chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy, Movement disorder, Pain, Paraesthesia
Clinical narrative: Lump under my armpit the same arm where I got my shot at; It give me tingle all the way down my arm; Its like a paddy sack and its like very sore; Its like hard to open and close my arm; It still have a lymph node but they are excessively swollen on the one side; This is a spontaneous report from a contactable consumer (patient). A female patient of a 38-years-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Apr2021 (at the age of 37-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EW0164), dose 1 via an unspecified route of administration on 08Apr2021 (at the age of 37-years-old) as DOSE 1, SINGLE for covid-19 immunisation and reported my first time was just sore. On an unspecified date, the patient reported that I had developed a lump under my armpit the same arm where I got my shot at. I am kind of figure out what should I do, I because its like a paddy sack and it was like very sore and its like hard to open and close my arm, It gave me tingle all the way down my arm. This was my first time, my first time was just sore the second was when I had the tingles and lump under my arm. Patient stated no, it was just an armpit issue, it still had a lymph nodes but they were excessively swollen on the one side. The patient received Tylenol, 500mg, taking 3 so its 1500, only taking twice a day. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose, Vaccination site haemorrhage
Clinical narrative: Patient may or may not have received about half the recommended Covid 19 vaccine dose; the syringe malfunctioned; There was spray back from the syringe contents and the patient's blood that sprayed the nurse; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a 22-year-old female patient. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mrna vaccine, solution for injection; Batch/Lot Number: EN6206), dose 2 via an unspecified route of administration on 04May2021 (at the age of 22-year-old ) as dose 2, single for covid-19 immunisation. The patient's medical history included asthma. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as dose 1, single for covid-19 immunisation. On 04May2021, the patient experienced patient may or may not have received about half the recommended covid 19 vaccine dose, the syringe malfunctioned, there was spray back from the syringe contents and the patient's blood that sprayed the nurse. Pharmacist reported that on 4May2021 there was a nurse who was gave a patient their second BNT162B2 vaccine and as the nurse injected the vaccine, the syringe malfunctioned. He estimated that maybe about half of the Covid 19 vaccine was injected before the syringe malfunctioned. The patient may or may not have received about half the recommended Covid 19 vaccine dose. There was spray back from the syringe contents and the patient's blood that sprayed the nurse. They cannot determine exactly how much the patient received. Pharmacist asked if the patient received enough vaccine to be protected or does the patient need to have another dose. At the time of this report, the outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Glossodynia, Headache, Hyperaesthesia teeth
Clinical narrative: Extreme Fatigue; Chills; Cold; All over body muscle aches; Teeth sensitive to cold; Sore Tongue, like it was burnt, has bumps; Headache; Sore arm at injection site left arm; Sore Tongue, like it was burnt, has bumps; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and loratadine (CLARITIN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 03:45, the patient experienced extreme fatigue, chills, cold, all over body muscle aches, teeth sensitive to cold, sore tongue, like it was burnt and had bumps, headache and sore arm at injection site left arm. Therapeutic measures were not taken as a result of the reported events. The adverse 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. The clinical outcome of the events extreme fatigue, chills, cold, all over body muscle aches, teeth sensitive to cold, sore tongue, like it was burnt and had bumps, headache and sore arm at injection site left arm were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Tongue disorder, Vaccination site pain
Clinical narrative: Extreme Fatigue; Chills; Cold; All over body muscle aches; Teeth sensitive to cold; Sore Tongue, like it was burnt, has bumps; Headache; Sore arm at injection site left arm; Sore Tongue, like it was burnt, has bumps; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and loratadine (CLARITIN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 03:45, the patient experienced extreme fatigue, chills, cold, all over body muscle aches, teeth sensitive to cold, sore tongue, like it was burnt and had bumps, headache and sore arm at injection site left arm. Therapeutic measures were not taken as a result of the reported events. The adverse 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. The clinical outcome of the events extreme fatigue, chills, cold, all over body muscle aches, teeth sensitive to cold, sore tongue, like it was burnt and had bumps, headache and sore arm at injection site left arm were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash; I have it all over my mid-section, my back, my upper legs and it's very itchy; It's very itchy; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified gender and age reported that he/she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date in 2021 about a week after the second dose patient started breaking out rash, had it all over his/her mid-section, back and upper legs. It was very itchy and patient went to doctors, dermatologist and nobody knew what it was. Patient wanted to know how to get rid of it and mentioned that he/she did not have any problem until he/she got the second shot. The event outcome was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Limb discomfort, Somnolence
Clinical narrative: wanted to do sleep/sleep all the time; could barely lift her arms; Eyes swelled shut; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for covid-19 immunisation. Medical history included cholecystectomy and liver operation where the patient described as they took out her gallbladder and seared her liver from her diaphragm. The patient was in the hospital last year for 9 days The patient concomitant medications were not reported. On an unspecified date in 2021, the patient experienced wanted to do sleep/sleep all the time, could barely lift her arms, eyes swelled shut. The patient could not sleep anymore, her eyes were even swelled shut. All she did sleep all the time, she slept so much her eyes swelled It was reported that she was a real high energy person. Outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained .
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Somewhere under her armpits there was a big bump; This is a spontaneous report from a contactable consumer (patient child). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient (reporter mother) took the COVID vaccine and under her armpits there was a big bump and her mom (patient) was asking if that was normal. The clinical outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Odynophagia, Pain in extremity, Rash, Rash pruritic
Clinical narrative: left arm lymph node pain; pain when swallowing; pain in the arm; itchy rash patch on the arm; itchy rash patch on the arm; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 01May2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and known allergies. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced left arm lymph node pain, pain when swallowing, itchy rash patch on the arm and pain in the arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 left arm lymph node pain, pain when swallowing, itchy rash patch on the arm and pain in the arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Miliaria, Photosensitivity reaction, Pruritus
Clinical narrative: heat rashes or sun rash; heat rashes or sun rash; itching a little bit before the 2nd dose of the Pfizer COVID19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: EW0158) via an unspecified route of administration, administered in left arm on 13Apr2021 01:45 (age at vaccination 21 year) as DOSE 1, SINGLE for COVID-19 immunization. Medical history was reported as none. Family history relevant to AE was reported as none. Concomitant medications were not reported. Patient had not received any other vaccine within 4 weeks. On an unspecified date in 2021, the patient had heat rashes or sun rash when he got in the sun and he was out in the sun a long time and  itching a little bit before the 2nd dose of the Pfizer COVID19 vaccine reported that could be his anxiety getting the best of him right then but he wanted to know if it was ok to take Benadryl or if he needed to take more serious action. The patient was not received any treatment for events. The patient had no relevant laboratory test. Patient did not require to visit emergency room or MD office due to adverse events.  Patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration administered in left arm on 04May2021 13:45 (age at vaccination 21 years) as DOSE 2, SINGLE for COVID-19 immunization and experienced adverse events. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer vial wasn't diluted so higher than normal dosing wa s administered. patient had got around 150-180mcg dosing instead of 30mcg
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: undiluted vial of Pfizer vaccine was given to patine patine could have received upto 180mcg instead of 30mcg dose
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on left shoulder blade
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Significant soreness in arm 6 days after receiving 2nd dose Covid-19 vaccine.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Calcinosis, Joint space narrowing, Knee deformity, Loose body in joint
Clinical narrative: The night I received the vaccine my left knee started hurting me. To the best of my knowledge my knee was normal before. I got up and went to bathroom, upon standing up it really hurt. A few days later my right knee started hurting but in a different location. My doctor suggested that the vaccine might have stirred up an old injury causing swelling. That might have contributed to the results (see below)
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vascular calcification, X-ray limb abnormal
Clinical narrative: The night I received the vaccine my left knee started hurting me. To the best of my knowledge my knee was normal before. I got up and went to bathroom, upon standing up it really hurt. A few days later my right knee started hurting but in a different location. My doctor suggested that the vaccine might have stirred up an old injury causing swelling. That might have contributed to the results (see below)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Sex: M
Vaccine: COVID19
Symptoms: Crying, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Itchiness in our ear to our bottom of our feet.; terrible fatigue; Nausea; Headache; we are not doing well; my son got up crying this morning; This is a spontaneous report received from a non-contactable reporter (parents). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "This was not good for Pfizer they should have people who could concentrate because it was hard for us who had the shot. Reporter had kidney failure from the shot, reporter got chronic fatigue, reporter's son has terrible fatigue, they both have nausea, they both have headache, son got up crying this morning and they are not doing well and if reporter die from the shot reporter wanted to document that they are having adverse drug event from the Pfizer shot. Reporter stated, "This shot made us both very devastated, they have itchiness in ear to bottom of feet." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness in our ear to our bottom of our feet.; terrible fatigue; Nausea; Headache; we are not doing well; my son got up crying this morning; This is a spontaneous report received from a non-contactable reporter (parents). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "This was not good for Pfizer they should have people who could concentrate because it was hard for us who had the shot. Reporter had kidney failure from the shot, reporter got chronic fatigue, reporter's son has terrible fatigue, they both have nausea, they both have headache, son got up crying this morning and they are not doing well and if reporter die from the shot reporter wanted to document that they are having adverse drug event from the Pfizer shot. Reporter stated, "This shot made us both very devastated, they have itchiness in ear to bottom of feet." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Electromyogram, Fatigue, Guillain-Barre syndrome
Clinical narrative: Developed Guillain-Barre Syndrome following second dose of Pfizer COVID-19 vaccine. Within 12 hours of vaccination, I developed a strong fever, body aches, and fatigue. These acute symptoms resolved within 24-36 hours. In the days following that I had increasing dizziness, ringing in the ears, and a sense of lethargy. Within 5 days of vaccination, I had a 2 inch by 2 inch area of total numbness, on my left arm below the injection site. On the twelfth day I developed rapid-onset muscle weakness in both legs, with progressive loss of sensation, pins and needles, tingling, and muscle twitching. Over the next two days these symptoms progressed upwards to my torso, arms, neck, jaw, and scalp. Autonomic nervous system was also affected, with fluctuating blood pressure, and strange sensations in chest. Muscle symptoms peaked three days after initial onset of weakness in legs, and I never lost the ability to walk or move, and never required hospitalization. But there has been a slow and fluctuating recovery over the following 6 months, with gradual improvement of symptoms, but not yet a complete resolution.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Muscle twitching, Muscular weakness, Nerve conduction studies
Clinical narrative: Developed Guillain-Barre Syndrome following second dose of Pfizer COVID-19 vaccine. Within 12 hours of vaccination, I developed a strong fever, body aches, and fatigue. These acute symptoms resolved within 24-36 hours. In the days following that I had increasing dizziness, ringing in the ears, and a sense of lethargy. Within 5 days of vaccination, I had a 2 inch by 2 inch area of total numbness, on my left arm below the injection site. On the twelfth day I developed rapid-onset muscle weakness in both legs, with progressive loss of sensation, pins and needles, tingling, and muscle twitching. Over the next two days these symptoms progressed upwards to my torso, arms, neck, jaw, and scalp. Autonomic nervous system was also affected, with fluctuating blood pressure, and strange sensations in chest. Muscle symptoms peaked three days after initial onset of weakness in legs, and I never lost the ability to walk or move, and never required hospitalization. But there has been a slow and fluctuating recovery over the following 6 months, with gradual improvement of symptoms, but not yet a complete resolution.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Sensory loss, Tinnitus
Clinical narrative: Developed Guillain-Barre Syndrome following second dose of Pfizer COVID-19 vaccine. Within 12 hours of vaccination, I developed a strong fever, body aches, and fatigue. These acute symptoms resolved within 24-36 hours. In the days following that I had increasing dizziness, ringing in the ears, and a sense of lethargy. Within 5 days of vaccination, I had a 2 inch by 2 inch area of total numbness, on my left arm below the injection site. On the twelfth day I developed rapid-onset muscle weakness in both legs, with progressive loss of sensation, pins and needles, tingling, and muscle twitching. Over the next two days these symptoms progressed upwards to my torso, arms, neck, jaw, and scalp. Autonomic nervous system was also affected, with fluctuating blood pressure, and strange sensations in chest. Muscle symptoms peaked three days after initial onset of weakness in legs, and I never lost the ability to walk or move, and never required hospitalization. But there has been a slow and fluctuating recovery over the following 6 months, with gradual improvement of symptoms, but not yet a complete resolution.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemianaesthesia, Hemiparaesthesia
Clinical narrative: Pt developed left sided numbness and tingling 48 hours post vaccine of face/jaw, left upper extremity, left upper chest, left leg.  Recommended ER evaluation, but not sure if pt followed up.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Hypoaesthesia, Laboratory test, Paraesthesia, Sensory disturbance
Clinical narrative: Pt developed left sided numbness and tingling 48 hours post vaccine of face/jaw, left upper extremity, left upper chest, left leg.  Recommended ER evaluation, but not sure if pt followed up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Higher than recommended dose of vaccine administered. Patient received up to 180mcg dose instead of 30mcg. Vial dilution not done.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Higher than recommended dose of vaccine administered. Patient received up to 180mcg dose instead of 30mcg. Vial dilution not done.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Higher than recommended dose of vaccine administered. Patient received up to 180mcg dose instead of 30mcg. Vial dilution not done.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Fatigue, fever to 101.3, headache, chills, back rash, red warm injection site. Fever present 10/26, 10/27. Back rash developed 10/27 pm, arm redness and warmth and back rash continuing 10/29
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Fatigue, fever to 101.3, headache, chills, back rash, red warm injection site. Fever present 10/26, 10/27. Back rash developed 10/27 pm, arm redness and warmth and back rash continuing 10/29
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bell's Palsy on 10/20/21
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Higher than recommended dose of vaccine administered. Patient received up to 180mcg dose instead of 30mcg. Vial dilution not done.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Higher than recommended dose of vaccine administered. Patient received up to 180mcg dose instead of 30mcg. Vial dilution not done.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation test normal, Full blood count normal, Herpes zoster, Metabolic function test normal, Rash
Clinical narrative: Shingles like rash on both legs, inside near knee that has lasted two weeks.  Rx hydrocortisone calmed it down, but still visible.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Shingles like rash on both legs, inside near knee that has lasted two weeks.  Rx hydrocortisone calmed it down, but still visible.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Pyrexia
Clinical narrative: Fever; Feeling sick; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient himself). A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0167; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 04May2021 09:00 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE(s) was reported as none. History of all previous immunization with the Pfizer vaccine was none. Additional vaccines administered on same date of the Pfizer Suspect: reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had received the first dose of the COVID vaccine and when he retired that night on 05May2021 he woke up about 1:00AM with a fever, feeling sick and difficulty breathing. He took an aspirin and stayed awake for about two hours. He finally felt better. The next morning, he called the clinic where he got the first dose of the COVID vaccine and canceled his appointment for the second dose of the COVID vaccine. He was not going to go through that again. He had also called the FDA, and CDC to report his symptoms. His fever, feeling sick and difficulty breathing all lasted for about two hours. AEs did not require a visit to: emergency room or physician office. Therapeutic measures were taken as a result of AEs as patient took aspirin. The outcome of all events was recovered on 05May2021.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fear, Heavy menstrual bleeding, Incomplete course of vaccination, Menstruation irregular
Clinical narrative: I've always had a very regular, 28 day cycle my whole life.  I've never had an irregular period or any irregular bleeding. I've also never been on birth control.  I got the 1st shot on 10/2.  I started my period on time on 10/8; however, my breast pain didn't go away when I started (which is not normal).  My period only lasted from 10/8 - 10/10 (which also isn't normal for me).  Then it stopped.  But I got a second period on 10/18 and have been bleeding continuously for the last 11 days...bleeding  VERY heavily, with hemorrhaging and clots.  I also could tell that I didn't ovulate this month.  I've always been able to tell when I'm ovulating and I definitely didn't.  The bleeding won't stop and I will not be getting the second shot because now I'm terrified that it has messed up my reproductive system, which was a very healthy one before I got the shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I've always had a very regular, 28 day cycle my whole life.  I've never had an irregular period or any irregular bleeding. I've also never been on birth control.  I got the 1st shot on 10/2.  I started my period on time on 10/8; however, my breast pain didn't go away when I started (which is not normal).  My period only lasted from 10/8 - 10/10 (which also isn't normal for me).  Then it stopped.  But I got a second period on 10/18 and have been bleeding continuously for the last 11 days...bleeding  VERY heavily, with hemorrhaging and clots.  I also could tell that I didn't ovulate this month.  I've always been able to tell when I'm ovulating and I definitely didn't.  The bleeding won't stop and I will not be getting the second shot because now I'm terrified that it has messed up my reproductive system, which was a very healthy one before I got the shot.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Extreme fatigue & muscle pain throughout body; headache;  All symptoms lasted approximately 20 hours.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chills
Clinical narrative: Almost exactly one day later, I had chill and started to shake rather violently....I failed to realize that it was a reaction to the booster shot I received one day ago....I lied down on a couch with a blanket over me, still shaking a lot....I stayed like that for about 2 and a half hours, and the symptom went away, and it never came back.  I did not take any medication to treat this symptom.
Age: 32.0
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Pain
Clinical narrative: Intense body aches and joint pain, mild headache, intense pain at injection site
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium, Chest X-ray, Chest pain, Differential white blood cell count, Electrocardiogram
Clinical narrative: Chest pain starting evening the day after shot. Peaked that night before slowly fading into the following day.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Metabolic function test, Troponin
Clinical narrative: Chest pain starting evening the day after shot. Peaked that night before slowly fading into the following day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest X-ray normal, Cough, Dehydration, Discomfort
Clinical narrative: 54-year-old female received the vaccine on 8/27/21. 3 days later she began experiencing tingling and muscle twitching in her arms and hands. One week post-jab, muscles in her legs also began to periodically spasm. Beginning 8/28/21, she reports developing chest congestion and coughing which resolved after 3 weeks but returned 9/27/21 along with pain, numbness and fatigue in her legs, especially after exercise. The cough improved again after about a week but the leg symptoms have not. She was an avid walker but hasn?t been able to manage even short walks now without significant discomfort. 10/15/21 she awoke in the night with a racing heart and arrhythmia. She suspected this was due to dehydration and taking too much magnesium in attempt to alleviate her other symptoms but it has happened a couple more times since after decreasing the dose.  In the latter half of October, the muscle spasms spread to her head and neck, particularly while lying down which has made sleep difficult at times. Massages and lifestyle advice from a physical therapist brought some temporary relief but symptoms keep resurfacing and increasingly interfering with daily life.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Hypoaesthesia, Inflammatory marker test, Insomnia, Loss of personal independence in daily activities
Clinical narrative: 54-year-old female received the vaccine on 8/27/21. 3 days later she began experiencing tingling and muscle twitching in her arms and hands. One week post-jab, muscles in her legs also began to periodically spasm. Beginning 8/28/21, she reports developing chest congestion and coughing which resolved after 3 weeks but returned 9/27/21 along with pain, numbness and fatigue in her legs, especially after exercise. The cough improved again after about a week but the leg symptoms have not. She was an avid walker but hasn?t been able to manage even short walks now without significant discomfort. 10/15/21 she awoke in the night with a racing heart and arrhythmia. She suspected this was due to dehydration and taking too much magnesium in attempt to alleviate her other symptoms but it has happened a couple more times since after decreasing the dose.  In the latter half of October, the muscle spasms spread to her head and neck, particularly while lying down which has made sleep difficult at times. Massages and lifestyle advice from a physical therapist brought some temporary relief but symptoms keep resurfacing and increasingly interfering with daily life.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Muscle spasms, Muscle twitching, Pain in extremity, Palpitations
Clinical narrative: 54-year-old female received the vaccine on 8/27/21. 3 days later she began experiencing tingling and muscle twitching in her arms and hands. One week post-jab, muscles in her legs also began to periodically spasm. Beginning 8/28/21, she reports developing chest congestion and coughing which resolved after 3 weeks but returned 9/27/21 along with pain, numbness and fatigue in her legs, especially after exercise. The cough improved again after about a week but the leg symptoms have not. She was an avid walker but hasn?t been able to manage even short walks now without significant discomfort. 10/15/21 she awoke in the night with a racing heart and arrhythmia. She suspected this was due to dehydration and taking too much magnesium in attempt to alleviate her other symptoms but it has happened a couple more times since after decreasing the dose.  In the latter half of October, the muscle spasms spread to her head and neck, particularly while lying down which has made sleep difficult at times. Massages and lifestyle advice from a physical therapist brought some temporary relief but symptoms keep resurfacing and increasingly interfering with daily life.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Respiratory tract congestion, Sleep disorder, Vitamin B12 normal
Clinical narrative: 54-year-old female received the vaccine on 8/27/21. 3 days later she began experiencing tingling and muscle twitching in her arms and hands. One week post-jab, muscles in her legs also began to periodically spasm. Beginning 8/28/21, she reports developing chest congestion and coughing which resolved after 3 weeks but returned 9/27/21 along with pain, numbness and fatigue in her legs, especially after exercise. The cough improved again after about a week but the leg symptoms have not. She was an avid walker but hasn?t been able to manage even short walks now without significant discomfort. 10/15/21 she awoke in the night with a racing heart and arrhythmia. She suspected this was due to dehydration and taking too much magnesium in attempt to alleviate her other symptoms but it has happened a couple more times since after decreasing the dose.  In the latter half of October, the muscle spasms spread to her head and neck, particularly while lying down which has made sleep difficult at times. Massages and lifestyle advice from a physical therapist brought some temporary relief but symptoms keep resurfacing and increasingly interfering with daily life.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Aphthous ulcer, Lip discolouration, Lip injury, Lip swelling
Clinical narrative: Permanent lip damage. Burning. Discolored. Enlarged. Constant canker sore on tip of tongue.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: Permanent lip damage. Burning. Discolored. Enlarged. Constant canker sore on tip of tongue.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: Itchiness at various sites in body with a rash, later nausea and headache, fever fatigue, then extreme itchiness on hands, especially between fingers , on palms and backs of hands
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Itchiness at various sites in body with a rash, later nausea and headache, fever fatigue, then extreme itchiness on hands, especially between fingers , on palms and backs of hands
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hot flush, Lip pain
Clinical narrative: severe system reaction: chills, hot flashes, aching in lips and shoulders; severe system reaction: chills, hot flashes, aching in lips and shoulders; severe system reaction: chills, hot flashes, aching in lips and shoulders; severe system reaction: chills, hot flashes, aching in lips and shoulders; This is a spontaneous report from a 71-year-old female contactable consumer (Patient) or other non-HCP.  A 71-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9269) via an unspecified route of administration, administered in Arm Right on 10Feb2021 (at 05:00) (age at the time of vaccination was 70-years-old), as DOSE 2, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9262) via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at 17:00), as DOSE 1, SINGLE dose for COVID-19 immunization. On an unspecified date, the patient experienced severe system reaction: chills, hot flashes, aching in lips and shoulders. With the 2nd injection, the patient did not have a topical reaction, there was no lump or rash. However, had a severe systemic reaction: chills, hot flashes, aching in lips and shoulders. The aching only lasted for about 4 days and she slept a lot. The chills and hot flashes continued sporadically for about 6 weeks. The clinical outcome of events aching in lips and shoulders was resolved and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neck pain, Pyrexia
Clinical narrative: Neck pain started might of injection, woke up with migraine headache and fever lasted throughout the day . I did not have any side effects with first two . Only booster at half the dose 8 months later
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Dizziness, Laboratory test, Vertigo
Clinical narrative: I got booster on oct 1, 2021,  4 days later got vertigo. I have dizziness still on oct 29. Saw dr 2 times. Took 2 antihistamines, no help. Antibiotics no help. Still dizzy.  Doing head exercises for Bppv still dizzy. Dizzy during day and mostly when go to bed and turn head. Off balance sometimes.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: Extreme pain in left shoulder and left arm from the day of the injection to present.  The pain is continuous. I have tried recommended remedies of flexing arm, acetaminophen,and heat . Nothing has eliminated the pain.  It lessens some after taking pain pills but not for long.  It interferes with my sleep and ability to complete daily tasks.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Area around site of injection is swollen and sore. Soreness spread to inside of left arm. Applied ice.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms
Clinical narrative: Fatigue, joint pain and extra cramps
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: had a small cough; This is a spontaneous report from a sponsored program support via a contactable consumer (Patient) who reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received first shot of the COVID 19 vaccine, had a small cough (on an unspecified date) and wanted to know if she should still take second COVID tomorrow (unspecified date). The patient underwent lab test and procedure which included COVID-19: negative on an unspecified date. Outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.