chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Flushing, Hyperhidrosis, Muscle twitching
Clinical narrative: the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Tremor
Clinical narrative: the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Pain
Clinical narrative: Extreme burning pain; It felt like hot gasoline on fire all throughout my body; my arms and legs started to feel heavy; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 15Mar2021 09:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Patient previously received the first dose of BNT162B2 on 24Feb2021 at 15:30 in the right arm for COVID-19 immunisation. Medical history included Celiac, IBD (inflammatory bowel disease), Colitis, suspected rheumatic condition (undergoing diagnosis now) , from an unknown date and unknown if ongoing other medical history: Celiac, IBD, Colitis, suspected rheumatic condition (undergoing diagnosis now) , colitis from an unknown date and unknown if ongoing other medical history: Celiac, IBD, Colitis, suspected rheumatic condition (undergoing diagnosis now) from an unknown date and unknown if ongoing. Patient's known allergies: Sulfa, Arithromeyician (for clarification) and Gluten (Celiac patient); all from an unknown date and unknown if ongoing. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTINE) taken for an unspecified indication, start and stop date were not reported; zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported; and gabapentin taken for an unspecified indication, start and stop date were not reported.  On 16Mar2021 17:00, the patient's arms and legs started to feel heavy. Extreme burning pain sets in around 03:00 on 17Mar2021. She further described it as "It felt like hot gasoline on fire all throughout my body".  She was unable to work the next day. Feeling did not stop until 9pm that night. Outcome of events was recovered. Patient did not receive any treatment for the events.   Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: dead feeling has escalated to tinnitus; dead feeling has escalated to tinnitus; This is a spontaneous report from a contactable consumer(patient).  A 35-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 10:30 (Batch/Lot Number: ER2614) as SINGLE DOSE for covid-19 immunisation. Medical history included bradycardia from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination and not Covid tested post vaccination. The patient also has no known allergies. No other vaccine in four weeks. The patient was vaccinated at Public Health Department. The patient previously took bnt162b2 first dose on 27Feb2021 02:00 PM (Lot number: EN6198) at the left arm for covid-19 immunization. Concomitant medications (reported as Other medications in two weeks) included: ibuprofen, vitamin C and unspecified multivitamin; all taken for an unspecified indication, start and stop date were not reported. The patient reported that "Two hours after receiving my second dose on 20Mar2021, I went on a car ride that had several thousand feet of elevation change. Throughout the drive, my ears equalized pressure comfortably. When I reached my destination about three hours later (3:30 PM), my left ear began experiencing a "dead" feeling, but I could still hear and distinguish sounds and tones. I went to sleep, and the sensation remained. The dead feeling has escalated to tinnitus, which is a condition that I have rarely experienced in my life." The outcome of the events was not recovered. No treatment was given.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Exposure via breast milk, Infant irritability, Urticaria
Clinical narrative: presumably anaphylaxis.; baby broke out in hives; course cough; wheezing; she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for ab; she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for ab; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and baby. This is a baby report.   A 12-month-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via transmammary on 20Mar2021 as a single dose for Covid-19 immunization.The medical history and concomitant medication not reported.The patient mother received first in series covid vaccine on 20Mar2021 09:15 and she breastfed her 12-month-old infant shortly thereafter without problem. On 20Mar2021, around 12:15, patient was getting fussy and breastfed for about 5 minutes before baby broke out in hives. EMS was called and epinephrine/diphenhydramine (Benadryl) administered for course cough/wheezing, presumably anaphylaxis. Other foods consumed by patient on same day included banana, kids fig newton bar, dried apples, meat from frozen meal, and two piece of 'Trix' cereal (new to baby). ER course required 4 hours of monitoring. The events result in emergency room/department or urgent care. The outcome of the events was recovered in Mar2021.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccine with BNT162B2 in the mother played a contributory role in triggering the onset of the events in the infant exposed to the suspect product via breast milk. ,Linked Report(s) : US-PFIZER INC-2021305721 mom/baby
Sex: U
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: presumably anaphylaxis.; baby broke out in hives; course cough; wheezing; she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for ab; she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for ab; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and baby. This is a baby report.   A 12-month-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via transmammary on 20Mar2021 as a single dose for Covid-19 immunization.The medical history and concomitant medication not reported.The patient mother received first in series covid vaccine on 20Mar2021 09:15 and she breastfed her 12-month-old infant shortly thereafter without problem. On 20Mar2021, around 12:15, patient was getting fussy and breastfed for about 5 minutes before baby broke out in hives. EMS was called and epinephrine/diphenhydramine (Benadryl) administered for course cough/wheezing, presumably anaphylaxis. Other foods consumed by patient on same day included banana, kids fig newton bar, dried apples, meat from frozen meal, and two piece of 'Trix' cereal (new to baby). ER course required 4 hours of monitoring. The events result in emergency room/department or urgent care. The outcome of the events was recovered in Mar2021.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccine with BNT162B2 in the mother played a contributory role in triggering the onset of the events in the infant exposed to the suspect product via breast milk. ,Linked Report(s) : US-PFIZER INC-2021305721 mom/baby
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Malaise, Pain in extremity
Clinical narrative: garden variety of other symptoms that I think may be sinus with spring now coming around; an elevated temperature, stating that her normal temperature " for me is 94-96 but I was starting with 99; sore arm; a really severe throbbing headache, a scary headache; she still doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her first vaccine dose on 04Mar2021 and "about 8 or 9 days later she began having symptoms that have persisted through today". Now she worries about getting the second shot. She reports that her husband is a pharmacist and told her that she could delay the second dose by 1-2 months. Caller reported that having a sore arm initially, but 8-9 days after her vaccination she reports experiencing headaches, "a really severe throbbing headache, a scary headache" and a "garden variety of other symptoms that I think may be sinus with spring now coming around". Caller also reported having an elevated temperature, stating that her normal temperature " for her was 94-96 but she was starting with 99". She asked if she should delay her second dose given the fact that she still doesn't feel well. She called to talk about follow up with the second vaccine and asking if she can delay it. Confirmed Pfizer covid vaccine. Referred to HCP for evaluation and guidance. The patient was asking, how much protection is achieved from the first covid vaccine dose. Outcome of the events was not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: garden variety of other symptoms that I think may be sinus with spring now coming around; an elevated temperature, stating that her normal temperature " for me is 94-96 but I was starting with 99; sore arm; a really severe throbbing headache, a scary headache; she still doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her first vaccine dose on 04Mar2021 and "about 8 or 9 days later she began having symptoms that have persisted through today". Now she worries about getting the second shot. She reports that her husband is a pharmacist and told her that she could delay the second dose by 1-2 months. Caller reported that having a sore arm initially, but 8-9 days after her vaccination she reports experiencing headaches, "a really severe throbbing headache, a scary headache" and a "garden variety of other symptoms that I think may be sinus with spring now coming around". Caller also reported having an elevated temperature, stating that her normal temperature " for her was 94-96 but she was starting with 99". She asked if she should delay her second dose given the fact that she still doesn't feel well. She called to talk about follow up with the second vaccine and asking if she can delay it. Confirmed Pfizer covid vaccine. Referred to HCP for evaluation and guidance. The patient was asking, how much protection is achieved from the first covid vaccine dose. Outcome of the events was not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Myalgia
Clinical narrative: soreness in her muscles/her neck was becoming sore with some pain in her collarbone area; swollen jelly gland; Soreness in her muscles were worse; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old-female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as single dose for COIVD-19 immunization. The patient's medical history endometrial cancer (currently in remission) and COVID-19 (twice - once in May where she was asymptomatic and the second time in Jul where she had "every symptoms but respiratory problems" and was subsequently hospitalized and given steroids). Concomitant medications were not reported. On an unspecified date, after the vaccination, when the patient got home, she noticed that she was getting soreness in her muscles that continued throughout the night and were worse when she woke up the next morning. She then reported that on Saturday she noticed her warm was "very, very" sore and could not even lift it. The previous day, the patient stated that she noticed her neck was becoming sore with some pain in her collarbone area. Upon inspection, she noticed two knots that she describes as feeling like "swollen jelly gland" and "pea size." She stated that they were very tender and if she pressed on them, they hurt. The patient would like to know if these knots could be a side effect of the vaccine. She was concerned about getting the second dose of the vaccine because of these symptoms. Response: Spoke from the Full Emergency Use Authorization (name) Prescribing Information Pfizer-Biontech Covid-19 Vaccine Prescribing Information (LAB-1457-6.0. Revised: 25Feb2021), Section 6 to let her know that 0.3% of clinical trial participants reported lymphadenopathy after their vaccination doses. Also spoke from the Fact Sheet for recipients/caregivers (LAB-1451-3.0. Revised: 25Feb2021) regarding contraindications to receiving a dose of the vaccine and what signs of a severe allergic reaction could include. Referred patient to HCP for further guidance. The patient further stated that she needs to have an MRI done this weekend and would like to know if the swollen lymph nodes she is experiencing after her first dose of the Pfizer BioNTech COVID-19 vaccine will affect the MRI. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318427 for same drug same reporter different patient
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Patient showed no antibodies; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unspecified date. The patient experienced patient showed no antibodies (antibody test negative) (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included antibody test: negative on unspecified date.    The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable consumer via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose (Batch/Lot number was not reported) and first dose (Batch/Lot number was not reported); both via an unspecified route of administration on unspecified dates as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient who has gotten 2 doses of the vaccine, tested positive on 19Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; slight headache.; This is a spontaneous report from a contactable consumer (Patient). A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 22Mar2021 11:00 at single dose for Covid-19 immunization. Medical history included before the vaccine, he was exposed to poison ivy and developed a slight poison ivy rash that got worse. The patient's concomitant medications were not reported. In the past patient took when he had this in his hands and face he usually takes a steroid pill like prednisone or cortisol. The patient experienced sore arm, slight headache. The outcome of events were unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Peripheral swelling, Rash, Urticaria
Clinical narrative: full on hives; bad body rash; underarm pain; armpit swelling; Exhaustion; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (first dose) for COVID-19 immunisation. The patient experienced underarm pain on Mar2021, armpit swelling on Mar2021, exhaustion on Mar2021, full on hives on 18Mar2021, bad body rash on 18Mar2021; all (non-serious). The caller stated that she received her second dose of the Pfizer COVID-19 vaccine on 15Mar2021 and she had the "basic" side effects of "underarm pain, armpit swelling and exhaustion." She stated that 3 days after her second dose she experienced "full on hives, a bad body rash." She stated that did not experience any throat swelling or difficulty breathing, no anaphylaxis. She did go to the hospital to be evaluated due to the severity of the rash and hives and out of fear that it may get worse and turn into anaphylaxis. She was not admitted to the hospital but she was kept for observation and treated with steroids which did help improve her symptoms. She is still currently on a course of steroids now. Her doctor told her to report this reaction to Pfizer. She stated that she gone online and reported her side effects and spoken with someone at Pfizer and filed a report regarding her symptoms. She would like to know if her experience is common and if it has been previously reported. She stated that she did not have any side effects at all after her first dose of the Pfizer COVID-19 vaccine. Response: The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema). Also let the caller know that we would refer her back to HCP regarding any future doses of the Pfizer COVID-19 vaccine based on her reaction to the second dose. For event, underarm pain, outcome was unknown, for armpit swelling, outcome was unknown, for exhaustion, outcome was unknown; for full on hives, outcome was recovering, for bad body rash, outcome was recovering.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Muscle disorder, Pyrexia
Clinical narrative: chills; fever; couldn't even walk; whole body muscles; This is a spontaneous report received from a contactable consumer. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration in Mar2021 as single dose for COVID-immunization. The patient previously received the first dose of bnt162b2 two weeks ago for COVID-immunization. Concomitant medications were not reported. On an unspecified date, the patient experienced chills, fever and whole body muscles. The patient couldn't even walk. The patient was taking vitamins for immune system. The reporter asked what adverse events to anticipate with the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19 test/tested positive again; COVID-19 virus test positive; This is a spontaneous report from a Pfizer sponsored reported by a contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Feb2021 at a single dose for covid-19 immunisation. Medical history included covid 19 from 01Dec2020 to an unknown date (got infected with Covid-19 last year December 1). The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 on 05Feb2021 at a single dose for covid-19 immunisation. The patient tested positive after getting the 2nd dose of the covid-19 vaccine in Feb2021. She underwent a covid-19 test on 15 Mar2021 and tested positive again. The events were considered serious with seriousness criteria medically significant. She wants to know why she was tested positive. She had the 1st dose last 05Feb2021 and 2nd dose was on 24Feb2021. The outcome was unknown for the events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Pain
Clinical narrative: achiness; Fatigue; Lost her sense of taste; Headache; This is a spontaneous report from a contactable consumer reporting for his daughter. A female patient of an unspecified age, (reported as "26") received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date on "Tuesday" as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unspecified date, the patient experienced achiness, fatigue, lost her sense of taste and headache. The outcome of the events achiness, fatigue, lost her sense of taste and headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rash
Clinical narrative: First vaccine 28Dec2020 and got Covid toes - Second dose 19Jan2021 and 5 weeks later got covid toes on 26Feb2021 and then today again; First vaccine 28Dec2020 and got Covid toes - Second dose 19Jan2021 and 5 weeks later got covid toes on 26Feb2021 and then today again; Covid toes; This is a spontaneous report from a contactable consumer from a female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) on 28Dec2020 and her second dose on 19Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 28Dec2020 and experienced COVID toes on an unspecified date. On 26Feb2021, five weeks after receiving the second dose, she again experienced COVID toes. At the time of reporting, it was reported that the patient has COVID toes again. The reported wanted to know if there were any studies on this or if this was normal. The outcome of the event "COVID toes" was not recovered and unknown for all other events.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: His neuropathy is gone now after Covid vaccine; This is a spontaneous report from a Pfizer-sponsored program, Support via a contactable consumer (reporting for himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included neuropathy and type 2 diabetic. The patient's concomitant medications were not reported. On an unspecified date, the patient stated that his neuropathy is gone now after COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dizziness, Dyspnoea, Hypoaesthesia oral, Lip swelling
Clinical narrative: angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. 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.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhoidal haemorrhage
Clinical narrative: Started bleeding after the shot/bleeding Hemorrhoids; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, Cholesterol, depression, and haemorrhoids. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, and depression, start and stop date were not reported. On an unspecified date, it was reported that the patient experienced Started bleeding after the shot/bleeding Hemorrhoids. The event was described as: "I wanted to know if it is ok to keep taking my allergy medicine, my Lipitor for cholesterol, for depression, and cream for hemorrhoids because I began to bleed from them, since getting the Pfizer Covid vaccine." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported), from a Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation. Patient's medical history included diarrhea. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), gabapentin, metformin, atorvastatin (LIPITOR) and trazodone. Historical vaccine included first dose of BNT162B2 for COVID-19 immunisation. Patient stated that he had his second dose of the COVID-19 Vaccine, today (11Feb2021), and had a question, that after his first dose he was able to take all of his regular medications and wanted to know if after the second dose, can he still continue his regular medications?. Patient said that he had a little bit of diarrhea, but he was feeling fine otherwise, but he was not sure that was related to the vaccine or not. He added he was already experienced prior. He wants to know if it is okay to take Tylenol or ibuprofen in case, he experiences some side effects (chills or fever). Patient wants to know if he can continue taking his regular medicine like metformin and trazodone, mentioned that he also took those medicine after his 1st dose of the vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: frist dose of the COVID vaccicne and then tested positive; received his first dose of the COVID vaccine and then tested positive, although with no symptoms; This is a spontaneous report received from a non-contactable physician (reporting for himself), via Pfizer from another company. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient's Medical history and concomitant medications were not reported. It was reported that patient was prescribed ILUMYA. He did not start the medication yet. Patient received his first dose of the COVID vaccine and then tested positive, although with no symptoms (per patient "I tested positive but I was never sick"). Patient asked if there's any risks with starting the medication after taking the vaccine and being infected. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  vaccine in this patient cannot be completely excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Woke up super achy; 100.5 F fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 27-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247; Expiration: Not provided) via unspecified route on 10Feb2021 at 02:45 PM (at 27-years-old) in the left arm as a single dose for COVID-19 immunization. Patient's medical history was not reported and no known allergies. Concomitant medications included Wellbutrin SR (bupropion hydrochloride) and Zoloft (sertraline hydrochloride). It was reported that the patient did not receive other vaccines with in 4 weeks. The patient did not have COVID-19 prior vaccination and not tested post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3247; Expiry date: unknown) on 22Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. On 11Feb2021, the patient woke up super achy and with 100.5 F fever along with chills. Events were not treated. Outcome of events was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: mild sore throats; This is a spontaneous report from a contactable consumer (patient) via medical information team. This consumer reported similar event for two patients (himself and partner). This is the first of two reports.  A male patient of unspecified age received first dose of PFIZER-BIONTECH COVID-19 VACCINE (BNT162B2; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due to receive the second dose and reported that he experienced mild sore throat, no fever on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324389 same drug/reporter/event and different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain
Clinical narrative: Muscle cramps in right calf; all over body aches; Headache for 1 1/2days; This is a spontaneous report received from a contactable consumer (patient). This 66-year-old female patient received the second dose of bnt162b2 (PFIZER COVID-19 VACCINE) on 09Feb2021 at single dose (lot/batch number: EL9264/MRN 38072873, expiry date: 31May2021) on Arm left for COVID-19 immunization. Medical history was not reported. Concomitant medications included Salmeterol xinafoate (ADVAIR) from an unspecified date and stop on an unspecified date; Alectinib hydrochloride (ALECENSA), Tiotropium bromide (SPIRIVA), Dupilumab (DUPIXENT), Rivaroxaban (XARELTO), all from an unspecified date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot/batch: EP8982/MRN 38072873; Expiration Date: 31JMay2021) on 21Jan2021 as single dose and experienced Swelling in her ankles on 26Jan2021, her feet are swelling and it has been swelling for about 4 days now on 26Jan2021, she was having liver and kidney issue which could be reason for her ankles are swelling. The patient experienced Muscle cramps in right calf on 24Mar2021, all over body aches, Headache for 1 1/2 days on unspecified date in FEB2021. No Admission to the hospital due to the events. No Surgical treatment needed for the event. The outcomes of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer sponsored program COVAX Support. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever and chills on an unknown date of Mar2021 after her first dose of the vaccine on 22Mar2021.  She took Tylenol twice for it. Events outcome was unknown.  Information on the lot/ batch number has been requested.