-headedness when standing up and feeling spaced out. 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 tingling/ pins and needles feeling in both hands and arms, light-headedness when standing up, feeling spaced out and unable to sleep first night after the vaccine were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Skin warm
Clinical narrative: Headache; Skin was warm to touch; Chills; Difficulty sleeping; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via intramuscular route of administration on 14Apr2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and colectomy. It was unknown if the patient had allergies to medications, food or other products. The patient received unspecified antibiotics 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 14Apr2021 at 16:00, the patient experienced headache, skin was warm to touch, chills and had difficulty sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, skin was warm to touch, chills and difficulty sleeping were resolved the day following vaccination, on 15Apr2021 by 08:00.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Muscle soreness; Very tired; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the arm left on 24Apr2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to strawberries and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 03Apr2021 at 16:45 (at the age of 60-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 vaccine. On 24Apr2021 at 20:00, the patient experienced being very tired, nausea and muscle soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcome of the events very tired, nausea and muscle soreness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en9581) via an unspecified route of administration in the left arm on 24Apr2021 at 15:30 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included tinnitus; left ear had mild tinnitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. On 25Apr2021 at 06:00, the patient experienced left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear after day 1 of vaccine. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 5 weeks after the second shot I have pain in my arm from the shot area down to my hand.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 14:30 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy (sulfur). 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 14:30 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 08:00, five weeks after the second shot, the patient experienced pain in arm from the shot area down to hand. This has been going on for one week. 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 adverse event which included treatment with Aspirin (which helped only somewhat). The clinical outcome of the event pain in arm from the shot area down to hand was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Mild dizziness developed two days post injection.; When moving from vertical to horizontal or vise versa I would get a dizzy feeling and loose balance.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,  Lot Number: ER8733) via an unspecified route of administration in the arm left on 31Mar2021 at 13:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The medical history included asthma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 02Apr2021 at 04:00, the patient experienced mild dizziness and loose balance. It was reported that when moving from vertical to horizontal or vise versa the patient would get a dizzy feeling and loose balance. An example was getting out of bed after sleep, he would have to wait for the body to adjust to vertical orientation and dizziness to subside before taking steps. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild dizziness and loose balance were recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Ocular migraine headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 at 11:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issue, blood pressure high (HBP), high cholesterol and high sugar. The patient had known seasonal/yearly allergies, allergy to dust, dust mites and pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR), all for unknown indications from an unknown date and unknown if ongoing. On 17Mar2021 at 20:00, the patient experienced ocular migraine headaches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event ocular migraine headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Pain in arm similar to tetanus shot; Slight headache off and on for a day; Slight fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 13:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to soy milk. The patient previously took amoxicillin on an unknown date for unknown indication and experienced drug allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 00:00, the patient experienced pain in arm similar to tetanus shot, slight headache off and on for a day and slight fatigue. 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 pain in arm, headache and fatigue were recovered on 25Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Fatigue; Body aches; Flu like symptoms; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 22Apr2021 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date in Apr2021 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced fatigue, body aches, flu like symptoms after second dose lasting two days and unknown if fever occurred. By second day, symptoms were resolving but not completely resolved. 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 the result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, body aches and flu like symptoms were resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Slightly light headed for about 15 minutes.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 13:00 (at age of 70-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 vaccine. On 22Apr2021, after second shot, the patient became slightly light headed for about 15 minutes. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slightly light headed for about 15 minutes was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oral pain, Pain in extremity
Clinical narrative: Sharp like needle poking pain in feet/ sore arm; Nausea; Headache; Pain in mouth; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 24Apr2021 at 08:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and unspecified birth control pill; all taken from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021 at 17:00, the patient experienced sharp like needle poking pain in feet, nausea, headache, sore arm and pain in mouth. 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 sharp like needle poking pain in feet/ sore arm, nausea, headache and pain in mouth were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: 4 days after vaccine, noticed swelling to lymph node on right clavicle. It is painful to touch.; 4 days after vaccine, noticed swelling to lymph node on right clavicle. It is painful to touch.; Pain radiates up the right side of neck towards the back of right ear; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 16:00, 4 days after vaccine, the patient experienced swelling to lymph node on right clavicle, it was painful to touch and pain radiated up the right side of neck towards the back of right ear. 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 swelling to lymph node on right clavicle, it was painful to touch and pain radiated up the right side of neck towards the back of right ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Irritability, Nausea
Clinical narrative: Pain at the shot site; Swelling at the shot site; Headache; Blurred vision; Nausea; metal taste in mouth; Irritability; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, and gluten sensitivity. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); taken for unknown indication on an unknown date and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue. It was unknown whether therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vision blurred
Clinical narrative: Pain at the shot site; Swelling at the shot site; Headache; Blurred vision; Nausea; metal taste in mouth; Irritability; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, and gluten sensitivity. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); taken for unknown indication on an unknown date and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue. It was unknown whether therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling, pins and needles in hands and legs; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Apr2021, the patient experienced tingling, pins and needles in hands and legs and was happening all the time. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling, pins and needles in hands and legs was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: I smelled and tasted cigarette smoke; I smelled and tasted cigarette smoke; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Apr2021 at 09:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced tasted and smelled cigarette smoke for about 7 full days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events smelled and tasted cigarette smoke was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Tinnitus
Clinical narrative: Ringing ears; Body aches; Shooting pains; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 20Apr2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mangoes and cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received prednisone (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 20Apr2021 at 22:00, the patient experienced body aches, ringing ears, chills and shooting pains. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, ringing ears, chills and shooting pains were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node under right armpit; Tender lymph node under right armpit/tenderness has extended into under right arm area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. The patient did not take any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 09:30, 9 days after first dose. the patient experienced swollen and tender lymph node under right armpit (injection site was right arm) and noticed tenderness. On 25Apr2021, the tenderness had extended into under right arm area. The adverse event resulted in emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node under right armpit and tender lymph node under right armpit/tenderness has extended into under right arm area were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Pain at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 13:00, immediately after vaccination, the patient experienced pain at the injection site. On 20Apr2021, the patient experienced sore throat. On 21Apr2021, the patient's arm felt better but sore throat remained. 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 event pain at the injection site was resolving, whereas the event sore throat was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Arm was sore, but not able tonuse for 3 days. There was no strength for any movement.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Vaginal haemorrhage
Clinical narrative: Spotting; heavy flow/menstrual fluid is watered down; heavy flow; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0716), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:30 (03:30 pm) (at the age of 29-years-old) (pregnancy at time of vaccination: no) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies and no other medical history. The patient's concomitant medication/medications the patient received within 2 weeks of vaccination included nitrofurantoin (MACROBID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the last day of the patient's menstrual cycle was 15Apr2021, the day after she received my first round of Pfizer (24Apr2021) on 25Apr2021 07:00, she began spotting. The following day and every day since she has been experiencing a heavy flow. Her menstrual fluid was watered down and very unusual for her. The patient not received treatment for the adverse events. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.