chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole.; Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; I didn't feel well, but not sick; Just weak and didn't want to eat.; Just weak and didn't want to eat.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and pseudotumor cerebri. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included furosemide (LASIX), hydrochlorothiazide (HYDRODIURIL), verapamil hydrochloride (CALAN-SR) and malus spp. vinegar extract (APPLE CIDER VINEGAR); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 29-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 20Apr2021 at 18:30, the patient experienced large red, itchy, hot knot on the left arm. The knot was where the injection was, but it was bigger than the injection hole. The patient did not feel well, but not sick, just weak and did not want to eat. The events did not result in doctor or other health care 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 large red, itchy, hot knot on the left arm, did not feel well, but not sick, just weak and did not want to eat were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: 30 hours of 102+ fever; Headache; Chills; Nausea; sore arm; Large rash; Pain at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 44-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. Concomitant medications included birth control for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 15:30, the patient experienced 30 hours of 102+ (unspecified units) fever, headache, chills, nausea and sore arm. The patient also had several days layer large rash and pain at injection site. On the same day, the patient underwent body temperature test and the result was more than 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, headache, chills, nausea, sore arm, large rash and pain at injection site was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: 30 hours of 102+ fever; Headache; Chills; Nausea; sore arm; Large rash; Pain at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 44-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. Concomitant medications included birth control for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 15:30, the patient experienced 30 hours of 102+ (unspecified units) fever, headache, chills, nausea and sore arm. The patient also had several days layer large rash and pain at injection site. On the same day, the patient underwent body temperature test and the result was more than 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, headache, chills, nausea, sore arm, large rash and pain at injection site was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Menstruation delayed
Clinical narrative: Bruising (quarter size); Missed menstrual period 7 days late (ongoing); This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 09:45 (at the age of 40-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 concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced bruising (quarter size) for 7 days. The patient missed her menstrual period which was 7 days late and was ongoing. The patient reported that she rarely if ever was late and had been regular the entire duration of the pandemic, neither any dietary changes nor any lifestyle changes that can be attributed to irregularity. 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 bruising (quarter size)  was resolved on 23Apr2021 with the duration of 7 days; while that of the event menstrual period which was 7 days late was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Felt terrible, with fever of 104; Chills; Couldn't move arms or legs; Profound soreness and tiredness in her body.; Tiredness in her body.; felt terrible/she felt like she'd been hit by a truck; Intense Headache; Diarrhea with a strong smell; Stench/burning in her nose; Stench/burning in her nose; This is a spontaneous report from a contactable physician. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 08Apr2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to coconut flavor. 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. The patient previously received codeine (MANUFACTURER UNKNOWN) and oil (LAVENDER OIL) for unspecified indication from unknown date and experienced drug allergy. On 09Apr2021, the day after the vaccine, the patient felt terrible, with fever of 104, chills. The next day her fever and chills passed, she felt like she'd been hit by a truck, couldn't move arms or legs, profound soreness and tiredness in her body. This improved, but then had 4 days of intense headache. The patient also experienced diarrhea with a strong smell which had been persistent since 4 days after the vaccine. The patient had stench/burning in her nose that was persistent at all times, had been worsening over time. Currently, at the time of this report, the patient was having 3-4 times per day diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 09Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 104 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt terrible, with fever of 104 and chills were resolved on 10Apr2021. The clinical outcome of the event headache was resolved on an unspecified date in Apr2021, after the duration of 4 days; while that of the events couldn't move arms or legs, profound soreness and tiredness were resolving. The clinical outcome of the events stench/burning in her nose and diarrhea with a strong smell was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Nasal discomfort, Pain, Parosmia
Clinical narrative: Felt terrible, with fever of 104; Chills; Couldn't move arms or legs; Profound soreness and tiredness in her body.; Tiredness in her body.; felt terrible/she felt like she'd been hit by a truck; Intense Headache; Diarrhea with a strong smell; Stench/burning in her nose; Stench/burning in her nose; This is a spontaneous report from a contactable physician. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 08Apr2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to coconut flavor. 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. The patient previously received codeine (MANUFACTURER UNKNOWN) and oil (LAVENDER OIL) for unspecified indication from unknown date and experienced drug allergy. On 09Apr2021, the day after the vaccine, the patient felt terrible, with fever of 104, chills. The next day her fever and chills passed, she felt like she'd been hit by a truck, couldn't move arms or legs, profound soreness and tiredness in her body. This improved, but then had 4 days of intense headache. The patient also experienced diarrhea with a strong smell which had been persistent since 4 days after the vaccine. The patient had stench/burning in her nose that was persistent at all times, had been worsening over time. Currently, at the time of this report, the patient was having 3-4 times per day diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 09Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 104 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt terrible, with fever of 104 and chills were resolved on 10Apr2021. The clinical outcome of the event headache was resolved on an unspecified date in Apr2021, after the duration of 4 days; while that of the events couldn't move arms or legs, profound soreness and tiredness were resolving. The clinical outcome of the events stench/burning in her nose and diarrhea with a strong smell was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt terrible, with fever of 104; Chills; Couldn't move arms or legs; Profound soreness and tiredness in her body.; Tiredness in her body.; felt terrible/she felt like she'd been hit by a truck; Intense Headache; Diarrhea with a strong smell; Stench/burning in her nose; Stench/burning in her nose; This is a spontaneous report from a contactable physician. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 08Apr2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to coconut flavor. 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. The patient previously received codeine (MANUFACTURER UNKNOWN) and oil (LAVENDER OIL) for unspecified indication from unknown date and experienced drug allergy. On 09Apr2021, the day after the vaccine, the patient felt terrible, with fever of 104, chills. The next day her fever and chills passed, she felt like she'd been hit by a truck, couldn't move arms or legs, profound soreness and tiredness in her body. This improved, but then had 4 days of intense headache. The patient also experienced diarrhea with a strong smell which had been persistent since 4 days after the vaccine. The patient had stench/burning in her nose that was persistent at all times, had been worsening over time. Currently, at the time of this report, the patient was having 3-4 times per day diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 09Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 104 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt terrible, with fever of 104 and chills were resolved on 10Apr2021. The clinical outcome of the event headache was resolved on an unspecified date in Apr2021, after the duration of 4 days; while that of the events couldn't move arms or legs, profound soreness and tiredness were resolving. The clinical outcome of the events stench/burning in her nose and diarrhea with a strong smell was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness; Tingling from shoulder down to hand; Wrist pains; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first 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 12:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), generalized anxiety disorder, carpal tunnel and sulfonamide allergy. Prior to 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. Concomitant medications included fluoxetine hydrochloride (POZAC), methylphenidate hydrochloride (CONCERTA), atomoxetine hydrochloride (STRATTERA), glycopyrronium tosylate (QBREXZA) and Rethinylestradiol, norgestimate (MILI) from an unknown date for an unknown indication and unknown if ongoing. On 24Apr2021 at 13:15, after about 35-45 minutes, the patient experienced numbness and tingling from shoulder down to hand accompanied by wrist pains. She was unsure if that is a common side effect, but it was not listed so she wanted to report it anyways. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events numbness, tingling from shoulder down to hand and wrist pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Exactly one week later on 4/22 I started to develop hives (which I initially thought were mosquito bites). By today 4/24, I am positive they are hives and huge welts on my face and arms and torso, they itch; Half of my face is swollen; Exactly one week later on 4/22 I started to develop hives (which I initially thought were mosquito bites). By today 4/24, I am positive they are hives and huge welts on my face and arms and torso, they itch; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX); taken for unknown indication from an unknown date and unknown if ongoing. On 22Apr2021, exactly one week later, the patient started to develop hives (which she initially thought were mosquito bites). By today (at the time of this report, as reported) on 24Apr2021, she was positive that they were hives. She had huge welts on her face and arms and torso. They itch and half of her face was swollen. 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 exactly one week later, the patient started to develop hives (which she initially thought were mosquito bites). By today (at the time of this report, as reported) on 24Apr2021, she was positive that they were hives. She had huge welts on her face and arms and torso. They itch and half of her face was swollen was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in both knees that was never present before. It hurts to stand up and sometimes just sitting, never related to activity.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced joint pain in both knees that was never present before. The patient reported that it hurt to stand up and sometimes just sitting, never related to activity. 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 joint pain in both knees that was never present before was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia, Tinnitus
Clinical narrative: Fever; Chills; Migraine; Tinnitus; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19.  On 23Apr2021, the patient experienced fever, chills, migraine and tinnitus. 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 fever, chills, migraine and tinnitus was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Swollen lymph node; Diarrhea; 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: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as oodles of them (unspecified). The patient had unspecified 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 received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 09:00, the patient had normal immune system responses that lasted 12 days after the second shot including fever, swollen lymph node, diarrhea and others. 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 fever, swollen lymph node and diarrhea was resolved on 08Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: is pregnant Yes; After dose 1: arm pain for 2 days; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:00AM (age at vaccine 31-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient did not have any known allergies. It was reported that the patient was a pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced after dose 1: arm pain for 2 days on 23Apr2021 02:00AM and is pregnant yes on an unspecified date. The mother reported she became a pregnant while taking bnt162b2. The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on 30Sep2021. The clinical outcome of the events arm pain for 2 days was recovered other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Headache, Pain
Clinical narrative: Normal weak; Headaches for 24 hours; Severe diarrhea; Stomach pain; Body pain all over; This is a spontaneous report from a contactable consumer, the patient. A 58-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 17Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paroxetine hydrochloride (PAXIL), atorvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), celecoxib (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL A); all were for an unknown indication from an unknown date and unknown if ongoing. On 11Apr2021, the patient experienced normal weak and headaches for 24 hours. On an unknown date in 2021, almost 2 weeks later, the patient experienced severe diarrhea, stomach pain and body pain all over. 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 normal weak and headaches for 24 hours was resolved on 12Apr2021, after the duration of 24 hours; while that of events severe diarrhea, stomach pain and body pain all over was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysuria, Emotional distress, Herpes virus infection, Urinary incontinence
Clinical narrative: Herpes; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. Had an outbreak also.; Wouldnt go to the doctor because "I" was embarrassed by it all; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 an unknown date as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 13Mar2021, the patient did not realize herpes was something that should be reported. With the second shot the patient had the worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. The patient had an outbreak also and had never had one in the 12 years of diagnosis. The patient was embarrassed by it all and did not go to the doctor. 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 herpes, urine that was so golden and smelled so foul (boiled eggs) and burned when it passed and urine outbreak was resolved on an unknown date in 2021; while that of the event embarrassed by it all and did not go to the doctor was unknown 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.
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: Herpes; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. Had an outbreak also.; Wouldnt go to the doctor because "I" was embarrassed by it all; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 an unknown date as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 13Mar2021, the patient did not realize herpes was something that should be reported. With the second shot the patient had the worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. The patient had an outbreak also and had never had one in the 12 years of diagnosis. The patient was embarrassed by it all and did not go to the doctor. 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 herpes, urine that was so golden and smelled so foul (boiled eggs) and burned when it passed and urine outbreak was resolved on an unknown date in 2021; while that of the event embarrassed by it all and did not go to the doctor was unknown 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen lymph nodes in right arm pit; Fever; Chills; Fatigue; Full body aches; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8731) via an unspecified route of administration in the right arm on 21Apr2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included reflux and sulfa allergy which causes nausea. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and desogestrel/ethinylestradiol (APRI); both were from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8730) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 20:30, symptoms started 12 hours after second vaccination, for 12-16 hours the patient had fever, chills, fatigue and full body aches. On 22Apr2021, next day the patient woke up with swollen lymph nodes in right arm pit that continue today (at the time of this report) and fatigue was continuing. 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 fever, chills, fatigue, full body aches and swollen lymph nodes in right arm pit was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding
Clinical narrative: Heavy menstrual bleeding; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0151) via an unspecified route of administration in the left arm on 20Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovary syndrome (PCOS). 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. Concomitant medication included unspecified birth control pill from an unknown date and unknown if ongoing. On 22Apr2021, the patient experienced heavy menstrual bleeding and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if any 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 heavy menstrual bleeding and fatigue was resolving 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: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Feels like the sides of my throat is swollen day after I took my first dose of Pfizer, causing a sore throat; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 21Apr2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Apr2021, the patient felt like the sides of throat were swollen day after she took first dose of Pfizer and also caused a sore throat. 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 event felt like the sides of throat were swollen and sore throat were 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Peripheral swelling, Rash papular
Clinical narrative: ''I'' noticed ''my'' fingers developed slight swelling and a minimal rash that consisted of small red non-itchy bumps; ''I'' noticed ''my'' fingers developed slight swelling and a minimal rash that consisted of small red non-itchy bumps; ''I'' felt dizzy and had a headache.; ''I'' felt dizzy and had a headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and ethinylestradiol/etonogestrel (NUVARING); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, approximately 120 minutes after receiving the first dose of the vaccine, the patient noticed her fingers developed slight swelling and a minimal rash that consisted of small red non-itchy bumps, the patient felt dizzy and had a headache. The patient reported that the rash became increasingly prominent over the next 60 minutes and then stopped changing and it was present for about 8 hours and then slowly went away. 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 fingers developed slight swelling and a minimal rash that consisted of small red non-itchy bumps, felt dizzy and headache were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual spotting; Irregular menstrual cycle; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via an unspecified route of administration in the right arm on 19Apr2021 at 11:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/ levonorgestrel (AVIANE) for an unknown indication from an unknown date and unknown if ongoing. On 21Apr2021, the patient experienced menstrual spotting and irregular menstrual cycle. The 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 menstrual spotting and irregular menstrual cycle were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Extremely sore vax arm, left side for 2 weeks straight after first shot; Slight swelling and occasional itch around vax site; Slight swelling and occasional itch around vax site; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient was allergic to soft shell crab. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 09Apr2021, the patient experienced extremely sore vax arm, left side for 2 weeks straight after first shot. Started to fade at 14 days with regular ice treatment, slight swelling and occasional itch around vax site, as well, but no rash or dermal issues. 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 event extremely sore vax arm and included treatment with regular ice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore vax arm, left side for 2 weeks straight after first shot, slight swelling and occasional itch around vax site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Left armpit swelling. Received vaccine in January. From then to now I have random armpit pain and swelling in both armpits; Random armpit pain and swelling in both armpits; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation and also received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination were not reported. On 01Jan2021 the patient experienced left armpit swelling. The patient had received vaccine in January. From then had random armpit pain and swelling in both armpits. Not bad pain but enough to be irritating. Everyday the patient had flare ups of pain in either armpit and the left one gets swollen quite a bit. 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 left armpit swelling; random armpit pain and swelling in both armpits, not bad pain but enough to be irritating; everyday the patient had flare ups of pain in either armpit and the left one gets swollen quite a bit was not resolved 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: Chest pain, Headache, Lymphadenopathy, Pain, Pain in jaw
Clinical narrative: Severe headache; Jaw pain; Swollen lymph node left armpit; chest pain; Left pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 35-year-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 take 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: EZ9262) via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 02:30, the patient experienced severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain. 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 been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.