chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling in the injection area, and redness in the injection area. Right arm.; Swelling in the injection area, and redness in the injection area. Right arm.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Apr2021 at 12:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hyperthyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), levothyroxine (MANUFACTURER UNKNOWN) and probiotics nos (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received benzoyl peroxide (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 14:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. On 26Apr2021 at 07:00, the patient experienced swelling in the injection area and redness in the injection area right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in the injection area and redness in the injection area in the right arm 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Fever; Chills; Body aches; Swelling at injection sight; Redness at injection sight; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left  arm on 24Apr2021 at 17:30 (at the age of 35-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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 at 18:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 16:00, the patient experienced fever, chills, body aches, redness and swelling at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, redness and swelling at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Pyrexia
Clinical narrative: Nose bleed; Light Fever; Tiredness; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 08:30 (at the age of 48-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. 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 orphenadrine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 18Apr2021 at 11:30, the patient experienced light fever, tiredness, headaches 3 days including day of vaccine. On 20Apr2021, the patient had nose bleed between 48 and 72 hours of vaccine application. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 light fever, tiredness, headaches and nose bleed were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Migraine, Pain in extremity
Clinical narrative: Mild arm pain; Growing fatigue/Extreme exhaustion; ''I'' had a migraine (unusual for ''me'', I rarely get bad migraines), the migraine lasted about 2 hours,; ''I'' could not walk without help; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 09Apr2021 at 13:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac, MCTD (mixed connective tissue disease) and migraine. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 10Apr2021 at 07:00, the patient experienced mild arm pain the day of; the following morning the patient had a migraine (unusual for patient, rarely got bad migraines), the migraine lasted about 2 hours, the patient had growing fatigue through the morning and by mid-day (10Apr2021), she could not walk without help because of the extreme exhaustion. The day after that, the patient still had very bad fatigue but could walk slowly without assistance. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event mild arm pain, growing fatigue/extreme exhaustion and unable to walk was recovered on unknown date of Apr2021, while that of migraine was recovered on 10Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lip swelling, Swelling face
Clinical narrative: Face swelled up slightly; Face swelled up slightly, including upper lip; Felt flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 46-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 20Apr2021 at 12:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, Ethanol (EtOH) abuse, pre-diabetic, neuropathy and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received 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 12:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 14:00, the patient experienced that his face swelled up slightly including upper lip and felt flu-like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events face swelled up including upper lip swelling and felt flu-like symptoms were 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: Chills; Fever; Aches; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 10Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 20Mar2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously also received sulfur (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 11Apr2021 at 00:30, the patient experienced chills, fever, aches, and was lethargic for about 18 hours. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events chills, fever, aches and lethargic was recovered on 11Apr2021 at 18:30. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Product administered at inappropriate site, Rash, Rash pruritic
Clinical narrative: BNT162B2 was administered at Left leg; 8 days after receiving the second vaccine I developed a rash.; It started as big red patches on my face; Hives on my neck and torso; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left leg on 23Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included under active thyroid. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously 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 02Mar2021 at 15:00 (at the age of 46-years-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 31Mar2021 at 06:00, 8 days after receiving the second vaccine, the patient developed a rash. It started as big red patches on face and hives on neck and torso. The hives cleared up the next day but the rash on face continued to be present and continues to be present four weeks later. Some days the rash was worse than others, it was hot and it itched just a little. It was more hot than itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified cream and the patient stopped taking other medications. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab test and the result was found to be negative. The clinical outcome of the event hives was resolved on 01Apr2021. The clinical outcome of the events rash, big red patches on face and it was hot and it itched just a little were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BNT162B2 was administered at Left leg; 8 days after receiving the second vaccine I developed a rash.; It started as big red patches on my face; Hives on my neck and torso; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left leg on 23Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included under active thyroid. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously 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 02Mar2021 at 15:00 (at the age of 46-years-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 31Mar2021 at 06:00, 8 days after receiving the second vaccine, the patient developed a rash. It started as big red patches on face and hives on neck and torso. The hives cleared up the next day but the rash on face continued to be present and continues to be present four weeks later. Some days the rash was worse than others, it was hot and it itched just a little. It was more hot than itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified cream and the patient stopped taking other medications. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab test and the result was found to be negative. The clinical outcome of the event hives was resolved on 01Apr2021. The clinical outcome of the events rash, big red patches on face and it was hot and it itched just a little were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye irritation
Clinical narrative: Pink eye; Eye irritation right eye; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 24Apr2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 other medications within two prior to the vaccination. The patient previously took aspirin (MANUFACTURE UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 26Apr2021 at 07:00, the patient experienced pink eye and eye irritation right eye. 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 pink eye and eye irritation right eye was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Chills; fever; Sore joints; Headache; Diarrhea; Nausea; Fatigue; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included unspecified hair skin and nails supplement and women's multivitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Chills; fever; Sore joints; Headache; Diarrhea; Nausea; Fatigue; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included unspecified hair skin and nails supplement and women's multivitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: I have had extreme tiredness or sleepiness prompting me to take a 1.5 to 2 hour nap every afternoon which is something I did not do prior to vaccine; I have had extreme tiredness or sleepiness prompting me to take a 1.5 to 2 hour nap every afternoon which is something I did not do prior to vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 29Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. After second dose of Pfizer COVID vaccine, the patient had extreme tiredness or sleepiness prompting her to take a 1.5 to 2 hour nap every afternoon which was something she did not do prior to vaccine. This began on 30Mar2021, the day after second vaccine and had continued to the day of report. 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 had extreme tiredness or sleepiness prompting to take a 1.5 to 2 hour nap every afternoon which was something she did not do prior to vaccine was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Energy increased, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Breast pain same side as injection day of; Feelings of being hyper and lots of energy; Period unexpectedly started early 2 days later, heavy; Period unexpectedly started early 2 days later, heavy; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old 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 19Apr2021 at 14:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history reported COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took diphenhydramine hydrochloride (BENADRYL), sulfamethoxazole; trimethoprim (BACTRIM) and levofloxacin (LEVAQUIN); and experienced drug allergy. On 21Apr2021 at 18:00, the patient experienced breast pain same side as injection day of, feelings of being hyper and lots of energy and period unexpectedly started early 2 days, later heavy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events breast pain same side as injection day of, feelings of being hyper and lots of energy and period unexpectedly started early 2 days later, heavy 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Massive Bruising to the left arm. Lower below the elbow to the hand; 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: EW0169) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 15:00, the patient experienced massive bruising to the left arm, lower below the elbow to the hand. 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 massive bruising to the left arm, lower below the elbow to the hand was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging head, Menstruation delayed, Vision blurred
Clinical narrative: Blurry vision; This has been a big problem for "me" and has been preventing "me" from doing many of the normal tasks "I" would do (including reading for long periods of time); Menstrual period was 2 days late (which is extremely rare); This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included tachycardia, bradycardia, mitral valve prolapse and migraines. 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 magnesium (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and unspecified daily vitamin; all for unknown indications from an unknown date and unknown if ongoing. On 08Apr2021, 6 days after the first vaccine dose, the patient experienced blurry vision and had not gone away since (it had been two weeks currently at the time of this report). This had been a big problem and had been preventing patient from doing many of the normal tasks she would do including reading for long periods of time. The patient also reported that menstrual period was 2 days late (which was extremely rare). On an unknown date in Apr2021, the patient underwent brain MRI and the result was "nothing found" (issue persists). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events (blurry vision and big problem preventing from doing normal tasks) and included treatment with brain MRI. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurry vision was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysmenorrhoea, Urine odour abnormal, Vaginal haemorrhage
Clinical narrative: Mild spotting; Painful menstrual cramps; Urine has been darker and smells more than usual; Urine has been darker and smells more than usual.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 09Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks, prior to the vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), birth control pill (MANUFACTURE UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all for unspecified indications from an unknown date and unknown if ongoing. On 11Apr2021 at 09:30, the patient experienced having mild spotting and painful menstrual cramps since from the Sunday after first dose of the vaccine and nothing like that had ever happened before. It was reported that, sometimes the patient got mild spotting, but it was only lasts three or four days. Also, patient had urine in darker and smells more than usual. The patient period was too painful due to endometriosis, hence used to take birth control pills on everyday without skipping a week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were 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 events mild spotting, painful menstrual cramps and urine had been darker and smells more than usual was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Severe stuffy nose; Pain in arm; Chills; Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 07:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The medical history included depression, anxiety, diabetes and was 20 pounds overweight. 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 received unspecified medications for diabetes, depression and anxiety within two weeks of vaccination. On 23Apr2021, the patient experienced severe stuffy nose, pain in arm, chills, fatigue and fever. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stuffy nose, pain in arm, chills, fatigue and fever was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Muscle spasms, Nausea
Clinical narrative: severemigraine; Felt nauseous; Muscle cramps in legs; Headache; This is a spontaneous report from a contactable consumer. A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an intramuscular route of administration in the arm right on 20Apr2021 at 14:45 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 adapalene (MANUFACTURER UNKNOWN) and benzoyl peroxide, clindamycin phosphate, 1-5% (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the right arm on an unknown date in Mar2021 at 16:45 as a single dose for COVID-19 immunisation. On 20Apr2021 at 16:00, the patient had muscle cramps in her legs in the evening of the 2nd vaccination along with a headache. The following day on 21Apr2021, the patient woke up with a severe migraine and felt nauseous. She was not able to go to school and the headache persisted until the evening. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle cramps in legs, migraine and felt nauseous were recovered on an unknown date in Apr 2021 whereas the event headache was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; painful lymph nodes; chills; fever; body aches; headache; fatigue; pain redness and itching at injectionsite; itching at injection site; pain redness and itching at injectionsite; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and spinal arthritis with radiculopathy. 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 cyclobenzaprine (MANUFACTURER UNKNOWN) and brimonidine tartrate (ALPHAGAN); both from an unknown date, for an indication and unknown if ongoing. 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 30Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 (also reported at 00:00), the patient experienced swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swollen lymph nodes; painful lymph nodes; chills; fever; body aches; headache; fatigue; pain redness and itching at injectionsite; itching at injection site; pain redness and itching at injectionsite; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and spinal arthritis with radiculopathy. 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 cyclobenzaprine (MANUFACTURER UNKNOWN) and brimonidine tartrate (ALPHAGAN); both from an unknown date, for an indication and unknown if ongoing. 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 30Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 (also reported at 00:00), the patient experienced swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes, painful lymph nodes, chills, fever, body aches, headache, fatigue, pain redness and itching at injection site 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Bad stomach pain; Loose stool; This is a spontaneous report from a non-contactable consumer, the patient. An 18-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 05Apr2021 at 16:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 were not reported. On 07Apr2021, the patient experienced bad stomach pain and loose stool since injection.. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad stomach pain and loose stool were 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Muscle spasms, Peripheral swelling
Clinical narrative: In the second week again some muscle cramps, heavy legs; In the second week again some muscle cramps, heavy legs, swollen legs; In the second week again some muscle cramps, heavy legs, swollen legs turning purple; In the second day from first shot tiredness; In the first week after shot headache; Muscle cramps in the legs, especially in the calves.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history included hepatitis A at 5 years old (in 1989). 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 medications within two weeks of vaccination. On 12Apr2021, in the second day from first shot, the patient experienced tiredness. On an unknown date in Apr2021, in the first week after shot, the patient had headache, muscle cramps in the legs, especially in the calves. On an 24Apr2021 at 20:00, in the second week again the patient had some muscle cramps, heavy legs and swollen legs turned purple. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle cramps in the legs, especially in the calves, heavy legs and swollen legs turned purple was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: In the second week again some muscle cramps, heavy legs; In the second week again some muscle cramps, heavy legs, swollen legs; In the second week again some muscle cramps, heavy legs, swollen legs turning purple; In the second day from first shot tiredness; In the first week after shot headache; Muscle cramps in the legs, especially in the calves.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history included hepatitis A at 5 years old (in 1989). 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 medications within two weeks of vaccination. On 12Apr2021, in the second day from first shot, the patient experienced tiredness. On an unknown date in Apr2021, in the first week after shot, the patient had headache, muscle cramps in the legs, especially in the calves. On an 24Apr2021 at 20:00, in the second week again the patient had some muscle cramps, heavy legs and swollen legs turned purple. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle cramps in the legs, especially in the calves, heavy legs and swollen legs turned purple was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Spondylitis
Clinical narrative: Severe inflammation of lumbar spine - had been symptom free for 14 years.; This is a spontaneous report from a contactable consumer (patient).    A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 15:00 (Lot Number: EN6203) as single dose (at the age of 71 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included known allergies: Penicillin. Concomitant medications included unspecified drugs. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318) on 04Feb2021 03:00PM in the left arm (at the age of 71 years old) for COVID-19 immunisation.  On 27Feb2021, the patient experienced severe inflammation of lumbar spine - had been symptom free for 14 years. The outcome of the event was not recovered. The events required a visit to the physician's office. Therapeutic measures were taken as a result of the event included Corticosteroid Epidural Injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.