chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: With in 24 hours, became hot; Light headed; Felt clammy; Felt sick to my stomach; Vomited; Very weak; slept another 8 hours; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and levothyroxine sodium (EUTHYROX); both from an unknown date for an unknown indication and was unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, within 24 hours, the patient experienced, hot and light headed. She felt clammy and began to shed the layers, she felt sick to her stomach and vomited. It was reported that she never throws up, the last time she did was when she was 7 years old. She made it to her living room couch and slept 5 hours, she was still very weak, made it to bed and slept another 8 hours. She didn't take her temperature and when she woke, she was more herself but remained weak for several more days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room department or urgent care. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt hot, light headed, felt sick to her stomach, slept for 8 hours and vomited was recovered on an unknown date Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Nauseous in the morning after the shot; Pain in arm overnight after injection (same arm as injection); This is a spontaneous report from a contactable consumer. A 26-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 on 04Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Mar2021, the patient felt nauseous in the morning after the shot and pain in arm overnight after injection, in the same arm as injection. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Mar2021, the patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the event nauseous in the morning after the shot was resolved and of pain in arm overnight after injection, in the same arm as injection was resolved on 05Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pain of skin
Clinical narrative: Scalp became highly sensitive; Chills down back when hair shifted overnight after vaccination; Arm was in pain overnight and day after; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Mar2021, the patient's scalp became highly sensitive, chills down back when hair shifted overnight after vaccination and her arm was in pain overnight and day after. 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 scalp became highly sensitive, chills down back when hair shifted overnight after vaccination and arm was in pain overnight and day after was resolved on 05Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Within 20 to 30 minutes after vaccine, a feeling of sinus pressure, mild to moderate; still feeling it more than 6 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included lumpectomy in 2018 and mild hypertension. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), colecalciferol (VIT D3), anastrozole (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid; caffeine; paracetamol (FIORINAL) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 15:45, within 20 to 30 minutes after vaccine, the patient experienced a feeling of sinus pressure, mild to moderate. The patient felt it for more than 6 hours after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling of sinus pressure, mild to moderate was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Adverse event, Blood test, Chills, Headache
Clinical narrative: Started having chills; Upset stomach; Slight nausea; Headache; Feeling unwell; Mild symptoms; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), thyroid disease and lactose intolerant. 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 levothyroxine (MANUFACTURER UNKNOWN), famotidine (PEPCID), escitalopram oxalate (LEXAPRO) and linum usitatissimum seed oil (FLAX OIL); all for unknown indications from unknown dates and unknown if ongoing. It was reported that the patient had mild symptoms with 48 hours and those were subsided. On 01Mar2021 (Monday) at 17:00, about one week after the shot, the patient started having chills, upset stomach, slight nausea, headache and feeling unwell. On the same day, the patient underwent blood test (reported as blood taken) for routine tests ordered by one of her doctors and the result was unknown. The patient was still having these symptoms and she was wondering if this was a latent reaction to the Pfizer vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events headache and upset stomach and included treatment with paracetamol (TYLENOL) for headache and simethicone (MANUFACTURER UNKNOWN) for stomach. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild symptoms was recovered on an unknown date in Feb2021. The clinical outcome of the events started having chills, upset stomach, slight nausea, headache and feeling unwell was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Started having chills; Upset stomach; Slight nausea; Headache; Feeling unwell; Mild symptoms; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), thyroid disease and lactose intolerant. 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 levothyroxine (MANUFACTURER UNKNOWN), famotidine (PEPCID), escitalopram oxalate (LEXAPRO) and linum usitatissimum seed oil (FLAX OIL); all for unknown indications from unknown dates and unknown if ongoing. It was reported that the patient had mild symptoms with 48 hours and those were subsided. On 01Mar2021 (Monday) at 17:00, about one week after the shot, the patient started having chills, upset stomach, slight nausea, headache and feeling unwell. On the same day, the patient underwent blood test (reported as blood taken) for routine tests ordered by one of her doctors and the result was unknown. The patient was still having these symptoms and she was wondering if this was a latent reaction to the Pfizer vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events headache and upset stomach and included treatment with paracetamol (TYLENOL) for headache and simethicone (MANUFACTURER UNKNOWN) for stomach. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild symptoms was recovered on an unknown date in Feb2021. The clinical outcome of the events started having chills, upset stomach, slight nausea, headache and feeling unwell was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness with no resolved 24 hours later; This is a spontaneous report from a non-contactable consumer. A 33-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 on 04Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 04Mar2021, the patient experienced arm soreness with no resolved 24 hours later. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was not recovered 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst rupture, Dermal cyst, Inflammation, Pain
Clinical narrative: A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured; A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine; A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured; Very very painful; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome, bipolar II disorder, allergic to cats, house dust mite allergy and house dust 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 lurasidone hydrochloride (LATUDA), gabapentin (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL); all for unknown indication from an unknown date and unknown if ongoing. On 26Feb2021, the patient experienced a tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured which was "very very" painful. The events resulted in doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the reported events and the cyst had to be drained by MD with use of lidocaine (MANUFACTURER UNKNOWN) on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured and "very very" painful was resolved on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Vertigo positional
Clinical narrative: Benign paroxysmal positional vertigo (BPPV); Dizziness; Elevated blood pressure; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: NDC:59267-1000-01) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and high cholesterol. 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. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 2.5 mg, atorvastatin (MANUFACTURER UNKNOWN) 10 mg and olopatadine (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021 at 20:00, the patient experienced benign paroxysmal positional vertigo (BPPV), dizziness only when lying down and also elevated blood pressure. It was reported that, there was no other side effects at the time of reporting. On 05Mar2021 at 20:00, the patient underwent blood pressure test and the result was elevated blood pressure of 158/85 (unspecified units). 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events benign paroxysmal positional vertigo (BPPV), dizziness and elevated blood pressure was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: Heart rate was accelerated; It was scary and I did not feel comfortable driving on thefreeway.; I was extremely tired after receiving the vaccine and had to take the afternoon off work to rest.; "I" felt ok, but a bit off, after that.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, Hashimoto's disease, sensitivities to gluten, soy allergy and goitrogens. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN) and other supplements (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 04Mar2021 at 12:30, the patient felt ok, but a bit off, after that the patient drove home and noticed her heart rate was accelerated. It was scary and she did not feel comfortable driving on the freeway. The patient exited and took surface streets. The patient was extremely tired after receiving the vaccine and had to take the afternoon off work to rest. The patient's heart rate stayed elevated for probably at least half an hour. On 04Mar2021, the patient underwent lab tests and procedures which included heart rate test and the result was elevated heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart rate accelerated was recovered on 04Mar2021, while the events a bit off, extremely tired, was scary and did not feel comfortable driving were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Feeling cold, Musculoskeletal stiffness, Mydriasis, Paraesthesia
Clinical narrative: Felt cold inside, did not have chills or fever,; Left side of the neck was stiff.; Left side of the face tingled.; Felt like the eyes were dilated;; Left eye feels cold inside; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish 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 diphenhydramine / paracetamol / phenylpropanolamine hydrochloride (BENADRYL) and ibuprofen (MANUFACTURER UNKNOWN). On 01Mar2021 at 15:00, the patient felt cold inside, did not have chills or fever, left side of the neck was stiff, left side of the face tingled, vision felt like the eyes were dilated, behind the left eye felt cold inside. 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 felt cold inside, did not have chills or fever, left side of the neck was stiff, left side of the face tingled, vision felt like the eyes were dilated, behind the left eye felt cold inside was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Have been feeling worn out and tired ever since.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Feb2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Feb2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 14:30, the patient had been feeling worn out and tired and for the last 6 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had been feeling worn out and tired was resolving 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Nausea, Tinnitus
Clinical narrative: Started to feel whooshing in left ear/whooshing (tinnitus); started to feel tired/fatigue; started feeling nauseous, by 5hours after vaccine having serious nausea; By bedtime arm was hot; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient 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 01Mar2021 at 07:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis, arthritis and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA), cyclobenzaprine hydrochloride (FLEXERIL), atorvastatin calcium (LIPITOR), hydrocodone (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC): all for unknown indication from unknown date and unknown if ongoing. The patient previously received povidone-iodine (BETADINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 08:15, the patient on way home started to feel whooshing in left ear, started to feel tired, started feeling nauseous, by 5 hours after vaccine, had serious nausea and by bedtime arm was hot. The patient reported on the day of reporting as 'today- had whooshing (tinnitus), nausea and fatigue'. Therapeutic measures were taken as a result of the events feel whooshing in left ear, feel tired, feeling nauseous/had serious nausea and included treatment herself with tums and diphenhydramine hydrochloride (BENADRYL) and for the event arm was hot included treatment herself with ice pack on for about an hour. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcomes of the event arm was hot was recovered on unknown date in Mar2021 and of the events whooshing in left ear, feel tired and feeling nauseous/serious nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed moderate to bad tinnitus shortly after first vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 07Feb2021 at 16:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history was healthy and took no medicines and prescriptions. 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 4 weeks prior to the COVID-19 vaccine. On 15Feb2021, the patient developed moderate to bad tinnitus shortly after first vaccine. The patient would be making an appointment with a physician in the next few weeks as it had not subsided at all from the time of onset. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to bad tinnitus shortly after first vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Began being dizzy; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6198) via an unspecified route of administration in the left arm on 26Feb2021 at 17:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included heart attack in 2014 (with stents), shingles, penicillin allergy and sulfa drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included aciclovir (ACYCLOVIR) from an unknown date until 24Feb2021 for shingles, rosuvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (kASPIRIN); both taken for heart attack from an unknown date and was ongoing and also other unspecified medications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Mar2021 at 17:30, 72 hours after vaccination, the patient began being dizzy to the extent that the patient could not think straight and was nauseous. The events did not result in doctor or other health care professional office/clinic visits, and the 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 began being dizzy and nauseous was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Limb discomfort, Pain in extremity
Clinical narrative: Arm started to feel sore; Arm became so heavy it was hard to even lift it up; Arm became so heavy it was hard to even lift it up; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 01Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 01Mar2021, 10 minutes after the shot, the patient's arm felt sore and then had minor soreness throughout the day on and off, the biggest issue she had even with no soreness was her arm became so heavy that it was hard to even lift it up; on 02Mar2021 (day 2), it was better but still similar. 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 arm started to feel sore and arm became so heavy it was hard to even lift it up was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Muscle spasms
Clinical narrative: A few hours after taking the vaccine, "I"developed mild cramping muscle pain in "my" left arm (where "I" received the shot).; Cramping muscle pain in left arm (where received theshot); "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; This is a spontaneous report from a non-contactable consumer, the patient. A 22-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 arm left on 01Mar2021 at 10:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The medical history included meniere's disease and obesity, both were from unknown date and were ongoing, anemia, sinusitis and migraine(past). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01Mar2021, a few hours after vaccination, the patient developed mild cramping muscle pain in left arm (where the patient received the shot) and had a moderate headache, drowsiness, fatigue, thirst and mild diarrhea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild cramping muscle pain in left arm(where the patient received the shot), moderate headache, drowsiness, fatigue, thirst and mild diarrhea 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Thirst
Clinical narrative: A few hours after taking the vaccine, "I"developed mild cramping muscle pain in "my" left arm (where "I" received the shot).; Cramping muscle pain in left arm (where received theshot); "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; "I" had a moderate headache, drowsiness, fatigue, thirst, and mild diarrhea.; This is a spontaneous report from a non-contactable consumer, the patient. A 22-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 arm left on 01Mar2021 at 10:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The medical history included meniere's disease and obesity, both were from unknown date and were ongoing, anemia, sinusitis and migraine(past). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01Mar2021, a few hours after vaccination, the patient developed mild cramping muscle pain in left arm (where the patient received the shot) and had a moderate headache, drowsiness, fatigue, thirst and mild diarrhea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild cramping muscle pain in left arm(where the patient received the shot), moderate headache, drowsiness, fatigue, thirst and mild diarrhea 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain
Clinical narrative: Severe body aches and pain still continues after 7 days.; Sometimes it is difficult to walk due to the pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 23Feb2021 at 10:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). 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 COVID vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (MANUFACTURER UNKNOWN) and Vit D3 (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously taken hydromorphone hydrochloride (DILAUDID), sulfamethoxazole/trimethoprim (BACTRIM), dextran sulfate (MANUFACTURER UNKNOWN) all on unknown date for unspecified indication and experienced drug allergy. On 26Feb2021 at 00:00, the patient experienced severe body aches & pains still continues after 7 days. Sometimes it was difficult to walk due to the pain. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body aches & pains and difficult to walk due to the pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Mar2021, the patient experienced arm soreness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight arm soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 01Mar2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history 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-19 vaccine. Concomitant medications included loratadine (CLARITIN) and vitamin d nos (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and experienced drug allergy. On 02Mar2021, the patient experienced slight arm soreness at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight arm soreness at injection site was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Presyncope, Vertigo
Clinical narrative: On 2021 Mar 01 at 11am I started becoming dizzy and my head spinning. To prevent fainting/falling I had to lie down immediately. I had to stay lying down until 8pm. After that I remained light headed until 2am.; On 2021 Mar 01 at 11am I started becoming dizzy and my head spinning.; I had headaches during the 12+ hours.; I went from being active to lying down in minutes, and could have fainted/fallen.; This is a spontaneous report from a non-contactable consumer, the patient. A 47-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 left arm on 23Feb2021 at 09:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 02Feb2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 11:00 the patient started becoming dizzy and his head started spinning. To prevent fainting/falling he had to lie down immediately. The patient had to stay lying down until 20:00. After that he remained light headed until 02:00. The patient had headaches during the 12 plus hours. Onset was fast, with no warning. The patient went from being active to lying down in minutes, and could have fainted/fallen. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL). 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. The clinical outcome of the event started becoming dizzy, remained light headed was resolved on 02Mar2021 at 02:00. The clinical outcome of the event head started spinning; to prevent fainting/falling had to lie down immediately; had headaches during the 12 plus hours; onset was fast, with no warning; went from being active to lying down in minutes, and could have fainted/fallen was resolved an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Fatigue; Sore throat; Pain around site of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Mar2021 at 13:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 01Mar2021 at 14:45, the patient experienced fatigue, sore throat and pain around site of injection. All occurred within an hour of injection. Pain at site and sore throat persisted 18 hours past injection time. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat and pain around site of injection was resolved on 02Mar2021 at 08:45, after the duration for 18 hours and fatigue 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: 20 hours - 28 hours after vaccination, all of the above and headache and nausea; 20 hours - 28 hours after vaccination, all of the above and headache and nausea; Around 28 hours after vaccination, vomited 5 times; Approximately 10 hours after vaccination, arm pain; Approximately 10 hours after vaccination, arm pain, chills and fatigue; Approximately 10 hours after vaccination, arm pain, chills and fatigue; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3247) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within two weeks of vaccination was not reported. It was not reported whether the patient received 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: 3247) via an unspecified route of administration in the left arm on 05Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 20:00, approximately 10 hours after vaccination, the patient experienced arm pain, chills and fatigue. On 26Feb2021, 14 hours - 20 hours after vaccination, the patient experienced arm pain, chills, body aches, thirst, fatigue, difficulty sleeping. On 27Feb2021, 20 hours - 28 hours after vaccination, all of these and headache and nausea. On 27Feb2021, around 28 hours after vaccination, the patient vomited 5 times. In 30-36 hours symptoms started to subside and 48 hours after vaccine, symptoms were mostly gone except for sore arm. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue, body aches, thirst, difficulty sleeping, headache and nausea, vomiting was resolved on an unknown date in 2021, while that of arm pain was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.