chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at the site of injection; fatigue; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL3247), via an unspecified route of administration on 12Feb2021, 10:00 AM as single dose at Right arm for covid-19 immunisation. The patient medical history and concomitant medications included none. On 22Jan2021 patient taken the first dose. On 13Feb2021, the patient had Soreness at the site of injection and fatigue for 24-48 hours after administration. The outcome of event was Recovered.  No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Headache, Pain, Pyrexia
Clinical narrative: my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 12Feb2021 08:00 on Left arm at single dose for covid-19 immunisation. The patient medical history included Asthma, Eczema, Peppermint allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), on 22Jan2021 15:45 on Left arm at single dose for covid-19 immunisation and experienced headache and Dizziness. Concomitant medications in two weeks include Montelukast (Strength: 10mg), Loratadine (Strength: 10mg) and cyclobenzaprine. On 12Feb2021 09:00, the patient reported, on his first shot he had headache and he was light head for 2 days. One the 2nd shot he was having headaches, my body was aching with cold sweat and he was having fever and temperature was 101. He states, he never had the covid at all. He started feeling better after 4th day. He started drinking emergency C one pack 1000 mg and had 3 packages in a 23oz water bottle. No other vaccine in administered in four weeks of vaccination. No treatment was given. No covid prior vaccination. Covid was not tested post vaccination. The outcome of events was resolving.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his son tested positive after receiving the 1st dose.; his son tested positive after receiving the 1st dose.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (son) who received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The reporter reported that his son tested positive after receiving the 1st dose. The patient underwent lab tests and procedures which included covid test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medication(s) included probiotics taken for an unspecified indication, start and stop date were not reported; clotrimazole taken for an unspecified indication, start and stop date were not reported; diphenhydramine taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient previously administered first of BNT162B2 (lot number :EL3247) on 27Jan2021 11:30 AM administered in Left arm for covid-19 immunisation. The patient experienced headache, left arm pain, chills and body aches on 17Feb2021 11:45. The patient did not received prior vaccination and covid tested post vaccination and also reported known allergies as no. Therapeutic measures were taken as a result of headache, left arm pain, chills and body aches and included treatment with acetaminophen 500 mg x 2 tablets. The outcome of the events was reported as not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller got his 1st Covid dose and then got Covid right after; Caller got his 1st Covid dose and then got Covid right after; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got his 1st Covid dose and then got Covid right after. They had to do an antibody infusion so he wants to know what effect that will have. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: blood run down her arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL8982) via an unspecified route of administration on 05Feb2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lump in her breast (5 years ago and removed it, she is now cancer free), arthritis and high blood pressure, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported; however, the patient reported that she took "high blood pressure medication, 2 pills by mouth, 10 mg". The patient experienced "blood run down her arm" on 05Feb2021. The event was reported as non-serious. It was reported that on 05Feb2021 the caller received her first dose. She was sitting there, and they had someone give her the injection, and blood ran down her arm like water. She wanted to know why blood ran down her arm. She wanted to know if he scratched her, if he was a student, and if so, why would they have students practice on her. She stated that the staff placed a cotton ball and a band aid over the cotton ball. The patient stated that she was not bleeding anymore. She left the band aid on for a couple of days. She stated that there was blood all over the cotton ball. She wanted to know why she bled like that. She also stated that she received her second dose on 26Feb2021 in her right upper arm (Lot number: EN6202) and after the second dose did not even have a blood spot on her band aid, she thought that was the way it was supposed to be. The patient thought she might have gotten the first shot incorrectly. The patient also mentioned that she ate before she got her vaccine and had not been to a doctor after she received the vaccine. The clinical outcome of the event "blood run down her arm" was recovered/resolved on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Near Syncopal Episode; Dizziness; This is a spontaneous report from a contactable other health professional. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the right arm on 03Mar2021 12:30 (batch/lot number: EN6206) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Covid prior to vaccination. It was unknown if Covid tested post vaccination. The patient experienced near syncopal episode and dizziness on 03Mar2021 12:30. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Adverse event treatment reported as "evaluation/transportr". The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis, confirmed by ER; This is a spontaneous report from a contactable other healthcare professional (HCP). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was unknown), intramuscularly, administered in the left arm on 19Feb2021 at 12:15 PM as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and hydrocodone bitartrate, paracetamol (VICODIN), from which she had known allergies. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 19Feb2021 at 12:15 PM, the patient experienced anaphylaxis, confirmed by emergency room (ER). The adverse event (AE) resulted in a doctor or other HCP office/clinic visit and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of anaphylaxis, confirmed by ER, which included epinephrine, steroids, and antihistamines. The patient recovered from the event on an unspecified date.; Sender's Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular
Clinical narrative: Experienced rapid heartbeat; difficulty breathing; This is a spontaneous report from a non-contactable consumer reporting for sister-in-law. A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9264), via an unspecified route of administration, on 03Mar2021 at a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving BNT162B2.  Medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced rapid heartbeat and difficulty breathing 5 minutes after receiving vaccine on 03Mar2021. The adverse events did not require a visit to emergency room of physician office/clinic. No treatment was received for the adverse events. The patient recovered from the events on an unspecified date. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination site pain
Clinical narrative: diagnosed with Covid on 11Mar2021; Tenderness in area around injection site; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration on her right arm on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history included myelodysplastic syndrome (MDS), bone marrow transplant, low thyroid, hyperparathyroidism, oral and ocular graft versus host disease (GVHD). On 03Mar2021 at 17:00, the patient experienced tenderness in area around injection site. The patient reported with symptoms of COVID (irritated throat, stuffy nose, sneezing) on 11Mar2021. The patient was diagnosed with COVID on 11Mar2021 via PCR nasal swab. The patient went in for testing and was negative on 12Mar2021 via PCR nasal swab. However, the symptoms progressed to include low grade fever and worse fatigue so the patient was rested on 15Mar2021. The patient was tested positive for COVID via PCR nasal swab on 15Mar2021. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Immune system disorder
Clinical narrative: had no detectable immunity; This is a spontaneous report from a contactable nurse (patient's wife) via the medical information team. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), both via unspecified routes of administration from unspecified dates at single dose for COVID-19 immunisation. Medical history included Non hodgkins lymphoma and chemotherapy (recently finished with his second round). Concomitant medications included unspecified antiviral and antibacterial medications (still taking) while the effects of the chemo was still in his system (until mid April). The nurse reported that her husband had both Pfizer vaccines and after he had an antigen blood test he found out he had no detectable immunity. The nurse asked if the chemo or the antiviral or antibacterial meds would cause the vaccine not to work at this time in his system and should get revacinated later. 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
Clinical narrative: patient tested positive for the COVID virus; This is a spontaneous report from a non-contactable consumer (patient). A 31 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 23Feb2021 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of vaccination on 23Feb2021, 7 or 8 days later she started developing symptoms, she was sick the following Wednesday (unspecified date in 2021) then she got tested and it came back positive yesterday evening, last night (04Mar2021). The patient tested positive for the COVID virus. The patient asked if she could get the vaccine as scheduled and if there is any time frame for the 2nd dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: confirmed COVID infection; confirmed COVID infection; This is a spontaneous report from a non-contactable consumer. An 83-year-old male consumer received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # unknown) via an unspecified route of administration on 02Feb2021 (at the age of 83-year-old) at single dose for COVID-19 immunisation. First dose (Lot # unknown) was received via an unspecified route of administration and on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had not COVID-19 prior vaccination. The patient had confirmed COVID -19 infection on 01Mar2021. Date of COVID test positive was reported as 03Mar2021. The patient was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I am itching really bad; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 60, unspecified unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunisation .  The patient's medical history included iodine allergy and thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient had an itching that was really bad. It was further mentioned that she had a really bad allergic reaction when they did some kind of test on her a long time ago. Patient stated she forgot to ask if there was iodine in the vaccine as she had thyroid cancer. The outcome of the event was unknown.   Information about the Lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via intramuscular on the left arm, on 18Feb2021 (at 11:00) as single dose for COVID-19 immunisation, administered at hospital. She was planned to receive the second dose of vaccine on 11Mar2021. Relevant medical history included blood pressure problems and type 2 diabetes. Historical vaccine included pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13) administered many years ago for pneumonia and developed swollen arm for about 2 weeks. No relevant concomitant medications were provided. On 04Mar2021, the patient started getting chills, cough, feeling goose bumpy, cold and aches and pains like the flu but she had no fever. On 04Mar2021, rapid COVID 19 test was negative and COVID-19 PCR test was positive. The patient had not recovered from the events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Dyspnoea, Eye swelling, Headache
Clinical narrative: high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache; difficulty breathing; difficulty speaking; shortness of breath; This is a spontaneous report from a contactable consumer (patient).   This 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN7206) at the age of 25 years, via an unspecified route of administration at single dose in the left arm on 07Mar2021 10:00 AM for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL HFA), lansoprazole (PREVACID), both taken for an unspecified indication. Previously the patient received the first dose of BNT162B2 (Lot Number: EL9266) at the age of 25 years on 13Feb2021 10:00 AM in the left arm for COVID-19 immunisation. On 07Mar2021 23:00,  the patient experienced high fever, chest tightness, vicious vomiting, left eye swelling, restlessness, body aches, headache, difficulty breathing, difficulty speaking, shortness of breath. No treatment required. The events required a visit to the physician's office. The outcome of the events was not recovered. The vaccine was administered at a Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restlessness, Speech disorder, Vomiting
Clinical narrative: high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache; difficulty breathing; difficulty speaking; shortness of breath; This is a spontaneous report from a contactable consumer (patient).   This 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN7206) at the age of 25 years, via an unspecified route of administration at single dose in the left arm on 07Mar2021 10:00 AM for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL HFA), lansoprazole (PREVACID), both taken for an unspecified indication. Previously the patient received the first dose of BNT162B2 (Lot Number: EL9266) at the age of 25 years on 13Feb2021 10:00 AM in the left arm for COVID-19 immunisation. On 07Mar2021 23:00,  the patient experienced high fever, chest tightness, vicious vomiting, left eye swelling, restlessness, body aches, headache, difficulty breathing, difficulty speaking, shortness of breath. No treatment required. The events required a visit to the physician's office. The outcome of the events was not recovered. The vaccine was administered at a Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Suspected COVID-19
Clinical narrative: "deathly ill"/got very sick like if had Covid-19; "deathly ill"/got very sick like if had Covid-19; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This consumer reported similar events for 2 patients (herself and her husband). This is first of two reports. An 84-year-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 02Mar2021 (at the age of 84-years-old) at single dose for COVID-19 vaccination. Medical history included Covid-19 in Dec2020. Concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 02Mar2021, the next day (03Mar2021) she got very sick like "deathly ill" when she had Covid-19 (got the Covid-19 back in December and were told that it was safe for them to receive the vaccine). The symptoms went as fast as they came, around 6:30 for her. The outcome of the events was recovered in Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): same reporter/drug/event, different patient (husband)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pyrexia
Clinical narrative: fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201, expiry date: Jun2021), in left arm, shoulder area, on 09Mar2021 at 13:30 (at the age of 64-years-old) at single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS), cervical myelopathy, and arthritis that was bone on bone in her right hip. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Family medical history relevant to AEs was reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included ongoing duloxetine hydrochloride (CYMBALTA), ongoing baclofen, ongoing calcium, ongoing multivitamins (vitamins NOS), ongoing tamsulosin hydrochloride (FLOMAX), ongoing ergocalciferol (VITAMIN D), vitamin D3, diclofenac sodium (VOLTAREN). No additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks). The patient reported fever post vaccination. She was told by a nurse to not take MOTRIN but TYLENOL 24 hours after receiving the vaccine. The patient got the vaccine on 09Mar2021 and was told she could not take her MOTRIN. She had multiple sclerosis, cervical myelopathy, and arthritis that was bone on bone in her right hip. She told not to take pain relievers for 24 hours after the shot as it would cause something to happen with the vaccine. Patient explained that when someone had all these different things, it was hard to be told that they could not take medications. After the vaccine, she could not walk good and had a fever. The fever and the other events started on 10Mar2021, about 3am. She could not walk well at 3am in the morning when she got up. When a person had multiple sclerosis, whenever anything happened it took out their legs. It was also noted that she had muscle aches after the shot on 10Mar2021 at 3 am, all of that too. This was getting better. The patient was told she could take TYLENOL and relayed she did take a couple TYLENOL for the fever. The events did not require a visit to emergency room or to physician office. Relevant tests were reported as no. No treatment was administered for muscle ache and walking difficulty. The patient was recovering from the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Movement disorder, Pain in extremity
Clinical narrative: arm very sore; feeling just awful; could not move legs without help; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female consumer (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration administered in arm left on 27Feb2021 at 10:15AM as single dose for covid-19 immunisation. Medical history included ongoing myasthenia gravis, No Pituitary, COVID prior vaccination and codeine allergy. The patient had other medications in two weeks. The patient was fine on the day of vaccination. Next day on 28Feb2021 06:00AM, the patient could not move legs without help and arm very sore. Generally feeling just awful. Second day mostly the same. Woke up third day and all symptoms gone. No treatment received for the events. The outcome of the event was recovered in Mar2021. There was no COVID tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Confusional state, Feeling abnormal
Clinical narrative: feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel "right"/felt funny; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 (at 46 years old) as single dose for covid-19 immunisation. Medical history included ongoing hypotension and ongoing hoshimoto's disease. The patient's concomitant medications were not reported. The patient experienced feeling uneasy, bp was 150/80, confused, anxiety, flush through her whole body, shaking, didn't feel "right"/felt funny all on 19Feb2021 with outcome of unknown. The HCP told patient to take a diphenhydramine hydrochloride (BENADRYL) beforehand, and her cardiologist also provided her with a prednisone dosepak. Clinical course was reported as follows. About 10 minutes after receiving her first dose, the patient reported reactions that "hit her so hard, out of no where" including flushing throughout her entire body, shaking, feeling uneasy like "something is happening".  She tried to cool herself down by taking off her coat. She did not require an epipen. When EMS arrived, her BP was 150/80 mmHg which is out of character for her, as she normally has a BP of 80/40 mmHg (very low, almost "Dead").  She also reports that she "didn't feel right" for the rest of the week following vaccination. She was very confused, didn't feel "right" and had these anxiety/felt funny for a week afterward.  She also reported having Hoshimoto's disease. The people at the vaccination site thought maybe it was anxiety or a panic attack.  She was nervous about receiving her second dose on 12Mar2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Malaise, Tremor
Clinical narrative: feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel "right"/felt funny; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 (at 46 years old) as single dose for covid-19 immunisation. Medical history included ongoing hypotension and ongoing hoshimoto's disease. The patient's concomitant medications were not reported. The patient experienced feeling uneasy, bp was 150/80, confused, anxiety, flush through her whole body, shaking, didn't feel "right"/felt funny all on 19Feb2021 with outcome of unknown. The HCP told patient to take a diphenhydramine hydrochloride (BENADRYL) beforehand, and her cardiologist also provided her with a prednisone dosepak. Clinical course was reported as follows. About 10 minutes after receiving her first dose, the patient reported reactions that "hit her so hard, out of no where" including flushing throughout her entire body, shaking, feeling uneasy like "something is happening".  She tried to cool herself down by taking off her coat. She did not require an epipen. When EMS arrived, her BP was 150/80 mmHg which is out of character for her, as she normally has a BP of 80/40 mmHg (very low, almost "Dead").  She also reports that she "didn't feel right" for the rest of the week following vaccination. She was very confused, didn't feel "right" and had these anxiety/felt funny for a week afterward.  She also reported having Hoshimoto's disease. The people at the vaccination site thought maybe it was anxiety or a panic attack.  She was nervous about receiving her second dose on 12Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Blood test, Dysuria, Micturition urgency, Mobility decreased
Clinical narrative: urinating problems, during the night I can barely move, then I get up to go to the bathroom by the time i get there it's leaked out/It's painful; i get the urge to go to bathroom. It's painful, its not improving; I loss my sense of smell; can barely move; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. As per reporter, 1-2 days after getting the vaccine, started having "urinating problems, during the night I can barely move, then I get up to go to the bathroom by the time I get there it's leaked out enough to get my pajamas wet and then when I go to the toilet nothing comes out. This happens 5-6x per night it seems if I move, I get the urge to go to bathroom. It's painful, it's not improving. I loss my sense of smell, my wife thinks the urine smells terrible." Is this normal? He then added before getting the vaccine "had a blood test and urine test and the to doctor said I had a slight leak on the kidney". The patient underwent lab tests and procedures which included blood test: unknown results and urine analysis: unknown results on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: urinating problems, during the night I can barely move, then I get up to go to the bathroom by the time i get there it's leaked out/It's painful; i get the urge to go to bathroom. It's painful, its not improving; I loss my sense of smell; can barely move; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. As per reporter, 1-2 days after getting the vaccine, started having "urinating problems, during the night I can barely move, then I get up to go to the bathroom by the time I get there it's leaked out enough to get my pajamas wet and then when I go to the toilet nothing comes out. This happens 5-6x per night it seems if I move, I get the urge to go to bathroom. It's painful, it's not improving. I loss my sense of smell, my wife thinks the urine smells terrible." Is this normal? He then added before getting the vaccine "had a blood test and urine test and the to doctor said I had a slight leak on the kidney". The patient underwent lab tests and procedures which included blood test: unknown results and urine analysis: unknown results on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Heart rate, Hyperhidrosis
Clinical narrative: violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Suspected COVID-19
Clinical narrative: very sick like both if they had COVID-19; very sick like both if they had COVID-19/ deathly ill; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of two reports.  An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) on 02Mar2021 (85-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient medical history included COVID-19 from Dec2020. Concomitant medications were not reported. Patient's wife stated both she and the patient got the COVID-19 back in December (Dec2020). They were told that it was safe for them to receive the vaccine. They received the first dose of BNT162B2 on 02Mar2021. The next day (03Mar2020) they got very sick like both if they had COVID-19, this symptoms went as fast as they came, 05:00 for the patient; both she and the patient were deathly ill; they got up very sick on 03Mar2020. Stated that they are scheduled to the get the second shot and has wondered if it they should get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same reporter/drug/event, different patient (wife)
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for the COVID-19 Virus after receiving his first COVID-19 Vaccine dose; Some congestion; Slight fever; This is a spontaneous report through the Pfizer-sponsored program. Two contactable consumers (one was patient's parent) reported that a 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm, with route of administration unspecified, on 24Feb2021 (15:30) as a single dose for COVID-19 immunization at the public health department (not a military facility). The patient's medical history was not reported. There were no concomitant medications. On 08Mar2021, after receiving the first dose of vaccination, the patient had tested positive for COVID-19 virus. The patient had a positive rapid COVID-19 Virus test on 08Mar2021, and was waiting for the results the COVID-19 virus PCR test. The patent was in quarantine. In Feb2021, the patient had some congestion and slight fever. The events were reported to be non-serious. The outcome of the events, 'tested positive for COVID-19 virus', 'some congestion' and 'slight fever', was recovering. The patient was scheduled for the second dose of vaccination on 17Mar2021, and would like to know if he should receive it.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid afterward; tested positive for Covid afterward; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported same events for two patients. This is the first of two reports. A 67-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The healthcare professional from a Pediatrician's office reported in behalf of patient's parents, she believes them to be 67 years old. The reporter mentioned that they received first dose of Pfizer vaccine at the end of Feb2021 and then tested positive for Covid afterward (2021). They are due to receive second dose of vaccine this next Tuesday (Mar2021). The reported inquired on the guidelines to receiving the second dose if testing positive for Covid between the first and second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reevaluated should additional information become available.,Linked Report(s) : PFIZER -2021328881 same reporter/drug/events, different patient
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia, Vaccination site erythema
Clinical narrative: Knot detected in lymph node under right arm; Redness continues to spread after 6 days after receiving shot along with fever on this area; Redness continues to spread after 6 days after receiving shot along with fever on this area; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:00 (Lot Number: EN6206) (at the age of 67-year-old) as single dose for COVID-19 immunisation.  Medical history included leukemia and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced knot detected in lymph node under right arm and redness continues to spread after 6 days after receiving shot along with fever on this area. No therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe, dehabilitating headache for someone who has less than 5 headaches; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 09Mar2021 14:45 as a single dose for COVID-19 immunisation. Medical history included colitis and H1N1 influenza. Allergies to medications, food, or other products was unknown. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. On 11Mar2021 08:00, the patient experienced severe, dehabilitating headache for someone who has less than 5 headaches ever, the last of which was during H1N1. No treatment was received for the adverse event. The outcome of the event was not recovered. Event was reported as non-serious. The patient had not been tested for COVID-19 since the vaccination.  No further follow-up needed. Batch/Lot number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Burning sensation, Condition aggravated, Feeling abnormal, Malaise
Clinical narrative: She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels like her symptoms from her thyroid have like over taken her body; She feel like everything is aching, everything hurt; everything burns; It's hard for her to have her balance; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration at the age of 82 years, on 07Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated, "I am a daughter for patient who got the Pfizer shot". On an unspecified date, the reporter further stated, "I am calling in regards to my mother, she is 82 years old and she got her second vaccine on the 7th, on the Sunday and ever since then, she has not been feeling right, she has a condition where she has too many antibodies for her thyroid, but the first shot she got she felt fine after. This time she feels like her symptoms from her thyroid have like over taken her body and she feels very sick, she does not feel normal, she feel like everything is aching, everything  burns, everything hurt, her head is fuzzy, it's hard for her to have her balance, it's only after she got the second shot she started feeling like that, the next day Monday, so we don't know what to do because we don't know how long will this last, she feels like she is dying, which is lot for my mom to say because she can take some pain, so I want to know the way this functions." The outcome of the events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels like her symptoms from her thyroid have like over taken her body; She feel like everything is aching, everything hurt; everything burns; It's hard for her to have her balance; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration at the age of 82 years, on 07Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated, "I am a daughter for patient who got the Pfizer shot". On an unspecified date, the reporter further stated, "I am calling in regards to my mother, she is 82 years old and she got her second vaccine on the 7th, on the Sunday and ever since then, she has not been feeling right, she has a condition where she has too many antibodies for her thyroid, but the first shot she got she felt fine after. This time she feels like her symptoms from her thyroid have like over taken her body and she feels very sick, she does not feel normal, she feel like everything is aching, everything  burns, everything hurt, her head is fuzzy, it's hard for her to have her balance, it's only after she got the second shot she started feeling like that, the next day Monday, so we don't know what to do because we don't know how long will this last, she feels like she is dying, which is lot for my mom to say because she can take some pain, so I want to know the way this functions." The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: testing pos (positive) for Covid 19; This is a spontaneous report from a contactable pharmacist reporting for a patient.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient tested positive for COVID 19 on 11Mar2021. The patient underwent lab tests and procedures which included rapid COVID 19 test: positive on 11Mar2021. The outcome of the event tested positive for COVID 19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.