chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received vaccination at 1556. Pt reported right hand tingling/numb and lightheadedness. Pt requested anti-gravity chair and reported decreased dizziness immediately. Vitals assessed: 102/62 BP, 118 pulse, and 99% O2. Pt received diphenhydramine 25 mg/10ml oral solution at 1613. At 1628, pt reassessed. Right wrist slightly numb and dizziness  diminished. Pt reported no pain and left facility with steady gait. Pt left with mother at approximately 1638.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Tinnitus
Clinical narrative: A few minutes following vaccination, patient reported dizziness and ringing in the ears. We had her lower her head between her knees to increase blood flow. Checked blood pressure and it was 122/81.  She reported feeling better within minutes of having her head lowered. Did not require further treatment like lying on the ground or applying cold compresses to wrists and neck. We monitored her for 30 minutes instead of 15 minutes to make sure she was safe to go.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I have had mild tinnitus for the last 12 years.   I received the 1st dose of Pfizer Covid 19 vaccine on March 31 2021.  Around 12 PM April 1st I noticed a distinct increase in the sound level of the tinnitus which has continued since.  I contacted my personal physician's office by phone and was told nothing could be done and to go ahead for the 2nd dose on April 21 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Palpitations, Tremor
Clinical narrative: Heart racing, shaking, light headed, and nauseated it started right away pretty much and lasted about 30min.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash at injection which started approx 1 week after vaccine
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on the both lower forearms
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Shaking chills, fever to 102 over night#1, onset of cough about 30 hrs after vaccine was administered.   Body aches for 18 hours...onset about 12 hours after dosage given. Shaking chills and on set of 102 fever about 8 hours after dosage Continuing body aches x 36 hours Immunologist RX'd medrol pack to bring immune response under control.  Body aches started improving about 3 hours after Medrol first 3 tab dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Disease recurrence, Thirst
Clinical narrative: Went into A Fib; Went into A Fib; thirsty; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) at the age of 79-years-old, via an unspecified route of administration in left arm on 19Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, arthritis, and episodic atrial fibrillation (AFib) in which she had 3 episodes in the last two years. The patient has no COVID prior to vaccination. Concomitant medications included apixaban (ELIQUIS), diltiazem, colecalciferol (VITAMIN D), and bifidobacterium lactis (PROBIOTIC). The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 79-years-old, via an unspecified route of administration in left arm on 22Feb2021 at 11:00 at single dose for COVID-19 immunization. The facility the vaccine was administered was public health clinic/veterans administration facility. The patient went into AFib on 19Mar2021 at 23:45, 12 hours after receiving the dose (as reported). She was told to drink plenty of liquids following the shot, which she did because she was so thirsty. The patient was in AFib for about 18 hours until it resolved into sinus rhythm. She wondered if there was any association with the vaccine and heart rhythm. The patient did not receive any treatment for the event "went into A Fib". She was not tested with COVID post vaccination. The outcome of the event "went into A Fib" was recovered on 20Mar2021 at 17:45 and unknown for the other event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Arthralgia, Back pain, Body temperature increased, Condition aggravated
Clinical narrative: 3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg., tiny bit of left arm soreness, tiredness; 4/1/21 RIGHT arm soreness (the LEFT arm had been injected), headache, aching behind eyes, tiredness; 4/2/21  BAD left jaw pain, headache, tiredness; 4/3/21 headache, tiredness, general muscle pain; 4/4/21 tiredness, general muscle pain, fever blister on lip, canker sore in mouth (both at same time and had not experienced in several years); 4/5/21  very sore throat, fever blister and canker sore; 4/6/21 headache, fever blister, canker sore, sore throat; 4/7/21 (tomorrow) I still expect to have a headache and pain from the mouth sores.  NOTE: only previous extreme backache and knee ache was experienced at age 16 before diagnosis with rheumatic fever;  have experienced fever blisters and canker sores most of my life, except for last 10 years, these have been an unusual occurrence, nothing I did precipitated it.; left jaw ache experienced 20 years ago before diagnosis of Temporo-Mandibular Joint Dysfunction, this was also an unusual occurrence;  I haven't had a sore throat in over 35 years.  I FEEL THESE REACTIONS MANIFESTED MOSTLY FROM OLD MEDICAL EXPERIENCES.  But the adverse effects just keep continuing.  I am still suffering side effects almost a week after the second shot.  It has been a VERY DEPRESSING experience.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Eye pain, Fatigue, Myalgia, Oral herpes
Clinical narrative: 3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg., tiny bit of left arm soreness, tiredness; 4/1/21 RIGHT arm soreness (the LEFT arm had been injected), headache, aching behind eyes, tiredness; 4/2/21  BAD left jaw pain, headache, tiredness; 4/3/21 headache, tiredness, general muscle pain; 4/4/21 tiredness, general muscle pain, fever blister on lip, canker sore in mouth (both at same time and had not experienced in several years); 4/5/21  very sore throat, fever blister and canker sore; 4/6/21 headache, fever blister, canker sore, sore throat; 4/7/21 (tomorrow) I still expect to have a headache and pain from the mouth sores.  NOTE: only previous extreme backache and knee ache was experienced at age 16 before diagnosis with rheumatic fever;  have experienced fever blisters and canker sores most of my life, except for last 10 years, these have been an unusual occurrence, nothing I did precipitated it.; left jaw ache experienced 20 years ago before diagnosis of Temporo-Mandibular Joint Dysfunction, this was also an unusual occurrence;  I haven't had a sore throat in over 35 years.  I FEEL THESE REACTIONS MANIFESTED MOSTLY FROM OLD MEDICAL EXPERIENCES.  But the adverse effects just keep continuing.  I am still suffering side effects almost a week after the second shot.  It has been a VERY DEPRESSING experience.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pain in jaw
Clinical narrative: 3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg., tiny bit of left arm soreness, tiredness; 4/1/21 RIGHT arm soreness (the LEFT arm had been injected), headache, aching behind eyes, tiredness; 4/2/21  BAD left jaw pain, headache, tiredness; 4/3/21 headache, tiredness, general muscle pain; 4/4/21 tiredness, general muscle pain, fever blister on lip, canker sore in mouth (both at same time and had not experienced in several years); 4/5/21  very sore throat, fever blister and canker sore; 4/6/21 headache, fever blister, canker sore, sore throat; 4/7/21 (tomorrow) I still expect to have a headache and pain from the mouth sores.  NOTE: only previous extreme backache and knee ache was experienced at age 16 before diagnosis with rheumatic fever;  have experienced fever blisters and canker sores most of my life, except for last 10 years, these have been an unusual occurrence, nothing I did precipitated it.; left jaw ache experienced 20 years ago before diagnosis of Temporo-Mandibular Joint Dysfunction, this was also an unusual occurrence;  I haven't had a sore throat in over 35 years.  I FEEL THESE REACTIONS MANIFESTED MOSTLY FROM OLD MEDICAL EXPERIENCES.  But the adverse effects just keep continuing.  I am still suffering side effects almost a week after the second shot.  It has been a VERY DEPRESSING experience.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Community health worker came to this RN, after several attempts made to check patient was unsuccessful.  It was subsequently realized she 14yrs/10mos. and should not have been vaccinated.  Upon hearing this, this RN realized that she had personally administered this vaccine. RN immediately notified Dr who felt that in the next few months this age group would be included in the vaccine, and that someone, "with more authority than he" should determine if patient is to get her 2nd dose as this was not scheduled. This RN spoke directly to patient's mother, asking, "what prompted her to bring patient realizing that she was only 14 y'o'?"  Mom stated, "I received a note from the school telling me that it was ok so I brought her".  This RN shared that we must get our information from the scientist/researchers/health care experts and government on when this age would be included and that as a part of the team, she should have waited until she heard this on a news station that she could trust to which she agreed. This RN shared that patient will surely benefit from some degree of immunity for this 1st dose, and responded that she is not clear if she will need 2 or just one dose when her time comes per the moms question. RN met w/ clinic manager to discuss how processes not people failed to work in this instance and that we would develop a process to ensure that this does not occur again.  Met w/ CHW who signed her  in and shared the same content r/t creating a new process.  Again, shared w/ AAC Director as well.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia
Clinical narrative: Approximately 1 hour following vaccine a mild headache started and persisted through the evening.  At approximately 11:11 PM I woke with uncontrollable chills and persisting mild headache as well as muscle aches.  Temperature was 98.7.  I took 1000mg Tylenol for muscle aches and chills.  Chills have not yet subsided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Photosensitivity reaction
Clinical narrative: It took my Photo Sensitivity to a much higher level . It does not seem to be getting any better .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: lower back pain, very slow walking, tylenol had no effect, exercises in 2nd week seemed to help and the back pain was negligible after 2 weeks. i had had a history of lower back lumbar sacral muscle spasm, but it had been years ago and more responsive to treatment back then. this was different.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large swelling size of baseball at injection site, hard raised, itchy, and painful to the touch. I did not have this at all after first shot; just the second.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: 4/2 -2am - freezing cold, ache in muscles & bones:  4/2-6am fever 100.4 until 3pm - then 98.4 and by 8am following day - back to normal for me- 97.5. Headache.  Aches in muscles and bones.  exhausted.  afternoon nap - &  Slept 10 hrs  night April 2nd;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 4/2 -2am - freezing cold, ache in muscles & bones:  4/2-6am fever 100.4 until 3pm - then 98.4 and by 8am following day - back to normal for me- 97.5. Headache.  Aches in muscles and bones.  exhausted.  afternoon nap - &  Slept 10 hrs  night April 2nd;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Nausea, Pain
Clinical narrative: Nausea, chills, high fever, throwing up, major headache, body aches.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, chills, high fever, throwing up, major headache, body aches.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician.  A 30-years-old male patient received bnt162b2 (Formulation: Solution for injection Lot Number: EL3247), dose 1 via intramuscular, administered in Arm Left on 04Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications.  The patient experienced right foot pain on 04 Mar 2021. Patient developed right foot pain 4 hours after vaccination and lasting 18 hours. Resolved spontaneously without treatment. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Erythema, Swelling
Clinical narrative: Eight days after her injection, Raised bump  that looked like two mosquito bites about the size of two nickels  pushed next to each other; brief 99-101 F fever that lasted only an hour or two for two consecutive nights. Bump turned flat and area got to be more of a red spot in similar size. Resolved itself in 24 hours after redness.  Not serious but worth mentioning because I have read about this fairly uncommon side effect from recent NEJM article, but ghe article stated the effects were coming from folks who had the Moderna shot, and not the Pfizer.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Miscarriage. April 1st. Estimated due date was November 10, 2021. First pregnancy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hot flush, Muscle tightness, Pain in jaw
Clinical narrative: Received shot, immediately felt sharp pain in left lower jaw, extreme tightness in back of neck - muscles really seized, and had a hot flash and my face flushed. I did not seek medical treatment.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Nausea, Pain
Clinical narrative: Dose 1: Pain and swelling at injection site and swelling of lymphoid under same arm for 1.5 weeks after injection. Dose 2: 11 hours after injection, woke up with fever, nausea, body aches.  Nausea turned into vomiting for the next 12 hours.  Couldn't stand up without nausea.  The fever, nausea, and body aches lasted for 72 hours.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Dose 1: Pain and swelling at injection site and swelling of lymphoid under same arm for 1.5 weeks after injection. Dose 2: 11 hours after injection, woke up with fever, nausea, body aches.  Nausea turned into vomiting for the next 12 hours.  Couldn't stand up without nausea.  The fever, nausea, and body aches lasted for 72 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Faltigue, headache?, nausea, diarrhea, shortness of breath on exertion ( no difficulty breathing), dizziness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Faltigue, headache?, nausea, diarrhea, shortness of breath on exertion ( no difficulty breathing), dizziness.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intermittent ringing & loud buzzing of Left ear; This is a spontaneous report received from a contactable other Health care professional. A 58-Year-old non-pregnant female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Mar2021 at 16:00 as single dose in arm left for covid-19 immunization. Relevant medical history included Allergies to medications, food, or other products: Sulfa. Concomitant medications included an unspecified medication. Past drugs included Amoxicillin with allergies to amoxicillin, Vicodin with allergies to vicodin, Codeine with allergies to codeine. On 08Mar2021 at 11:00, the patient experienced Intermittent ringing & loud buzzing of Left ear. The patient did not take any treatment for the event. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Oxygen saturation decreased, Tremor
Clinical narrative: Client received Janssen COVID vaccine @ 2:11pm, reported not feeling well @ 2:23pm.  Stated, "I can't get enough oxygen".   Client placed in zero gravity chair, was noted to be shaky and diaphoretic.  Oxygen saturation 100% on room air, pulse 47, BP 122/68.  At 2:28pm, client states she's not dizzy anymore, able to drink water, vital signs stable.  Client also reports she has fainted before with other vaccines and blood draws.  2:37 pm, client states she feels better.  2:56pm, client able to stand and leave observation area with steady gait and fiancé present.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: The following morning and for 3 days - very tired, exhausted, aches in muscles.  Unusual tiredness
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Nasopharyngitis
Clinical narrative: Swollen, stiff, arm at injection site, one week after vaccination
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: 3/30/21- Chills, inability to sleep, nausea 3/31/21 - Chills, Headache, severe Muscle/body aches, runny nose, fatigue 4/1/21- chills, headache, muscle/body aches
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sleep disorder
Clinical narrative: 3/30/21- Chills, inability to sleep, nausea 3/31/21 - Chills, Headache, severe Muscle/body aches, runny nose, fatigue 4/1/21- chills, headache, muscle/body aches
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Approximately  11-12 hours  after receiving my second dose of Moderna?s COVID-19 Vaccine on 2/3/21 (received first dose on 1/6/21), I began suddenly feeling symptoms such as: fatigue, chills, body aches, headache, and fever (103 degrees Fahrenheit). The symptoms came on suddenly/abruptly. The fever lasted approximately 24 hours and the other symptoms lasted approximately 48 hours.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Intense menstrual cramps Week early menstrual cycle
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Discomfort, Fatigue, Headache, Pain
Clinical narrative: Tinnitus @4 times existing volume in right ear: hasn't returned to normal volume to this date; 102.6 temp Aching all over Very fatigued  Head hurt and felt very heavy, especially with the loud volume of ringing in right ear
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus @4 times existing volume in right ear: hasn't returned to normal volume to this date; 102.6 temp Aching all over Very fatigued  Head hurt and felt very heavy, especially with the loud volume of ringing in right ear
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: sore arm at site of injection,  chills, fever, headache, fatigue
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Chills, injection site pain, injection site swelling, injection site redness, joint pain, tiredness, body ache.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: Chills, injection site pain, injection site swelling, injection site redness, joint pain, tiredness, body ache.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea, Urinary tract pain
Clinical narrative: lighteheadedness, nausea; urinary tract pain;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, achy
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Pain in extremity, Paraesthesia, Throat tightness
Clinical narrative: While waiting at the pharmacy the requested 15 minutes after getting the shot, I started to feel intense tingling in my left arm (the arm that received the shot) and achiness in my elbow and wrist.  The intensity gradually lessened but did not go away. I spoke to the pharmacist who suggested that I wait another 15 minutes. After a total of 30 minutes, the intense tingling had lessened (but was still present) so after talking with the pharmacist again I left to go home.   As I was heading home the tingling moved to my head, neck and upper chest and I began to feel a tightness in my throat. I was able to swallow but had the sensation that my throat was closing up.  After several hours the sensation had not gone away
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt came to pharmacy wanting a covid shot with online form already filled out.  RN on duty took in form, gave vaccine. No ill effects, just that pt was not 18
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Fourteen days after the second dose I had chills, fever, body aches, headache, and nausea followed by sever diarrhea.  After two days without much improvement I contacted  the  nurse who referred me to the on call doctor.  She recommended Immodium over the counter and GatorAde.  Also, she advised me to get a covid 19 test.  Results still unknown.   My concern is the delayed reaction and severity when the stated norm is 2 to 4 days after the second shot.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fourteen days after the second dose I had chills, fever, body aches, headache, and nausea followed by sever diarrhea.  After two days without much improvement I contacted  the  nurse who referred me to the on call doctor.  She recommended Immodium over the counter and GatorAde.  Also, she advised me to get a covid 19 test.  Results still unknown.   My concern is the delayed reaction and severity when the stated norm is 2 to 4 days after the second shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme fatigue that lasted 2 days. The first day I slept 19 hours. The second I slept 14. The following 3 days I was groggy, but it was manageable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Extreme nausea and vomiting post Covid Shot, patient became syncopal with the vomiting episodes and was admitted to the hospital
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Left arm sore for 2 days, headache for a day, body chills for 24 hours, low grade fever for 1 day, muscle soreness for 2 days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I have existing non-stop Tinnitus in my left ear and occasional quieter tinnitus in the right ear. The day after the vaccine the volume in the left ear more than doubled to the point it is so loud I am having a hard time hearing conversations. The right ear which before the vaccine only occasionally had tinnitus has it now nearly constantly. The volume has not subsided and I am very concerned that this could be a permanent problem.Where before the tinnitus was live able, this is awful and makes it hard to hear and understand. I don't know what to do about a second dose, if this stays at this level or gets worse it will be intolerable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pyrexia, Rash macular
Clinical narrative: I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots.  Symptoms got worse over the next few days, and I ended up being admitted in the hospital for thrombocytopenia for 5 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia, Vomiting
Clinical narrative: I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots.  Symptoms got worse over the next few days, and I ended up being admitted in the hospital for thrombocytopenia for 5 days.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Myalgia
Clinical narrative: Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain), followed in the afternoon by severe fatigue (I slept two hours in the late afternoon before dinner), then by evening mild nausea and chills.  I ended up going to bed at 9pm and slept nearly 10-1/2 hours after, for a total of 12-1/2 hours.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain), followed in the afternoon by severe fatigue (I slept two hours in the late afternoon before dinner), then by evening mild nausea and chills.  I ended up going to bed at 9pm and slept nearly 10-1/2 hours after, for a total of 12-1/2 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal discomfort, Nausea, Pain, Pyrexia
Clinical narrative: High fever, severe headache, body aches, nausea, vomiting, sinus (nose) burning.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: High fever, severe headache, body aches, nausea, vomiting, sinus (nose) burning.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives,
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Subjective fevers, body aches; started several hours after the vaccine was given. Treated with tylenol, motrin, rest and hydration
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Swelling face
Clinical narrative: allergic reaction; couldn't hear; numbness around her mouth; Facial swelling; fingers were numb; tongue was swollen; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine on 12Mar2021 and then on 18Mar2021 she started having a numbness around her mouth, facial swelling, her fingers were numb, she couldn't hear, and her tongue was swollen. The patient took Benadryl every four hours. The following day the patient still had the swollen tongue and numb fingers. The patient thinks it was an allergic reaction. The patient wanted to know if it could be from the vaccine. The patient thought it was a spider bite, but the reaction didn't occur until 6 days after the vaccine. The patient has allergies that's why she didn't put it together. It was further reported that the patient had the vaccine on 12Mar2021 and started having an allergic reaction approximately 7 days later. The outcome of events swollen tongue and numb fingers was not recovered; the outcome of other events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: allergic reaction; couldn't hear; numbness around her mouth; Facial swelling; fingers were numb; tongue was swollen; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine on 12Mar2021 and then on 18Mar2021 she started having a numbness around her mouth, facial swelling, her fingers were numb, she couldn't hear, and her tongue was swollen. The patient took Benadryl every four hours. The following day the patient still had the swollen tongue and numb fingers. The patient thinks it was an allergic reaction. The patient wanted to know if it could be from the vaccine. The patient thought it was a spider bite, but the reaction didn't occur until 6 days after the vaccine. The patient has allergies that's why she didn't put it together. It was further reported that the patient had the vaccine on 12Mar2021 and started having an allergic reaction approximately 7 days later. The outcome of events swollen tongue and numb fingers was not recovered; the outcome of other events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Oral mucosal blistering
Clinical narrative: the problem is she has had a herpes like reaction.; She has had blisters all over her mouth and inside.; This is a spontaneous report from a contactable consumer patient herself via Pfizer-sponsored program.   A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient was calling because she got her 1st shingles dose, then did the 1st dose of the Covid dose and her 2nd dose of the Covid vaccine was due 24Mar2021 and she also needs to get a 2nd dose of the shingles vaccine as well. However, the problem was she has had a herpes like reaction. She has had blisters all over her mouth and inside. She was worried about getting the 2nd dose and wants to know what we recommend. At the time of this report events outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Tinnitus
Clinical narrative: brain ringing and it is debilitating; brain ringing and it is debilitating; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date 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 were not reported. On an unspecified date, the patient experienced brain ringing and it was debilitating. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331312 Same reporter/drug/events; different patients
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: was out for the count; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was out for the count on an unspecified date. The patient commented that she'd heard about the first dose will affect you severely. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Tinnitus
Clinical narrative: have brain ringing and it is debilitating; have brain ringing and it is debilitating; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient stated that she have brain ringing and it is debilitating. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021313764 Same reporter/drug/events. different patient; PFIZER INC-2021330802 Same reporter/drug/events. different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in 2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband received the first dose of vaccine almost three weeks ago and developed COVID-19 on an unspecified date in 2021 and their primary doctor said to delay second shot because of illness. The patient wanted to know if this was okay. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331422 Same reporter, drug, and events; different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in 2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband received the first dose of vaccine almost three weeks ago and developed COVID-19 on an unspecified date in 2021 and their primary doctor said to delay second shot because of illness. The patient wanted to know if this was okay. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331422 Same reporter, drug, and events; different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, SARS-CoV-2 antibody test
Clinical narrative: Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in 2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband received the first dose of vaccine almost three weeks ago and developed COVID-19 on an unspecified date in 2021 and their primary doctor said to delay second shot because of illness. The patient wanted to know if this was okay. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331422 Same reporter, drug, and events; different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in 2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife received the first dose of vaccine almost three weeks ago and developed COVID-19 on an unspecified date in 2021 and their primary doctor said to delay second shot because of illness. The patient's wife wanted to know if this was okay. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331412 Same reporter, drug, and events; different patient
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site warmth
Clinical narrative: 3-4 hot welts on left arm near injection; 3-4 hot welts on left arm near injection; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 09:15 (Batch/Lot Number: Ep7534) as SINGLE DOSE for covid-19 immunisation.The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BNT162B2) dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 AM (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient experienced 3-4 hot welts on left arm near injection on 22Mar2021 at 08:00 AM. No treatment was received for the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm after receiving the covid vaccine; This is a spontaneous report received from Pfizer sponsored program COVAX US Support. An unspecified age of non-contactable female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 23Mar2021 at single dose for covid-19 immunization. On 23Mar2021, the patient had experienced pain in her arm after receiving the covid vaccine. The patient wanted to know if she can take Tylenol to the event and wanted to know if she may have a glass of wine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the soreness in the arm was less the second time than the first; This is a spontaneous report received from a  sponsored program. A con-tactable consumer reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.The patients medical  history was unknown. The patients concomitant medication included estrogens conjugated (PREMARIN) taken for an unspecified indication, start and stop date were not reported.The patient stated that she had problems with her eyes. she stated that after she had  her second COVID vaccine shot, not only did it not have any after effects, but the soreness in the arm was less the second time than the first. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The soreness in the arm was less the second time than the first.; This is a spontaneous report received from a sponsored program. This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation, estrogens conjugated (PREMARIN), via route of administration on an unspecified date (batch/lot number and dose were not reported) for an unspecified indication. Medical history included eye disorder. During the call, the patient stated I have problems with my eyes. The patient previously received first single dose of BNT162B2 on unknown date for Covid-19 immunization. The patient's concomitant medications were not reported. It was reported by patient that I had my second COVID vaccine shot and I had Pfizer and not only did it not have any after effects, the soreness in the arm was less the second time than the first. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature decreased, Migraine, Myalgia
Clinical narrative: mild muscle and joint pain; mild muscle and joint pain; low grade temperature; severe migraine; This is a spontaneous report from a contactable consumer (patient) reported unspecified age and gender received first dose of of BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot Number were not reported, Expiration date: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. Medical history included autoimmune disorder, three auto immune disorders, hasimoto's, raynaud's and another that hasn't been given a name, raynaud's phenomenon. The patient's concomitant medications were not reported. The patient experienced mild muscle and joint pain (arthralgia, mild muscle and joint pain (myalgia), low grade temperature (body temperature decreased), severe migraine (migraine). The outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Therapeutic response unexpected
Clinical narrative: acute dementia improved in an unbelievable way; acute dementia; This is a spontaneous report from a contactable consumer (patient's daughter) from a Pfizer-sponsored program. A 96-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced acute dementia (medically significant), and acute dementia improved in an unbelievable way (medically significant). The clinical course was reported as follows: The patient's daughter wanted to report that after receiving two doses of the COVID vaccine, the patient's "acute dementia improved in an unbelievable way." The patient went from being nonverbal and inarticulate, to becoming articulate and reading short words; something the patient's daughter had not seen in two years at least. The patient's daughter reported that there was only one change in her environment, which was the vaccine. The patient's daughter wanted to share her story and hoped this could help others. The patient's daughter stated: "I've seen anecdotal evidence and am amazed." The clinical outcome of the event, acute dementia, was recovering. The clinical outcome of the event, unexpected beneficial therapeutic response, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Left arm/hand numbness; This is a spontaneous report received from contactable nurse. This is the second of two reports. A 36-year-old adult [non-pregnant] female received the second dose of intramuscular BNT162B2 (solution for injection; Lot EL9764 expiry not provided) as a single dose in the left deltoid on 16Feb2021 (at 36-years-old), for COVID-19 immunization. Relevant medical history included known allergy to coconut, obesity (BMI 32), and former smoker. Concomitant medications included ascorbic acid/ dexpanthenol/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine hydrochloride/ tocopheryl acetate (MVI), and levonorgestrel (MIRENA). The patient previously received COVID-19 immunization with intramuscular BNT162B2 (Lot EJ1685) in the right deltoid on 05Jan2021 at 13:00 (at 36-years-old) and experienced sensation change (pins and needles) in left arm and tested positive for COVID. The patient was not pregnant at the time of vaccination. The patient did not receive any immunomodulating or immunosuppressing medications or any other vaccinations around the time of the vaccination. The patient tested positive for COVID via oropharynx PCR on 23Jan2021. On an unspecified date in 2021 the patient experienced Left arm/hand numbness which required hospitalization. Treatment for the event included aspirin (81mg) for thirty days. The outcome of the event Left arm/hand numbness was recovering.   The reporting nurse was unsure if the event was related to the use of the Pfizer product.; Sender's Comments: Based on temporal association, the causal association between the reported event numbness and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up 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.,Linked Report(s) :PFIZER INC-2021105933 PFIZER (Same reporter/patient/product, different event)