chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Dose 4= Moderna, Dose 5=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Allergy"; Aspirin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2022 at 14:00, outcome "unknown", described as "Dose 4= Moderna, Dose 5=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative days 6 to 11; (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 08Feb2023 to 12Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Little pain in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little pain in the arm at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 056A21A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Wheelchair user (a double-leg amputee). Concomitant products included INSULIN ISOPHANE BOVINE (INSULIN NPH [INSULIN ISOPHANE BOVINE]), CLOPIDOGREL, GABAPENTIN, DULOXETINE, ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication, LISINOPRIL.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Little pain in the arm at the injection site) outcome was unknown.            Concomitant products included Probiotic pills (NOS) for an unknown indication.  No treatment information was reported.
A single dose of a multidose vaccination remained in box.  We are unsure which patient did not receive the total dose.  There was not adverse reaction to the vaccination.
Patient received the 2nd vaccine dose and 2 days later presented to the Emergency Department with chest pain.
Pt states vaccine given 2-14-12 & was very painful x 2 days, then had a knot on (R) arm x 2 days, very red, warm to touch & swollen. In office 2/23/12 (R) arm red, warm, swollen (L-6 inches W-5.75 inches) at injection site.
Patient informs that she is covid positive; Patient informs that she is covid positive; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 77-year-old elderly female received a dose (unknown dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunization. There was no medical history or concomitant medications reported. The patient previously received treatment for an unspecified indication with palbociclib (IBRANCE) from 15Oct2020 which was on hold during this time. The patient reported that she is COVID positive and was told to hold palbociclib. Treatment details, if any, were not reported. The outcome of the event COVID positive was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Itching all over my body within 5 minutes, redness and swelling at sight of injection, shortness of breath, tightness in chest. Pharmacist administered Zyrtec and symptoms subsided after 2 hours. Brain fog for 2 weeks, extreme fatigue.  Still having itching episodes and numbness throughout body.
8 hours post vax, the pts experienced swelling, redness, and heat on the under side of their arms, away from the injection site. Unspecified medical attention was sought.
Immediately after injection I had an onset of feeling flushed and lightheaded without loss of consciousness. Then my heart rate increased to 150-160 with very frequent ectopic beats for several minutes. I then experienced frequent episodes of tachycardia with heart rates ranging from 160-170 and frequent ectopic heart beats requiring both emergency treatment and medications and 4 months of the inability to work. The tachycardic episodes lasted 6 months and the frequent ectopic heart beats are still persistent.
Tinnitus (both ears) Major Skin Rashes (very itchy) -lower back, abdomen,   Minor Skin Rashes (very itchy) - legs, back of neck.
received his first Pfizer Covid-19 vaccine on 19Feb2021/tested positive for covid on 07Mar2021; received his first Pfizer Covid-19 vaccine on 19Feb2021/tested positive for covid on 07Mar2021; This is a spontaneous report from a contactable consumer (patient wife) from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 19Feb2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's second vaccination is scheduled 12Mar2021. However, the patient tested positive for covid on 07Mar2021.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021.  Outcome was unknown.  Information on the batch/lot number has been requested.
Patient states: "received my flu vaccine on Thurs 15th and approximately 36 hours later I developed severe itching, hives, swelling in eyelids and unusual knotted feeling from my esophagus. I am itching from both of my inner forearms, face, neck, torso and thighs. notified my physician of the symptoms."  Patient states she took BENADRYL in the night of 11/18/2018 and the hives resolved. She was later contacted by her MD and directed: "that she could take BENADRYL and ZANTAC if needed.
Got the vaccine that afternoon and after midnight she  stated to feel cold in her bones. She started having uncontrollable yawning and shivering. Her jaw started moving uncontrollably from left to right to up and down she didn't have any control over it.  She has fatigue and tiredness all the time now and everything else has subsided.
Short of breath 7/19, called EMS and arrived in ED morning of 7/20.   While in ED became agitated hypoxic and apneic.   Intubated.  Diagnosed with PE and admitted.
This spontaneous report was received from a pharmacist via company representative and refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and exp. date were not provided). On an unknown date, the patients experienced hard lump at the injection site. The patients sought medical attention, they called the pharmacy. The outcomes of the event were not reported. The relatedness between vaccination and ZOSTAVAX and the event of hard lump at the injection site was not reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a Certified medical assistant (also reported as administrator) refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-APR-2018, the patient was inadvertently administered with a expired dose of VAQTA injection lot # N005605 (expiry date: 08-APR-2018) for prophylaxis (dose not reported) (expired vaccine used). No adverse effects reported. No product quality complaint (PQC) was involved.
Arm still painful at injection site. ALEVE (OTC) helps with pain. More aware of pain when asleep.
About 40 minutes after the vaccine, when I was driving home, my feet and lower legs went numb. I was unable to feel pressing the brake pedal, and had to  stop and call someone to drive me home. The condition improved in the first 2 weeks, but the numbness has not gone away at this point. I also have a slight numbness in my finger tips. Neurology determined I have neuropathy in my legs.  I currently have numbness mid calf and below on both legs, and in my feet, and finger tips, although the left seems worse.
Chills, no fever, body ache, severe headache, only slight soreness at injection sight. Had to lie down with blanket. 1 Aleve. Didn't feel good for apx. 15 hours
Fever 102, nausea, swollen arm/shoulder for 3 days, chills and shoulder/arm sore for 3 days.
Information has been received from a physician concerning a 23 year old female who on 11-SEP-2008 was vaccinated with GARDASIL (lot no. and route of administration were not reported). On 11-SEP-2008, the patient fainted after receiving GARDASIL at the doctors office. The physician reported that the patient had not eaten any meals prior to vaccination. As of 11-sep-2008, the patient was recovering. Additional information has been requested.
Transient global amnesia - hospitalized 11/07/2021 All tests to rule out stroke or TIAs were performed. Dismissed from hospital on 11/08/2021. Follow up with neurologist, cardiologist, endocrinologist, primary care physician.
pt recv vax;sl fever, limped;sl lethargic;next am mom reported  welts all over body;call PHNS;given  tavist D liquid;
Three days after getting the second dose of the vaccine I had stiffness in my right leg. The stiffness got worse as the day progressed. The next day I could not put any weight on the leg, and it was very swollen. My leg was painful, and it progressively got worse. Ten days after the vaccine I went to the ER because I could not walk, and my leg felt very heavy.  There was no evidence of Blood Clot by Ultrasound. Two weeks later I had to call the Ambulance and they took me to the ER. I was in Extreme pain, and they did an Ultrasound and CT scan which were normal. I went to an Orthopedic doctor two days later and they did an X-Ray. My leg is extremely swollen all over and I have been using a walker. The swelling has not gone down in any way, and it is still painful. It has been over three weeks and I am now scheduled for an MRI today.
Pregnant at the time Estimated Date of Delivery:  17 July 2021 Delivery 34/35 weeks 5 May 2021 had a strange feeling, but ignored because everyone I know complained about the 2d dose causing flu symptoms 6 May 2021:  started getting worse with rapid heart rate, hard time breathing, chills and fever (105).  Went to Hospital because I was nervous about the temperature while being pregnant.  A serious a test were ran and I was initially told I was fine; however, my temperature slightly went down and my heart and breathing continued to get worse.  A CT scan showed multiple clots on the lungs and a strain on my heart.  Was transported by an ambulance to different Hospital and stayed for about 4 days.  Was placed on Lovenox.
Increased frequency of heart palpitations for about 1-2 weeks (I have had episodes of palpitations in the past with no diagnosis made)
PATIENT HAD VASOVAGAL REACTION, FAINTED, WAS SUPER SWEATY AND HOT, DIZZY, AND LIGHTHEADED
Information has been received from a health professional concerning a 44 year old female with a history of anxiety and sinusitis who on 2/23/05 was vaccinated with a dose of MMR (lot # 645521/0297N). Laboratory evaluations performed on 3/29/05 and 4/19/05 showed seroconversion for rubella and mumps but not for measles. Unspecified medical attention was sought. At the time of this report, no symptoms were reported. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 48 year old female patient who on 26-JUN-2009 was vaccinated with a dose of PNEUMOVAX. The patient had pain in her left arm after the vaccination. On 28-JUN-2009, two days after the vaccination, the patient presented to the Emergency room at the hospital. The emergency room told the patient the pain was caused by the vaccination of PNEUMOVAX and the patient went home. On 29-JUN-2009, the next day, the patient could not move her arm. Magnetic resonance imaging (MRI) was conducted and the patient was found to have 2 herniated discs and the patient was diagnosed with cervical radiculopathy. The patient had a surgery and was hospitalized (date unspecified as to when this hospitalization took place). At the time of the report, the patient had not yet recovered and still had weakness in her arm. But the patient was no longer hospitalized. Pain in her arm, having 2 herniated disks and cervical radiculopathy were considered to be disabling and life threatening by the reporting nurse. Additional information has been requested.
Received 4 doses of Lymrix. After 4th dose, developed arthritic symptoms. Swelling of knees, elbows, joints. Symptoms continued to worsen. Seeing a rheumatologist.
I started loosing hair about 3 months after the vaccine, I had a biopsy and it didn't show anything. I went to the dermatologist and they haven't figured out why I am loosing hair. I am going to see more doctors to see if they can find a solution.
Started experiencing tiredness, weakness, weight loss.  Eventually experienced neuropathy in hands/arms and feet/legs over next weeks. In March 2013 experienced nerve and bodily function breakdown and hospitalized 3/23/2013. In hospital for next four months, including rehab. Was eventually diagnosed with chronic demyelinated neuropathy/Guillain Barre syndrome. Still going through treatment/follow up.
I received my second shot on Friday 01/29/21 at 5:30 pm.  The next morning (01/30/21) at @ 10:45 am I experienced an extremely rapid heart rate (195+) which did not go down even after laying down and putting my feet up.  My husband took me to the hospital ER and they  gave me cardizem (10 mg via I?ve) which brought it down.  I was let there for four hours then transferred to the main hospital and kept overnight in the cardiac decision unit and monitored. I really released @ 12:25 pm on 01/30/21 and referred to my own cardiologist
Fully vaccinated individual who subsequently became symptomatic and tested positive for COVID-19 on 03/28/2021
Received Influenza vaccine at approximately 7:30am on 10/10/07. At approximately 11:00am EHS received call that employee c/o itching all over especially hands  and feet. Given Benadryl 25mg which did help. Later that evening took another 50mg of Benadryl. On 10/11/07 report symptoms resolved.
Stomach ache; rash at injected site; Headache after taking vaccine after 5 hr it resolved.; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the parent.  A 26-year-old male patient received bnt162b2 (BNT162B2), on 14Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Headache after taking vaccine after 5 hr it resolved."; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Stomach ache"; VACCINATION SITE RASH (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "rash at injected site". Therapeutic measures were not taken as a result of abdominal pain upper, vaccination site rash, headache.  Additional information: The patient has no known allergies. The patient thinks that 20,000 people experienced rash at injection site, pruritus, and itching after taking Pfizer vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Next day mouth and lips swollen, eyes puffy, top of tongue swollen up. Ate breakfast, cheeks swelled up again, today 5/6/2021 still cheeks a bit swollen.  Has not had this reaction with moderna shot only second.
Fever of 100.4. Muscle aches and pains. Chills. Tylenol and rest. Fever broke overnight.
Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Mar2021 11:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from 19Mar2021 (Batch/Lot number was not reported) to 19Mar2021, at 10 mL for an unspecified indication. Medical history included allergy to bees, hornets, all insects with a stinger and egg allergy; all ongoing. The patient's concomitant medications were not reported. The patient experienced anaphylactic shock within 10 minutes after her first dose on 19Mar2021. Patient took children's Benadryl 10 ml one hour before vaccination like ger doctor suggested but still went to anaphylactic shock. She ended up in the emergency room for 6 hours because her mouth still felt funny and they were waiting until she was breathing and swallowing better, and stated that for a week and a half up to two weeks afterward, she still had trouble breathing and swelling of mouth and throat. The clinic gave her a Benadryl shot when her reaction happened and the Emergency Room gave her one also. Emergency Room also gave her three other medications in her IV.  She thinks the Benadryl shots she received were 25mg; but isn't sure. Patient was not admitted to the hospital. Outcome of the event was recovered on an unspecified date in 2021.
Immediate sweating; Dizziness; Shortness of breath; Rash developed within the next 12 hours; Face swelling; Arm swelling at injection site; Body aches; Chills; Headache; Nausea following next 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0514) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) and asthma. The patient was allergic to multiple medications, lactose, bees, and multiple environmental factors. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 08Jan2021, the patient experienced immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling, arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling and arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours was resolved on an unknown date in 2021.
stomach ache; body is painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Lot number: EW2181) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 25Jun2021, outcome "unknown", described as "stomach ache"; PAIN (non-serious) with onset 25Jun2021, outcome "unknown", described as "body is painful". Therapeutic measures were not taken as a result of abdominal pain upper, pain.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning an 80 year old hospitalized female with no known allergies who on 01/12/2005 was vaccinated with pneumococcal 23v polysaccharide vaccine .5ml subcutaneously (lot # 650087/0815P).  The pharmacist reported that on 01/15/2005 the patient had redness, swelling, tenderness and heat at the right deltoid injection site.  The physician was notified.  The pharmacist reported that triamcinolone cream was to be applied to the site and acetaminophen was given for discomfort.  The pharmacist reported that the injection site swelling, tenderness redness prolonged hospitalization.  The pharmacist reported that the patient was recovering.  The pharmacist expressed a concern regarding the lot.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  Additional information has been requested.