chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Off label use; Booster; unsteady gaits; chest pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 92-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 92 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer's disease" (unspecified if ongoing); "Fluid retention" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 12Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 12Apr2022, outcome "unknown"; CHEST PAIN (non-serious) with onset 12Apr2022, outcome "unknown"; GAIT DISTURBANCE (non-serious) with onset 12Apr2022, outcome "unknown", described as "unsteady gaits". The event "unsteady gaits" required physician office visit.  Additional information: Caller asked if there were any reports of patients with chest pain and unsteady gaits following administration of the Pfizer-BioNTech COVID-19 vaccine and also stated that this is definitely good to know and very helpful. NDC number of COVID Vaccine. Pharmacist was informed about the role of Pfizer. Patient's height and weight was unknown. When probed if adverse reaction was for first or second dose: Pharmacist stated that it was for the fourth dose for patient. Time of vaccination was given in vaccination clinic and was between the time of 1:30 and 3:30. Anatomical site of administration was left arm, deltoids, intramuscular. Expiration date was unknown. When probed for lab test details, Pharmacist stated, "Not that I know of." Pharmacist stated, "I'm not sure another experiencing them it was at least 6hours after the vaccination at the facility where they reported them on April 13th 2022." Still experiencing the adverse events: Pharmacist stated, "Unknown." Worsened, improved and persisting (Adverse Event): Pharmacist stated, "Unknown, I don't think they are worsening we heard any reports for worsening." When asked about treatment, Pharmacist stated, "They did well it was reported by the facility that they were taken to the hospital to get look at another word what treatment they might receive. That's what were reported to us that they were taken for the hospital to get test, yes that's what we were told." Causality: Pharmacists stated, "In my medical opinion I think it's unlikely just because how long after the experiencing reactions and because the unsteady gaits which was reported is not necessary be I don't think actually report unsteady gaits haven't see in fact either all of the patients who did that have a history of falls and you know they are more elderly so unsteady gaits may not be related in my opinion, I say unlikely." This is cross linked with.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1/6/21: 8pm (1hour after shot): sore arm, relieved with heated blanket, slept through night with no issue   1/7/21: 7am (12 hours after shot): woke up with headache and dehydration, arm where injection occurred was sore and stiff, hit to move  11am: sudden and sever fatigue, beginning of swollen lymph node (left, side of injection), felt better after laying down for around 20 minutes and drinking water& 2excedrin tablets, sore arm continuing, felt feverish though no fever, nausea  6:30pm: sudden and intense fatigue, struggling to think straight, sore arm, exhaustion, headache (, nausea, unable to lift items with left arm without considerable pain  7:30pm: arrive home and lie down  By 8pm: intense chills, headache, left lymph-node swollen so it was visible to the naked eye, hurt to swallow, racing pulse despite lying down, inability to complete ADLs/ get up to take medication, frustration to the point of crying, joint pain;  8:30pm took temperature registered at 97.4 (normal), was able to take 2 excedrin pills, shortly after body temperature was regulated, racing pulse continued 11pm: asleep   1/8/21 8am: groggy to wake, arm still aching but able to move, swollen lymph node to touch but no longer glaringly obvious, throat ache (not as much as night before), abdominal pain,  hot shower and excedrin and water, slow to start but able to complete ADLs and resume work   12pm: first meal of day (soup and soaked bread), hurts to swallow at times, excedrin   3:30pm (present time) thoughts are clear, throat still hurts w/o drinking/eating, arm hurts but able to lift and carry normal amount without making noises of pain
After 15 minutes of rest, patient complained of feeling tired and her arm hurt. Pain scale 2 out of 10.  Patient vitals were within normal limits. Patient was evaluated by PCP with no concerns of adverse reaction
Flu symptoms for 18 hours.  Fever, chills, aces, pains.
Red, warm, swollen area - upper deltoid/IM at sight of injection.  Gave Tylenol only.  (DTAP reaction).
Patient currently hospitalized.  This is a pleasant 78 year old female with history of angioblastic T cell lymphoma as well as CKD, diastolic heart failure, and Afib who presented to the ED today with worsening SOB. She tells me that her home lasix dose had decreased in December and she has gradually noted an increase in lower ext edema since that time. As well as a gradually weight gain and slowly increasing SOB. This past week she did develop a low grade fever and was started on oral abx as an OP for an UTI. Low grade fevers have continued and she has been more fatigued with more sleeping and her appetite has decreased in the last several days. Her Daughter is with her and she reports that today when she went to bring her to the ED, moving her around made her quite SOB. In the ED labs revealed a positive Covid-19 PCR, as well as a BNP of 59,999 and a CXR that showed mild fluid overload. Her Hgb appeared relatively stable as to what she has had in the office at 8.6 and her Kidney function actually was better with a Cre at 1.82 than what it had been previously. She is admitted for further medical management and work-up.
Pt reported reaction to first dose of fever chills and skin break out on LLE. Client presented with open circular lesions from rash on the Left lower leg with no complaint of pain nor discomfort at this time.  2nd dose administered on left arm. Vitals WNL and client remains stable at this time.
Tired achy around 2pm on the 8th went away quickly  Chills, fever, major aches, headache gone after three hours (2am-5am on the 9th) Sore red arm and sore arm pit 8pm on the 9th
In clinic 10/30/07 for 4 mo. immunizations. Mother related that baby "went limp, eyes rolled back in his head and wouldn't respond to them" on 9/8/07. Has started vomiting earlier in the evening. Took baby to ER where they told her that they thought baby was allergic to soy milk. States that baby did not have any fever or other symptoms after immunizations on 8/30/07. Copy of ER notes were requested and received by HD. Neuro exam was normal in ER stated that "initially" baby looked chilled and cyanotic" with physicians notation. "Child may have choked with vomiting". Child has not had any further episodes.
Very swollen lymph nodes under left arm. Started the following day and lasted  11 days.
I have constant ringing in my ears - I was told this is called tinnitus.  I HAVE NEVER HAD THIS UNTIL AFTER THE 2ND SHOT.  Started about 10 minutes after the shot and has never stopped.
7:00am woke with a fever and dizziness, temperature 105F (measured by digital no touch style thermometer) , aches and pains, chills, fever, night sweats continued for 24-36 hours, tiredness. Treated with rotating ibuprofen and acetaminophen.
Breakthrough COVID; Breakthrough COVID; Booster; This is a spontaneous report received from a contactable reporter (consumer).  An 88-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 88-years as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) at the age of 88-years as dose 1, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 88-years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "Breakthrough COVID". The event "Breakthrough COVID" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and included treatment with vitamin supplement, cough medicine, and paracetamol.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Rash and swelling around injection site.  Still ongoing and has gotten worse.  Rash is about 6 inches across and 5 inches vertically.
Chest pain; Terrible halal headache; Nausea; Dizziness; Belly pain; Postural hypotension; Persistent malaise; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension) and MALAISE (Persistent malaise) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included BENAZEPRIL for Renal impairment.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak) and NAUSEA (Nausea). On 09-Apr-2021, the patient experienced HEADACHE (Terrible halal headache). On 14-Apr-2021, the patient experienced CHEST PAIN (Chest pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak), HEADACHE (Terrible halal headache) and NAUSEA (Nausea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded. On 04-Jun-2021: No specific follow-up information recorded.
6 days post vax pt experienced fever of 104.3 and decreased fluid intake. 8 days post vax pt developed generalized rash. As of two days later rash is fading and fever is decreasing. Physician diagnosed MMR reaction versus viral illness. Full recovery expected.
Pain in left ribs, left breast and left chest. Doctor stated it was costochondritis and have taken medicine for it.
Acute side effects started 12 hours after second injection: Severe headache, nausea, and dizziness combined with a fever of 103F.  Extreme body aches and joint pain in arms, legs, back, and neck.  Tylenol was taken to control fever.  Acute side effects lasted total of 24hrs but some lingered for one week.  Lingering side effects: Extreme dizziness and lightheadedness that persisted for 5 days following second injection.  Blood rushing to head and heart flutters when getting up/sitting down too quickly.  Primary care physician was notified after 3 days of side effects and patient was monitored for two more days.  Extreme dizziness and lightheadedness subsided on 5th day following second injection.   Patient will undergo follow-up during yearly physical in October or earlier if needed as minor episodes of dizziness/lightheadedness have sporadically occurred since second injection.
the patient's hands got even colder than after she use Suprep. Her hands were freezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022BTE00712.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "the patient's hands got even colder than after she use Suprep. Her hands were freezing". Therapeutic measures were taken as a result of peripheral coldness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given Pfizer 5-11 Bivalent Booster instead of the 6m-4y Bivalent Booster
After the patient was administered the Shingrix vaccine, I proceeded to administer the Fluzone vaccine in the same arm, since she had a condition in the left arm. After the administration of Fluzone, the injection site became a bruise. Two days later, patient was called to follow-up on arm condition and she mentioned that after the vaccine she suffered headaches, dizziness, shivering chills and vomiting. Also, she presented with inflammation at the injection site.
Frontal headache was 1st symptom, followed severe nausea, retching, chills, generalized significant muscle pains, skin painful burning sensation and fatigue. A few hours later sever abdominal crps and diarrhea started, along with nausea again amd dizzinesa
Swelling to upper and lower lips; lump to cheeks; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE and HYALURONIC ACID (RESTYLANE) from 27-Feb-2021 to an unknown date for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) from 03-Jul-2021 to 11-Jul-2021 for Swelling lips and Cheek swelling, at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were antibiotics.
low grade fever 99.8 F; chills; Joint pains; aches; piercing headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; NAPROXEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever 99.8 F), CHILLS (chills), ARTHRALGIA (Joint pains), MYALGIA (aches) and HEADACHE (piercing headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by the reporter.
Sweating, saw spots, about to pass out, lasted about 2 minutes , checked my blood pressure read 70/50 normal for me in the 120s/80s. Blood pressure started to return normal after two days. Stopped taking my meds on 3/17 restarted on 3/20
My 15 year old son started experiencing hives on Wednesday. September 21st at 6:00 am. The hives could have started earlier, but he was asleep. The next morning he woke up with them again. He also has soreness/weakness in his legs.
3.  covid positive, no symptoms.  Pt likely had covid when her son and grandson who live in house tested positive about 1-2 months ago.  No need for meds or oxygen.
Community member recieved 2nd dose within 21 days of  first dose of Pfizer
p/vax arm swelled up, hard knot, size of grapefruit w/5th anthrax shot;heat, rash & itching on site of shot;rash is persisting, swelling is going down & still a bit warmth on arm;
On Wednesday, April 21st (2 weeks after dose 1 of Covid-19 Pfizer vaccine), I started feeling itchy in both my upper arms. Itchiness continued until Saturday April 24th at which time I saw red dots in both my upper arms. I took Benadryl that Saturday afternoon. Shortly after that the itchiness disappeared. Sunday, April 25th afternoon I started seeing hives in my upper arms and under both my eyes. I went to the ER  who treated me with Prednisone and benadryl and requested me to follow up with my primary care.   On Wednesday, April 28th, I followed up with a doctor from my primary care physician's office. She mentioned that she would not rule out the vaccine and requested me to follow up with an allergist just to make sure. She also put me on Allegra and Pepcid AC.   On May 12th, I got my 2nd shot of the Covid-19 Pfizer vaccine and I was fine.   On June 3rd, I met with an Allergist who said that I am the 15th patient he is seeing with similar reactions and requested me to report to the CDC. He also requested me to wean off the Allegra and Pepcid 6 weeks after I started since I am feeling fine now.
Afib was detected the day following the vaccine.  Patient has had Afib or supraventicular ectopy every day since the vaccine.
I got swollen multiple lymph nodes 5/6 under the armpit the size of a marble. Also, large swollen lymph node the size of tennis ball under the collar bone was painful and didn't get smaller. Was prescribed: oxycodone 5mg May 7th, one pill, May 9th two pills, Prednisone 50mg for3days, 25mg for2days. May 14th for 5days.
Rash on  both arms, face and ears; Redness on  both arms, face and ears; Pins and needles on the fingers; Pins and needles on the fingers which turned into numbness; Pain on the right side which radiated down exclusively to the liver.; Pain on the right side which radiated down exclusively to the liver.; This is a spontaneous report from a contactable pharmacist. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration in the left arm on 24Mar2021 at 14:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 14:45 immediately after the vaccine, the patient started experiencing rash and redness on both arms, face and ears. Then patient experienced pins and needles on the fingers which turned into numbness within a couple of minutes. Then 5 to 10 minutes after, the patient started experiencing pain on the right side which radiated down exclusively to the liver. This pain lasted for several days. The patient took a TYLENOL as per the doctor's instruction which did help but the pain came back after the medication wore off. Even at the time of this report, the patient still experienced soreness on the right side where the liver was present. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL and BENADRYL. The clinical outcome of the events rash and redness on both arms, face and ears, pins/needles on the fingers which turned into numbness were recovered with lasting effects on an unspecified date in 2021 while the outcome of pain on the right side which radiated down exclusively to the liver was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Heart Failure; AFIB; Death by probable Myocardial Infarction; This is a spontaneous report received from a contactable Consumer.  An 85 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 26Feb2021 13:00 (Lot number: EN6201) at the age of 85 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no known allergies. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Jan2021, when the patient was 85 years old, for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: MYOCARDIAL INFARCTION (death) with onset 22Sep2021, outcome "fatal", described as "Death by probable Myocardial Infarction"; ATRIAL FIBRILLATION (hospitalization, life threatening) with onset 12May2021, outcome "unknown", described as "AFIB"; CARDIAC FAILURE (hospitalization, life threatening) with onset 01Jul2021, outcome "unknown", described as "Heart Failure". The patient was hospitalized for atrial fibrillation, cardiac failure (start date: 2021, discharge date: 2021, hospitalization duration: 5 days). The events "death by probable myocardial infarction", "afib" and "heart failure" were evaluated at the physician office visit and emergency room visit. A pacemaker placed on 02Jul2021 upon heart failure. Therapeutic measures were taken as a result of atrial fibrillation, cardiac failure. The patient date of death was 22Sep2021. The reported cause of death was myocardial infarction. No autopsy was performed.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Probable Myocardial Infarction
Severe hives all over upper and lower arms, upper and lower legs, stomach, back, sides, hips, entire body except face. Also, per my dermatologist to examine to me, the hives triggered an auto immune reaction and I also developed plaque psoriasis on my upper legs as a result of my body reacting to the Covid vaccination hives.  This did not resolve on its own, I had to use anointment on my whole body twice a day for another three weeks, before the rashes disappeared around mid May 2021. Because of this, I will not be getting any boosters because of my severe  reaction to this vaccine. The next one could be even worse for me.