chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Raynaud's phenomenon, Red blood cell sedimentation rate, SARS-CoV-2 test, Skin discolouration
Clinical narrative: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen, Urine analysis, White blood cell count
Clinical narrative: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: Rapid Heart Beat; chest pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in right arm on 04Jun2021 at 16:00 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Relevant medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. On 07Jun2021 at 02:00 AM, patient experienced rapid heart beat and chest pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Outcome of the events was not recovered. No treatment received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles; This is a Spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A Contactable Nurse reported for a 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 62 year), as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR, prolonged-release tablet), via Oral, from 19Mar2021 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history included allergies: codeine. Concomitant medications included urea, methotrexate, valaciclovir hydrochloride, hydroxychloroquine sulfate, duloxetine HCL, pregabalin, and methylprednisolone. The patient held her doses of xeljanz prior to receiving her second COVID-19 vaccinations. It was reported that on 29May2021, the patient was broke out with shingles. Outcome of the event was not resolved.  Please provide the Information of lot/batch number of suspect product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Formication, Headache, Pain
Clinical narrative: developed chills; achiness; headache; crawling sensation in her throat; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 (received at the age of 62-years-old) as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included immune compromised from an unspecified date and ongoing. Concomitant medications were not reported. The patient experienced chills, achiness, headache, crawling sensation in her throat on May2021. The patient received her first Pfizer Covid vaccine dose on 19May2021. After which she developed chills, achiness, and a headache. She states that later that same day she had "a crawling sensation" in her throat. She was apprehensive about getting the second dose and was advised by an HCP to take Benadryl before the second dose of the vaccine on 08Jun2021. Therapeutic measures were taken as a result the adverse events. Outcome of the events was unknown.   Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: having dreams about dead people following the second dose of the Covid-19 vaccine; This is a spontaneous report received from a contactable other healthcare professional (nurse). This nurse reported similar event for two patients. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 from an unspecified date for COVID-19 immunisation. The nurse reported that she was not the only one having nightmares.  Nurse reported that her coworker, the patient, had the PFIZER-BIONTECH COVID-19 VACCINE and said that she had the same problem.  Nurse stated that her coworker reported that she was having dreams about dead people following the second dose of the COVID-19 vaccine. The nurse reported that the patient was better now but that the patient said she thought she was going to die. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677871 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Electrocardiogram, Musculoskeletal stiffness
Clinical narrative: arm was stiff; This is a spontaneous report from a contactable consumer and other healthcare professional. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; ruxolitinib phosphate (JAKAFI), oral from 30Jan2020 (Batch/Lot Number: 1232358; Expiration Date: 28Feb2023) to an unspecified date, at 5 mg, 2x/day for chronic myeloproliferative disease. The patient medical history and concomitant medications were not reported. Ruxolitinib phosphate was used off-label for chronic myeloproliferative disease. Patient's arm was stiff on an unspecified date. Relevant test included on date unknown: routine EKG on tread mill (unknown results), Stress test by cardiologist visit with no problems (normal). The action taken in response to the events for ruxolitinib phosphate was unknown. The outcome of event was unknown.  Information about Lot /Batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching all over and breaking out into hives. Arms, legs, back, neck, face; itching all over and breaking out into hives. Arms, legs, back, neck, face; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 11:00 (at the age of 20-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. On 03Apr2021, 23:00, about 12 hours after the shot, the patient started itching all over and breaking out into hives in her arms, legs, back, neck, and face. She applied diphenhydramine (BENADRYL) cream which helped somewhat. By the morning, it was gone. When she went to get the 2nd vaccine, they wouldn't give it to her because of the reaction she had and said that the 2nd could give a worse reaction. She stated that she will play soccer in college and was required to get a full vaccine prior to returning to school in August, so she needs to know what she can/should do. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered in Apr2021.  Information about batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (Pfizer/BionTech COVID 19 brand), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (Lot Number: ER8734) as single for COVID-19 immunization. Medical history included allergies, obesity, and exercise-induced asthma (diagnosed) from an unknown date and unknown if ongoing. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; chlorpheniramine maleate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced sensitive to codeine product. After the first vaccine on 01Apr2021, patient experienced chills in the early evening first, then fever overnight on 01Apr2021. The patient was lethargic for approx. a week from Apr2021. Outcome of events was recovered in Apr2021. Events was reported as non-serious. The patient has received 2nd dose (lot # ER8736) on 29Apr2021 18:00 in the left arm.  Follow-up attempts are needed. Further information is requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first dose all he had was a sore arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 25-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single (at the age of 25-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 07Jun2021 as 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. After the first dose all patient had was a sore arm. The outcome of the event was unknown.   Information about lot/batch number is requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:30 (Lot Number: ew0186) at 14 years old as single dose for covid-19 immunisation.  Medical history was none. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 on 13May2021 16:30 (lot number: ew0186) at 14 years old in left arm for covid-19 immunisation. The patient experienced severe chills, headache, nausea, vomiting for approximately 1-1/2 hours on 09Jun2021 23:00. Treatment received for the adverse event was aleve pm. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered. This case was reported as not serious.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Gait inability
Clinical narrative: could not stand on her feet.; severe dizziness; the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom); This is a spontaneous report from contactable consumers (one is patient's husband). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 (Lot Number: EW0167) at 73 years old as single dose for covid-19 immunisation.  Medical history included thyroid, glaucoma, heart, blood pressure and vertigo. Concomitant medication(s) included ongoing amlodipine besilate taken for Blood pressure; ongoing levothyroxine sodium taken for thyroid; ongoing atenolol taken for heart; ongoing latanoprost taken for glaucoma. The patient previously took flu vaccine over 20 years ago and she got like hot, like hitting herself, like her head was burning; took the pneumococcal vaccine, maybe 3-4 years ago. 2 days after (8May2021) the patient received the vaccination she started to feel severe dizziness, the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom).  Patient stated this began on 08May2021 around nighttime, says it was not too much. The following day was really crazy, said she never felt anything like this before. She has had vertigo, but never this kind of dizziness, she experienced this for two or two-and-a-half days. It started about day-and a-half after the vaccine for two days. Patient stated the dizziness was gone, but may have lasting effects, she was not sure. What she went through those two days, she thought she was dying and could not stand on her feet. No emergency room or physician office visit. The patient had to see the doctor for a year because of her thyroid, he made her take a blood test to see if the thyroid was working properly. The outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Illness, SARS-CoV-2 test, Wrong product administered
Clinical narrative: she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021; Caller had the first dose of the Pfizer COVID-19 vaccine on 08Apr2021 tested positive for COVID-19 on 18Apr2021.; I got sick; went to a physician with severe symptoms; Physician told her she needed to start over with the Vaccine with first and second dose; This is a spontaneous report from a contactable consumer(patient).   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as, 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that she  received the Pfizer vaccine the first dose on 08Apr2021 then came down with COVID on 10Apr2021, just two days later, went to a physician with severe symptoms on 18Apr2021 and he diagnosed me Positive and he told me that since she had the Pfizer Vaccine just before I got sick I was going to have to start over another first dose and then a second dose, so not knowing you know there may be any difference she received first dose of Moderna on 18May so, she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021  and she don't know since the first dose of Pfizer was a long ago and  she asked do I go ahead with the second dose of Pfizer or do I go ahead with the Moderna since I got it on 18May2021 and get the second dose of Moderna. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021. Reporter seriousness for Had her first dose of Pfizer COVID-19 Vaccine on 08Apr2021 and came down with COVID on 10Apr2021, 2 days after: Unspecified. The outcome of the events was unknown.    Follow up (10Jun2021): This is a Follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: event details.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives; rash; itching; This is a spontaneous report from a contactable consumer reported for herself. This 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 19May2021 10:30 (Lot Number: EW0182) at single dose for COVID-19 immunisation.  Medical history included Hypothyroid, allergies. The patient's concomitant medications were not reported. Patient was not pregnant.  The patient experienced hives, rash, itching on unspecified date with outcome of recovering - did not relate to vaccine at the time.  Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE Treatment: Steroid, diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID). Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nerve conduction studies, Paraesthesia, Somnolence
Clinical narrative: Has happened for 3 months now on both arms; fall asleep; pins and needles sensation/ tingling in my feet; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included migraine (hormone triggered). Concomitant medications included diclofenac potassium (CAMBIA); rizatriptan benzoate (MAXALT) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced has happened for 3 months now on both arms, fall asleep, pins and needles sensation, tingling in my feet on 25Mar2021 22:00. Clinical course reported as: If I lay on my side the arm will fall asleep and pins and needles sensation will continue for hours even after no longer laying on the side. Has happened for 3 months now on both arms. Also tingling in my feet. Outcome of events was not recovered. Treatment included Gabapentin not working. The patient underwent lab tests and procedures which included nerve study: normal. events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Fatigue, Inflammation, Joint swelling
Clinical narrative: Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pain, Pyrexia
Clinical narrative: Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Palpitations
Clinical narrative: Heart palpitation of 122 hps that lasted 12 hours; Fatigue; short of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 46 years old, in left arm on 14May2021 11:30 at single dose for COVID-19 immunisation. The patient medical history was none. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously took hydrocodone bitartrate and acetaminophen (VICODIN) and eritromicina (reported as erithromicine) and experienced allergies. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 46 years old, in left arm on 23Apr2021 11:30 at single dose for COVID-19 immunisation. The patient experienced heart palpitation of 122 hps that lasted 12 hours, fatigue and short of breath on 15May2021 02:00. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of events was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jun2021 as dose 2, single for COVID-19 immunisation; medroxyprogesterone acetate (DEPO-PROVERA, Formulation: Suspension for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16Jun2021 as dose number unknown, single for birth control. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. No investigation assessment was provided. It was reported that she got a second dose on 07Jun2021 and had a doctor appointment "today". She said that the doctor injected a medication, in the same site, that she got her vaccine. She reported that the area hurt a little more "today", then when she got her vaccine. She confirmed that she was calling about the Pfizer vaccine for COVID virus. She reclarified that she got the second vaccine on 07Jun2021, and "today", she went to the doctor for her birth control, for the Depo shot (medroxyprogesterone acetate). She didn't think about anything, until later. She asked if it was alright, that she got the vaccine and her Depo shot, in the same site and if there would be an interaction. She clarified that her arm was sore, originally, from the COVID vaccine and stated her arm is also sore, from the Depo shot. The outcome of event was reported as unknown.  Information on lot/ batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypersomnia, Malaise, Pharyngeal swelling, Urticaria
Clinical narrative: doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's been sleeping for days  so she is not feeling well; She's been sleeping for days  so she is not feeling well; Broke out in hives and hives went around her mouth; Throat  was getting swollen; This is a spontaneous report from a contactable consumer (parent). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported; Expiration Date: Aug2021, patient was 22-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 15Jun2021 at 08:00 as single dose for covid-19 immunisation. No medical history was reported. Concomitant medication(s) included spironolactone and birth control (unspecified). Reported that caller was not sure about lot number, it just says EW, it could be 0 or it could be an O, it just says EW it might be 0, its just say EW0178 or O187, I am not sure. It was reported that caller reported on behalf of patient and stated that caller and her daughter got a vaccine on Tuesday morning and Tuesday afternoon, she broke out in hives and I had to take her to the emergency room and get her shot of epinephrine (Treatment) and they put her prednisone (Treatment) on because her hives were around to her mouth and throat was getting swollen and their doctor told her that it was an adverse reaction to the vaccine and not to get the second dose and they told us to call an report it. she's been sleeping for days so she is not feeling well. Patient was about about 5 (feet) 7 (inches) and about 200 (pounds) and she will be 23 on Saturday. Patient not received prior Vaccination within four weeks. On 15Jun2021, the patient experienced broke out in hives and hives went around her mouth, throat was getting swollen, on an unspecified date, She won't be getting her second dose, she's been sleeping for days so she is not feeling well. Reporter seriousness for Broke out in hives and hives went around her mouth, Throat was getting swollen, she's been sleeping for days so she is not feeling well was unspecified. Patient visit emergency room after the Broke out in hives and hives went around her mouth, Throat was getting swollen. Reported that the hives went away, and they have not come back, she just went all off. Reported that doctor said that we should call because she has definitely a serious reaction so, she won't be getting her second dose, but I will. Patient received treatment for event (broke out in hives and hives went around her mouth and throat was getting swollen). The outcome of event (broke out in hives and hives went around her mouth) was recovered on an unspecified date in 2021 and the outcome of events (Throat was getting swollen, she's been sleeping for days so she is not feeling well) was unknown.  Information about lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, IgA nephropathy, Kidney infection
Clinical narrative: This is a spontaneous report from a contactable physician. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) (Age at Vaccination 30 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included transgender operation from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing , haematuria from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRACE) 2 mg TID; spironolactone (SPIROLACTONE) 50 mg TID; ibuprofen (IBUPROFEN) 200mg PRN and vitamin d3 (VITAMIN D3) 200u one daily. The patient historical vaccine included (BNT162B2), dose 1 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation and had no adverse event. The patient referred to nephrology for evaluation of proteinuria and microscopic hematuria in the setting of the second dose of the COVID 19 vaccine. It was wondered if there wasn't an autoimmune reaction like HSP or IgAN type syndrome. Kidney biopsy preformed, confirmed IgA Nephropathy, primary and secondary forms as well as infection on unknown date in Mar2021. If primary IgA nephropathy the findings are consistent with Oxford Classification of MI E0 S1 T0 C0. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: I woke up with severe hearing distortion in my left ear.; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old non pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 09:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history reported as none and there were no concomitant medications.  On 17Jun2021 05:45, the patient woke up with severe hearing distortion in her left ear. She made a doctor or other healthcare professional office/clinic visit and received steroids as treatment. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Outcome of the event was not recovered.   Information about lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Dysphagia, Eating disorder
Clinical narrative: Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swallow; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization.Medical history included gastrointestinal issues and high blood pressure. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination was high blood pressure meds, pain meds.On 04Mar2021, the patient was not eating, unable to eat without choking. Couldn't swallow. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Duration of hospitalization was 30. The patient had not yet recovered from the event.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Influenza, Nasopharyngitis
Clinical narrative: Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at military base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered.  Information on the lot/ batch number has been requested.