chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unclear if event is related to vaccination but occurred 5 days after the 2nd dose of vaccine    Pt admitted on 5/12/2021 with refractory cardiac arrest.  (PMH unknown).  Patient reportedly went for a walk with his wife.  Upon returning home, he went to take the garbage out.  The patient was found down approximately 15 minutes later in his garage.  The patient's wife called 911 immediately?it is unclear if bystander CPR was initiated.  EMS was on scene within several minutes and initiated CPR.  The patient 3 shocks, and epinephrine.  ROSC was achieved at approximately 14:41.  At approximately 14:50, the patient again went into VF.  He received an additional  5 shocks, 1 mg of epinephrine, and 300 mg of amiodarone.  He went into asystole at approximately 1510.  ACLS was continued and the patient was given an additional 1 mg of epinephrine.  Upon arrival to the University of Minnesota cardiac Cath Lab, the patient remained in asystole with Lucas on.  He was cannulated on VA ECMO.  In the cardiac cath lab, he was found to have OM disease and diffuse CAD involving LAD Received intervention to his OM.  Initial LA was 14.3.  ABG 6.94/54/44/12.
Pt states she received Hep-B #2 on 6/14/01 and woke early AM of 6/15/01 with itching, red raised rash to entire body (hives). OTC Benadryl gave no relief. Saw PMD for meds. No reported respiratory difficulty.
Fever, chills, body aches. Brief prickly pin point rash in the abdomen. Next day mid face swelling below the lower eyelid area around the maxillary area with very mild tenderness. Angioedemq
Patient received COVID-19  shot and shortly after passed  out hitting her head on the floor. Paramedics were called  to check her out. We did a wellness check patient had a headache but otherwise was fine.
Swollen lymph nodes in my left underarm for about two weeks, very painful. These symptoms subsided.  Metallic taste in my mouth for over a week. These symptoms have subsided.  Fatigue for two weeks. These symptoms have subsided.  Reddened, obvious veins all over my eyes eyes, sore eyes, pain in eyes, mucus in eyes. Very painful. Eyes get tired easily. These symptoms have improved but have not subsided entirely.  Tinnitus, started off very severe one night, in my right ear alone, now it's on and off daily in both ears, not as severe but still disturbing. These symptoms are still occurring intermittently on a daily basis.  No treatment, I don't have health insurance until July 1st, so I haven't been able to go to the doctor.
Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; muscle aches; lymph glands swollen left axillary large and very painful; lymph glands swollen left axillary large and very painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:30 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies : Penicillin " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious), SPLEEN DISORDER (non-serious), SWELLING (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Swollen spleen severe left sided pain"; MYALGIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "muscle aches"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "lymph glands swollen left axillary large and very painful". The events "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "muscle aches", "lymph glands swollen left axillary large and very painful" and "lymph glands swollen left axillary large and very painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain, spleen disorder, swelling, myalgia, lymphadenopathy, axillary pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
major headache; vomiting; I can't get up and get the paper, I am too tired; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 24Mar2021 11:00 (Lot number: ER8727, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "major headache"; VOMITING (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "I can't get up and get the paper, I am too tired"; MALAISE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "not feeling well".  Additional information: Patient got the vaccine yesterday (24Mar2021) at 11:00, during the day everything was okay, then patient go to bed  and still was okay and then events started around 3 o'clock in the morning.  No follow-up attempts are possible. No further information is expected.
Received Influenza vaccine (R) deltoid 11-16-10. Approx. 45 minutes later injection site with "a lot of pain" RTC at approximately 1530. C/o pain to injection site and lower (R) arm "sore and stiff". Upon exam by FNP, no redness, swelling to (R)arm or hand. Has full ROM. 11-17-10 -> Pt. RTC -> states "I'm fine" no further sx.
I had the booster on Dec 6, 2021 around 10:30 a.m.  Later that day, had bitter taste in mouth.  This was on a Monday, and my dentist was closed.  I thought it might be a dental issue because I have a crown, bridge, and an implant.  Went to the dentist on Tuesday, Dec. 7, and I guessed at a specific tooth, but no problem found.  On January 4th, I had a cleaning and x-rays and still no problem found.  And my dentist will verify I have great oral hygiene.  I contacted my doctor and asked for labs to see if anything stood out.  Labs were done on 1/20/2022.  No problems found.  I still get a bitter taste in my mouth daily.  It isn't as strong or as often throughout the day, but it is still daily.  The bitter taste is fading.  I hope that my report combined with someone else's report, verifies the truth.
Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given water and Acetaminophen, 25mg of Diphenhydramine. BP 140/64 Pulse 74
From telephone contact received at Aventis Pasteur Inc. on 07/30/2002, it was reported that an 11-year-old male received 2 doses of Imovax in the thigh. Date of vaccination not specified. Pt experienced local soreness and muscle stiffness for approximately one hour after each dose. Also after first dose Imovax, pt experienced headache and continues daily, most severe in evenings.
Reacted to vaccine after 8 hours with fever, muscle aches, fatigue, headache, injection site pain, swollen lymph nodes.  Felt better in 24 hours but arm pain and swelling persisted, light red rash appeared over injection site.  Arm is still swollen and painful, lymph nodes still swollen and sensitive, rash still present as of 72 hours later.  Still having some headache as well.  The symptoms are decreasing but I felt it was important to report the reaction.
Lung pain/ache on left side, heavy chest, burning sensation in the middle of the chest, shortness of breath, healthcare provider confirmed vitals were fine.
The 1st  shot was ok. Had a very slight breathing problem. Similar to when I  have accidently eaten shellfish and starts with coughing.  Not nearly enough to use Epi-pen.  Took  Benadryl. Got the 2nd shot  this past Tuesday and started  getting itchy on different parts of my body approx. 20 min. after the 2nd shot. Today is Sat. and I am still taking occasional Benadryl.  Am itchy on my ankles, my torso,  my arms, thigh,  knee, butt....forehead.  In certain spots there are what looks like little tiny pimples.  Yet on my knee and thigh  were larger welts similar to hives. ps...I feel like I have flees! which I don't!
Patient was admitted to the hospital due to fall. She required to be placed in observation due to  advanced age, and high fall risk. She tested positive for corona virus disease 19,  she did not have any respiratory symptoms, did not require supplemental oxygen, was given vitamin-C, zinc, vitamin-D.  Seen by Occupational and Physical therapy, felt that she will benefit from skilled nursing facility placement, she was discharged when bed available.
Patient was administered 0.5ml instead of 0.25ml booster 3rd vaccine, a letter was sent to her informing her of dosage given
App. 4:10 p.m., client returned to clinic c/o shortness of breath and chest pain. A coarse, respiratory stridor was audible during conversation. Client was taken to lab room and seated. Per protocol, .3 cc of epinephrine 1:1000 was administered, S.Q. Immediately following, Diphenhydramine (50 mg/ml) 1 ml. was administered IM, after no improvement was noted, 911 was called. Patient drove herself several blocks back to clinic from college approx 30 min after receiving first dose each of MCV4 and HPV vaccines. Moderate distress and coarse inspiratory stridor was observed while speaking and accompanied reports of shortness of breath, feeling of throat swelling and chest pain. Pt. remained conscious and coherent without signs of rash, cyanosis or expiratory delay throughout treatment with 0.3 cc of 1:1000 EPI times 2 doses followed by BENADRYL 50 mg IM. EMS was called via 911 when symptoms failed to improve. Pulse ox showed SAO2 was 99 or 100 on each recording. She was given O2, ATROVENT neb and SOLUMEDROL again without significant improvement in complaints. End tidal CO2 remained ~33 and capnogram waveform was not suggestive of bronchospasm. She was then transported non-emergently by EMS to ED. Physician confirmed previous findings on arrival and described her breathing as "almost stridor". Therapeutic trials of RACEMIC and IV EPI and albuterol also did not relieve symptoms. Pt did not become cyanotic or fatigued but continued complaints of difficulty breathing prompted Anesthesia consult. As a precaution and in order to gain control of her airway she was sedated with Propophol and intubated. Patient remained in ICU over night and extubated the following morning. Extubation was followed by resumption of similar symptoms which were managed with VALIUM. Patient was discharged to home the following morning.
I received my TDAP vaccine while pregnant at 32/33 weeks in my left arm at my health provider clinic. I do not know the brand name but I do know it did not contain mercury (because I asked) but did contain aluminum.  3 days after injection, I began experiencing the smell of sulfur and strange ash smell. I then lost the center of my visual field, and experienced zigzags and extreme light sensitivity. This symptom  came and went for a week and a half, until I woke up without my sight, and my husband too me to the ER. There, I went back to zigzags and a halo of light in my visual field. I was told my symptoms were migraine with aura. I had loss of vision off an on for approximately 8 months post vaccine. I have had this type of Migraine since, though less frequently then several times a month, it is now a few times a year.
Onset of pustular, pruritic lesions at neck on day 2 after vaccine.  Also had redness, heat , swelling, pain and itching to entire left upper arm that started with arm soreness 1 day after vaccine and remainder of symptoms on day 2.  Lesions at neck then transition to  mildy erythematous superficial  plaques and continue to itch severely at time of report on 4/8/2021. Arm reaction started to subside on 3/10/2021 and swelling resolved on 3/12/2021.
A month after having both doses of the Covid Vaccine (Pfizer) I started having irregular menstruation, menstruation lasting 2 weeks and then getting menstruation every 2 weeks as well. I only get 2 weeks in between my period of not having menstruation. It has been happening for 4 months as of today. Before I had my period for 7 days monthly. Today, I had hormonal blood test and will schedule a pelvic ultrasound.
2nd Update: injection site is now red, raise and still very sore ?? 1st Update:  so I still have a headache and of course leave it to me for weird issues, my left armpit (lymph nodes I guess) is oddly swollen and throbbing ???????   About 12 hours post Covid booster  ? headache ? low grade fever ? flush feeling all over really  ? vomiting  ? itchy  ? very sore arm   Yay me ??
Left arm tenderness, red blotchy patches on left arm, itching, warm to touch.
About 40 min post vaccination, patient came back to pharmacy complaining of itching. Pharmacist inspected injection site and saw redness where patient had been scratching. RPh gave pt 20ml of diphenhydramine 12.5 mg/5ml  at 2:08pm and asked pt to check back in at the immunization area in 15 minutes or sooner if pt felt worse. Pt came back and said she was fine. RPh asked if she was sleepy from the Benadryl and she said no. Pt said she lived 10 minutes away. RPh said she would call to check up on her later. RPh left mssg for pt at 4pm.
Patient reports having a sore arm for about a month after administration. She went to the emergency room. She received gabapentin which she is still currently taking (as of 6/6/22).
Appx 3:45 p.m. pt. received .5ml BOOSTRIX, IM RT. delt. and .5ml MMR SC. RT. Arm. Pt. had no adverse events at 3:45 p.m. Pt. returned saying felt dizzy, was bleeding from vaccine site. I laid pt. down in exam room with her feet up and her knees drawn up. I explained the situation to head RN. RN went to exam room and took vitals. After 5 min. pt. told RN she felt better. We offered pt. to lie down longer, pt. refused saying she had a cab waiting for her. RN advised warning signs or symptoms if she has any of them pt. is to go to the emergency room. All pts vital were normal before pt. left the clinic at 4:30 p.m. on 9-13-16.
Received flu vaccine in the left deltoid on 11/04/05.  Started to have left arm pain on 11/06/05 which progressed to the right.  Reported to the ED on 11/07/05 with severe bilateral arm pain radiation from his neck requiring hospitilization.  He complained of  feverand pain from his waist up.  He denied lower expremity involvement. He had elevated LFT's and was diagnosed with viral syndrome.  Cardiac workup was negative and c-spine x-ray revealed DJD of the neck. He was discharged on 11/08/05 with dilaudid.  He followed up with his PCP and had a CT of the chest which revealed a small infiltrate in the LLL.  MRI of the neck revealed mild disc herniation at C-6.  He wqs treated with a Medrol Dose pack and Zithromax which initially relieved his pain.  He reported back to the ED on 11/16/05 and was admitted, again with severe bilateral arm pain.  Neuro consult determined symptoms were not caused by the C-spine and he was diagnosed with bilateral brachial plexitis.  The pain was relie ved by IV Medrol and he was discharged on 11/19/05. Medical record states dehydration. msv
Pfizer-biontech covid-18 vaccine eua.  Injection site was immediatly burning. Afer 1 hour burning went away and turned to injection site soreness. At 10 pm I started feeling achey and having chills. Nausea followed. I vomitted every 30 minutes from 10:20pm(march 20) to 530am(march 21). I had a fever, ranging from 99.5 tp 100.5 from 10 pm on march 20th until 2pm march 22nd. My body was achey everywhere from march 20th to march 23rd. I was very tired from March 21 to march 23. Today. March 25 my injection site is still semi sore but all other side effects have subsided.
SINUS INFECTION; This spontaneous case (PVX2019-2224) was received from a pharmacist on 30-Aug-2019. It described an adult female consumer (between 18 to 64 age) who had sinus infection (PT: Sinusitis), after administration of Vivotif for an unknown indication.  Case report: The consumer was on therapy of Vivotif from an unknown date. After started taking Vivotif doses, she developed a sinus infection. The last dose was taken on 28-Aug-2019. On 30-Aug-2019, she went to the physician, who prescribed Keflex for treatment, but he did not have the dosing regimen as he was still deciding whether he should take it.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the reported event was unknown.  Company's Comment: In this case, the consumer developed a sinus infection after receiving Vivotif vaccine. Since sinus infection is an infectious condition, the causality of the event sinus infection is assessed as unlikely with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, the consumer developed a sinus infection after receiving Vivotif vaccine. Since sinus infection is an infectious condition, the causality of the event sinus infection is assessed as unlikely with Vivotif vaccine.
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
11:28 pt reports nausea and vomited, taken to Triage 1 to be evaluated by MD and EMTs. BP 147/87, HR 99, 02 98%, RA 11:54:  BP 104/67, HR 76, resp 20, 02 96%, RA Pt states she felt better.  Dc'd home stable condition
Vestibular neuritis.  Was dizzy for 5 days.  Went to doc on 5th day.   Condition improved in about 2 weeks.  Still having some dizziness.  Never had any ear problems/dizziness.
Arm started hurting , felt tired, had chills, head aches and body aches last  for 36 hours,  went to work and work got worse at work and workplace sent  home.
106°F fever; severe shakes; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106°F fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERPYREXIA (106°F fever) (seriousness criterion medically significant), TREMOR (severe shakes) and FATIGUE (very fatigued). At the time of the report, HYPERPYREXIA (106°F fever), TREMOR (severe shakes) and FATIGUE (very fatigued) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Began vomiting 6/6/07, trip to ER on 6/9/07 where she recieved 500ml of fluid and Zofran, still recovering...occasional vomiting and diarrhea.
itchy rash over body, concentrated on chest & around waist; lasted 2 days;
Drop in milk supply; This is a spontaneous report from a contactable consumer (patient). This 29-years-old Female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiry date was not provided), via an unspecified route of administration on Left arm on 28May2021 at 07:15 PM as (at the age of 29-years-old) as an 2nd dose, single dose for COVID-19 immunisation. Patient medical history included anxiety and depression. she had Known allergies with Zofran. Concomitant medications taken by patient in two weeks included Sertraline Hydrochloride (ZOLOFT) for Depression, PRENATAL (unspecified), Norethisterone (INCASSIA) for Oral contraception and sunflower lecithin for Eczema. Patient previously received bnt162b2 (Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 07May2021 at 07:30 PM as (at the age of 29-years-old) as a 1st dose, single dose for COVID-19 immunisation. Facility type vaccine was in Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks prior to the suspect vaccine. Patient did not have covid prior vaccination. On 30May2021 at 11:45 PM Patient experienced, drop in milk supply. Patient did not receive any treatment for the event. She had not been tested for covid post vaccination. Outcome of the event was Not recovered.
sicker; Initial information received on 26-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was sicker while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "sicker" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported" Never ever getting this poison. Had to when working in hospital got sicker and sicker."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sicker).  At time of reporting, the outcome was Unknown for the event sicker.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored M-M-R II (lot # M010426 with expiration date 01-MAR-2018, lot # M015931 with expiration date 30-MAR-2018, lot # M029919 with expiration date 13-JUN-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines with lot # M010426 were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes and the vaccines with lot # M015931 and lot # M029919 were stored under temperature 9-25 degrees Celsius with time frame 2 hour and 31 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013.