chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL; AMLODIPINE; ATENOLOL; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant) with onset 28Dec2022, outcome "unknown", described as "ischemic stroke". The patient was hospitalized for ischaemic stroke (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: Patient did not received other vaccine in four weeks. On 28Dec2022, the patient sufferred an ischemic stroke of unknown origin. A provider suggested vaccine as a potential cause. To date no other cause has been identified. My relatively young age was perplexing those involved in my care. Patient had no COVID prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies.    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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event ischemic stroke with the suspect drug BNT162B2 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 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.
Subject became slightly tired the day after her first shot, which increased each day with labored breathing until she died 4 days later.  (March 17th, 5:00 a.m.)
Patient with syncope after vaccination and unconscious for at least 5 minutes. BP initially low, but later recovered when alert. Provided rest and water. After about 20 minutes, patient asymptomatic and back to baseline. Sent home.
1/14/21 Arm sore to touch. Lump appeared on shoulder blade quarter size. Red, itchy rash from elbow to shoulder. Headache. Stiffness in arm and back of neck 1/26/21 Lump on shoulder blade, dime size. Red itch rash and soreness resolved but discoloration on arm palm size at injection site. 1/16/21 Cough, stuffy nose, SOB, fatigue, HA, diarrhea.
Patient presented with redness and swelling covering most of her right arm. She also stated that it was warm to the touch. We talked and she was worried enough to go see her primary doctor for evaluation. Asked her to give us a call back or come in to let us know the outcome. I have made 2 attempts to call her and left message with no response as of yet.
Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium, Additional Details: Patient came in 2/7/2023 and described having body aches and a bad head ache that started 1 day after bivalent moderna given. The effects lasted about a week. Says she still has a headache but thinks it may be her sinuses.
On a scale of 1 to 10 it was a 6-7/ the arm was not useful; significant pain in my arm almost immediately after the shot and lasting about 3 days approximately; Within the first night there was mild chills that lasted for about an hour.; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.). At the time of the report, MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-163778 (Patient Link).
32 year old female received injectable 10/6/2010 in left arm. Immediately after the injection pt. had bleeding at the site. Patient c/o pain, swelling, erythema, bruising, and induration 4 inches in diameter that began on the day of vaccination. 4 hours later erythema developed and 8 hours later pt. had swelling and erythema. Symptoms peaked at 48 hours and pt. began experiencing mild fever, chills, malaise, myalgia and fatigue. Patient was concerned about cellulitis but symptoms improved immensely with ibuprofen and hot compresses. The induration and erythema subsided by 4 days after the injection. As of (10/18) there still remained a bruise at the site of injection which was slowly improving. Patient is a physician herself and consulted with a few physician colleagues who all ruled out cellulitis, and diagnosed her with a local vaccine reaction.
I had covid in April/May of 2021, I think that is important to note. I began having a headache the evening after getting my first dose of the Pfizer vaccine. I woke up the next morning with a fever of 102, nausea, SEVERE headache, joint pain, and fatigue. I continued to have these symptoms all day, night, and the following day. The fever even reached 104 at one point. Tylenol worked to reduce the fever for a short time, but it always spiked back up. The following day (three days after vaccine), the fever left but I was still feeling nausea, fatigue, and had a SEVERE headache. The fourth day, the nausea subsided but the fatigue and headache persisted. It is now one week since I received the vaccine and the headache has finally subsided. I have a high tolerance of pain so when I say it was severe (a 12 on the 0-10 pain chart), it was very concerning. I got this vaccine because of the mandate to get it or lose the job I love. Vaccines should not be given to people who have already had covid - I felt like I was going through it all over again and am nervous of getting the second dose. Please, I am begging you, do not sweep natural immunity under the rug.
Patient started complaining of arm pain, became very tired and weak, she began to turn very pale. I ran with her back to the clinic and the nurse elevated her legs, had her lay down, gave her water, and checked her vitals. Her blood pressure was low,  but within a few minutes her BP came back up, her color returned, and her mood returned to normal.
the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; I got really hot after thefirst 15 minutes which followed by amigraine headache; I got really hot after thefirst 15 minutes which followed by amigraine headache; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ep6955), via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Patient had previously had sulfur (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), nuts and pineapples and experienced allergy to sulfur (MANUFACTURER UNKNOWN), azithromycin (ZITHROMAX), nuts and pineapples. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: en6205), via an unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and had no side effects.. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 14:45, 15 minutes after vaccination, the patient experienced feeling hot and migraine headache. After the second dose she got really hot after first 15 minutes which was followed by a migraine headache. The next day, on 28Mar2021, migraine continued along with fatigue, slept, joint aches, fever, sweats and restless sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcomes of feeling hot, migraine headache, fatigue, slept, joint aches, fever, sweats and restless sleep were resolving.   No follow-up attempts are needed. No further information is expected.
3inx1.5in red rash at vaccine site, not itchy or uncomfortable at the moment.
PMS week before blood flow abnormal bloating; diarrhea; mood swings; Blood flow heavy clotting/Bleeding thru tampons; bloating; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 09:45 (at the age of 27-years-old) as dose 1, single for covid-19 immunization and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported) via an unspecified route of administration, administered in right arm on 01Apr2021 (at the age of 27-years-old) as dose 1, single (as reported) for covid-19 immunization. The patient medical history was none. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 08Apr2021 the patient experienced PMS week before blood flow abnormal bloating, diarrhea, mood swings, Blood flow heavy clotting. Bleeding thru tampons need to change more often than usual. No treatment was received for adverse event. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms began 11/14/2021. Tested positive for COVID-19 11/15/2021. First symptoms were fatigue, then quite a bit of sneezing. Shortness of breath, fever (101 the highest), after the fevers had gone away, what stuck around was the shortness of breath. I felt like I couldn't fill my lungs with enough air. The symptom that has stayed with me since November has been loss of taste and smell. That's when I saw the doctor a couple weeks after and she gave me an inhaler that I only used for a couple days. 12/08/2021 I was able to get the booster. As of this last Friday, I'm symptomatic for the latest variant because I did not get the 2nd booster yet. To this day, still can't smell or taste.
mild fever - 99.5 flu like body aches (lasted about 1 day)
12/17/22 that evening I started to feel tired. I felt it was from a surgery I had recently had. By 7:30 that night, I was so tired, I felt I was going to fall down and cry. I had to go to bed earlier than normal. I had horrible fatigue. Going into the next day, I developed a postnasal drip. I took a home COVID test and it was negative. For the remainder of the day, I remained tired with postnasal drip. That evening into the next day, I woke up and I was shaking. I could tell I had fever, but could not get up to take it. I fell back asleep and when I woke up, I felt better. I took my temperature, and it was 102.2. I had a little bit of a cough and runny nose. I took a home COVID test and it was positive. I tried to stay hydrated and did not take anything for the fever because it did not feel as high. I called my doctor and he did not consider me high risk and said if I wanted to wait, I had until day 5. So I decided to wait until day 5 to decide about prescribing any medications. On 12/21/22, I felt better. On 12/22/22 I had a cough that was more bronchial.  I contacted my doctor and she prescribed PAXLOVID. I started the PAXLOVID on 12/23/22 in the morning. I finished the PAXLOVID on 12/27/22. The fatigue has not returned. I have a minimal cough. Before I had COVID I had Costochondritis and it flared up again for the past 3 days. All the symptoms of COVID are minimal. I realized the other day when I was cooking, my smell had not gone away, but the smell was like it was far away.
p/vax pt face became very red & swollen w/hives & welts;some dyspnea;went to ER & tx w/DPH, Solumedrol & pred;ER MD told mom could have been rxn to vax;no other immun given recently;
Information has been received from a pharmacist concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, at a dose of 65 ml, administered via subcutaneous, the frequency was reported as "one time" (anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On an unknown date, the patient developed a rash that resembled "five red bumps with white heads" in between her legs that were red and sore following the administration of ZOSTAVAX. On an unknown date, the patient sought unspecified medical attention and was seen at the pharmacy, no laboratory studies were performed and no treatment was given for the adverse events. No product quality complaint was involved. At the time of reporting, the outcome of the rash papular and rash was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Pain, discomfort, tired, swollen glands, collarbone, L armpit Narrative:
dementia; immunocompromised; chills; gout; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's wife). An elderly male patient of an unspecified age (reported as over 65) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at dose 1, single and second dose at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received both doses of BNT162b2 and currently they were hearing about a third dose. Reporter stated that a lot of people were being told by their doctor to go and get the third dose of the vaccine because if they were over 65 then they were at increased risk but they were not immunosuppressed. The patient had gout and dementia and the reporter was worried if she were to contract the virus and had to go into the hospital that he would not have anyone to care for him. She stated that with the first two doses the only side effects that her husband had were some chills but her friend who got Moderna said she felt like she got hit by a truck so it was much worse. She stated that someone in their community was around unvaccinated people and got the virus even though she was vaccinated and she ended up on a ventilator. She stated that she had to have had underlying conditions. Reporter would like to know if the 3rd dose of the vaccine was the same as the other two. The patient also had dementia and was considered immunocompromised, she would like to know if husband should also get the 3rd dose. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up
CARDIAC DISRYTHMIA.  3 DAYS TREATMENT IN THE HOSPITAL. ON GOING SYMPTOMS
This case was reported by a physician to a sales representative and described the occurrence of fever in a 6 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. On an unspecified date on or before 06/21/2005 the subject received a dose of Pediarix. At an unspecified time after vaccination with Pediarix, on or before 06/21/2005, the subject experienced a fever of 103 degrees Fahrenheit. The outcome of the fever was not reported.
1st 2 weeks: arm/muscle ached. Progress to tingling, numbness, weakness on entire arm per client. On 04/24/02, referred to PMD for care.
Woke up 2 days after receiving the shot with a lump under my left armpit and extreme soreness.  As of today, 3 days after receiving the shot and the swelling and lump under my left arm has increased as well as the soreness.
Patient given Pfizer vaccine for ages 5-11 years, instead of Moderna for 6 months - 5 years.
Covid symptoms Came back; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1,single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: DEPO-TESTOSTERONE, start date: 22Apr2021. Past drug history included: Humira, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid symptoms Came back"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid rebound several days after stopping Paxlovid. Covid symptoms Came back after they had previously resolved. Other medication within 2 weeks of vaccination was Depo-testosterone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain in the face on left side lower jaw; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (pain in the face on left side lower jaw) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No  Medical History was reported.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FACIAL PAIN (pain in the face on left side lower jaw). At the time of the report, FACIAL PAIN (pain in the face on left side lower jaw) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
sever daily migrainehead ache began 4 days post vaccine. History of rare migraines prior to vaccine
Med error, provider ordered a covid vaccine booster, LPN gave Moderna vs Pfizer. Report was filed prior to being notified by employee and provider notified immediately. The patient has not reported ANY adverse event and was checked on.
Lost in 30-50% of taste and numbness in tongue/face. Redness in face, unsure if swelling. No visual swelling, face "might be feeling puffy".
Came for an adult vaccination app, she received a Ped vaccine dose. no side effects were reported or observed at the clinic
Information has been received from a LPN concerning a pt who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N). Other therapy administered on that same day included a dose of influenza virus vaccine (unspecified). The LPN reported that the pt developed cellulitis. The LPN reported "the don't know which vaccine caused it."  It was noted the pt required an oral antibiotic for treatment. It was noted the pt was not hospitalized. No other information was provided. There was no product quality complaint involved. The pt sought unspecified medical attention.  Upon internal review cellulitis was determined to be an other important medical event (OMIC). No additional information is expected. The reporter also indicated that another 3 pt's developed injection site reactions consisting of redness, swelling and itching; and another 2 pt's developed severe cellulitis-like reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N).
expired dose of adacel was given to the patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine and meningococcal vaccine for Prophylactic vaccination (immunization).  On 19-Jun-2023, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U70938A; expiry date: 18-Jun-2023; strength: standard; frequency: once) via intramuscular route in left deltoid for immunization.  On 19-Jun-2023 the patient was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.