chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: develop hives on my inner thighs, wrists, mid abdominal area, chest, and lower legs. Hives were itchy and raised; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162HNMC) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis and covid-19.  Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), both from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 14Dec2020, the patient underwent COVID-19 test and the result was positive. On 06Jan2021, the patient underwent COVID-19 test and the result was negative. On 16Apr2021 at 02:00, around 36-48 hours after vaccination, the patient started to develop hives on his inner thighs, wrists, mid abdominal area, chest, and lower legs. Hives were itchy and raised - none apparatus near injection area on arm. No previous history of any allergic reactions to vaccines or otherwise. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event hives was recovering.  No follow-up attempts are needed. No further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Lethargic; Slight fever; Headache; Nausea; Chills; 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 14Apr2021 at 08:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, adhd and arthritis. The patient did not have any allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADERALL) from unknown date for unspecified indication. 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 25Mar2021 at 13:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced lethargic, slight fever, headache, nausea and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargic, slight fever, headache, nausea and chills were resolved on an unknown date in Apr2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Feeling abnormal, Lymph node pain
Clinical narrative: Felt weird; Sore back that felt like organs inside sore, not like muscle ache; Awful night sweats; Awful chills 12 hours after vaccine; Swollen tender lymph node on axillary of injection side; Fever 101.4; Felt so sick; Swollen tender lymph node on axillary of injection side; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included food allergy (garlic, onion).  The patient received unspecified birth control medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), ceftriaxone (CEFTIN), vancomycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and experienced drug allergy.   Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 00:00, the patient experienced awful chills 12 hours after vaccine, swollen tender lymph node on axillary of injection side, fever 101.4, next day, felt weird, sore back that felt like organs inside sore, not like muscle ache, awful night sweats then fever broke and the patient felt fine. The patient was barely able to function at work, the patient felt so sick. The patient went home and slept at 5pm until next morning. The patient was not tired and had no headache, slept from feeling awful. 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 13Apr2021 at 00:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.4 (units unspecified). The clinical outcome of the events awful chills, swollen tender lymph node on axillary of injection side, fever 101.4, felt weird, sore back that felt like organs inside sore, awful night sweats and felt so sick were resolved on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Night sweats, Pyrexia
Clinical narrative: Felt weird; Sore back that felt like organs inside sore, not like muscle ache; Awful night sweats; Awful chills 12 hours after vaccine; Swollen tender lymph node on axillary of injection side; Fever 101.4; Felt so sick; Swollen tender lymph node on axillary of injection side; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included food allergy (garlic, onion).  The patient received unspecified birth control medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), ceftriaxone (CEFTIN), vancomycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and experienced drug allergy.   Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 00:00, the patient experienced awful chills 12 hours after vaccine, swollen tender lymph node on axillary of injection side, fever 101.4, next day, felt weird, sore back that felt like organs inside sore, not like muscle ache, awful night sweats then fever broke and the patient felt fine. The patient was barely able to function at work, the patient felt so sick. The patient went home and slept at 5pm until next morning. The patient was not tired and had no headache, slept from feeling awful. 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 13Apr2021 at 00:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.4 (units unspecified). The clinical outcome of the events awful chills, swollen tender lymph node on axillary of injection side, fever 101.4, felt weird, sore back that felt like organs inside sore, awful night sweats and felt so sick were resolved on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Lymphadenopathy
Clinical narrative: 4/16/2021 around 5:30pm I noticed pain in my right armpit. but it's increasing in intensity as time progresses.  Like a constant pain in my armpit; It was initially just odd and  uncomfortable; I assume it's lymph nodes, and it's not an emergency situation, but I wanted you to know for your records. (If swollen lymph nodes do not fall under the category of "adverse event," I apologize form is understanding.); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the right arm on 15Apr2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included herpetic viruses all currently dormant (Epstein Barr Virus; Herpes Simplex I and II), osteoarthritis and food allergy that caused anaphylaxis but is unknown what it was. The patient did received medication(unspecified) within two weeks of vaccination (the patient reported that the space was too small to answer fully for other medications).The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration on 24Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient also took promethazine (PHENERGAN), levofloxacin (LEVAQUIN) previously and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 17:30, the patient experienced pain in right armpit. It was initially odd and uncomfortable, but it increased in intensity as time progressed, like a constant pain in the armpit. The patient assumed that it was lymph nodes and it was not an emergency situation, but the patient wanted us to know for the records. (The patient also felt that, if swollen lymph nodes does not fall under the category of "adverse event," she apologized for the misunderstanding). No therapeutic measures were taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events pain in right armpit, odd and uncomfortable feeling and swollen lymph nodes was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sensitive skin
Clinical narrative: Fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch.; Fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. 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 14Apr2021 at 07:00, the patient fells like a rash around his torso, started on his belly above the belt line. Spread around to his back in a circle. No rash visible but skin was very sensitive to the touch. The patient did not receive any treatment for the events. The 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. The clinical outcome of the event fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Left side headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 07Apr2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic 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 vaccination. On 11Apr2021, the patient experienced left side headache. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Rapid heartbeat; Inappropriate schedule of vaccine administered to Dose 1: 02Apr2021; Dose 2: 16Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphedema on an unknown date and unknown if ongoing. The patient was allergic to penicillin (PCN), non-steroidal anti-inflammatory drugs (NSAIDS) and acetyl salicylic acid (ASA). The patient previously took acetylsalicylic acid (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient received unspecified medication(s) within two weeks of the 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 COVID vaccine. 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 02Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 11:15, the patient experienced rapid heartbeat. The event 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 event and included treatment with diphenhydramine hydrochloride (BENADRYL) on 16Apr2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rapid heartbeat was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More tired than usual; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 15Apr2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Other medical history included depression and penicillin allergy. The patient had drug allergies to doxycycline, ultram, codeine, prilosec; all on an unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included potassium (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), diclofenac (VOLTAREN) and carvedilol (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 09:00, the patient was more tired than usual. 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 reported event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event more tired than usual was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Nausea
Clinical narrative: Lightheadedness; nausea; extreme weakness; difficulty breathing; chest pain; This is a spontaneous report from a contactable consumer. This 18-year-old female consumer (patient) reported for herself that:   Country:  Language: en Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient  Age group: Adult (18-64 Years) Current age: 18 Current age unit: Years Gender: Female Is pregnant: No Race: (Withheld)  Covid vaccine details: Product=COVID 19 Brand=Pfizer-Biontech Lot number= EW0164 Lot unknown=False Administration date=16Apr2021 Administration time=11:15 AM Vaccine location= Left arm Dose number=1  Facility type Vaccine: Public Health Clinic Administration facility If other vaccine in four weeks: No Other medications in two weeks: Birth Control and Setraline  Adverse event: Lightheadedness and nausea within 5 minutes of injection. Followed by extreme weakness and difficulty breathing with chest pain. Took 45 minutes to be able to sit up. Adverse event start date: 16Apr2021 Adverse event start time: 11:15 AM Adverse event country:  If patient recovered: Recovered If treatment ae: Yes Ae treatment: Ice/cool cloth for head and apple juice  If Covid prior vaccination: No If Covid tested post vaccination: No  Known allergies: No Other medical history: No  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected. This is a spontaneous report from a contactable consumer or other non hcp.   A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:15 (Batch/Lot Number: EW0164) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included contraception from an unknown date and unknown if ongoing Other medications in two weeks: Birth Control. Concomitant medication(s) included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced lightheadedness (dizziness) (non-serious) on 16Apr2021 11:20 with outcome of recovered , nausea (nausea) (non-serious) on 16Apr2021 11:20 with outcome of recovered , extreme weakness (asthenia) (non-serious) on 16Apr2021 with outcome of recovered , difficulty breathing (dyspnoea) (non-serious) on 16Apr2021 with outcome of recovered , chest pain (chest pain) (non-serious) on 16Apr2021 with outcome of recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of lightheadedness (dizziness), nausea (nausea), extreme weakness (asthenia), difficulty breathing (dyspnoea), chest pain (chest pain).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100° fever; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (COMIRNATY; Lot number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021(at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. The patient previously took amoxicillin(MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient has taken unspecified concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 19:45, the patient had 100 degree fever. Therapeutic measures were not taken as a result of  the adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event 100 degree fever was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Palpitations
Clinical narrative: experiencing episodes of palpitations and chest discomfort; experiencing episodes of palpitations and chest discomfort; palpitations; lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7933) via an unspecified route of administration in the arm left on 14Apr2021 at 10:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (EUTHYROX) from an unknown date for an unknown indication. The patient had no known allergies. 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 13:30, about 3.5 hours after the vaccination, the patient experienced heart racing and lightheadedness at rest which was resolved after a few minutes. On 16Apr2021, two days after the vaccine, the patient started experiencing episodes of palpitations and chest discomfort for 5-10 minutes at a time. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included the treatment with aspirin (MANUFACTURER UNKNOWN). The clinical outcomes of the events heart racing and lightheadedness was recovered on 14Apr2021 and of the episodes of palpitations and chest discomfort were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A few days after receiving my first Pfizer Covid vaccine I started experiencing frequent headaches I have now had a headache almost 10 days. A dull ache headache. That wakes up at night and come and go all day long.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines and headaches which was ongoing from an unknown date. The patient was allergic to dairy and its proteins, almonds and mushrooms. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), vitamin D nos (MANUFACTURER UNKNOWN) and Tur ; all from an unknown date, for an unknown indication, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, at 12:00 the patient experienced frequent headaches and had a headache almost 10 days The patient reported a dull ache headache that woke her up at night and come and went all day long. The patient was suffering from chronic migraines but reported that this was different. and she used to take Botox for her headaches every three months. 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 frequent headaches was not recovered at the time of this report.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test, Tendon pain
Clinical narrative: experiencing near-constant muscle pain throughout the body to varying degrees. There are days when it is debilitating, and days when it is manageable. This includes forearms, biceps, hips and thighs and does not include any joint pain; This includes forearms, biceps, hips and thighs and does not include any joint pain, it is specifically limited to muscles and tendons.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 17:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indication from unknown start date and unknown if ongoing. The patient had no known allergies to medications, food or any 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: EL9266) via an unspecified route of administration in the left arm on 22Feb2021 at 13:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, after receiving second shot, the patient experienced near-constant muscle pain throughout his body to varying degrees. There were days when it was debilitating, and days when it was manageable. This included forearms, biceps, hips, thighs and did not include any joint pain. It seemed specifically limited to muscles and tendons. 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 been tested for COVID-19. On 21Mar2021, the patient underwent SARS-COV-2 RNA, QL, RT PCR and the result was Negative. On 22Mar2021, the patient underwent (Nasal swab) Rapid Test and the result was Negative. On 12Apr2021, the patient underwent (Nasal swab) SARS-COV-2 RNA, QL, RT PCR and the result was Negative. The clinical outcome of the events constant muscle pain throughout the body, tendon pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Influenza like illness, Pruritus, Urticaria
Clinical narrative: I had a case of hives occurring on both legs above the knees, and lower trunk both front and back below breast line.; Hydrocortisone Cream to relieve the itching.; Soreness in shoulders; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; There was a sense of a typical flu-like symptom but on days 4, 5 and 6; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 17:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as to be confer with the patient's doctor. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN )80mg and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY MEN'S VITAMIN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, day 1 through 4 after the second dose the patient experienced soreness in shoulders, back and hip and knee joints. There was a sense of a typical flu-like symptom but on days 4, 5 and 6, On31Mar2021, the patient had a case of hives occurring on both legs above the knees and lower trunk both front and back below breast line. This was the first time, the patient ever had hives and self-medicated with a daily loratadine and hydrocortisone cream to relieve the itching. Early on day 6, it was over with no noticeable residual effects. 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 hives, itching and included treatment with daily loratadine (MANUFACTURER UNKNOWN) and hydrocortisone (MANUFACTURER UNKNOWN) cream. The clinical outcome of the events soreness in shoulders, back and hip, knee joints and flu like symptoms were recovered day4 on 31Mar2021 and events hives and itching were recovered on day6 on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria
Clinical narrative: Hives; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 13:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol. The patient had known allergies to fish and seafood. The patient did not receive any 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 16Apr2021 at 15:30 the patient experienced hives and nausea. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives and nausea was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Nasal discomfort, Rhinorrhoea, Sneezing
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 44-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 44, via an unspecified route of administration, on Apr 15, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history: none. The patient has no allergies to food, medications or other products. Concomitant medications not reported.  Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 22:00, patient experienced allergy symptoms: runny nose, sneezing, red burning eyes and nasal irritation. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the event allergy symptoms runny nose, sneezing, red burning eyes and nasal irritation: not recovered (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Fever; Chills; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 56-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 id not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 17:00, the patient experienced fever, chills and sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills and sweats were 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of personal independence in daily activities, Rash
Clinical narrative: Body was really heavy to maneuver.; Tiny headache.; Rash on lower legs and feet.; I felt like my body was really heavy to maneuver; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's and diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Patient had no allergies to medications, food, or other products. The patient received other vaccines within four weeks prior to the vaccination which included adalimumab (HUMIRA) via an unspecified route of administration in the right thigh on 14Apr2021 for an unknown indication. On 16Apr2021 at 15:30 the patient felt that body was really heavy to maneuver, tiny headache and rash on lower legs and feet. Therapeutic measures were not taken as a result of the events. 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 clinical outcome of the event body was really heavy to maneuver, tiny headache and rash on lower legs and feet was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 antibody test
Clinical narrative: Muscle pain in my left leg only; on and behind knee cap; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 05:00, the patient experienced muscle pain in left leg only; on and behind knee cap. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent SARS-Cov 2 rapid ag (COVID 19) test (nasal swab test type) and the result was negative. The clinical outcome of the event muscle pain in left leg only; on and behind knee cap was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Where the patient had filler injected in her face was swollen; This is a spontaneous report from a contactable consumer, the patient. A 43-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 14Apr2021 at 19:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection (the patient had filler injection in face back in January) on an unknown date in Jan2021 and unknown if ongoing. The patient was not allergic to medications, food, or other products. Concomitant medication was 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 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 07:00, where the patient had filler injected in her face, was swollen. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the event where the patient had filler injected in her face was swollen was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Erythema, Flushing, Headache
Clinical narrative: Face was very flushed; Face red and hot; Had rosacea but it was never inflamed.; Headache; Chills; Fever; This is a spontaneous report from a non-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: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 08:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea which was ongoing. The patient was allergic to swordfish. Concomitant medications included famotidine (PEPCID), levocetirizine dihydrochloride (XYZAL), alprazolam (XANAX), ascorbic acid (VITAMIN C), calcium (MANUFACTURER UNKNOWN) and K2-D2; all from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced face was very flushed-red and hot for 48 hours almost immediately after received the shot. The patient had rosacea but it was never this inflamed (Condition aggravated). On 23Mar2021, the patient had a headache, chills and fever on the first night after the shot; felt fine the next day but that night again experienced chills and fever. 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 these events. The clinical outcome of the events of rosacea condition aggravated, face flushed red and hot, headache, chills and fever were recovered on 25Mar2021, after the duration of 2 days.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Face was very flushed; Face red and hot; Had rosacea but it was never inflamed.; Headache; Chills; Fever; This is a spontaneous report from a non-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: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 08:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea which was ongoing. The patient was allergic to swordfish. Concomitant medications included famotidine (PEPCID), levocetirizine dihydrochloride (XYZAL), alprazolam (XANAX), ascorbic acid (VITAMIN C), calcium (MANUFACTURER UNKNOWN) and K2-D2; all from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced face was very flushed-red and hot for 48 hours almost immediately after received the shot. The patient had rosacea but it was never this inflamed (Condition aggravated). On 23Mar2021, the patient had a headache, chills and fever on the first night after the shot; felt fine the next day but that night again experienced chills and fever. 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 these events. The clinical outcome of the events of rosacea condition aggravated, face flushed red and hot, headache, chills and fever were recovered on 25Mar2021, after the duration of 2 days.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Lethargy, Pain
Clinical narrative: Immediate and constant asthma attacks from lung swelling; Body aches; Lethargy; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-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 13Apr2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypoglycaemia, high cholesterol and lung swelling. The patient had allergies to eggs, shellfish, molds, radish and sulfa antibiotics. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control (unspecified) started from an unknown date for unspecified indication, atorvastatin (MANUFACTURER UNKNOWN) started from an unknown date for unspecified indication, cetirizine hydrochloride (ZYRTEC) started from an unknown date for unspecified indication, montelukast sodium (MONT) started from an unknown date for unspecified indication and fluticasone propionate (FLONASE) started from an unknown date for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 13:30, the patient experienced immediate and constant asthma attacks from lung swelling, body aches and lethargy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events- immediate and constant asthma attacks from lung swelling, body aches and lethargy were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.