chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Peripheral swelling, Vaccination site pain
Clinical narrative: Swollen hands and feet; Tight sensation and discomfort in back of legs/ heaviness in my feet and lower legs; Swollen gland in right armpit; Nausea; Burning sensation in back; Pain in injection site; ''I'' have experienced tingling, tightness and heaviness in ''my'' feet and lower legs.; ''I'' also feel slightly off; Having loose stool; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to unknown form of anxiety medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included ethinylestradiol/ norethisterone acetate (LOESTRIN), multivitamin (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. On 11Apr2021, the patient experienced swollen gland in right armpit, nausea and burning sensation in back 3 days later. The patient experienced swollen hands and feet next day (12Apr2021), had tight sensation and discomfort in back of legs, pain in injection site for 2 days. For the last 2 weeks and at the time of reporting, the patient experienced tingling, tightness and heaviness in her feet and lower legs. She also felt slightly off and had loose stool. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in injection site was resolved on an unknown date in Apr2021, after a duration of 2 days; while that of the tight sensation and discomfort in back of legs/ heaviness in my feet and lower legs, tingling feet, swollen gland in right armpit, nausea, burning sensation in back, swollen hands and feet, also feel slightly off and had loose stool was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Not adverse!! Advantageous!!! All my post COVID symptoms went away! Headaches diarrhea. Tiredness and fatigue/aches. All left after the FIRST vaccine. Then all my eczema on my feet and psoriasis on my scalp wentaway after vaccine 2!; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 26Mar2021 at 14:30 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9729) via an unspecified route of administration in the arm left on 16Apr2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history reported as nothing related. Prior to the vaccination it was unknown whether the patient was 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 27Mar2021 at 08:00, the patient reported not adverse!!  but advantageous!!!  all her post COVID symptoms went away, headaches diarrhea, tiredness and fatigue/aches, all left after the first vaccine. Then all her eczema on her feet and psoriasis on her scalp went away after vaccine 2!!! she feels amazing!! Great effects! she wasn't sure how to let this know and said this was the only way and asked to please ensure someone follows up on this and told it's a miracle of science!!. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, not adverse!!  Advantageous!!! all her post COVID symptoms went away!  headaches diarrhea, tiredness and fatigue/aches, all left after the first vaccine, then all her eczema on her feet and psoriasis on her scalp went away after vaccine 2 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity, Tinnitus
Clinical narrative: Both arms sore; Back pain; Ringing in ears; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 27Apr2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, high blood pressure and 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 amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL XR), losartan potassium (LOSARTIN) and tamsulosin (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 15:00, the patient experienced both arms sore, back pain, ringing in ears and tiredness. 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 both arms sore, back pain, ringing in ears and tiredness were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Myalgia, Peripheral swelling
Clinical narrative: Severe joint pain; Muscle pain; Red, swollen left arm; Red, swollen left arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 42-years-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 cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM); both taken for an unknown 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: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, after the second shot, the patient experienced severe joint and muscle pain for more than 4 days and red, swollen left arm. 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 severe joint and muscle pain and red, swollen left arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Constipation; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8724) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to penicillins. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient experienced constipation. The event constipation did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constipation was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tinnitus, Vertigo
Clinical narrative: 14 DAYS AFTER 2ND VACCINE "I" HAVE VERTIGO; swelling of lymph nodes under left arm and neck for 5 days; Ringing in ears; This is a spontaneous report from a contactable other healthcare professional, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208) via an unspecified route of administration in the left arm on 15Mar2021 at 17:15 (at the age of 62-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 the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 16Mar2021, the patient experienced swelling of lymph nodes under left arm, neck for 5 days and ringing in ears. On 30Mar2021, 14 days after second vaccine, the patient had vertigo. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown whether 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 swelling of lymph nodes under left arm and neck was recovered on 21Mar2021 after the duration of 5 days, while the events ringing in ears and vertigo were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of personal independence in daily activities, Malaise
Clinical narrative: Difficult breathing night after shot; Feel very sick everyday- still lasting- can't do day to day things; Feel very sick everyday- still lasting- can't do day to day things; This is a spontaneous report from a contactable consumer, the patient. A 20-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 15:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 16:00, the patient felt difficult breathing night after shot and felt very sick everyday which was still lasting at the time of report and the patient could not do day to day things. 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 felt difficult breathing night after shot, felt very sick everyday which was still lasting at the time of report and could not do day to day things 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea, Pain
Clinical narrative: I had body aches and chills; I had body aches and chills; A massive migraine which caused nausea when any movements were made; A massive migraine which caused nausea when any movements were made; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. 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 metoprolol (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication and experienced drug allergy. On 27Apr2021 at 06:00, the patient had body aches and chills, a massive migraine which caused nausea when any movements were made. 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 he had body aches and chills and a massive migraine which caused nausea when any movements were made was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea, fever and chills; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 07:30 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. Medical history included immune thrombocytopenic purpura. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received erythromycin (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy and received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 07:30 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. On 27Apr2021 at 18:00, the patient experienced nausea, fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea, fever and chills was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: Shortness of breath; Chills; Fever; Muscle aches all over; Weak body; Arm pain; Diarrhea; Nauseous; Haven't wanted to eat in over 13 hours when symptoms began; Severe headaches; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 07:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included patient was obese. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and topiramate (MANUFACTURER UNKNOWN); all from unknown date for unknown indication 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 on an unknown date as a single dose for COVID-19 immunisation. The patient previously took cefixime (MANUFACTURER UNKNOWN), phenytoin sodium (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN), fosphenytoin sodium (MANUFACTURER UNKNOWN) and possibly experienced drug allergy but it was unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 17:30, the patient experienced shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches. 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 shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Shortness of breath; Chills; Fever; Muscle aches all over; Weak body; Arm pain; Diarrhea; Nauseous; Haven't wanted to eat in over 13 hours when symptoms began; Severe headaches; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 07:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included patient was obese. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and topiramate (MANUFACTURER UNKNOWN); all from unknown date for unknown indication 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 on an unknown date as a single dose for COVID-19 immunisation. The patient previously took cefixime (MANUFACTURER UNKNOWN), phenytoin sodium (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN), fosphenytoin sodium (MANUFACTURER UNKNOWN) and possibly experienced drug allergy but it was unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 17:30, the patient experienced shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches. 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 shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incomplete course of vaccination, Peripheral swelling
Clinical narrative: Had pneumonia Vaccine about 5 years ago and arm swelled up for almost 6 months and was red; Had pneumonia Vaccine about 5 years ago and arm swelled up for almost 6 months and was red; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), MANUFACTURER UNKNOWN, Lot number not reported), via an unspecified route of administration on and unspecified date in 2016 as single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had pneumonia vaccine about 5 years ago and arm swelled up for almost 6 months and was red on an unspecified date in 2016. Patient mentioned she that never received second pneumonia vaccine. Outcome of the events was unknown.   Pfizer is a marketing authorization holder of [pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] has submitted the same report to the regulatory authorities.  Follow-up (18Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Very swollen gland above collar bone on left side.  It has been over 2 weeks since "I" received the second dose of the vaccine and my gland is still swollen; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN); all 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 COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 14Apr2021, the patient had very swollen gland above collar bone on the left side that had been over 2 weeks since the patient received second dose of vaccination and her gland was still swollen (when reported by the patient). 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 very swollen gland above collar bone on the left side was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Headache
Clinical narrative: Brain fog started within 5 hrs of injection; Confusion started within 5 hrs of injection; Terrible headache started overnight following injection; Extreme fatigue; 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: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not take any concomitant medications within 2 weeks of vaccination. 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 left arm on 05Apr2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 15:00, the patient experienced brain fog and confusion started within 5 hours of injection, terrible headache started overnight following injection and extreme fatigue. 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 foggy feeling in head, confusion, headache and fatigue extreme was not resolved at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Tinnitus
Clinical narrative: Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night; Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night.; Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male 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 05Apr2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medications. 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 06Apr2021 at 04:00, the patient experienced loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night. Ringing has continued for several weeks and shows no sign of subsiding. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Where i received my injection my arm is still sore whenever I move it it feels like its in my muscle; This is a spontaneous report from a contactable consumer, the patient. A 70-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 right arm on 19Feb2021 at 09:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Where the patient received her injection, her arm was still sore on 19Feb2021 at 23:00, whenever she moved it, it felt like it's in her muscle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event where the patient received her injection arm was still sore whenever she moved it, it felt like it's in her muscle 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Wheezing
Clinical narrative: Have experienced shortness of breath; Increased wheezing; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 23-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 26Apr2021 at 13:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol (VENTOLIN) and fexofenadine hydrochloride (ALLEGRA); for unknown indications, from an unknown date and unknown if ongoing. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 27Apr2021 at 12:00, the patient experienced shortness of breath, increased wheezing and headaches. The patient did not see shortness of breath on the side effects so he wanted to make it noted. The events did not result in doctor or other healthcare professional office/clinic, 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 reported events. The clinical outcome of the events shortness of breath, increased wheezing and headaches was recovering 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Emotional disorder, Menstruation irregular, Pain
Clinical narrative: Period came 7 days early; I had PMS symptoms much worse than I usually get; Bloating; Overly emotional; Terrible cramps/ soreness; Terrible cramps/ soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 07Apr2021 at 18:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. On an unknown date in Aug2020, the patient underwent COVID-19 test via nasal swab and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) 50mg, melatonin (MANUFACTURER UNKNOWN) 5mg and vitamin D NOS (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. On 16Apr2021, the patient's period came 7 days early. The week prior to that, the patient experienced premenstrual syndrome (PMS) symptoms much worse than she usually got: overly emotional, bloating, terrible cramps and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events period came 7 days early, PMS symptoms much worse than she usually got: overly emotional, bloating, terrible cramps, soreness was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome, SARS-CoV-2 test
Clinical narrative: Period came 7 days early; I had PMS symptoms much worse than I usually get; Bloating; Overly emotional; Terrible cramps/ soreness; Terrible cramps/ soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 07Apr2021 at 18:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. On an unknown date in Aug2020, the patient underwent COVID-19 test via nasal swab and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) 50mg, melatonin (MANUFACTURER UNKNOWN) 5mg and vitamin D NOS (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. On 16Apr2021, the patient's period came 7 days early. The week prior to that, the patient experienced premenstrual syndrome (PMS) symptoms much worse than she usually got: overly emotional, bloating, terrible cramps and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events period came 7 days early, PMS symptoms much worse than she usually got: overly emotional, bloating, terrible cramps, soreness was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Limb discomfort, Muscular weakness, Paraesthesia
Clinical narrative: Tingling in right leg-whole leg; Leg also feels heavy and weak; Leg also feels heavy and weak; Left temporal headache; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included REM sleep behavior disorder (RBD) sleep disorder, attention deficit hyperactivity disorder (ADHD) and chronic sinusitis. The patient had known allergies to shellfish and sulfa. 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 sertraline (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took ondansetron (ZOFRAN), metoclopramide (REGLAN) and lamotrigine (LAMICTAL); all for unknown indications and experienced drug allergy. On 27Apr2021 at 15:45, the patient experienced tingling in right leg-whole leg, leg also felt heavy and weak, left temporal headache and confusion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether 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 tingling in right leg-whole leg, leg also feels heavy and weak, left temporal headache and confusion was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Migraine, Neck pain, Skin burning sensation
Clinical narrative: Continuous migraine; Fatigue; Neck pain; Remittent chest pain; Burning back; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 16Apr2021 at 13:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included interstitial cystitis, endometriosis, penicillin allergy, meat allergy (beef, pork, poultry), egg allergy and milk allergy (diary). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), amitriptyline (MANUFACTURER UNKNOWN) and hyoscyamine sulfate, methenamine, methylthioninium chloride, phenyl salicylate, phosphoric acid sodium (URIBEL) all were taken for unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 14:45, the patient experienced continuous migraine, fatigue and neck pain since the vaccine date every day for two weeks, still going strong. Remittent chest pain since then as well. Burning back, chest pain, migraine, neck pain, and fatigue began about an hour after receiving the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continuous migraine, fatigue, neck pain, remittent chest pain and burning back were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period or menstruated out of cycle; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 at 10:30 (at the age of 34-years-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 take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 09:00 the patient experienced period or menstruated out of cycle. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period or menstruated out of cycle 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Vision blurred
Clinical narrative: Moderate blurry vision / haze; Moderate blurry vision / haze; Eyes feel strained.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) in the left arm on 25Mar2021 at 09:30 (at the age of 43-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) in the left arm on 22Apr2021 at 09:15 (at the age of 43-years-old) as a dose for COVID-19 immunisation. Medical history included left eye cornea injury when patient was 12 or 13, that inhibits focus and gives a haze on left eye only. Right eye has always compensated and given perfect vision and color representation. One of patient's professions is as graphic designer and over past two years patient's close vision has slowly decreased due to age. The patient has known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN); for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced moderate blurry vision/haze which started after first dose. No distance range was in perfect focus, eyes felt strained and it seemed to be getting worse every day. The patient reported that these new issues were not related to his previous medical history of eye cornea injury. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether 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 blurry vision/haze and eyes felt strained were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Lymph node pain
Clinical narrative: Chronic mild nosebleed; Cough; Axillary lymph node pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24Feb2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperhomocysteinemia, anxiety and ADHD. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and doxycycline (MANUFACTURER UNKNOWN); all for unknown indication from 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 intramuscular route of administration in the left arm on 03Feb2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 the patient experienced chronic mild nose bleed, cough and axillary lymph node pain. The events resulted in doctor or other health care professional office/clinic visit. 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 chronic mild nose bleed, cough, axillary lymph node pain was recovered with sequelae on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness in the chest area and feels heavier; This is a spontaneous report from a non-contactable consumer, the patient. A 46-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 26Apr2021 at 12:00 (at the age of 46-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 vaccination. On 26Apr2021, the patient experienced tightness in the chest area and felt heavier. 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 tightness in the chest area and felt heavier 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: Severe menstrual cramps; Fever; Chills; Muscle/joint aches in legs; Muscle/joint aches in legs; Headache; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 11:15 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included isotretinoin (MANUFACTURER UNKNOWN); on an unknown date, for unknown indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:00 (at the age of 18-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 03Apr2021 at 21:30, the patient experienced severe menstrual cramps, fever, chills, muscle/joint aches in legs, headache and tiredness. Since the vaccination, on 10Apr2021, the patient underwent nasal swab SARS-CoV-2 test and the result was negative. The clinical outcome of the events severe menstrual cramps, fever, chills, muscle/joint aches in legs, muscle/joint aches in legs, muscle/joint aches in legs, headache and tiredness was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.