chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client 5 minutes after receiving Pfizer  1 st dose vaccine  client felt lightheaded. Client laid down to floor supine and was awake and alert. Client face was flushed and client appeared anxious--HR 80bpm. Client's extremities cool and client reported tongue was swelling and bilateral arms were tingling. Epi pen 0.3 mg IM administered in left thigh and 911 called. Client remained alert until paramedics arrived--breathing labored and hands clenched down. Mother at side
Fever is 100; Chills; Runny nose; Sneezing; I am hurting every where my ribs, my hand, my arms/she can't move her hands and her arm, and both of her arms hurt; Terrible headache; I am hurting every where my ribs, my hand, my arms; Having deep down spasm in my leg; I can't get warmed; My whole body hurts; This is a spontaneous report from a contactable nurse (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on 07Jan2021 both via an unspecified route of administration at a single dose for COVID-19 immunization, and guselkumab (TREMFYA), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for psoriasis. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his/her second injection yesterday (07Jan2021). He/She was very sick today (08Jan2021). He/She have fever and chills, he/she still have a runny nose and sneezing, he/she can't move his/her hands and arm, and both of his/her arms hurt. He/She didn't go to work today. He/She can't move his/her hands, if he/she try to move his/her hands, his/her hand hurts, the bones in his/her arm hurts, both of his/her arms hurts, he/she just feel really bad today (08Jan2021). This is the worst, he/she have ever felt. He/She have a lot of bad symptoms and the last time he/she took the shot, he/she had same symptoms but they were not as much bad as they are now. He/She just thought that with the second vaccination he/she wouldn't get sick. He/She have been taking Ibuprofen every 6 hours. He/She can't get warm. But he/she knew he/she will get better but he/she just wanted to report this symptoms that he/she was having. He/She wanted to talk and get better but all he/she was saying is he/she have had single shot and he/she was really sick then and this is 10 times worse than that (first dose). His/Her whole body hurts, he/she have fever, chills. His/Her fever is 100. He/She have a terrible headache, he/she feel so bad right now. He/She wanted to let know that he/she was not feeling good and he/she was sure he/she will feel good by Monday but he/she just had some complications. He/She don't feel good, he/she was hurting everywhere his/her ribs, hand, arms. He/She was having deep down spasm in his/her leg and he/she have taken Aspirin (Intent: treatment) for that and he/she have been taking Ibuprofen (Intent: treatment) for his/her body ache and fever and he/she knew he/she was going to get better. He/She don't want to be wimpy but he/she don't feel good. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Case completed his Covid-19 vaccine series on 3/1/21 and 3/22/21 and was hospitalized for Covid pneumonia from 8/2/21-8/4/21.
a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization, reaction(s): "a few sore arms"; Bnt162b2 (Dose: 02), for Covid-19 immunization, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms". Additional information: Reporter stated that they did have a relatively high opinion of Pfizer because both hiim and his wife (patient) and had received their COVID 19 shots and boosters from this company and they have had practically NO side effects to date; apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same reporter/AE, different patient;
rash on the belly; This is a spontaneous report from a contactable consumer.  An 80-year-old male patient (reporter's boss) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the Hospital (a family member that works there and the worker's were allowed to pick one of their family members to give the vaccine to) via an unspecified route of administration on 10Jan2021 at 11:30 AM at a single dose on the left upper arm for COVID-19 immunization. The patient had no medical history. Concomitant medication included simvastatin (manufacturer unknown), dutasteride (manufacturer unknown) and montelukast (manufacturer unknown) all from an unknown date and unknown if ongoing. The reporter stated that her boss received the first dose on 10Jan2021 and developed a rash on the belly. She wanted to know if he could take the second dose as scheduled or if he needs to wait. He was scheduled in 3 weeks. He has a rash all over his belly and the doctor said it was like a reaction to the vaccine. She does not know if he has to go the ER or what. His primary care physician (PCP) ordered him Benadryl pills and ointment. The reporter confirmed that the patient was ordered both oral and ointment. The outcome of the event was not recovered.
Pt. fainted within 5-8 minutes of IM vaccinations. Since that date he has complained most days of headaches, lightheadedness, dizziness phonophobia and needing to sleep more. Symptoms do not occur during exercise.
PT STATES AXILLARY SWELLING THAT EXTENDS DOWN THE WHOLE LEFT ARM AND REDNESS ALONG WITH BRUISING FROM THE SWELLING ALSO CAUSING JOINT PAIN
Mom states 24-48 hours following administration of Dtap-IPV in left thigh patient developed swelling and increased tenderness to left thigh. Seen in office 04/23/2021. Found to have left thigh swelling, no discharge, no fever.  Instructed to initiate bengay, cold compresses, and acetaminophen.
Extreme chills, extreme pain in arm where shot given, could barely move arm, overall aches and pain, but especially in back shoulder blade area and neck.
Chickenpox disease present at Dr office visit.  Approximately 25-30 lesions present.
She got her vaccine, she was fine and drove home and within that hour she got a shooting pain that shot up into her head, quick like like a sunburst and then it would stop. Shortly after that she would get it again that was pretty regular, on and off every 15 minutes at least, sometimes sooner. It lasted all day until he evening. She went to bed at 10:30 or 11:00 PM and settled down after that. She felt it once or twice this morning and not since then. She had a sore arm, which she has had with all the arms. The first shot she had a shooting up into her head that went up from her shoulder, that was on the left side and they felt like they may have hit a nerve, but did not repeat with subsequent vaccines. She was worried about things since she had AFib. She has had bumps/rash that is annoying on her back since Sept/October and is going to see a dermatologist for this.
she received the first dose of the Pfizer-BioNTech COVID-19 vaccine subcutaneously instead of intramuscularly; arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administered in arm, administration date 29Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "she received the first dose of the Pfizer-BioNTech COVID-19 vaccine subcutaneously instead of intramuscularly"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".Reporter asked if the second dose of the Pfizer-BioNTech COVID-19 vaccine induces more side effects than the first. She said she feels like she received the first dose of the Pfizer-BioNTech COVID-19 vaccine it was administered by a pharmacy technician and then she injects 2 'O' subcutaneously instead of intramuscularly, the present day. She explained the injection was too low. She specified she has arm pain. She asked if the efficacy of the vaccine would be impacted given this inadvertent administration. Putting up injection she believe on almost like triceps area; Did not give her in IM shot it was almost like a subcutaneous shot; Not into the muscle but more into the subcutaneous site. It was not about the quality of the product but it was about the wrong injection technique, that she was concerned. So, she was wondering if the vaccine was still being affective or she need a first dose again, like a total of 3 dose. She stated, she was a pharmacist herself, she knew that it was wrong when it was given. It did not feel right when it was given into the deltoid muscle but it was really there in her arm. She knew that the vaccine have the approval when looked at the prescription information it should IM but her injection was not given at the IM site. She stated it was given to her really low in her arm, it was like pretty much IM injection subcutaneously. Not into the muscle but more into the subcutaneous site. She would like to know if the vaccine was not given into the muscle whether it is effective or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swelling of arm and redness, hot to touch. headaches, fever, (left arm) lasted three days. called my doctor and he told me to go to the emergency room.
Injection site pain x one day then resolved. Five days after vaccination c/o severe Lt shoulder pain, decreased ROM, no ?, no redness, no swelling, no pain on palpation. ROM decreased to 15 deg (pt allergitic ASA/Ibuprofen). Tx Tylenol 1000mg q 6/ heat/ ice. Not as of 4/30/03, but sx improved.
Patient administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023.  Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 6th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Patient developed a firm large nodule with redness, pain at the injection site.  Subsequently developed red spots on the inner arm as well as swollen lymph nodes in the left axilla.  Also experienced high fever, headaches, chills, fatigue and an inability to place arm next to her side.  Symptoms are better at day five, but not completely resolved.  Her mammogram was recommended to be rescheduled given her symptoms.
SEVERAL URINARY TRACT INFECTION; SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT; SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION), VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Penicillin allergy and Drug allergy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT). In August 2021, the patient experienced URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION). In 2021, URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION), VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) had resolved.            No relevant concomitant medications were reported.   The patient took booster covid shot.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of sore arm and rash reaction to booster covid shot, sore arm and rash reaction to booster covid shot and several urinary tract infection with humira(adalimumab) was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever 104.00 - 104.6 last night 3-5-10 about 1:30 and went down to 100.00. Her right gland under neck swell and right under her ear swell. Dr ran test and everything was fine they said it was vaccine.
Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic.  I remained there for 90 minutes and the symptoms did not change.  Still have splitting headache and some dizzyness here we are two days later . . .
Discharge Provider:  DO Primary Care Provider at Discharge:  MD   Admission Date: 9/4/2023 Discharge Date: 9/6/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Orthostatic hypotension [I95.1] COVID [U07.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 84 year old male with a history of HLD, DM 2, CKD stage 3. He was admitted for chest pain, NSTEMI, on 8/31, had a dobutamine stress test and post infusion developed atrial fib with RVR, alternated with NSR, SVT. Rhythm management took several days and he was discharged with the addition of metoprolol succinate and apixaban on 9/3. History of hypotension with metoprolol in past. He returned to the ED on 9/4 with increased cough overnight, feeling of low blood pressure with dizziness and feeling "out of it". He reports a decreased appetite, shortness of breath, palpitations, and rhinorrhea as well. He denies chest pain, sore throat, nausea, vomiting, diarrhea. Vital signs significant for orthostatic hypotension in ED, heart rate controlled and NSR, afebrile, oxygen sat stable on room air. Lab work significant for AKI, hyperglycemia, elevated LFTs, trop 38, 31 indeterminate. He was Covid positive. He was given a 1 liter bolus in ED. He was admitted with Covid-19 and orthostatic hypotension for further monitoring and treatment as needed.  Patient was admitted remained stable throughout his stay he never had significant physical symptoms from the COVID-19.  His inflammatory markers did not require acute intervention.  He remained stable and was seen on the day of discharge anxious to go home.  He was evaluated by Physical and Occupational therapy who recommended home with no skilled services.  He could return to his regular medications as previously ordered.  He could return to diet and activity as tolerated.  He was cautioned that given his COVID-19 infection he was to make sure he was getting plenty of rest for the next 2-4 weeks.  He understood all these instructions and was discharged home in stable condition.   32 minutes were spent discharging this patient over 50% of this was spent in face-to-face counseling and coordination of care
Fever, decreased appetite and activity. Treated with Amoxicillin 125mg/5 ml tid. Child was given infant Tylenol for fever.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 with a home test on 08/08/2022. I had severe fatigue, difficulty in breathing, fluid on lungs and minor pneumonia. I went to an urgent care center because I had low oxygen levels and they send me to an emergency room. I did not have a blood clot as they thought I did but I did have pneumonia. I was sick for a month. As of today, I continue to have fatigue.
lt arm w/redness, warmth, swelling & severe pain distal to inj site w/onset several hours p/vax;pt consulted pvt MD who recommended cold packs & elevation of extremity;
Presented to ED (later the same day) after a seizure and anaphylaxis. About an hour and a half after receiving (Pentacel) per mom, she put him in his high chair and was feeding him when he went stiff, his eyes rolled to the back of his head and his entire body started jerking (he had just put the first piece of corn dog in his mouth). See ENTIRE record (ED Report attached: MRN 002253586 from NCBH)/br
Red welt appeared at the site of the injection on day of vaccination and was swollen and sore. It dissipated in 48 hours. One week after the vaccination, a red, itchy rash appeared at the injection site. Looking online, it seems as if it?s called ?covid arm.?
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned an unspecified age male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808978, and expiry: Unknown) dose was not reported, dose number in series was 1, 1 total, administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient had suspected covid-19 infection. He started experiencing symptoms which included runny nose and cough since 24-DEC-2021, followed by loss of taste and smell since 26-DEC-2021. On 28-DEC-2021, the patient underwent COVID-19 antigen test which was found to be positive which result in suspected clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210601.; Sender's Comments: V0: 20220109995-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
8 days after the first injection, I developed a hard knot and hot, red, itchy rash at injection site. The injection site also had swelling and fever in it, which lasted for about 5 days.
Nausea,; Vomiting; Delusions; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 06Jun2021 at 11:00 (at the age of 27 years old) as single for covid-19 immunisation. Medical history included post-traumatic stress disorder (PTSD). The patient had no history of known allergies. Concomitant medications included aripiprazole (ABILIFY); methadone for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021, the patient experienced nausea, vomiting, delusions and extreme anxiety. 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. The outcome of events was not recovered at the time of reporting.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
1 week after vaccine, red, warm, swollen, sore and itching suddenly - about half an inch below injection site (bruise is still at injection site).  next day (today) more swelling, warm, sore swelling and itching.  Saw PA - could be delayed reaction, also testing for Lyme.  Will watch.
feeling kind of shaky/got a little shaky; severe headache; super nauseous; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 13:00 (lot number: EK9231), and first dose on 16Dec2020 (Lot Number: ETT9899 as provided), via an unspecified route of administration in left arm at single dose for covid-19 immunization. Vaccine was not administered at Facility but in hospital. Medical history was none. There were no concomitant medications. No additional administered vaccines. Prior vaccinations (within 4 weeks) was none. Relevant tests were None. Caller was a phlebotomist calling regarding Pfizer's COVID vaccine, the second one. It's been an hour since she received the second vaccine. She was feeling kind of shaky. She had a severe headache and she was super nauseous. She mentioned she was probably going to be sent home. The caller explained it's like she would rather be in bed right now than dealing with patients. It's the nausea and headache that was the main thing, she just got a little shaky right now. The caller stated she received the vaccine about an hour ago, around 1:00 p.m. The caller explained her symptoms have stayed the same so far. The events were occurred on 05Jan2021 did not require a visit to emergency room or physician Office. Outcome of the events was not recovered.