chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Night sweats
Clinical narrative: night sweats; different things like that, joints; The initial case was missing the following minimum criteria: adverse event NOS. Upon receipt of follow-up information on 11Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (Patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose (17-years age at the time of vaccination) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, Consumer reported that patient received his first dose. Consumer does not remember the date. On an unspecified date, patient had symptoms (night sweats, different things like that, joints). Patient was sensitive to a lot of things, so consumer is nervous. Consumer heard of healthy people getting the vaccine and dying shortly after. Consumer further wanted to know if he should get the second dose. Consumer indicated he was to have his second dose on Monday but awaiting blood test from HCP, delayed until 14Jun2021. On an unspecified date, the patient underwent lab tests and procedures which included blood test with unknown result. The outcome of events was unknown.  Information lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 1st dose January 27. Patient test positive February/ patient tested positive for covid last Feb 2; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for Covid-19 on 02Feb2021, didn't get the 2nd dose since. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 02Feb2021.The outcome of events unknown.  Information on the lot/batch number has been requested.  Follow-up (16-JUN-2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: I'm pregnant, 20 weeks, and my baby is still kicking.; minor sore arm; This is a spontaneous report from a non-contactable consumer reporting for herself. A 27-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 14May2021 at 15:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced minor sore arm on May2021, reporter added, "i'm pregnant, 20 weeks, and my baby is still kicking" on an unspecified date. The mother reported she was pregnant when she received BNT162B2.  The mother was due to deliver on 30Sep2021. Reporter stated "I had a VERY minor sore arm but kept it moving so the soreness eventually went away. Other than that I didn't have a reaction to the vaccine. I'm pregnant, 20 weeks, and my baby is still kicking." Outcome of minor sore arm was recovered on May2021. The outcome of I'm pregnant, 20 weeks, and my baby is still kicking was unknown. The patient received first dose of BNT162B2 on 23Apr2021. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizziness; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization and had no adverse effects (AEs). On 08May2021, the patient experienced a headache and dizziness. The symptoms had continued but for a few days it got a little better. The dizziness was worse this morning (19May2021). The patient asked if it was normal for symptoms to last this long. The outcome of headache was recovering. The outcome of dizziness was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is sore only if I look into it; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient drank alcohol and wanted to know if there was any interference with the vaccine. The patient reported no side effect, no headache, no stomachache. His arm was only sore if he looked into it. The outcome of arm was sore was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Influenza like illness, Paranasal sinus discomfort, Paranasal sinus hypersecretion
Clinical narrative: Flu like symptoms; Loss of taste and smell; Loss of taste and smell; Sinus pressure and discharge; Sinus pressure and discharge; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 09:00 (at the age of 27-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received dose 1 of BNT162B2 on 23Apr2021 at 09:00 for COVID-19 immunization. On 14May2021 at 19:00 the patient experienced flu-like symptoms, loss of taste and smell, and sinus pressure and discharge. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient received unspecified treatment for the events. The outcomes of flu-like symptoms, loss of taste and smell, and sinus pressure and discharge were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Pain
Clinical narrative: extreme dizziness; really bad cramps; pain; This is a spontaneous report from a contactable consumer (patient). This 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported receiving her vaccine about 30 minutes prior to calling and mentioned that she experienced side effects she did not see in the fact sheet. The patient stated that during her 15-minute waiting period, she had "it" very bad as she had extreme dizziness and really bad cramps all at once. She stated she was back at home as of calling and mentioned that the pain was already gone, and the dizziness was not extreme anymore but still there; she inquired if this was common. The clinical outcome of extreme dizziness was not recovered, the outcome of really bad cramps was unknown, and the outcome of pain was recovered in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Migraine, Nausea
Clinical narrative: Migraine; Extreme fatigue; Extreme joint pain; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 13May2021 at 12:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and sulfa allergy, both from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient reported receiving unspecified concomitant medications in two weeks. The patient previously received the first dose of BNT162B2 (lot number unknown) in the right arm on 23Apr2021 at 09:00 (at the age of 29-years-old) for COVID-19 immunisation. On 14May2021 at 01:00 the patient experienced migraine, extreme fatigue, extreme joint pain, nausea and lack of appetite. No treatment was received for the events. The clinical outcomes of migraine, extreme fatigue, extreme joint pain, nausea and lack of appetite were recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Gait inability
Clinical narrative: Could not make a whole 20 minutes walk; she felt tired; Consistent cough; This is a spontaneous report from a contactable consumer (patient' son). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The reporter stated the patient was an active 77-year-old with no medical history and after having the first dose, the patient told him that she could not make a whole 20-minute walk as she used to; further reporting she could for 10 minutes as she felt tired. The patient also presented a consistent cough, reported as not bad. The reporter wanted to consult if there were any reports of these side effects. The patient received her second dose of BNT162B2 on 31Mar2021. The clinical outcomes of could not make a whole 20-minute walk, consistent cough and she felt tired were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever; Body aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. This patient of unspecified age and gender received the first dose of BNT162B2 (lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation, and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient reported they received both doses of the vaccine and they experienced some really significant reactions of the vaccine; low grade fever and body aches for 36 hours, further reporting their test results were outside the upper limit of normal. The clinical outcomes of low-grade fever and body aches were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Nervousness
Clinical narrative: Feeling kind of dizzy and shaky; Feeling kind of dizzy and shaky; It could be anxiety from actually getting it; This is a spontaneous report from a contactable consumer (patient's mother). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EW0183, Expiration date not reported), via an unspecified route of administration on 21May2021 13:40 (at the age of 14-years-old) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling kind of dizzy and shaky and it could be anxiety from actually getting it on 21May2021. Patient was feeling kind of dizzy and shaky. Reporter just noticed that this was not kind of listed under the severe allergies but patient does not seem to having allergic reaction. Reporter was just wondering that if this was a side effect as it could be anxiety from actually getting it. Patient did not received treatment as a result of the events. Reporter said she gave patient food to see if she needed to eat. The outcome of events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure increased, Blood pressure measurement, Body temperature
Clinical narrative: Fever 101.1; Bones/Joints ache; joints ache/shoulder pain; blood pressure (BP) was increased to 164/80, 161/88; Pulse was low; threw up twice due to Covid vaccine issues; Horrible HA; back pain; This is a spontaneous report from a contactable consumer (patient) and nurse, based on information received by Pfizer from manufacturer control number is EC-2021-092764 for BNT162B2, and atorvastatin calcium. A female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization; atorvastatin calcium via an unspecified route of administration on an unspecified date at an unknown dose and frequency for an unspecified indication; lenvatinib mesilate (LENVIMA, strength: 4 mg lot number: 1391911, Expiration date:  30Apr2022), orally, on 04May2021 at 18 mg daily for malignant neoplasm of kidney except renal pelvis.  The patient's medical history included allergy on iodinated contrast media. The patient's concomitant medications included pantoprazole sodium, amlodipine besylate, and amoxicillin-clavulanate potassium. The previously took axitinib (INLYTA) and experienced tongue started to swell and blood pressure was elevated. On an unspecified date, the patient had second Pfizer COVID vaccine and had a fever (101.1), horrible headache, bones/joints ache, and couldn't get out of the bed. The patient reported that paracetamol (TYLENOL) has helped. The patient was advised to notify oncology physician. It was reported that the first couple days starting on lenvatinib mesilate blood pressure increased to 164/80, 161/88, hence the physician advised patient to take BP when on axitinib (INLYTA). After, the BP came down to 118/?. It was reported that pulse was low so physician wanted the patient to monitor BP and only take if BP shoots up. In the last two days, blood pressure has been 113/77 (19May2021), 103/78 (20May2021). The patient missed one dose since she threw up twice during COVID vaccine issues. It was reported that her shoulder pain was possibly due to the St. Bernard dog and center back pain (had prior to lenv, may be due to ergonomics, sitting at computer for job). The physician was not aware. The action taken in response to the events for atorvastatin calcium and lenvatinib mesilate was unknown. The outcome of the events fever 101.1, bones/joints ache, joints ache/shoulder pain, blood pressure (bp) was increased to 164/80, 161/88, pulse was low, threw up twice due to covid vaccine issues, horrible headache and back pain was unknown.  Pfizer is a marketing authorization holder of atorvastatin calcium 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 atorvastatin calcium has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Heart rate, Heart rate decreased, Pyrexia
Clinical narrative: Fever 101.1; Bones/Joints ache; joints ache/shoulder pain; blood pressure (BP) was increased to 164/80, 161/88; Pulse was low; threw up twice due to Covid vaccine issues; Horrible HA; back pain; This is a spontaneous report from a contactable consumer (patient) and nurse, based on information received by Pfizer from manufacturer control number is EC-2021-092764 for BNT162B2, and atorvastatin calcium. A female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization; atorvastatin calcium via an unspecified route of administration on an unspecified date at an unknown dose and frequency for an unspecified indication; lenvatinib mesilate (LENVIMA, strength: 4 mg lot number: 1391911, Expiration date:  30Apr2022), orally, on 04May2021 at 18 mg daily for malignant neoplasm of kidney except renal pelvis.  The patient's medical history included allergy on iodinated contrast media. The patient's concomitant medications included pantoprazole sodium, amlodipine besylate, and amoxicillin-clavulanate potassium. The previously took axitinib (INLYTA) and experienced tongue started to swell and blood pressure was elevated. On an unspecified date, the patient had second Pfizer COVID vaccine and had a fever (101.1), horrible headache, bones/joints ache, and couldn't get out of the bed. The patient reported that paracetamol (TYLENOL) has helped. The patient was advised to notify oncology physician. It was reported that the first couple days starting on lenvatinib mesilate blood pressure increased to 164/80, 161/88, hence the physician advised patient to take BP when on axitinib (INLYTA). After, the BP came down to 118/?. It was reported that pulse was low so physician wanted the patient to monitor BP and only take if BP shoots up. In the last two days, blood pressure has been 113/77 (19May2021), 103/78 (20May2021). The patient missed one dose since she threw up twice during COVID vaccine issues. It was reported that her shoulder pain was possibly due to the St. Bernard dog and center back pain (had prior to lenv, may be due to ergonomics, sitting at computer for job). The physician was not aware. The action taken in response to the events for atorvastatin calcium and lenvatinib mesilate was unknown. The outcome of the events fever 101.1, bones/joints ache, joints ache/shoulder pain, blood pressure (bp) was increased to 164/80, 161/88, pulse was low, threw up twice due to covid vaccine issues, horrible headache and back pain was unknown.  Pfizer is a marketing authorization holder of atorvastatin calcium 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 atorvastatin calcium has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 101.1; Bones/Joints ache; joints ache/shoulder pain; blood pressure (BP) was increased to 164/80, 161/88; Pulse was low; threw up twice due to Covid vaccine issues; Horrible HA; back pain; This is a spontaneous report from a contactable consumer (patient) and nurse, based on information received by Pfizer from manufacturer control number is EC-2021-092764 for BNT162B2, and atorvastatin calcium. A female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization; atorvastatin calcium via an unspecified route of administration on an unspecified date at an unknown dose and frequency for an unspecified indication; lenvatinib mesilate (LENVIMA, strength: 4 mg lot number: 1391911, Expiration date:  30Apr2022), orally, on 04May2021 at 18 mg daily for malignant neoplasm of kidney except renal pelvis.  The patient's medical history included allergy on iodinated contrast media. The patient's concomitant medications included pantoprazole sodium, amlodipine besylate, and amoxicillin-clavulanate potassium. The previously took axitinib (INLYTA) and experienced tongue started to swell and blood pressure was elevated. On an unspecified date, the patient had second Pfizer COVID vaccine and had a fever (101.1), horrible headache, bones/joints ache, and couldn't get out of the bed. The patient reported that paracetamol (TYLENOL) has helped. The patient was advised to notify oncology physician. It was reported that the first couple days starting on lenvatinib mesilate blood pressure increased to 164/80, 161/88, hence the physician advised patient to take BP when on axitinib (INLYTA). After, the BP came down to 118/?. It was reported that pulse was low so physician wanted the patient to monitor BP and only take if BP shoots up. In the last two days, blood pressure has been 113/77 (19May2021), 103/78 (20May2021). The patient missed one dose since she threw up twice during COVID vaccine issues. It was reported that her shoulder pain was possibly due to the St. Bernard dog and center back pain (had prior to lenv, may be due to ergonomics, sitting at computer for job). The physician was not aware. The action taken in response to the events for atorvastatin calcium and lenvatinib mesilate was unknown. The outcome of the events fever 101.1, bones/joints ache, joints ache/shoulder pain, blood pressure (bp) was increased to 164/80, 161/88, pulse was low, threw up twice due to covid vaccine issues, horrible headache and back pain was unknown.  Pfizer is a marketing authorization holder of atorvastatin calcium 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 atorvastatin calcium has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Herpes zoster, Malaise, Nausea
Clinical narrative: shingles "in her head"; Caller states that she is not feeling well; tired with a headache; nauseated; headache; experienced vomiting; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 20May2021 as 1st dose, single dose for covid-19 immunization. Medical history included rheumatoid arthritis and fibromyalgia. The patient's concomitant medications were not reported. The patient stated that she had first dose Thursday, she felt fine Friday no side effects on Thursday or Friday. On 22May2021, Saturday she felt really nauseated, and had a really bad headache. She started vomiting Saturday night. Sunday she was still nauseated. On 24May202, Monday her nausea was gone but she was very tired and still had a headache. She states she has a history of Rheumatoid Arthritis and Fibromyalgia and wants to know if those could be contributing to her adverse events. She also states she is just getting over shingles in her head.  she is still tired and has a headache. Patient asked how long she can expect this to last. She stated that she was not feeling well at this time and would rather call back later when she feels better to do a report. The outcome of the event nauseated was recovered on 24May2021. The outcome of the event tired with a headache was not recovered and outcome of the events vomiting, shingles in her head, not feeling well was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: shingles "in her head"; Caller states that she is not feeling well; tired with a headache; nauseated; headache; experienced vomiting; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 20May2021 as 1st dose, single dose for covid-19 immunization. Medical history included rheumatoid arthritis and fibromyalgia. The patient's concomitant medications were not reported. The patient stated that she had first dose Thursday, she felt fine Friday no side effects on Thursday or Friday. On 22May2021, Saturday she felt really nauseated, and had a really bad headache. She started vomiting Saturday night. Sunday she was still nauseated. On 24May202, Monday her nausea was gone but she was very tired and still had a headache. She states she has a history of Rheumatoid Arthritis and Fibromyalgia and wants to know if those could be contributing to her adverse events. She also states she is just getting over shingles in her head.  she is still tired and has a headache. Patient asked how long she can expect this to last. She stated that she was not feeling well at this time and would rather call back later when she feels better to do a report. The outcome of the event nauseated was recovered on 24May2021. The outcome of the event tired with a headache was not recovered and outcome of the events vomiting, shingles in her head, not feeling well was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Memory impairment
Clinical narrative: lightheadedness; very very tired for a day or two; Memory was worsened than that it was before; This is a spontaneous report from a contactable female consumer. This consumer(patient) reported for herself that: An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in left arm on 20Feb2021 (at the age of 82-years) as single dose for covid-19 immunization. The patient medical history included osteoarthritis and fibromyalgia. Concomitant medications were not reported. On 21Feb2021, the day after the first dose of covid-19 vaccination, the patient experienced lightheadedness for a day and then it was gone. She stated that she felt "very very tired for a day or two" on an unspecified date in 2021 and then was alright for a while. On an unspecified date in 2021, after the first dose, her memory was worsened than it was before. She stated that she had met two people, who had the same thing. She stated that she had initial symptoms one day and after that she had other things. The patient confirmed the vaccine was Pfizer Covid-19 vaccine. She wanted to know early that how long these symptoms would last and if more symptoms would appear. The outcome of the event lightheadedness was recovered on 22Feb2021. The outcome of the event tired was recovered on an unspecified date in 2021. The outcome of the event memory impairment was unknown.  Reporter seriousness for Memory was worsened than that it was before: Unspecified  Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Peripheral swelling
Clinical narrative: Redness and swelling of arm; Redness and swelling of arm; Headache; Chills; This is a spontaneous report from a contactable nurse (patient's mother) reported for son. A 15-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left upper arm on 13May2021 07:20 (Batch/Lot Number: EW0167) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient received dose 2 via an unspecified route of administration, administered in right arm on 03Jun2021 07:20 (Batch/Lot Number: ER8736) as 2nd dose, single. Medical history included patient is immunocompromised and oral steroid dependent due to asthma and adrenal insufficiency, ongoing Hypothyroidism Diagnosed about 10 years ago, ongoing Acid reflux Diagnosed since birth, ongoing Adrenal insufficiency Diagnosed about 2 years ago, Asthma Diagnosed since birth, ongoing allergies Diagnosed since birth/infancy, ongoing Pseudotumor cerebri since 2015. Concomitant medications include acetazolamide sodium (DIAMOX) taken for Pseudotumor cerebri from 2015 and ongoing, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma about 8 years and ondoing, Fluticasone taken for asthma about 4 years and ongoing, Budesonide for Sinus rinse from sinus surgery care about eight years and ondoing, Hydrocortisone for adrenal insufficiency since 16May2021 and ongoing, lansoprazole (PREVACID) taken for acid reflux since 2006 and ongoing, levothyroxine sodium (SYNTHROID) taken for Autoimmune hypothyroidism hashimotos and ongoing. Patient experienced pretty big redness and swelling of arm on 14May2021, and got worse about 2 weeks later, which was odd, like a delayed response. Had headache on 13May2021 around 14:00, lunch and took two regular strength Tylenol and drank water. Classifies as medically significant since patient had to miss two days of school. Other symptoms went away after 24 hours like the chills and normal vaccine symptoms, headache. His blood pressure and all vitals were all normal. The outcome of redness and swelling of arm was recovering but still has faint bruising color, other events outcome was recovered on 14May2021.   Information on the lot/batch number has been requested.  Follow-up (03Jun2021): New information reported from a contactable nurse (mother) includes: removed event "15 years old patient received t vaccine", add events "headache", "chill", "redness and swelling of arm". Case upgrade to serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: extreme fatigue; brain fog; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no other comorbidities or underlying issue. The patient experienced extreme fatigue and brain fog for 3 weeks after receiving his second dose of the Pfizer COVID-19 vaccine, that it is so severe they are considering taking him out of work for long term disability. Patient went to a neurologist and was given steroids but the symptoms are continuous and ongoing. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blepharospasm, Chest pain, Fatigue, Hypoaesthesia oral
Clinical narrative: my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid was twitching and it lasted for some time; I have felt changes in my mood and easily irritable; I have felt changes in my mood and easily irritable; feeling pain in my joints; Nassau; continue to feel lethargic and tired; chest pain; feeling tightness, spasms in my back; feeling tightness, spasms in my back; feeling lethargic; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in right arm single dose for COVID-19 immunization on 18May2021 10:30 AM, at 49-year-old. The medical history included: acquired brain injury back in 2004. Concomitant medication was not reported. The patient started feeling pain in her joints by 19May2021 at 1:00 pm and feeling lethargic. The patient lied down and woke up around 6pm, between 6pm and 6:30pm her upper right side of her lip was feeling numb and weird, her speech was compromised, her left eyelid was twitching and it lasted for some time. She went back to bed to continue getting different side effects, chest pain, feeling tightness, spasms in her back, 'Nassau', and continue join pain. The speech had continued to be compromise, she had felt changes in her mood and easily irritable, continue to feel lethargic and tired. Doctor or other healthcare professional office/clinic visited. The treatment received included followed up with neurologist waiting on CT scan. Outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events feeling lethargic, 'lip feeling numb and weird', 'speech was compromised' and chest pain cannot be excluded based on the temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Lethargy, Mood altered, Muscle spasms, Muscle tightness
Clinical narrative: my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid was twitching and it lasted for some time; I have felt changes in my mood and easily irritable; I have felt changes in my mood and easily irritable; feeling pain in my joints; Nassau; continue to feel lethargic and tired; chest pain; feeling tightness, spasms in my back; feeling tightness, spasms in my back; feeling lethargic; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in right arm single dose for COVID-19 immunization on 18May2021 10:30 AM, at 49-year-old. The medical history included: acquired brain injury back in 2004. Concomitant medication was not reported. The patient started feeling pain in her joints by 19May2021 at 1:00 pm and feeling lethargic. The patient lied down and woke up around 6pm, between 6pm and 6:30pm her upper right side of her lip was feeling numb and weird, her speech was compromised, her left eyelid was twitching and it lasted for some time. She went back to bed to continue getting different side effects, chest pain, feeling tightness, spasms in her back, 'Nassau', and continue join pain. The speech had continued to be compromise, she had felt changes in her mood and easily irritable, continue to feel lethargic and tired. Doctor or other healthcare professional office/clinic visited. The treatment received included followed up with neurologist waiting on CT scan. Outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events feeling lethargic, 'lip feeling numb and weird', 'speech was compromised' and chest pain cannot be excluded based on the temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Speech disorder
Clinical narrative: my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid was twitching and it lasted for some time; I have felt changes in my mood and easily irritable; I have felt changes in my mood and easily irritable; feeling pain in my joints; Nassau; continue to feel lethargic and tired; chest pain; feeling tightness, spasms in my back; feeling tightness, spasms in my back; feeling lethargic; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in right arm single dose for COVID-19 immunization on 18May2021 10:30 AM, at 49-year-old. The medical history included: acquired brain injury back in 2004. Concomitant medication was not reported. The patient started feeling pain in her joints by 19May2021 at 1:00 pm and feeling lethargic. The patient lied down and woke up around 6pm, between 6pm and 6:30pm her upper right side of her lip was feeling numb and weird, her speech was compromised, her left eyelid was twitching and it lasted for some time. She went back to bed to continue getting different side effects, chest pain, feeling tightness, spasms in her back, 'Nassau', and continue join pain. The speech had continued to be compromise, she had felt changes in her mood and easily irritable, continue to feel lethargic and tired. Doctor or other healthcare professional office/clinic visited. The treatment received included followed up with neurologist waiting on CT scan. Outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events feeling lethargic, 'lip feeling numb and weird', 'speech was compromised' and chest pain cannot be excluded based on the temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Headache, Malaise, Muscular weakness
Clinical narrative: Foot drop; pins and needles in her left leg/paresthesias; Nerve pain; Having trouble flexing her foot; weird headache; didn't feel well overall; aches and pains and bad headache with leg pain; This is a spontaneous report from a contactable consumer (patient parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24May2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Patient age at vaccination was 19 years old. Medical history included asthma, acne, patient diagnosed with COVID-19 prior to vaccination, she tested positive for COVID antibodies in Dec2019, known allergies to peanuts, some tree nuts, eucalyptus, tea tree oil. Historical vaccine included 1st dose of BNT162B2 on 03May2021 at 02:30 PM in left arm at age of 19 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multi-Vitamin, cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMIN C), VITAMIN D, bifidobacterium lactis (PROBIOTIC), all for unknown indication from unknown date; Topical Skin Creams for acne from unknown date. Reporter's daughter did not begin to experience symptoms until she woke up the next morning. She had a weird headache and didn't feel well overall. She began to experience pins and needles in her left leg. She went to bed around 4:30 pm as she had aches and pains and bad headache with leg pain. On Wed, she called in sick to work and contacted her primary care physician's office who instructed her to go to the emergency room. She had nerve pain and was having trouble flexing her foot. The pain increased the next day and she again contacted her primary care's office and went to the emergency room again. Both times she was referred to a neurologist. She had blood work, ultrasound and x-ray of the leg. She prev (preventively) has surgery to the leg on 14Jun2021- compartment syndrome release & peroneal nerve release (she had exertional compartment syndrome w/ release to all 4 compartments). Yesterday (02Jun2021) the neuro recommended an EMG and the diagnosis on the form was left foot drop and paresthesias. Patient still had headache. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events was reported as blood work, X-ray and ultrasound, all on 02Jun2021, 3 PT (physical therapy) appointments. Adverse event start date: 25May2021 at 07:00 AM. Patient was not recovered from the events.  Information for lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, Peroneal nerve palsy, SARS-CoV-2 antibody test
Clinical narrative: Foot drop; pins and needles in her left leg/paresthesias; Nerve pain; Having trouble flexing her foot; weird headache; didn't feel well overall; aches and pains and bad headache with leg pain; This is a spontaneous report from a contactable consumer (patient parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24May2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Patient age at vaccination was 19 years old. Medical history included asthma, acne, patient diagnosed with COVID-19 prior to vaccination, she tested positive for COVID antibodies in Dec2019, known allergies to peanuts, some tree nuts, eucalyptus, tea tree oil. Historical vaccine included 1st dose of BNT162B2 on 03May2021 at 02:30 PM in left arm at age of 19 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multi-Vitamin, cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMIN C), VITAMIN D, bifidobacterium lactis (PROBIOTIC), all for unknown indication from unknown date; Topical Skin Creams for acne from unknown date. Reporter's daughter did not begin to experience symptoms until she woke up the next morning. She had a weird headache and didn't feel well overall. She began to experience pins and needles in her left leg. She went to bed around 4:30 pm as she had aches and pains and bad headache with leg pain. On Wed, she called in sick to work and contacted her primary care physician's office who instructed her to go to the emergency room. She had nerve pain and was having trouble flexing her foot. The pain increased the next day and she again contacted her primary care's office and went to the emergency room again. Both times she was referred to a neurologist. She had blood work, ultrasound and x-ray of the leg. She prev (preventively) has surgery to the leg on 14Jun2021- compartment syndrome release & peroneal nerve release (she had exertional compartment syndrome w/ release to all 4 compartments). Yesterday (02Jun2021) the neuro recommended an EMG and the diagnosis on the form was left foot drop and paresthesias. Patient still had headache. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events was reported as blood work, X-ray and ultrasound, all on 02Jun2021, 3 PT (physical therapy) appointments. Adverse event start date: 25May2021 at 07:00 AM. Patient was not recovered from the events.  Information for lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Foot drop; pins and needles in her left leg/paresthesias; Nerve pain; Having trouble flexing her foot; weird headache; didn't feel well overall; aches and pains and bad headache with leg pain; This is a spontaneous report from a contactable consumer (patient parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24May2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Patient age at vaccination was 19 years old. Medical history included asthma, acne, patient diagnosed with COVID-19 prior to vaccination, she tested positive for COVID antibodies in Dec2019, known allergies to peanuts, some tree nuts, eucalyptus, tea tree oil. Historical vaccine included 1st dose of BNT162B2 on 03May2021 at 02:30 PM in left arm at age of 19 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multi-Vitamin, cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMIN C), VITAMIN D, bifidobacterium lactis (PROBIOTIC), all for unknown indication from unknown date; Topical Skin Creams for acne from unknown date. Reporter's daughter did not begin to experience symptoms until she woke up the next morning. She had a weird headache and didn't feel well overall. She began to experience pins and needles in her left leg. She went to bed around 4:30 pm as she had aches and pains and bad headache with leg pain. On Wed, she called in sick to work and contacted her primary care physician's office who instructed her to go to the emergency room. She had nerve pain and was having trouble flexing her foot. The pain increased the next day and she again contacted her primary care's office and went to the emergency room again. Both times she was referred to a neurologist. She had blood work, ultrasound and x-ray of the leg. She prev (preventively) has surgery to the leg on 14Jun2021- compartment syndrome release & peroneal nerve release (she had exertional compartment syndrome w/ release to all 4 compartments). Yesterday (02Jun2021) the neuro recommended an EMG and the diagnosis on the form was left foot drop and paresthesias. Patient still had headache. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events was reported as blood work, X-ray and ultrasound, all on 02Jun2021, 3 PT (physical therapy) appointments. Adverse event start date: 25May2021 at 07:00 AM. Patient was not recovered from the events.  Information for lot number has been requested.