chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Same day as vaccine (Wednesday): expected achy arm, spreading to aching all over. Overnight (Wednesday night): Woke in the night with aches strong enough to prevent me from sleeping. Near-hallucination sensations of being able to "feel" my body warring with my left arm (injection site). Able to stand and walk around. Fever unknown. Next day (Thursday): Extreme fatigue, slept most of the day. Unable to stand for very long before the world started to go grey as if I was going to faint (I always sat down before I had a chance to faint). Feeling of breathlessness as if I was at a higher altitude than usual. Home O2 monitor repeatedly read at 97% throughout the day. Low-grade fever of 100.7ºF. Nauseous. Friday: Able to stand for longer but not indefinitely before the world went grey. Limbs and extremities easily got pins-and-needles tingling sensation after a couple moments of rest. Saturday: Hands tingling without any rest or constriction. Able to stand and walk. Still fatigued, still a bit breathless. Sunday: Tingling better but still present. Still fatigued. Breathlessness gone, standing nearly normal but still tiring. [Next few days too vague to describe, but symptoms are mostly gone by the following Wednesday except for occasional tingling in hands and arms.]
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 and received the Pfizer COVID vaccine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Shortness of breath, chest pain, fever
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, X-ray
Clinical narrative: Shortness of breath, chest pain, fever
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Movement disorder, Periarthritis, Peripheral swelling
Clinical narrative: At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21.  Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion  of the left shoulder with sensation of swelling in the arm  on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain.  She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21  where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy.  An MRI was recommended.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff syndrome, Sleep disorder, X-ray
Clinical narrative: At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21.  Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion  of the left shoulder with sensation of swelling in the arm  on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain.  She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21  where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy.  An MRI was recommended.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Appendicitis, Breast pain, Computerised tomogram
Clinical narrative: abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in my abdomen; my left breast was experiencing significant stabbing pain around nipple area; This is a spontaneous report from a contactable consumer (reporting for herself). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 10:30 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunization. Medical history was reported as none.  The patient's concomitant medications were not reported. On 12Apr2021, immediately within 15 min. of injection, the patient's left breast had significant stabbing pain around nipple area. This lasted all day, until she went to bed at 9:30 PM. On 17Apr2021 throughout the week, her appetite decreased steadily and she had increasing discomfort in her abdomen. Saturday morning, she woke up at 5 AM in severe abdominal pain, she vomited, and was still horribly uncomfortable for hours. Finally, she went to the emergency room at 11 AM, where they performed a computerized tomography (CT) scan and told me she had acute appendicitis and required surgery to remove my appendix. The events resulted in emergency room / department or urgent care and hospitalization. The patient was hospitalized for 1 day and had emergency appendectomy. The patient underwent lab test and procedure which included nasal swab negative on 17Apr2021. The outcome of the event breast pain was recovered on 12Apr2021 at 21:30 while the outcome of the other events were recovering. The patient had no COVID prior to vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, SARS-CoV-2 test, Vomiting
Clinical narrative: abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in my abdomen; my left breast was experiencing significant stabbing pain around nipple area; This is a spontaneous report from a contactable consumer (reporting for herself). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 10:30 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunization. Medical history was reported as none.  The patient's concomitant medications were not reported. On 12Apr2021, immediately within 15 min. of injection, the patient's left breast had significant stabbing pain around nipple area. This lasted all day, until she went to bed at 9:30 PM. On 17Apr2021 throughout the week, her appetite decreased steadily and she had increasing discomfort in her abdomen. Saturday morning, she woke up at 5 AM in severe abdominal pain, she vomited, and was still horribly uncomfortable for hours. Finally, she went to the emergency room at 11 AM, where they performed a computerized tomography (CT) scan and told me she had acute appendicitis and required surgery to remove my appendix. The events resulted in emergency room / department or urgent care and hospitalization. The patient was hospitalized for 1 day and had emergency appendectomy. The patient underwent lab test and procedure which included nasal swab negative on 17Apr2021. The outcome of the event breast pain was recovered on 12Apr2021 at 21:30 while the outcome of the other events were recovering. The patient had no COVID prior to vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Felt facial numbness (right face) after the shot, and right face was swelling. First saw neurologist to see if it was bell's palsy and doc said it was not and prescribed prednisone for 9-days. Not getting better, saw allergist and continued to take zyrtec. Still TBD on how the vaccine causes allergy. Face is still swollen and need to take allergy test at the end of the month. Both doctors are from another state.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Cough, Dizziness, Flushing, Sleep disorder
Clinical narrative: ringing in the ears flushed face cough dizziness waken at night in a cold sweat
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears flushed face cough dizziness waken at night in a cold sweat
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Dysgeusia, Flushing, Hyperkeratosis
Clinical narrative: ringing in the ears flushed face cough dizziness waken at night in a cold sweat
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Stomatitis, Tinnitus
Clinical narrative: ringing in the ears flushed face cough dizziness waken at night in a cold sweat
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient had syncopal episode 5 minutes after vaccination. Paramedics were called for monitoring of vital signs.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Computerised tomogram abnormal, Fall, Magnetic resonance imaging abnormal
Clinical narrative: On March 7 at 23:30 (11:30) I awakened to go to urinate and everything seemed darker. Went back to bed not realizing I was possibly having a stroke. I had a Diabetic Dr Appointmnet at 0800 on the 8th so In went to the appointment and informed Dr that I was partially blind in my right eye. She immediately had me hospitalized and the diagnosis of a stroke was confirmed by CAT Scan and x-ray and I think a MRI. I was discharged and returned 9 days later with worsening vision and balance. I had a severe fall on discharge and hit head kept me in a extra day and actually broke a rod on a low back fusion.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, X-ray abnormal
Clinical narrative: On March 7 at 23:30 (11:30) I awakened to go to urinate and everything seemed darker. Went back to bed not realizing I was possibly having a stroke. I had a Diabetic Dr Appointmnet at 0800 on the 8th so In went to the appointment and informed Dr that I was partially blind in my right eye. She immediately had me hospitalized and the diagnosis of a stroke was confirmed by CAT Scan and x-ray and I think a MRI. I was discharged and returned 9 days later with worsening vision and balance. I had a severe fall on discharge and hit head kept me in a extra day and actually broke a rod on a low back fusion.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Hypopnoea, Speech disorder
Clinical narrative: Patient complaint of difficulty breathing, shallow breathing, feeling weak, difficulty talking after the 2nd dose of Pfizer vaccine. Pharmacist lay patient  with legs elevated. Called 911 immediately. 1 dose of 0.3 ml epinephrine given on right thigh(ndc 001151694-30 lot g201101x) monitored bp and hr every 2 minutes. Vitals remain stable and paramedics arrived to release patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I had a variety of side effects, but I am submitting this report about my postmenopausal bleeding. I have been bleeding for two days now. I don't know how long it will last.; This is a spontaneous report from a contactable consumer (patient).  This 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 15:15 (Lot Number: ER2613) as single dose (at 54 years old)  for COVID-19 immunisation.  Medical history included endometriosis, asthma and allergies to Tylenol, shellfish, mushrooms. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 in left arm on 05Mar2021 04:30 PM (Lot Number: EN6205) for COVID-19 immunisation. On 20Apr2021, the patient experienced "I had a variety of side effects, but I am submitting this report about my postmenopausal bleeding. I have been bleeding for two days now. I don't know how long it will last". No treatment required. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test normal, Menstruation irregular, Pregnancy test negative
Clinical narrative: I did not get my period for over 72 days. I?ve never been late. I took multiple pregnancy tests. I had abdominal cramping.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache  Started 2:00 am and felt better after taking ibuprofen at 7:00 am. By afternoon felt great.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Pruritus, Swelling
Clinical narrative: Redness, swelling, and itching around injection site started day after injection.  Symptoms abated after 6 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Immediate post-injection reaction, Muscle spasms
Clinical narrative: Fever of 100.1, chills, headache, cramps in feet, neck stiffness, severe muscle aches, severe pain in right arm, right arm swelling, redness and tenderness. Localized arm pain started immediately after injection on 5/4 followed by chills/fever/headache at 3:30 am on 5/5. It's 10 pm on 5/5 and still suffering from side effects. Only treatment has been acetaminophen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever of 100.1, chills, headache, cramps in feet, neck stiffness, severe muscle aches, severe pain in right arm, right arm swelling, redness and tenderness. Localized arm pain started immediately after injection on 5/4 followed by chills/fever/headache at 3:30 am on 5/5. It's 10 pm on 5/5 and still suffering from side effects. Only treatment has been acetaminophen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Fever of 100.1, chills, headache, cramps in feet, neck stiffness, severe muscle aches, severe pain in right arm, right arm swelling, redness and tenderness. Localized arm pain started immediately after injection on 5/4 followed by chills/fever/headache at 3:30 am on 5/5. It's 10 pm on 5/5 and still suffering from side effects. Only treatment has been acetaminophen.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: significant redness, swelling, and inflammation at injection site,  which later manifested into an infection
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Deafness unilateral, Dizziness
Clinical narrative: Severe Vertigo, profusely sweating, vomiting, severe dizziness, hearing loss (left), tinnitus.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Magnetic resonance imaging, Tinnitus, Urine analysis, Vertigo
Clinical narrative: Severe Vertigo, profusely sweating, vomiting, severe dizziness, hearing loss (left), tinnitus.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe Vertigo, profusely sweating, vomiting, severe dizziness, hearing loss (left), tinnitus.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Dizziness, Malaise, Nausea, Pain
Clinical narrative: brain bleed; started to not feel well; dizziness; nausea; rash all over her body; body aches; This is a spontaneous report from a contactable consumer (sister). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started to not feel well 2 weeks after her 2 covid injection given on 15Mar2021. She had the Pfizer vaccine. She started with dizziness, nausea. Her mother took her to a pharmacy. They sent her to a hospital. From there they transferred her by ambulance. She remained there under the care of a neurosurgeon for 5 days with a brain bleed. No answers as to how it happened but did confirm it was 2-3 weeks old (same time as covid injection). She was released last week and at the time of report she was back in emergency room with rash all over her body and body aches. Her friend pulled this info and the story from another station and she has most of these symptoms. The reporter stated that these last 2 weeks has been horrific for their family. Outcome of the events was unknown.  Information about Lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: brain bleed; started to not feel well; dizziness; nausea; rash all over her body; body aches; This is a spontaneous report from a contactable consumer (sister). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started to not feel well 2 weeks after her 2 covid injection given on 15Mar2021. She had the Pfizer vaccine. She started with dizziness, nausea. Her mother took her to a pharmacy. They sent her to a hospital. From there they transferred her by ambulance. She remained there under the care of a neurosurgeon for 5 days with a brain bleed. No answers as to how it happened but did confirm it was 2-3 weeks old (same time as covid injection). She was released last week and at the time of report she was back in emergency room with rash all over her body and body aches. Her friend pulled this info and the story from another station and she has most of these symptoms. The reporter stated that these last 2 weeks has been horrific for their family. Outcome of the events was unknown.  Information about Lot/batch number is requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient recieved vaccine when age not appropriate
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Bad body aches, fever over 100, fatigue, headache
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Herpes zoster, Rash
Clinical narrative: 4/22/2021 notice skin rash, 5/1/2021 evening severe pain at a skin rash near stomach, partial O2 at 90%, difficult breathing, 5/2/2021 severe pain near the back where there is a different skin rash
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated he tested positive for covid on 11Apr2021; Caller stated he tested positive for covid on 11Apr2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153), at the age of 52 years, intramuscular on 08Apr2021 17:00 and the first dose (Lot Number: EP7534) via intramuscular, administered on the left arm on 16Mar2021 16:15; both as a SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, ongoing gastrooesophageal reflux disease, ongoing blood cholesterol, gastric cancer from an unknown date and unknown if ongoing and pancreatic carcinoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for hypercholesterolaemia from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) taken for gastrointestinal disorder from an unspecified start date and ongoing; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for chronic obstructive pulmonary disease from May2019 and ongoing. The patient he tested positive for covid on 11Apr2021. It was stated that maybe he already had COVID in between the two shots. His question was, did the second shot still work or because he got COVID, it doesn't work. He has asked everyone even his doctors and no one can give an answer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Immune system disorder, Peripheral swelling
Clinical narrative: low immune system; cardiac arrest; Swelling/foot got swollen; This is a spontaneous report from a contactable consumer.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization; immunoglobulin human normal (HIZENTRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  The patient medical history was not reported.  The patient had unspecified concomitant medications.   On 20Apr2021, the patient experienced cardiac arrest, which was noted as a medical emergency with outcome of unknown; swelling/foot got swollen on 20Apr2021 with outcome of unknown; low immune system on an unspecified date with outcome of unknown. The consumer reported the events as non-serious.  Details were as follows: patient had a medical emergency (cardiac arrest), with swelling and she was administered with a steroid injection Decadron and was prescribed furosemide (LASIX) 40mg tablets for 5 days.  Patient reported that she has an immune support CBIs. The medical emergency she experienced the day prior was a reaction to the medication Hizentra for low immune system, so it was suspended. The action taken in response to the events for BNT162B2 was not applicable, and for immunoglobulin human normal was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of swelling/foot got swollen as aforementioned.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Hyperhidrosis, Pain, Peripheral sensory neuropathy
Clinical narrative: I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; Headache the following three days and still having the increased pain and sweats.; I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; I have been having sweat break outs day and night.; Headache the following three days and still having; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Apr2021 at 12:00 (Lot Number: EW0158) (at the age of 65-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included peripheral sensory neuropathy (I have sensory neuropathy that causes muscle and joint pain on a daily basis), diverticulitis, colitis, Raynaud's phenomenon, Sjogren's syndrome, gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing.  The patient had known allergies: Sulfur, aspirin, cevimeline. The patient did not experience COVID-19 before vaccination. The patient did not receive any vaccination in four weeks prior COVID-19 vaccine. Concomitant medications included pregabalin (LYRICA); hydrocodone; pantoprazole and mirabegron (MYRBETRIQ), all concomitants taken for an unspecified indication, start and stop date were not reported. The patient reported that: "I have sensory neuropathy that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds. I have been having sweat break outs day and night. Headache the following three days and still having the increased pain and sweats. The events were serious, disabling. The patient outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 14Apr2021 at 19:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to paint vapors and perfumes. The patient was not diagnosed with COVID-19 prior to immunization. Concomitant medications were none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER2613) on 24Mar2021 (at the age of 38-years-old) in the right deltoid for COVID-19 immunisation. On 15Apr2021, following administration of the second vaccine dose, the patient experienced tinnitus. It affected both ears but was more noticeable in the left ear where the frequency had gone from a static-like buzz to a high-pitched continuous beep. This event resulted in a physician office visit and was reported with a seriousness of disability or permanent damage. The patient was not treated for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "tinnitus (affects both ears, but it is more noticeable on the left)" was not resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: After 1st dose intense pain in right foot and knee overall joint pain.; After 1st dose intense pain in right foot and knee overall joint pain.; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021, in right arm, for COVID-19 immunisation. Medical history included mild preexisting shoulder issue. Covid prior vaccination: no. Covid tested post vaccination: no. Known allergies: no. Concomitant medications were not reported. After the first dose, on 26Feb2021, the patient experienced intense pain in right foot and knee overall joint pain. No treatment was received. The patient subsequently received the second dose of vaccine on 18Mar2021 at 13:00 in right arm. After the second dose pain intensified and spread to hands wrists and shoulders. Very limited mobility with intense pain. Both shoulders very intense pain even with NSAIDS. Without NSAIDS original pains returned until taking naproxen 500 mg or similar. Continuing with no improvement. The patient had mild preexisting shoulder issue but not pain and full mobility. He believed there was a genetic autoimmune issue. But these intense symptoms were directly resulting from both vaccinations. The events resulted in disability or permanent damage and had not yet resolved. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s): same patient, different drug dose/event
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Seizure, Urine output
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's father) via Medical Information team. A 16-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 02Apr2021 at 10:15 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The vaccination facility type was reported as a "drive thru COVID-19 vaccine clinic." The patient's parents thought it was best for the patient to take the Pfizer COVID-19 vaccine, since she was eligible to get it so she would be protected. Relevant medical history included acne on the face from an unknown date and unknown if ongoing. Concomitant medication included isotretinoin taken for acne on the face, which she took for almost 3 months from an unspecified start date to 19Apr2021. The patient had no history of previous immunization with the Pfizer vaccine, since this was her first dose. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient had no prior vaccinations (within 4 weeks) and had no adverse events (AEs) following prior vaccinations. The patient had no family medical history relevant to the AEs. On 17Apr2021 at about 16:15 in the afternoon, the patient experienced seizure. It was further reported that the patient had a side effect after receiving the Pfizer COVID-19 vaccine; the patient had a seizure 15 days after receiving the vaccine. The reporter was asking if seizure had been reported with the vaccine. The reporter had no idea for sure if it was the vaccine, but he wanted to let Pfizer know. The reporter was hoping the patient would be okay and it won't happen again. The patient would see her physician at the time of the report on 21Apr2021 in a few hours. They would listen to the doctor at the appointment, and they had an appointment with the neurologist to see if she should get the second dose on Friday. They didn't know yet. The reporter didn't have the vaccination card with him. The patient had no conditions other than this event. The patient went to the emergency room for the event on an unspecified from which she had blood tests, urine tests, and a computerized axial tomography (CAT) scan of her brain and they said they couldn't find anything wrong at that time. They needed to follow up with the hospital in the area to see a neurologist, which they would be doing the following day. They told them to follow up with the neurology department at their Hospital and told them until they find out more information; the patient could do what she needed to do, but she couldn't drive a car. The reporter asked if Pfizer has had any reports of this and wondered if there had been other reports of seizures. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a non-contactable consumer. A patient (the consumer's cousin) of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (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 experienced seizure and hospitalized over a week on an unspecified date. The outcome of event, seizure was unknown.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Hemianaesthesia, Musculoskeletal stiffness
Clinical narrative: Hemihypoaesthesia (numbness on the right side); Tired all the time; Early morning stiffness; This is a solicited report based on the information received by Pfizer from (Mfr. Control No. :21K-163-3813425-00). A contactable consumer (patient) reported that a 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 52-year-old, intramuscular on an unspecified date (Lot number and expiration date was not reported) as single dose for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Lot number and expiration date was not reported) to an unspecified date, at unspecified dose for Moderate to Severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced hemihypoaesthesia (numbness on the right side), tired all the time, and early morning stiffness on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of the events was not recovered.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: The causal relationship between BNT162B2 and the events hemianesthesia, fatigue and musculoskeletal stiffness cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The causal role of pre-existing RA cannot be excluded as well. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report from a contactable consumer, the patient, from a Pfizer-sponsored program Covax Support. 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 27Mar2021 (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 passed out on 17Apr2021. The patient was supposed to get the vaccine on 17Apr2021 but he passed out on that day and he missed the shot. The outcome of event, passed out, was unknown.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea, Pneumonia
Clinical narrative: I also have COPD; It felt like I had Pneumonia; having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization in an hospital. Medical history included pneumonia (had pneumonia many times before) from an unknown date. The patient's concomitant medications were not reported. On 09Apr2021, it was reported that the patient was having trouble breathing. On 12Apr2021, 10 days after, the patient reported "felt like I had pneumonia" and on an unspecified date, reported that "I also have COPD (chronic obstructive pulmonary disease)." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dry skin, Palpitations, Rash
Clinical narrative: Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Heart palpitations, heart fluttering; Heart palpitations, heart fluttering; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), single dose, dose 1 via an unspecified route of administration, administered in the right arm on 31Mar2021 at 09:30 (at the age of 66  ears-old) for COVID-19 vaccination. Medical history included hip arthroplasty from 21Nov2020 to an unknown date. Historical vaccine included felt like she had the flu and was down for a few days after she got the flu vaccine. Family Medical History Relevant to the adverse events included her aunt passed away from taking penicillin years ago but does not specify that she has an allergy herself. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On There were no additional vaccines administered on the same date of the Pfizer suspect. The patient experienced heart palpitations, heart fluttering on 31Mar2021, reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin on 04Apr2021. She felt was down for a few daysThe events did not require an emergency room or physician's office visit. The patient used moisturizer and Vitamin E oil for the rash. The clinical outcome of heart palpitations and heart fluttering was not recovered and recovering for rash and dry skin.                                                     .      .
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Feeling of body temperature change, Migraine
Clinical narrative: Temperature normally is 97.6 I went up to 98.6; I would be hot one moment and cold next; My hands and feet were extremely painful because they felt so cold to me; Raynaud's was triggered my hands and feets were extremely painful because they felt so cold to me which has never happened before; I woke up with the worst migraine; Chills feeling like I was going to vomit; Chills feeling like I was going to vomit; My hands and feet were extremely painful; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 46-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right deltoid on 20Mar2021 11:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Ehlers-danlos since birth, Hashimoto's from 1989 and ongoing, ongoing Raynaud's, thyroid disorder and blood pressure abnormal. No prior vaccination. Concomitant medications included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol, losartan and amlodipine all taken for blood pressure from an unspecified start date and ongoing. The patient took first dose of BNT162B2 on 27Feb2021 at 11:45 AM (Batch/Lot number: EN6202) via intramuscular administered in right deltoid for covid-19 immunisation in which patient had a mild headache for 4 days then it went away. Upon receiving the second dose on 20Mar2021 patient was fine until 2 am (21Mar2021) and woke up with the worst migraine patient had ever had and chills feeling like patient was going to vomit. Patient's body temperature normally was 97.6 and it went up to 98.6 which was normal but patient would be hot one moment and cold the next. Patient had Raynaud's, Hashimotos and third autoimmune disorder tat they had not given a name to yet. But even being cover with blankets patient's Raynaud's was triggered patient's hands and feets were extremely painful because they felt so cold to patient which had never happened before and by 9 AM Monday morning (22Mar2021) it stopped. The migraine stopped at 7 PM and from that point on patient had felt fine no other symptoms or issues. The outcome of events Chills feeling like patient was going to vomit, Temperature normally was 97.6 went up to 98.6, hot one moment and cold next was unknown, of other events was recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021335589 same patient, same product, different dose, different events.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral coldness, Raynaud's phenomenon
Clinical narrative: Temperature normally is 97.6 I went up to 98.6; I would be hot one moment and cold next; My hands and feet were extremely painful because they felt so cold to me; Raynaud's was triggered my hands and feets were extremely painful because they felt so cold to me which has never happened before; I woke up with the worst migraine; Chills feeling like I was going to vomit; Chills feeling like I was going to vomit; My hands and feet were extremely painful; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 46-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right deltoid on 20Mar2021 11:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Ehlers-danlos since birth, Hashimoto's from 1989 and ongoing, ongoing Raynaud's, thyroid disorder and blood pressure abnormal. No prior vaccination. Concomitant medications included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol, losartan and amlodipine all taken for blood pressure from an unspecified start date and ongoing. The patient took first dose of BNT162B2 on 27Feb2021 at 11:45 AM (Batch/Lot number: EN6202) via intramuscular administered in right deltoid for covid-19 immunisation in which patient had a mild headache for 4 days then it went away. Upon receiving the second dose on 20Mar2021 patient was fine until 2 am (21Mar2021) and woke up with the worst migraine patient had ever had and chills feeling like patient was going to vomit. Patient's body temperature normally was 97.6 and it went up to 98.6 which was normal but patient would be hot one moment and cold the next. Patient had Raynaud's, Hashimotos and third autoimmune disorder tat they had not given a name to yet. But even being cover with blankets patient's Raynaud's was triggered patient's hands and feets were extremely painful because they felt so cold to patient which had never happened before and by 9 AM Monday morning (22Mar2021) it stopped. The migraine stopped at 7 PM and from that point on patient had felt fine no other symptoms or issues. The outcome of events Chills feeling like patient was going to vomit, Temperature normally was 97.6 went up to 98.6, hot one moment and cold next was unknown, of other events was recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021335589 same patient, same product, different dose, different events.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Blood test, Computerised tomogram, Disease recurrence, Seizure
Clinical narrative: Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further).  The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown.  Information on the lot/batch number has been requested.