chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: feeling lightheaded; I went to bed as I was feeling lightheaded and exhausted; After dinner last night, I started to feel nauseated; vomited a small amount of digested food; immediately developed a headache; immediately developed a chills, required extra blankets for warmth and cycled through hot/chilling cycles all night; required extra blankets for warmth and cycled through hot/chilling cycles all night; I had severe stomach pain; This is a spontaneous report from a contactable nurse.  A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:45 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA), tinnitus and lactose intolerance. 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 tilactase (LACTASE), magnesium (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN); all for an unknown indication from an unknown dates and unknown if ongoing. On 04Mar2021 at 19:00, the patient felt nauseated after dinner and vomited a small amount of digested food, immediately developed a headache and chills. The patient reported that her husband completed his second Pfizerer dose, ate the same dinner and did not have any effects. On the same day at 20:00, the patient went to bed and was feeling lightheaded and exhausted 2 hours ahead of schedule. she required extra blankets for warmth and cycled through hot and chilling cycles all night, had severe stomach pain, but no diarrhea or coughing. At 06:00, effects disappeared with the exception of light headedness and exhaustion. The patient also reported that her 77-year-old sister received the Moderna vaccine on 22Feb2021 and had a massive stroke on 23Feb2021. That left her to wonder if she should get the second dose on 18Mar2021 or not. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nauseated, vomited, headache, hot chilling cycles, severe stomach pain, and chills were recovered on an unknown date in Mar2021, while the events feeling lightheaded and exhausted were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Since receiving 2nd dose of vaccine have had abdominal cramping and diarrhea daily; Since receiving 2nd dose of vaccine have had abdominal cramping and diarrhea daily; This is a spontaneous report from a contactable nurse, the patient. A 37-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 in the right arm on 13Jan2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), anxiety, GERD (gastroesophageal reflux disease), COVID-19 on an unknown date in Mar2020 along with pain stomach and diarrhea. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date in Mar2020. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included omeprazole (PRILOSEC), valsartan (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR) and melatonin (MANUFACTURER UNKNOWN); all for unspecified indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an 23Dec2020 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On an unknown date, the patient underwent 6-week V-safe check in and did mention possible complication. On 14Jan2021 after second dose, the patient experienced abdominal cramping and diarrhea daily. 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 abdominal cramping and diarrhea were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A female patient of unknown age received 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. It was unknown if the patient was pregnant. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue. The clinical outcome of the event fatigue 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Woke up in sweat; Pounding headache/ severe headache; Feeling super weak/ Too weak to get out of bed rest of day.; Dizzy; Started throwing up x3; Fell asleep and only woke up to intermediate alarms/ Was awake for a total of 2.5 hours before falling asleep again; Started feeling severely nauseous; Fatigued; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 14:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), diagnosed with ovarian cyst on 01Mar in an unknown year and gluten intolerance (allergy to gluten). 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 amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) daily for an unknown indication, from an unknown date and hydrocodone (MANUFACTURER UNKNOWN) on 01Mar2021 and 02Mar2021, for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 10Feb2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 20:30, the patient started feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15. On 04Mar2021 at 07:15, the patient woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, fell asleep and only woke up to intermediate alarms the patient set for herself, was too weak to get out of bed rest of day and was awake for a total of 2.5 hours before falling asleep again at 18:30 and waking up at 06:15 on 05Mar2021. On 05Mar2021, the patient felt better than the previous day but still had a severe headache. 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 feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15, woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, too weak to get out of the bed rest of the day, was awake for a total of 2.5 hours before falling asleep again and severe headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Vomiting
Clinical narrative: Woke up in sweat; Pounding headache/ severe headache; Feeling super weak/ Too weak to get out of bed rest of day.; Dizzy; Started throwing up x3; Fell asleep and only woke up to intermediate alarms/ Was awake for a total of 2.5 hours before falling asleep again; Started feeling severely nauseous; Fatigued; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 14:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), diagnosed with ovarian cyst on 01Mar in an unknown year and gluten intolerance (allergy to gluten). 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 amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) daily for an unknown indication, from an unknown date and hydrocodone (MANUFACTURER UNKNOWN) on 01Mar2021 and 02Mar2021, for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 10Feb2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 20:30, the patient started feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15. On 04Mar2021 at 07:15, the patient woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, fell asleep and only woke up to intermediate alarms the patient set for herself, was too weak to get out of bed rest of day and was awake for a total of 2.5 hours before falling asleep again at 18:30 and waking up at 06:15 on 05Mar2021. On 05Mar2021, the patient felt better than the previous day but still had a severe headache. 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 feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15, woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, too weak to get out of the bed rest of the day, was awake for a total of 2.5 hours before falling asleep again and severe headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity
Clinical narrative: Evening of 4th when arm pain disappeared digestive upset and diarreha resulted and continued throughout the night.; Evening of 4th when arm pain disappeared digestive upset and diarreha resulted and continued throughout the night.; Arm pain for two days; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 11:45 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pulmonary embolism [on blood thinners for pulmonary embolism (PE) in 2013]. The patient did not have any 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 lisinopril (MANUFACTURER UNKNOWN) and rivaroxaban (XARELTO); both for unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 at 14:00, the patient experienced arm pain for two days and on 04Mar2021, in the evening, when arm pain disappeared digestive upset and diarrhea resulted and continued throughout the night. Since the vaccination, the patient had not been tested for COVID-19. 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 event. The clinical outcome of the event arm pain for two days was recovered on 04Mar2021 and the events digestive upset and diarrhea resulted and continued throughout the night was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tired; Soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 01Mar2021 at 14:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 06Feb2021 at 15:00 as a single dose for COVID-19 immunisation. On 03Mar2021 at 12:00, the patient experienced tired and soreness. Since the vaccination, the patient had not been tested for COVID-19. 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  tired and soreness was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unspecified indication, from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 11:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 04Mar2021, the following morning after vaccination, the patient experienced running nose that lasted all day. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event running nose was resolved on 04Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Product administration error, Vaccination site dryness
Clinical narrative: The skin area around the injection (approximately 1 inch in diameter) felt dry and rough; The skin area around the injection (approximately 1 inch in diameter) felt dry and rough; At end of the injection, there was a pop from the needle; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 13Feb2021 at 14:45 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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 included calcium carbonate/colecalciferol (CALCIUM+VIT D), cyanocobalamin (VITAMIN B-12), tocopherol (VITAMIN E), tamsulosin (MANUFACTURER UNKNOWN) and multi vit; all for unknown indications from unknown dates and unknown if ongoing. It was reported that at end of the Pfizer injection, there was a pop from the needle, and the nurse told sorry and startled, then the nurse added a band-aid, then sent the patient and his wife on down the driving line. On 16Feb2021 at 14:00, a few days later after removing the band-aid, the patient noticed that the skin area around the injection (approximately 1 inch in diameter) felt dry and rough. No redness nor swelling or pain was there. On 04Mar2021, the skin still had the same dry, rough texture feeling when the patient rubbed his finger over that area. The patient did not know if the vaccine caused this skin reaction, like when they heard the pop might be some of the vaccine popped and dribbled on his left arm around the injection area. Anyway, the patient would like to know if this was the cause of the dry, rough skin area or any other ideas we might have and how long would this area take to get back to normal. 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 events the skin area around the injection (approximately 1 inch in diameter) felt dry and rough. The clinical outcome of the events the skin area around the injection (approximately 1 inch in diameter) felt dry and rough was unknown 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: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Chills (mild); Headache (mild); Fatigue (mild); Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 13:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19 . The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 13:15, the patient experienced injection site pain (mild). On 04Mar2021, the patient experienced injection site pain (mild), chills (mild), headache (mild) and fatigue (mild). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain (mild), injection site pain (mild), chills (mild), headache (mild) and fatigue (mild) were resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms
Clinical narrative: Arm cramping below the elbow of the injected arm. And Headache.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 05Mar2021 (at the age of 28-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. Concomitant medications were not reported. On 05Mar2021, the patient experienced arm cramping below the elbow of the injected arm and headache. 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 arm cramping below the elbow of the injected arm and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Diarrhoea
Clinical narrative: Extreme diahrrea; Inability to control bowels; This is a spontaneous report from a non-contactable consumer, the patient. A 69-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 right arm on 04Mar2021 at 12:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and vasoconstrictors. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 17:00, the patient experienced extreme diahrrea and inability to control bowels. 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 extreme diahrrea and inability to control bowels 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Chills; Headache; Very tired; Arm was also very sore.; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Mar2021 at 18:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was not sure if the patient had received any concomitant medication. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 18:00, 24 hours after vaccination, the patient experienced chills, headache, very tired and arm was also very sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. Since the vaccination, it was unknown whether the patient had tested for COVID-19. The clinical outcome of the events chills, headache, very tired and arm was also very sore was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Injection site soreness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG206) via an unspecified route of administration in the right arm on 04Mar2021 at 17:15 (at the age of 60-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. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (BC powder). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 20:00, the patient experienced injection site soreness and headache. 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder spasm, Rectal tenesmus
Clinical narrative: Tenesmus both urinary and rectal; Tenesmus both urinary and rectal; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 04Mar2021 at 12:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included UTI (urinary tract infection). 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 vaccine. Concomitant medications included nitrofurantoin (MACROBID), for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021 at 07:00, the patient experienced tenesmus both urinary and rectal. The adverse event did not result in a visit to the doctors 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. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events tenesmus both urinary and rectal was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Rhinorrhoea
Clinical narrative: Not feeling 100%; Headache; Nose drainage; Body aches; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 40-year-old 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 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced headache, nose drainage, body aches, and was not feeling 100 percent (%). 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 not feeling 100%, headache, nose drainage, and body aches were 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just felt like right arm was punched super hard but it was about 6 hours later. I put heat on it and it's helped alot; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Pfizer en 6199) via an unspecified route of administration in the right arm on 02Mar2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included knees replaced, both hips one 2xs 1 ,3xs both shoulders, rod in lower back for scoliosis and latex allergy. The patient previously received acetyl salicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication multi vitamin (C, d3, E, Iron, B12, potassium) (MANUFACTURER UNKNOWN) and vitamin B complex (SUPER B COMPLEX) both  for unknown indication from an unknown dates and unknown if ongoing. On 03Mar2021 at 00:00, the patient just felt like her right arm was punched super hard but it was about 6 hours later and she had put heat on it and it helped a lot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm was punched super hard was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 04Mar2021 at 09:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included low back pain (CLBP), hip pain, atrioventricular nodal re-entrant tachycardia (AVNRT), breast cancer, skin cancer, allergy to peanuts and nickel. 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 diltiazem (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received morphine and derivatives (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Mar2021 at 03:00, the patient experienced sudden involuntary and sustained (5 min) contraction of all muscles in both lower legs and soreness in both legs which persisted for 15 hours. 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 sudden involuntary and sustained (5 min) contraction of all muscles in both lower legs and soreness in both legs which persisted for 15 hours were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at spot of injection; This is a spontaneous report from a contactable consumer, the patient. A 61-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 04Mar2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergy. 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 vaccination. On 04Mar2021, at 18:00 the patient experienced sore at spot of injection and also reported that aspirin did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore at spot of injection and included treatment with aspirin. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore at spot of injection was not recovered at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; Chills; This is a spontaneous report from a non-contactable consumer, the patient. An 80-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 04Mar2021 at 12:45 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medication taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 22:00, the patient experienced fatigue and chills. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Mar2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fatigue and chills was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at site of injection; This is a spontaneous report from a contactable nurse. A female patient of unknown age received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021,  the patient experienced soreness at site of injection. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested positive for COVID-19.The clinical outcome of the event soreness at site of injection 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Pain and stiffness in back of head on the left side; Pain and stiffness in back of head on the left side; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 08Mar2021 at 17:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included short-bowel syndrome. The patient had no known allergies to medications, food, 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 vaccination. On 08Mar2021 at 17:30, the patient experienced pain and stiffness in back of head on the left side. 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 pain and stiffness in back of head on the left side was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain began 7-8 hours after injection; This is a spontaneous report from a contactable consumer the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 07Mar2021 at 13:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included nerve pain (chronic nerve pain issues as reported) and migraine. 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medications included multivitamin (MANUFACTURE UNKNOWN), pregabalin (LYRICA), vitamin d nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and cannabidiol (CBD); all from an unknown date for an unspecified indication and unknown if ongoing. On 07Mar2021 at 20:00, the patient experienced injection site pain began 7-8 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site pain was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Injection site pain; Chills; Feeling unwell; Tiredness/ "I" threw up/ more tiredness; Nausea; Headache; "I" threw up; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to CIPRO. 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 previously 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 an unknown date as a single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced chills, feeling unwell, tiredness, threw up, more tiredness, nausea and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. 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 chills, feeling unwell, tiredness, threw up, more tiredness, nausea and headache were resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Injection site pain; Chills; Feeling unwell; Tiredness/ "I" threw up/ more tiredness; Nausea; Headache; "I" threw up; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to CIPRO. 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 previously 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 an unknown date as a single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced chills, feeling unwell, tiredness, threw up, more tiredness, nausea and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. 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 chills, feeling unwell, tiredness, threw up, more tiredness, nausea and headache were resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild to moderate soreness at vaccination site for around 48 hours; This is a spontaneous report from a contactable physician, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 at 11:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced mild to moderate soreness at vaccination site for around 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild to moderate soreness at vaccination site was recovered on 05Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: Soreness in arm where vaccination was received; Chills; Fatigue; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 58-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 03Mar2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high, cholesterol high and allergy to penicillin medications(penicillin allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 at 12:00, the patient experienced soreness in arm where vaccination was received, chills, fatigue and loss of appetite. 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 soreness in arm where vaccination was received, chills, fatigue and loss of appetite were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained.