chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: It is worse at night and sometimes "I" cant sleep on my left side. The pain comes and goes throughout the day. "I" feel it from "my" shoulder to "my" elbow.; Pain on "my" left arm started near injection site.; The pain is sharp, sometimes stabbing pain which at night prevents "me" from sleeping.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included gastroesophageal reflux disease (GERD), high blood pressure, asthma (controlled) and hypothyroidism. 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. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ALLERTEC), estrogens conjugated (PREMARIN) and zol (unspecified); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Mar2021 at 13:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient previously took hydrocodone bitartrate/paracetamol (VICODIN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates and experienced allergy. On 09Apr2021, the patient underwent SARS-CoV-2 test and the result was found to be negative. On 23Apr2021 at 14:30, the patient had pain on her left arm near injection site. It was worse at night and sometimes she can't sleep on her left side. The pain was sharp, sometimes stabbing pain which at night prevents her from sleeping. The pain came and went throughout the day and she felt the pain from her shoulder to her elbow. The adverse 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 reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events pain on her left arm near injection site, stabbing pain and felt the pain from shoulder to elbow 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: Asthenopia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: noticed a rash (was not present last night); left arm watch itchy and warm; left arm watch itchy and warm; headaches; chills; tiredness; eye strain; difficulty focusing vision; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 20Apr2021 at 16:45 pm (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient's medical history included migraines from an unknown date. Concomitant medication the patient received within 2 weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021, the patient experienced headaches, chills, tiredness, eye strain and difficulty focusing vision. On 29Apr2021, the patient's left arm watch itchy and warm. On 30Apr2021, the patient noticed a rash (was not present last night). No treatment was received for the adverse events. The case was assessed as non-serious. The outcome of the events left arm watch itchy and warm and noticed a rash (was not present last night) was resolving. The outcome of the other events was not resolved.  Follow-up activities completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vision blurred
Clinical narrative: noticed a rash (was not present last night); left arm watch itchy and warm; left arm watch itchy and warm; headaches; chills; tiredness; eye strain; difficulty focusing vision; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 20Apr2021 at 16:45 pm (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient's medical history included migraines from an unknown date. Concomitant medication the patient received within 2 weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021, the patient experienced headaches, chills, tiredness, eye strain and difficulty focusing vision. On 29Apr2021, the patient's left arm watch itchy and warm. On 30Apr2021, the patient noticed a rash (was not present last night). No treatment was received for the adverse events. The case was assessed as non-serious. The outcome of the events left arm watch itchy and warm and noticed a rash (was not present last night) was resolving. The outcome of the other events was not resolved.  Follow-up activities completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Large area of swelling under armpit to front of lat and left ribs; swelling moved down the third day to left side of abs and down to waistline area; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 04:15 (at the age of 17-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. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included minocycline (MANUFACTURER UNKNOWN) and dexmethylphenidate (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. On 26Apr2021 at 09:00, the patient experienced large area of swelling under armpit to front of lateral and left ribs. The third day, swelling moved down to left side of abs and down to waistline area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling under armpit to front of lateral and left ribs, moved down to left side of abs and down to waistline area was unknown at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Seborrhoea
Clinical narrative: My face is extremely greasy and am breaking out/My hair is also oily which it never is; Face is extremely greasy and am breaking out; This is a spontaneous report from a contactable consumer, the patient. A 41-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 10Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), fibromyalgia, pimples when she was 14 and restless leg syndrome (RLS) since unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tofacitinib citrate (XELJANZ), gabapentin (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); for an unknown indication, from an unknown date and unknown if ongoing. The patient previously took benzoin (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 19Mar2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 00:00, the patient experienced extremely greasy face and breaking out. She did not have breakouts since she was 14. The patient got out of the shower and within 10 minutes she felt like she needed to scrub her face again. There had been no changes in any medicine or other health issues other than getting the COVID-19 vaccine. The patient's hair was also oily which it never was. She usually went 3 days between hair washes and reported that since Saturday when this all started, she had to wash her hair every day. The patient was not pregnant and had no menstrual related acne or oiliness. 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 event face was extremely greasy, breakouts and oily hair 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Paraesthesia
Clinical narrative: 48 hrs after  2nd dose experienced tingling in my breast; when pressed on both breast i can express milk like discharge; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second 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 the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) started at unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Apr2021 at 12:00, exactly 48 hours after second dose, the patient experienced, tingling in breast and when pressed on both breast express milk like discharge. The patient reported that exactly 48 hours after 2nd dose the patient experienced tingling in breast (same as would feel when breastfeeding) and since then when pressed on both breast the patient could express milk like discharge and the patient had not breastfeed for 5 years at the time of report. It was unknown whether any therapeutic measures were taken as a result of the events. The events resulted 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 tingling in breast and when pressed on both breast express milk like discharge was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest discomfort, Chest pain, Dyspnoea, Musculoskeletal pain
Clinical narrative: I had shortness of breath; Mild pain radiating from my left shoulder blade; Mild pain radiating from my left shoulder blade to my left armpit; Mild pain radiating from my left shoulder blade to my left armpit and arm.; I received the vaccination Friday. Saturday I started noticing chest pain; Chest tightness; Mild pain radiating from my left shoulder blade to my left armpit and arm; 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: EN6208) via an unspecified route of administration in the left arm on 23Apr2021 at 07:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. Concomitant mediations included flo vitamins (MANUFACTURER UNKNOWN) and one a day women's gummies (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bismuth subsalicylate (PEPTO BISMOL) on an unknown date and experienced drug allergy. The patient received the vaccination on Friday and that on Saturday 24Apr2021 at 08:00 she started noticing chest pain and tightness as well as mild pain radiating from her left shoulder blade to her left armpit and arm. The patient reported that on Sunday, 25Apr2021 it continued and had shortness of breath. This had continued daily for 5 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chest pain, chest tightness, mild pain radiating from her left shoulder blade to her left armpit and arm shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: I had shortness of breath; Mild pain radiating from my left shoulder blade; Mild pain radiating from my left shoulder blade to my left armpit; Mild pain radiating from my left shoulder blade to my left armpit and arm.; I received the vaccination Friday. Saturday I started noticing chest pain; Chest tightness; Mild pain radiating from my left shoulder blade to my left armpit and arm; 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: EN6208) via an unspecified route of administration in the left arm on 23Apr2021 at 07:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. Concomitant mediations included flo vitamins (MANUFACTURER UNKNOWN) and one a day women's gummies (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bismuth subsalicylate (PEPTO BISMOL) on an unknown date and experienced drug allergy. The patient received the vaccination on Friday and that on Saturday 24Apr2021 at 08:00 she started noticing chest pain and tightness as well as mild pain radiating from her left shoulder blade to her left armpit and arm. The patient reported that on Sunday, 25Apr2021 it continued and had shortness of breath. This had continued daily for 5 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chest pain, chest tightness, mild pain radiating from her left shoulder blade to her left armpit and arm shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Pain, Tremor
Clinical narrative: Strong aches; Extreme chills; Moderate fatigue; Muscle cramping; Minor shakes; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as not applicable. 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 medication included hydrochlorothiazide (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously 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 an unknown date as a single dose for COVID-19 immunisation. On 27Apr2021 at 10:00, the patient experienced strong aches, extreme chills, moderate fatigue, muscle cramping and minor shakes. 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 strong aches, extreme chills, moderate fatigue, muscle cramping and minor shakes was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: Swollen Lymph node in the armpit (4/2/1) starting the night of the vaccine shot and last for 24 hours; Swollen Lymph node in the armpit (4/2/1) starting the night of the vaccine shot and last for 24 hours, some inflammation after that for a couple more days.; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via intramuscular route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING) for unknown indication on unknown date and unknown if ongoing. The patient previously took clavulanic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced swollen lymph node in the armpit which measured 4inches/ 2inches /1inch, starting the night of the vaccine shot and lasted for 24 hours and some inflammation on an unknown date in Apr2021 after that for a couple more days. 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 swollen lymph node in the armpit which measured 4inches/ 2inches /1inch, starting the night of the vaccine shot and lasted for 24 hours was resolved on 15Apr2021, while that of some inflammation after that for a couple more days was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ejaculation disorder, Haematospermia, Inappropriate schedule of product administration
Clinical narrative: Blood in "my" semen; Every time "I" ejaculate, blood comes out.; Outside the window period 19-42 days vaccine administrated(16days); This is a spontaneous report from a contactable consumer, the patient. A 42-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 arm left on 25Feb2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa (sulfonamide 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. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) all for an unknown indication from unknown date and unknown if ongoing. The patient previously received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 12:00 as a single dose for COVID-19 immunisation. On 06Mar2021 at 12:00 the patient experienced blood in semen and every time the patient ejaculate, blood comes out. The patient went to a Urologist and they could not find anything wrong and it did not happen until the patient received second vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. 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 blood in semen and every time the patient ejaculate, blood comes out was not recovered 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Continued arm pain near injection site and down arm; Continued arm pain near injection site and down arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, macular degeneration, knee surgery, C-section and known allergies  to latex, cows [diary and meat, not eggs], sulfas(sulfonamide allergy) and two others that she could not remember. 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 levonorgestrel (MIRENA), paracetamol (TYLENOL), melatonin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 18Apr2021, the patient experienced continued arm pain near injection site and down arm. 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 events continued arm pain near injection site and down arm was recovered with sequelae (also reported as recovered with lasting effects) on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Late period; light bleeding; period over a week long; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced late period, light bleeding and period over a week long. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events late period, light bleeding and period over a week long was unknown 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Limb discomfort, Lymphadenopathy
Clinical narrative: Pins and needles in "my" hands and feet.; Numbness in "my" hands, feet, arms, legs, and occasionally neck and face.; Sharp prickling sensation; Extremely uncomfortable. It is most prominent in the arm in which "I" received the vaccine.; "I" am experiencing nausea; Vertigo; A mid-grade fever; A sore throat; Fatigue; Body aches; Headaches; Swollen lymph nodes; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO165) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anaemia, severe concussion in July 2022, COVID-19 and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ascorbic acid/ ferrous fumarate (Vitamin C) as iron supplements from an unknown date and unknown if ongoing. On 22Apr2021 at 09:30, immediately after the vaccination, the patient began experiencing pins and needles in her hands and feet. It was reported that the patient was kept in the clinic for 30 minutes in case of an allergic reaction. Since then, the patient had been experiencing this sensation as well as numbness in her hands, feet, arms, legs, and occasionally neck and face and sometimes it was escalated to a sharp prickling sensation and became extremely uncomfortable for the patient which was most prominent in the arm in which patient received the vaccine. Aside from this the patient also experienced nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes, and injection site soreness. It was reported that the patient had COVID-19 before and experienced similar pins and needles but was less extreme and was only in her hands and feet. 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 pins and needles in her hands and feet, numbness in her hands, feet, arms, legs/ occasionally neck and face, sharp prickling sensation and extremely uncomfortable in the arm in which received the vaccine, nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes and injection-site soreness was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: Pins and needles in "my" hands and feet.; Numbness in "my" hands, feet, arms, legs, and occasionally neck and face.; Sharp prickling sensation; Extremely uncomfortable. It is most prominent in the arm in which "I" received the vaccine.; "I" am experiencing nausea; Vertigo; A mid-grade fever; A sore throat; Fatigue; Body aches; Headaches; Swollen lymph nodes; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO165) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anaemia, severe concussion in July 2022, COVID-19 and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ascorbic acid/ ferrous fumarate (Vitamin C) as iron supplements from an unknown date and unknown if ongoing. On 22Apr2021 at 09:30, immediately after the vaccination, the patient began experiencing pins and needles in her hands and feet. It was reported that the patient was kept in the clinic for 30 minutes in case of an allergic reaction. Since then, the patient had been experiencing this sensation as well as numbness in her hands, feet, arms, legs, and occasionally neck and face and sometimes it was escalated to a sharp prickling sensation and became extremely uncomfortable for the patient which was most prominent in the arm in which patient received the vaccine. Aside from this the patient also experienced nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes, and injection site soreness. It was reported that the patient had COVID-19 before and experienced similar pins and needles but was less extreme and was only in her hands and feet. 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 pins and needles in her hands and feet, numbness in her hands, feet, arms, legs/ occasionally neck and face, sharp prickling sensation and extremely uncomfortable in the arm in which received the vaccine, nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes and injection-site soreness was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: Pins and needles in "my" hands and feet.; Numbness in "my" hands, feet, arms, legs, and occasionally neck and face.; Sharp prickling sensation; Extremely uncomfortable. It is most prominent in the arm in which "I" received the vaccine.; "I" am experiencing nausea; Vertigo; A mid-grade fever; A sore throat; Fatigue; Body aches; Headaches; Swollen lymph nodes; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO165) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anaemia, severe concussion in July 2022, COVID-19 and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ascorbic acid/ ferrous fumarate (Vitamin C) as iron supplements from an unknown date and unknown if ongoing. On 22Apr2021 at 09:30, immediately after the vaccination, the patient began experiencing pins and needles in her hands and feet. It was reported that the patient was kept in the clinic for 30 minutes in case of an allergic reaction. Since then, the patient had been experiencing this sensation as well as numbness in her hands, feet, arms, legs, and occasionally neck and face and sometimes it was escalated to a sharp prickling sensation and became extremely uncomfortable for the patient which was most prominent in the arm in which patient received the vaccine. Aside from this the patient also experienced nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes, and injection site soreness. It was reported that the patient had COVID-19 before and experienced similar pins and needles but was less extreme and was only in her hands and feet. 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 pins and needles in her hands and feet, numbness in her hands, feet, arms, legs/ occasionally neck and face, sharp prickling sensation and extremely uncomfortable in the arm in which received the vaccine, nausea, vertigo, a mid-grade fever, a sore throat, fatigue, body aches, headaches, swollen lymph nodes and injection-site soreness was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; Chills; Nausea; Vomiting; Body aches; Cold hands and feet; Muscle and joint pain; Muscle and joint pain; Jaw pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced headache, chills, nausea, vomiting, body aches, cold hands and feet, muscle and joint pain and jaw pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, chills, nausea, vomiting, body aches, cold hands and feet, muscle and joint pain and jaw pain was resolving 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Peripheral coldness, Vomiting
Clinical narrative: Headache; Chills; Nausea; Vomiting; Body aches; Cold hands and feet; Muscle and joint pain; Muscle and joint pain; Jaw pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced headache, chills, nausea, vomiting, body aches, cold hands and feet, muscle and joint pain and jaw pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, chills, nausea, vomiting, body aches, cold hands and feet, muscle and joint pain and jaw pain was resolving 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Skin irritation
Clinical narrative: Skin iritated, shed after a few days(similar to sun poisoning) on wrist of injection arm.; Skin iritated, shed after a few days(similar to sun poisoning) on wrist of injection arm. Specifically where fitbit band is; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, moderately high LDL cholesterol, allergy to nutmeg and bell peppers. 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 cetirizine hydrochloride (ZYRTEC) and generic multi-vitamins (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. On 28Apr2021 the patient experienced skin irritated, shed after a few days (similar to sun poisoning) on wrist of injection arm specifically where patient's Fitbit band was. 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 skin irritated, shed after a few days (similar to sun poisoning) on wrist of injection arm specifically where patient's Fitbit band was, was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Hypersomnia, Nausea
Clinical narrative: "I" was tired on day of the shot and slept a lot on the second day; Some brain fog; "My" arm was also very warm and somewhat red on 2nd day; "My" arm was also very warm and somewhat red on 2nd day; Just generally felt nauseated for and three days; Pain in left arm starting the evening of the 22nd and 2nd day was the worst pain pain was less on 3rd day and finally had no pain by 5th day; "I" was tired on day of the shot and slept a lot on the second day; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, obesity and known seasonal allergy; on unknown dates and unknown if ongoing and suspected COVID-19 in Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and naproxen sodium (ALEVE); all for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date, and experienced drug allergy. On an unknown date in Dec2020, the patient underwent SARS-CoV-2 test and the result was negative. On 22Apr2021 at 18:00 starting in the evening, the patient experienced pain in left arm, second day was the worst pain (hard to lift left arm out from the body laterally). Then the pain was less on third day and finally had no pain by fifth day and also was tired on day of the shot. On 23Apr2021 (reported as on the second day), the patient was slept a lot and had some brain fog (was not as bad as when patient was sick with COVID-19 on an unknown date in Dec2020 - though test came back negative, but had most symptoms, but was not hospital needed). On same day patient felt, arm was also very warm and somewhat red, and just generally felt nauseated for three days. The events did not result in doctor or other healthcare professional office/clinic, 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 event felt nauseated for three days was resolved on 26Apr2021; whereas the event pain in left arm starting the evening was resolved on 27Apr2021; thereof the events she was tired on day of the shot and slept a lot on the second day, some brain fog, her arm was also very warm and somewhat red on second day were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Skin warm
Clinical narrative: "I" was tired on day of the shot and slept a lot on the second day; Some brain fog; "My" arm was also very warm and somewhat red on 2nd day; "My" arm was also very warm and somewhat red on 2nd day; Just generally felt nauseated for and three days; Pain in left arm starting the evening of the 22nd and 2nd day was the worst pain pain was less on 3rd day and finally had no pain by 5th day; "I" was tired on day of the shot and slept a lot on the second day; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, obesity and known seasonal allergy; on unknown dates and unknown if ongoing and suspected COVID-19 in Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and naproxen sodium (ALEVE); all for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date, and experienced drug allergy. On an unknown date in Dec2020, the patient underwent SARS-CoV-2 test and the result was negative. On 22Apr2021 at 18:00 starting in the evening, the patient experienced pain in left arm, second day was the worst pain (hard to lift left arm out from the body laterally). Then the pain was less on third day and finally had no pain by fifth day and also was tired on day of the shot. On 23Apr2021 (reported as on the second day), the patient was slept a lot and had some brain fog (was not as bad as when patient was sick with COVID-19 on an unknown date in Dec2020 - though test came back negative, but had most symptoms, but was not hospital needed). On same day patient felt, arm was also very warm and somewhat red, and just generally felt nauseated for three days. The events did not result in doctor or other healthcare professional office/clinic, 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 event felt nauseated for three days was resolved on 26Apr2021; whereas the event pain in left arm starting the evening was resolved on 27Apr2021; thereof the events she was tired on day of the shot and slept a lot on the second day, some brain fog, her arm was also very warm and somewhat red on second day were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Injection site pain; swollen axillary lymph nodes; whole body joint pain; whole body muscle pain; whole body skin pain; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, peppers allergy, bananas allergy, latex allergy, dust allergy and boxelder pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), multi vitamins (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and oxymetazoline hydrochloride (AFRIN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clobetasol (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 01Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea. 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 outcomes of the events injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.