chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA - About 5 minutes after receiving her first dose of the Moderna covid-19 vaccine, pt vomited, became flushed and "felt like her blood pressure dropped."  Pharmacist gave her a cool rag and took her blood pressure and she was observed for an additional 30 minutes and no other incident was noted.
The day after my vaccination I had a fever, aches, chills, which I had with the second dose. Then started the stomach problems, which I also had with my second dose but much milder and shorter duration.  This time I've had bloating, my stomach just so full of air/gas, and pain so bad I wanted to double over. The fever and aches subsided after a few days, but my stomach problems did not, they got progressively worse. I lost appetite, I've lost 11 pounds, I am dizzy all the time, my breathing is labored, my heart flutters, I have no strength. But the chest pain is getting worse, constant.
Rash and intense itching on both arms  Treatment: take allergy oral medication and a topical steroid cream
neuropathy; neurological symptoms; cold like symptoms; Small fiber neuropathy; nerve pain; GBS; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 23Mar2021 12:00 (Lot Number: EP 7534) as dose 2, single (at the age of 26 years old) for COVID-19 immunization. Medical history included COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 02Mar2021 at 09:00 AM (Lot number: DOHCBRP) via unspecified route of administration administered in left arm as dose 1 for COVID-19 immunization. The patient had COVID-19 prior vaccination. The patient tested COVID post vaccination, test type post vaccination was rapid, COVID test date was 22Jun2021 and COVID test result was negative. No known allergies. Other medical history was none (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. Received vaccine on 23Mar2021. Developed neuropathy and neurological symptoms on 15Jun2021 after cold like symptoms. Currently dealing with small fiber neuropathy and nerve pain all over body. PCP believes atypical case of GBS (Guillain-Barre syndrome). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 7 days due to the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test: negative on 22Jun2021. The outcome of the events was not recovered.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated to Bnt162b2.   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 RAs, Ethics Committees, and Investigators, as appropriate
1st seen Jan c/o back/spinal pain full length (x 2-3 mo) tingling between shoulder blades. 2 wks later (2/4) tingling hands & feet, weakness, wt loss, loss of DTR's, decreased grips. 3/5/13 trouble walking, diffuse weakness. NCS/EMG 4/2/13 severe demyelination. CSF fluid oligoclonal c/w GBS Guillain Barre Syndrome.
Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard. I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice). The difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took my blood pressure, blood oxygen level, and listened to my lungs, heart, and throat. They said they sounded normal. After this, I waited at a parking lot for another 15-20 minutes. I felt a bit strange, but I could breathe better. They did not inject the EPI Pen.
patient got the flu was when patient got the flu shot; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case received via social media from a consumer (patient).  This case involved an unknown age patient who reported got the flu (Influenza), while he/she received INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (Influenza) when patient got the flu shot (INFLUENZA VACCINE ).  Relevant laboratory test was not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL and then did not received the 2nd dose until 2 years later. A 3rd dose may have been given 2 months after the 2nd dose. No vaccination dates were available. No adverse effect reported. Additional information has been requested.
Pt received 2nd dose Pfizer at 8:30am, came to nurse's office at 10:20 c/o chest pain. Blood Pressure 106/61, Pulse 78,  Pulse Ox 99%, Temp 97.8, normal color, pain rated a 5 out of 10 by Pt, occurred with activity and at rest, emergency services called and pt was evaluated by Paramedics, mom referred to ER for evaluation, mom drove pt to ER to be further evaluated, Pediatrician aware.
Nausea and vomiting. Received fly vaccine at the same time and same arm .
Around 12:00 pm patient got home and complained left arm was numb and tingling (blood drawn in left arm). Pt moved it around and sx resolved. After playing outside until about 1:00 pm, patient came inside to tell mom tongue was numb and she was talking funny. Mom sat her down gave juice and toast and sx resolved. Then horrible headache followed, mom gave TYLENOL. Patient then became nauseous. Mom called us, we advised BENADRYL. 30 minutes following BENADRYL pt felt better. Slight headache lingered.
Employee received vaccine at approximately 7:15 Am on 1/5/07. Employee went home after shift.  As she stated, around 11AM her throat started swelling up, she had difficulty swallowing, and lips started to swell.  She called rescue, and was taken to local ER
Pt calling d/t having possible reaction to PNEUMOVAX vaccine given on 06/18/2015. Pt states given vaccine at approx 0830 and was feeling fine until evening during dinner. Pt states at this time her shoulder became extremely painful and pt couldn't move it. Pt states she took IBP for relief and has used ice. Pt states she fell asleep on her couch and at approximately 0130 woke up with nausea and vomiting. Pt states she took temperature and was 99.4 and exp chills and sweats. Pt states these symptoms continued through late AM. Pt states left shoulder/arm pain continued as well as a HA. Pt attempted to control symptoms with ice, IBP, and EXCEDRIN. At present pt states nausea, vomiting, chills, sweats, temp, and HA have all been relieved. Pt states at this time pt is still exp left shoulder/arm pain, and that injection site is swollen with red rash. Pt states call is to inform them of reaction and possible allergy. Pt advised that if symptoms return to seek emergency attention. Please advise pt if anything further is necessary.
Patient have what appear to be vasovalgal response but also noted 30 seconds of seizure activity - 911 called and patient sent to ER. Stable VS and patient and alert in route to ER.
Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 34-years-old male patient who was vaccinated with first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U5241AA, expiry date: 13 January 2018, dose was not reported) intramuscularly in right deltoid and with a dose of TUBERCULIN PPD(M) 5 TU (Tubersol) (batch number: C4653AA, dose, dose in series, expiry date were not reported) via intradermal route in right forearm on 13 October 2015. The patient's illness at time of vaccination reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions reported as asthma. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, same day following the vaccination, the patient had developed redness at injection site; redness and swelling progressed under the patient's right arm. On 15 October 2015, two days following the vaccination, the patient had experienced flu like symptoms, night sweat, chills, pain and numbness at injection site. The patient was diagnosed with bacterial infection caused by the vaccination but no culture done. The patient required ER/doctor visit. Laboratory data was not reported. The patient was treated with IM antibiotic; oral antibiotic and IM pain medication. The outcome of event was unknown. List of documents held by sender: none. Follow-up information received from the healthcare professional on 18 January 2016. It was reported that the patient had received 0.5 ml dose of adacel and 0.1 ml dose of tubersol. The county and state of vaccination were also updated. No further information on recovery reported.
sore arm; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient age: 88; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 21Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm for a couple of days. The patient recovered from the event on an unspecified date in 2021. The patient received the second dose of BNT162B2 on 11Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Became violently ill a few hours later; Vomiting; Chills; Body pain; Redness all over; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ew0160) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. 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. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and unknown if ongoing. The patient previously took paracetamol (TYLENOL) for unknown indication on unknown date and experienced drug allergy. On 15Apr2021 at 20:00, few hours later, the patient experienced violently ill, vomiting, chills, body pain and redness all over. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events violently ill a few hours later, vomiting, chills, body pain and redness all over were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fully vaccinated with covid vaccine (pfizer). Tested positive for Covid 19 on 8/20/2021 and expired on 8/26/2021.
Fever, swollen lymph node, pain, tired, headache, joint pain, drowsy.
psoriasis flare ups; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced psoriasis flare ups on 23Feb2021. She will have the 2nd dose on 05Mar2021 and wanted to know if it is safe for her to have it. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after the DTaP shot was given my daughter's left upper thigh, around the area of the shot, was swollen, red, and hot to touch. The swelling and redness was 4 inches by 3 inches.  Then on 4/13/2012 her entire left thigh was swollen.
Patient reporte 2 days after covid booster that underarm/armpit in the arm that was injected was swollen and painful to a point that she couldn't hardly lift arm.  Patient is going to try acetaminophen/ibuprofen/ice/rest and see if it betters or resolves.  If gets worse or notices any other new symptoms, she will be seen by her physician.
Received the shot Saturday morning about 9:45 and woke up the next morning with chest pains (same pains I had when I had Covid) I rested throughout Saturday and Sunday, but ended up having to take Advil for the pain. I called my doctor's office the next week to inquire about an appointment and if I should go through with the second shot due to the reaction, and they told me to follow the CDC Guidelines (with no appointment scheduled). I looked up the information on the CDC website and it says to report. I cannot comfortably get a second dose with that severe of chest pains. I heard (from the pharmacist herself that the second dose of the Moderna is where most people had the reaction.
Vaccine triggered irregular menstrual cycle. I was due for my period on the first of April a couple of days after the first dose. I did not have my period until the 12th making it a 40 day cycle. Then, I got my second dose of the vaccine. The irregularity has continued and I am having very short bleeds with some spotting in between periods. The next few cycles were 28, 21, 34 and 34 days. I used to have very regular 28 day cycles. The doctor has prescribed me a new birth control to combat this unpredictability and change in my cycle. I will be starting that in a week.
pt recv vax 3JUL96 & 26JUL96 pt devel a low grade fever, cough & OM of the rt ear;pt to MD & was treated w/ATB;5AUG96 pt returned to MD @ which time otitis had resolved;had swollen jaw line;dx w/mumps/rt parotiditis;
Swollen and painful lymph nodes under both underarms ongoing - lasting over a week at this point. Injection site painful to touch over a week out as well.
Stated scratching self. Noted to have red lesion on face neck and chest. Given Benadryl 12.5 mg. Rash fading at at 5-10 minutes past medication. Left with PGM at 4:50 Pm Dr evaluated patient.
HEADACHE, FATIGUE, BODY ACHES, SWOLLEN ARM AROUND INJECTION SITE
A 26-year-old female patient had received second dose of ADACEL (lot number C4432AB, route of administration was not reported) in left deltoid on 12 JUNE 2013.  The patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 13 JUNE 2013, one day after vaccination, the patient developed redness, warm to touch and raised area 4 cm at the vaccination site. The patient was advised warm compress. The patient received Benadryl and Advil as corrective treatments on unspecified dates. No laboratory investigations were done. At the time of this report, the patient had not recovered from the events. Follow-up information received from a healthcare professional on 18 JULY 2013. The patient received ADACEL intramuscularly. Documents held by sender: none
Bright red itchy patch at site of injection with lump and swelling around it. Next day larger area of redness, itching and swelling. Today redness to my elbow with swelling and itching.
Deaf problems; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: DEAFNESS (medically significant), outcome "unknown", described as "Deaf problems". Clinical course: Caller said that her daughter took the Pfizer-BioNTech COVID-19 Vaccine (she didn't mention the formulation) and now she has deaf problems. She also said this vaccine has killed people in her family and many people in general. She wanted to know when Comirnaty became available. She asked for the Comirnaty clinical trial information.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt was seen at ED on5/8 for L sided weakness in the setting of a headache. Pt?s mother reports that these symptoms began 2 days after receiving second dose of Pfizer COVID-19 vaccination in R deltoid. She says that on 5/6, pt complained of L arm weakness during cooking class at school, which was followed by a mild L sided headache later in the day. Symptoms resolved without intervention but recurred on 5/8 with associated L sided facial droop, slurred speech, L arm spasms, and L foot drag.  Pt was seen at  ED for this and had a HA (5/10 in severity) at that time -- workup was unremarkable with a normal head CT, laboratory workup, and resolution of symptoms. Pediatric Neurology evaluated the pt, deemed no further workup necessary, and advised outpatient follow up.   Pt presented again to the ED on 5/10 with concern for full tonic/clonic seizure, witnessed by pt?s mother. Mother reports that she heard pt fall and went upstairs to find pt seizing on his bed -- says that pt had shaking of bilateral upper extremities (in flexed position close to chest) and symmetric lower extremity shaking; eyes were closed without clear focality or eye deviation. Also some drooling, though no incontinence or tongue biting. Episode lasted for approximately 2 minutes; pt was confused and did not recall what happened immediately afterwards but improved within the next 8 minutes. He was taken to the ED by EMS.   By the time he arrived in the ED, he had left sided weakness again. He was given Keppra 1g, placed on EEG, and was admitted. EEG overnight was read "normal" and additional workup was unremarkable. Pt had MRI brain completed showing cortical abnormalities in the R parietal lobe, suspected to be related to recent seizure. MRA showed patent intracranial cerebral vasculature. MRV showed no evidence of dural venous sinus thrombosis. Weakness resolved by the morning and pt was back to baseline on morning of 5/11/21. However, around 9 AM, L sided weakness (face, arm>leg) with associated headache recurred. Mom says that this event was captured on EEG. He was then transferred to our facility. He was placed on pEEG and had repeat labs, imaging completed. Pt did have L sided facial droop, L arm weakness, and slurred speech on arrival, but this resolved within 24 hours. Pt had one additional episode of "wave" of L sided weakness including L sided facial droop and slurred speech at one other time during the hospitalization, but no additional seizure like activity. He was discharged on 5/14 with a normal neuro exam-- some labs (including labs of Rheum and Id workup were pending at time of discharge.) Primary and consulting teams elected to forgo steroids but reconsider should symptoms worsen or return. Pt was readmitted on 5/16-- had an episode of expressive aphasia + headache while at a social gathering; states that he became overwhelmed by the noise. No additional seizure like activity.
Per Dad, fever started at 4am.  It was 102.8 rectally.  Gave Acetaminophen 2ml.  Fever responded, dropping to 99.9.  Fever continued to spike to 103 everytime the acetaminophen wore off throughout the day. Phoned after hours triage nurse at 7:54 pm and was instructed to continue with acetaminophen every 4 hrs as needed.
Angioedema of the lips began about 14 hours after vaccine administration. Progressed to full facial swelling by 18 hours without respiratory compromise. Developed body urticaria. Resolved with time and oral prednisone.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 and FLU VACCINE, both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pneumococcal pneumonia vaccine co-administered with flu vaccine at the same injection site and reported redness and painful to touch. The action taken in response to the events for the vaccines was not applicable. The clinical outcome for the events was unknown.
Janssen on 3/9. Positive on 8/12 admitted 8/13-current
Pt received vaccine and had increased joint pain, chest pain, and hand/feet tingling--she went to Urgent care who recommended some rest time. Symptoms lasted about a month and she feels like she continues to have "flares" from this vaccine.
Ever since the morning after the third shot I feel like my heart is racing and I cannot sleep well. I will make an appointment to see a doctor.
Patient was home and called office after-hours on-call pediatrician for lip swelling and facial/eye swelling. She was advised to seek care in the ER. There, she was diagnosed with angioedema and given epinephrine as well as diphenhydramine. Patient was discharged home, stable, with prescriptions for epinephrine auto-injector and oral diphenhydramine. Never complained of any respiratory symptoms. No new foods nor products used on the day of the vaccination. The only new thing were the three vaccines that never received previously.
began to feel chest and throat tightness. 25mg Benadryl and symptoms went away
rash, itching, burning, redness, pain, tender. patient said she took 2 Benadryl and used Benadryl cream. patient thinks it got worst - she said she's going to the urgent care today 10/31/19
Pt received H1N1 in right deltoid. Pt had persistant pain in area of the vaccine for 2 weeks after injection.  No induration, no surface bruising. Pain feels like a "bruised muscle." One week ago patient developed pain in all of her muscles of both of her legs from the hips down to her feet.  Four days after that she had excruciating pain that limited her activity.  Pain was not responsive to Tylenol or Motrin.  He has improve some since that overnight shift. Pt has had no abd pain n/v/d/c. no dysuria, no cough or dyspnea, or sore throat, and no URI symptoms. Pt is not currently takin any medications no herbal or OTC med usage, no tobacco, alcohol or drug use. No other immunizations and no occupational or hobby exposures to paints, fumes, etc.
Patient developed shingles the next day as confirmed by their doctor and was prescribed valacyclovir
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium