chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 hrs after receiving Hepatitis B vaccine, recipient noticed feelings of nausea, fine tremor, slightly dizzy and warmer than normal.  Symptoms had decreased by about half within a half hour, continued decreasing but still present (slight tremor, dizziness) 45 minutes after that.  He did not feel that he needed medical tx at this time.
Started with a sore arm 2.5 hrs after taking the shot followed by slight nausea. Body pains started after 7.5hrs followed by 101F fever after 9hrs. Took 750mg Tylenol to contain body aches, fatigue and fever every 6hrs. Fever consistent till 36hrs after shot. Finally body aches and fever reduced and only fatigue remains.
Arm pain, Lymph node swelling in right arm pit area. Headache. Fatigue.
She was still feeling very tired 6 days after her first dose of the Pfizer Covid-19 vaccine,; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Aug2021, the patient was feeling very tired 6 days after her first dose of the Pfizer Covid-19 vaccine, and that she wondered if that could be the cause. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event feeling very tired was unknown at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Arm is still red; Arm sore; This case was reported by a consumer and described the occurrence of erythema of extremities in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th January 2023, the patient received Shingles vaccine. On 13th January 2023, 1 days after receiving Shingles vaccine, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment:  The patient received Shingles vaccine and patient arm was still red and sore after the 6th day of getting shingles shot. The symptoms of patient were not treated. The reporter did not consent to follow up.
Breakthrough case admission after 2 vaccines Janssen 3/16/21 lot# 1802068;  Janssen 11/13/21 lot# 213D21A
Undiagnosed rash (symmetric and discrete) 0.25-2cm papules of a total of about 20 on outer arms, outer thigh and face. Resolved about 3-4 days and the dermatologist is not calling it an allergic reaction.
received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; This is a spontaneous report from a contactable other healthcare professional reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The reporter was asking what the recommendations are for the administration of the 2nd dose for a patient who received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic. She missed the dosing window of the 2nd dose scheduled on 30Dec2020 due to quarantine. Caller mentioned that patient is recovered and is back to work. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Dec2020.  Information about lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional 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.
Pt recvd vax & exp t102, pain & swelling locally w/red streak radiating to neck & down arm;
could not walk and sit up, unable to move around too much; very sleepy and drowsy; unable to move around too much, unable to stand long, have to sit back; could not get out of bed; right arm itchy; Really bad headache; little bit of fever; Fatigue; Chills; allergic reaction - could not breath, started sweating; Could not breath; Started sweating; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started sweating), GAIT DISTURBANCE (could not walk and sit up, unable to move around too much) and SOMNOLENCE (very sleepy and drowsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MA0N) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included INSULIN GLARGINE (BASAGLAR), INSULIN LISPRO (HUMALOG), CLONIDINE, METFORMIN, METOPROLOL, ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), RITUXIMAB (RITUXAN) and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating). On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HYPOKINESIA (could not get out of bed), VACCINATION SITE PRURITUS (right arm itchy), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved and HYPOKINESIA (could not get out of bed) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Flu-like symptoms for 24 hours.  Same effect from first shot on May 31, 2019.
Extreme body and joint aches, fatigue, weakness (general). Symptoms lasted - 3-4 days fatigue - 3 weeks. Started a few hrs after shots rec'd. Headache - chills - hot flashes. (R) arm swollen - very painful for several days. It was difficult to walk because of the joint pain. I did not seek medical attention. I took liquid BENADRYL and TYLENOL for symptoms. Fatigue lasted around 3 weeks. Body aches acute 4 days Joint aches acute 4 days (mild/moderate - lasted about 3 weeks). I don't know if I will have any lasting effect from the vaccine because I don't know what it did to my body causing the symptoms I had. I will/was advised go to tell my health care provider, I have a physical the end of June: I still have joint discomfort but not sure if this is due to the vaccine or the cold winter! I do feel better after going to the GYN!
PATIENT WAS SHAKING WHILE SLEEPING AND CONSTANTLY BEING WOKEN FROM HER SLEEP BY RESTLESSNESS AND MYOCLONIC EPISODES. THESE CONTINUED ALMOST EVERY NIGHT FOR MULTIPLE WEEKS, CAUSING THE CHILD TO BE HIGHLY SLEEP DEPRIVED. THE ONLY WAY TO ALLOW THE CHILD TO FALL BACK INTO A DEEP SLEEP WAS TO HOLD HER DOWN AND HELP HER IGNORE THE SPASMS. THESE EPISODES ARE STILL ON GOING AND EXTREMELY CHALLENGING AS THEY EFFECT HER EACH DAY. MORE DETAIL AND VIDEO CAN BE PROVIDED. PATIENT SAW MULTIPLE NEUROLOGISTS WHO DIAGNOSED HER WITH SLEEP MYOCLONUS.
heart problems; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient in his 40's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems".  Additional Information: It was reported that the patient had heart problems after getting two doses of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning an 85 year old male who on Nov 09 2004 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). The patient came to the pharmacy and reported that, on Nov 12 2004, he began feeling pain in the shoulder blade area and it lasted three days then went away. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information from the pharmacist indicated that the patient slept wrong on his back again. The pain was not from the vaccine and the patient recovered. There were no problems with any other patients and pneumococcal 23v polysaccharide vaccine. Additional infromation is not expected.
5 to 20 minutes after receiving varicella virus vaccine live the pt experienced a severe allergic reaction which is considered to be an other medical event, characterized by swelling of the eyelids and lips. The pt also had a facial rash. Pt was treated with Benadryl and epinephrine.
Flu vaccine administered 10/31/2001 8-10am. Pt c/o nausea, vomiting, visual disturbances, lightheaded, diarrhea. Vaccine reaction, Tx phenergan, tylenol. Referral to PDH ER and released.
pain in lt arm p/shot received; didn't sleep that noc; c/o generalized malaise & swollen lt upper arm; given Epi & DPH;
See attached Notes.  See back.  Client in today for immunization and PPD.  Client very apprehensive upon entering immunization room.  MENACTRA given via IM injection in left deltoid and PPD place in left forearm.  Immediately after placing PPD, client became flushed, sweaty and after only 1-2 minutes she became non-responsive.  Immediately called code blue.  Client placed in supine position with feet elevated with help from clinic staff.  Client became alert within seconds of being place in this position.  Injection site did not appear to have any adverse reactions.  Continued to take BP and pulse until client stabilized.  EMS called during code blue, when EMS arrived client already stable.  Instructed to call and report any further reactions or problems and to call EMS if symptoms repeat again.  Client brought in office today by mother and taken home by mother.
Cardiovascular/ Arrthythmia/ bradycardia; pre-existing diseases worsened: just weakness, joint pain; jaundice; dyspnea; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ckd" (unspecified if ongoing); "Colon polyps" (unspecified if ongoing); "prior pneumonia" (unspecified if ongoing); "egg allergy" (unspecified if ongoing); "shell fish allergy" (unspecified if ongoing); "pre-existing diseases: just weakness, joint pain" (unspecified if ongoing); "pre-existing diseases: just weakness, joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, intramuscular), administration date: Jan2020, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, intramuscular), administration date: Jan2020, for COVID-19 IMMUNIZATION. The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "Cardiovascular/ Arrthythmia/ bradycardia"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "pre-existing diseases worsened: just weakness, joint pain"; JAUNDICE (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.   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. ,Linked Report(s) : US-PFIZER INC-202200762322 same patient/vaccine, different dose/event;
Pt in few hour experienced numbness of the entire arm where he received the vaccine.  The numbness went away in few hours.
Pt was supposed to vaccinated with the MMR vaccine; instead he was vaccinated with rubella virus vaccine live.
congestion; fatigue; runny nose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself.  The female patient (age 39, unit unknown) received second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on 26Feb2021 as a single dose for covid-19 immunization. Medical history included autoimmune disease. Concomitant medications included SULFASALAZINE for autoimmune disease. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for covid-19 immunization. On 01Mar2021, it was stated that she did not feel great over the weekend, but then a day prior to this report, she had to call out of work and had all the side effects of the vaccine including fatigue and she experienced congestion and a runny nose. She does have an autoimmune disease in which she takes sulfasalazine but thinks she should be on something stronger. The outcome of the events of fatigue, congestion and a runny nose was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected
It's for injuries for vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "It's for injuries for vaccines".  Additional Information: Reporter stated was calling regarding Pfizer vaccine (unspecified vaccine) for grandmother. When paraphrased, Reporter stated called  for vaccine. When probed if reporter had any query. Reporter stated injuries for vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my second Moderna booster for COVID-19 on 4/6/2022. On the night of 7/4/2022, I developed a runny nose, a very slight headache, nasal congestion, a slightly scratchy throat, and a tenderness in both inner ears. When I woke up the morning of 7/5/2022, the symptoms were pretty much the same, though the headache was gone. I went ahead and went to work, because it just felt like I was getting a cold. As the day progressed at work, though, I noticed that my voice wasn't the same, as I sounded congested. That evening, the nasal congestion worsened. On the morning of 7/6/2022, the symptoms were pretty much the same, though slightly worse. As I was getting ready for work that day, it occurred to me that I had heard that COVID-19 symptoms are similar to those of a cold, so I took an at-home test, and the result was positive. I immediately called in sick to work and went to the urgent care clinic and underwent a PCR test. The PCR test also yielded a positive result. The NP or PA at the urgent care recommended that I treat my symptoms with OTC medicines like nasal spray and CLARITIN or ZYRTEC, which I did. She also told me to isolate at home for 5 days and told me I could leave the house afterwards as long as I wore a mask for 5 more days afterwards. On the night of 7/6/2022, I again had a slight headache, but it was nothing major. It was so mild that I didn't even take medicine for it. During my illness, I haven't felt especially bad. I'm slightly more tired than usual and aside from the discomfort caused by the abovementioned symptoms, I feel mostly fine.
LOW-GRADE FEVER, REDNESS/SWELLING AT INJECTION SITE, FUSSINESS IN CHILD WITH NON-STOP CRYING EPISODES LASTING OVER THREE HOURS.  THIS OCCURRED EARLY IN MORNING FOLLOWING IMMUNIZATIONS. REPORTED TO OFFICE 12/7/05 ORAPRED AND BENADRYL ORDERED.
started at my chin and my jaw line and to my cheek bones and had hives, face started to swell, lips, and eyelids, had to take 2 Benadryl.
I administered a Pfizer COVID19 shot to the patient as a first dose. I then had the patient go to the post vaccination waiting area to wait for the 15 minute post vaccination period. At about 7.5 minutes into the 15 minute time frame the patient approached the consultation window complaining of tightness in her throat and jawline, numbness and tingling in her face, and feeling faint. I administered 20ml of 12.5mg/5ml liquid diphenhydramine for a total of 50mg of oral liquid diphenhydramine. The patient then stated that the tingling was progressing to her extremities. I then administered 0.3mg epinephrine auto-injection to the outer aspect of the right thigh at 11:02am. 911 was called and a code white paged through the store. The patient continued to experience tightness in her throat and tingling and stated that it was worsening at 11:08am a second 0.3mg epinephrine auto-injection dose was administered to the outer aspect of her left thigh. Paramedics arrived on the scene at 11:09am and the patient was taken to the hospital. Patient remained responsive throughout.
Developed Bell's palsy, saw neurologist about 10 days after onset of symptoms treated with Prednisone and Valtrex. Currently recovering
feverish day of vax (Wed) THursday cont w/fever, became lethargic while @ caregives; mom stated had shaking behavior;
Lethargic x 3 d. Fever x 3 d. Rash.
patient HAD PFIZER COVID-19 VACCINE ON Dose 1 date: 12/30/2020, Dose 2 date: 01/20/2021, AND TESTED POSITIVE TO COVID.
This spontaneous report was received from a medical assistant referring to a 57 year old male patient with coronary artery disease, diabetes mellitus, hypertension, high cholesterol and allergy to DEMEROL. The patient's concomitant therapies were not reported. On 20-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564 and expiration date on 22-OCT-2018 (dose and route of administration were not provided) for pneumonia prevention. On the same day, after receiving the vaccine, the patient began experiencing tenderness, pain in his right arm and was unable to move it. It was additionally reported that, on 21-SEP-2017, in the morning, the patient had an unspecified fever; therefore, he was seen at physician's office on the same day in the afternoon, where he was found to have a fever of 102.7 degrees Fahrenheit (°F), the patient was prescribed ADVIL as fever treatment and he was also performed a complete blood count (unspecified results). No product quality complaints were reported. At the reporting time the patient had not recovered from fever, tenderness, pain in his right arm and was unable to move it and the and the causality assessment between PNEUMOVAX 23 and the events was unknown.
High fever, chills, sweating , thirst.  Lasted 3 hours and subsided after taking tylenol
Small red area where shot was given. Pain and swelling under the arm w/a knot. Pain down the arm. Occurred on the left arm.
headache, dizziness, brain fog/disorientation, tingling/numbness in extremities.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # reported as K002999, exp date: 27-AUG-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The PROQUAD had been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects was reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I thought I was having allergies, I had just gotten back from traveling. I attended two large graduations on May the 23rd and then also on the 27th. I also attended church on the 29th. I noticed a runny nose on that Monday, I called my doctor because I had an appointment the next day on the 31st. I had a scratchy throat, tingly ears and a crazy runny nose throughout that week. When I was at my Doctor on the 31st we thought that I had allergies. On June 5th I got a call from a friend I had just visited that they were positive for COVID-19 so I took a home test which was positive. I then went to a walk in clinic and that test was negative. I then took a PCR test and that was positive. I really had no other symptoms other than being fatigued on June 6th and 7th. The worst symptom was the runny nose. Since getting this booster my arm has been sensitive and has a tingling sensation when I touch it and its just tender. I have also had a pain behind my left knee and its tender and just hurts which is a new thing and only occurred after the booster.
My joints began clicking, snapping and popping in body. Right shoulder more so, and at times felt out of joint and muscles painful.  The problem continues three months later. No treatment.