chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately post vaccination, client slumped in car and had syncopal episode,  when MD on site arrived to asses client already conscious but pale, personnel and nurses on site also  attended to client, BP 121/63, pulse 70 NSR, sats O2 97% on RA; observed further at parking lot;  recommended transfer to facility, client agreed and was trasported by FD ambulance @ 1236.
Hospitalization for a fall and found to be positive for COVID-19 on dates 8/4/2022-8/5/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
I became dizzy.  I got a cough.  I had a headache and chills. I had hot flashes and a sore throat.  I also had a ear ache and fever.  My eyes was watery and draining.  I had abdomen pain and body ache.  I had some nausea and runny nose with congestion.  When I cough I have chest pain and I am weak and tired.  I went to the doctor about this.  They did  a COVID-19 test, negative result.
Employee reports IM injection given too high up and severe pain since injection, worsening over the next couple hours and persisting 20 days later still.
No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to a 14-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 14-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA007821: US-009507513-2205USA007852:
Patient's daughter called due to language barrier and stated that her father had more pain at injection site than last year and he had an elongated bruise at the sire of injection.
Severe headache about 30 mins after injection. Soar throat day after injection  nausea day of and day after injection
vaccine given @ 4:15pm, mom reports redness and swelling noted to left thigh around 6:00pm..Tylenol and cold compresses applied, low grade fever, child seen in the office @ 8:45am local reaction noted, area tender and warm to the touch, moderate swelling noted. Dr. observed and rec. Benadryl and Tylenol
Information has been received from a physician concerning a 16 year old female who in the "beginning of March" on approximately 01-MAR-2007 was vaccinated with Gardasil. "Approximately one to two weeks after receiving the first dose of Gardasil on approximately 15-MAR-2007 the patient experienced symptoms of uveitis. The diagnosis was confirmed with the patient's eye doctor. The physician noted that it could be related to arthritis. Additional information has been requested. 05/25/07-records received. Ocular inflammation, with 3 week history of blurry vision in left eye. Impression. Acute bilateral uveitis seems most like pars planitis.
No adverse reaction.  Patient received Moderna 1st dose from alternate provider on 2/25/2021
Surgery; The patient did not receive the second shot in time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SURGERY (Surgery) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SURGERY (Surgery) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time). The patient was hospitalized from 28-Mar-2021 to 02-Apr-2021 due to SURGERY. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Surgery, at a dose of UNK dosage form and METOPROLOL for Surgery, at a dose of UNK dosage form. At the time of the report, SURGERY (Surgery) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Description: The patient had surgery on 28 Mar 2021, the type of surgery was not specified and was hospitalized for six days. Due to this event patient did not receive the second shot in time.
Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
7/13/07 pt seen for "rash and blisters" on bilateral elbows. Pt received the Zostervax vaccine on 7/9/07. The day following the vaccination the patient noticed blisters on elbows and was itchy. Pt seen by Dr.  7/13/07 and prescribed 0.1% hydrocortisone cream. Diagnosis: Zostervax allergy
2nd dose given on 7/3. 3rd series of Tdap/HIB/PCV combo was administered on 9/17/13. Nurse administered extra dose on 9/23 by mistake instead of giving Hep B which was due. Doctor realized error when patient still in the office and apologized for mistake. Baby slept for 14 hours straight that day.
Injection site became red and swollen a few hours after injection. Now 2 days later the redness is 2.5 X 4 inches in size and site is sore and swollen. Using OTC pain medication and cold packs on site.
Very little hearing loss in left ear; Tinnitus ongoing; Ear pressure; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Mar2021 08:30 (at the age of 63-years-old) (Batch/Lot Number: en6200) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure from 12Oct2020 and ongoing, ankylosing spondylitis from 2018 and ongoing and taking a diuretic. Concomitant medications included lisinopril taken for high blood pressure from 12Oct2020 to 23Feb2021; sulfasalazine taken for ankylosing spondylitis from 2018 and ongoing; and hydrochlorothiazide taken as a diuretic from 14Oct2020 and ongoing. The patient previously took the first dose of BNT162B2 intramuscularly on the upper left arm on 12Feb2021 08:00 (Batch/Lot Number: EL9265) for COVID-19 immunization and experienced tinnitus intermittent: The tinnitus started approximately 7 - 9 days after 1st vaccine. It was intermittent. On 23Mar2021, the patient had ongoing tinnitus and mentioned that she also had ear pressure in both ears since 2021. She saw an ENT on 11Jun2021, and he said it might go away eventually. The patient had a hearing test on 11Jun2021 with very little loss: Very little hearing loss in left ear - probably from age. Tinnitus from vaccine according to ENT. The patient has not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Shingles vaccine caused hives everywhere above waist, had to get a steroid shot on Tuesday the 6th of September and didn't resolve completely...I still have redness on forearms, September 24th. Experienced throat tightness and shortness of breath as well. Burning instead of itching on the hives. I have been advised to not get the second dose.
PATIENT WAS TESTED ON 8/12/21 AND TESTED POSITIVE TO COVID
Several hours after vaccine administration left arm became itchy, red, swollen and hard to touch. Symptoms lasted 2 days and resolved without any other issues.
Received Moderna Covid Vaccine on 3/3/21 and 4/8/2021.  Nted onset 4/24 of right calf discomfort, swelling and firmess and at same time began to have exertional dyspnea with chest heaviness.  U/S RLE - extensive DVT. CTA - multiple segmental vessels with clot, dilated right ventricle
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EB8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: 30155 BA), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 55 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; positive; negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Other medication in 2weeks: Yes Anti-viral details: Product- COVID-19 Treatment, Brand: Paxlovid, Treatment start date- 30May2022, Treatment stop date- 03Jun2022. New symptoms and positive PCR one week after finishing course of Paxlovid and testing negative at end of Paxlovid course. Follow-up attempts are completed. No further information is expected.
Fever 101.8, body aches joint pain some nausea Sunday morning 1-31-21 fever down to 99.8 still joint pain.
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into  sweating/heat. Mild upset stomach throughout.  Soreness/brusing at injection site.  After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
Swelling and blistering began occuring at the distal L forearm/wrist on the ventral surface, approx 3 cm, and 2 more blistering welts, approx 1-2 cm, in the anticubital surface of the R arm within 4 hours of receiving the vaccination.  Welts were itchy, red, and throbbing. Welts on the R anticubital surface expanded dramatically by the following morning, approx 3 inches from medial bicep to the proximal forearm.  Used drying soap due to the rashs resemblance to poison ivy, though I have never had a previous reaction to nor have I been recently exposed.  Welts have continued to grow in numerous other areas of both arms, several as hard nodules with dark red color and micro blisters around the perimeter. Severe itching, swelling, and weeping. Smaller blisters have begun to appear along the torso and pelvic areas.
Muscle pains in back, muscle tightness, spasm, trouble breathing resulted in a hospital admission where the patient was given IV medications and kept overnight for observation.
Diagnosed with COVID-19 01/15/2022. It started with a mild ear ache and the next day scratchy throat and running nose. It started three days before being diagnosed. All three didn't start at the same time. I then saw the doctor on 01/13/2022.
leg. bl. in both eyes; constant pain; can barely walk; autoim dis; Initial information received on 25-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves adult and unknown gender patient who experienced leg. bl. in both eyes, autoim dis, constant pain and can barely walk 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 in 2009, the patient received a dose of suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date in 2009, the patient reported that immediately (next day) it started affecting, and the patient developed an autoim dis but didn't know what was going on at the time. (autoimmune disorder) following the administration of influenza vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a serious leg. bl. in both eyes (blindness) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious constant pain (pain) (unknown latency) following the administration of influenza vaccine. On an unknown date the patient developed a non-serious can barely walk (gait inability) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown; Sender's Comments: Sanofi company comment dated 02-Feb-2022: This case involves an adult patient of unknown age and gender who experienced leg. bl. in both eyes (Blindness), autoim dis (Autoimmune disorder), while receiving Influenza Vaccine. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance for legal blindness. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Client was given an undiluted dose of the pediatric Pfizer formulation. RN drew 5 doses of 0.2 ml from one pediatric Pfizer vial. Client was given one undiluted dose of 0.2mL in the deltoid.  Client felt fine immediatrly after receving the vaccine and again after the 15 minute wait period.  RN provided information on what occured to client's older sister and client's mother who were present at clinic. RN provided education on signs and sysmtoms to watch for nd when to seek medical attention.  RN attempted to call client's mother next day and left voice message for client/client's mother.
diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date, It was reported that, she had a friend who experienced it, too". Her friend said "the shot was great" then a few days later she "encountered" the diarrhoea. She told her friend it may also be a stomach bug. Expressed she was glad she received the product she wanted. She states she's glad she got the Pfizer product, and she think Pfizer's been one of the better ones and heard people were having a much harder time with Moderna. The clinical outcome of the diarrhea was unknown.   No follow-up attempts are completed; information about batch/lot cannot be obtained.
At 2:00am awoke with body aches.  Awake until 4:00am when I got up to go to the kitchen to take Aleve.  Began to feel faint or vertigo like.  Tried to make my way back toward bedroom to call for my wife, but wobbly and fell to the floor.  Legs, arms and body very weak.  Severe Chills, lots of sweats, and shaking.  She helped me back to bed to get warm.  Still shaking.  Extra blankets and warm compresses helped calm me.  Laid in bed, possibly a short sleep or two, until 8:15am.   Able to get up and walk, but very achy and somewhat unsteady. Able to eat some breakfast.  Now, 9:50am the same morning,  achy like flu symptoms with slight headache.  Note: I was not sick, or feeling sick before this event.
Suddenly I  appear to be cured from a disease which there is no cure for; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hereditary hemochromatosis" (not ongoing); "COVID" (unspecified if ongoing), notes: The only thing they have come up with is either your COVID vaccine or getting COVID. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Suddenly I  appear to be cured from a disease which there is no cure for". Additional information: Reporter is a RN (Registered Nurse) who has Hereditary Hemochromatosis. Stated "Suddenly I appear to be cured from a disease which there is no cure for. No doctor can make sense of it. The only thing they have come up with is either your COVID vaccine or getting COVID."   Follow-up attempts are completed. No further information is expected.
L deltoid induration (+) erythema, warm to touch.  Rx for TYLENOL/BENADRYL given.
I woke up at 3:30 am with burning in her left knee. She also had extreme back pain in the L 4-5 region. She had left ankle pain and burning. She had left shoulder pain. She had chills and a headache. She took Tylenol and Aleve. Then she took 1/2 muscle relaxer. Rested. It took 4 days to feel better. She said she couldn't get out of bed due to pain.
Pt recvd vax & exp an inject site reaction; pt reported erythema (between the size of a quarter & fifty cent piece) & warmth @ the inject site;
Notes by provider taken at hospital follow-up cellulitis right arm office visit: (History of Present Illness)  The symptoms began 1 week ago and generally lasts 1 week.  The symptoms are acute and have improved.  Pt received her flu shot 9/15/15, states her arm was not cleaned off prior to injection.  Her arm was sore that night but when she woke up it was very painful and swollen. Later that day she started feeling ill/fever so went to Hospital and was admitted for 4 days for IV antibiotics.  Feeling better and redness, swelling improved. (Assessment and Plan)  Cellulitis of right upper arm (682.3).  Pt left without plan, discussed with pt to continue to use ice and heat on right upper arm, monitor redness and swelling, if starts to get bigger, have a fever, feeling ill again need to call office or go to ER.  Finish all of the antibiotics given in the hospital.  Return to office on Monday 9/28/15 or sooner if needed. Notes when I talked with the pt before she left.  Received IIV4 and PPSV23, both IM in right deltoid on Tuesday, 9/15/15.  States area not prepped before injection.  That evening/night arm was sore.  Wednesday arm extra sore with redness on the deltoid area, hot to touch.  Used ice pack.  Thursday feeling nauseated, clammy, redness on right arm extended down to mid upper arm and anterior mid upper arm.  Went to ED and was admitted for cellulitis.  Given Clindamycin IV.  Discharged Sunday on oral Clindamycin.  Today, Wednesday, 9/23/15 at 4 pm, right deltoid area still sore and tender to touch, no redness or swell.  Still taking oral Clindamycin.
102 female who is a COVID survivor.. had a mild case of COVID in May 2020. Received first dose of Moderna at assisted living facility on approximately January 20th and suffered no ill effects.  Had second Moderna vaccination late afternoon of February 8th. Later that evening  or in the early morning of February 9th tried to go to the bathroom and either fainted or fell onto the bathroom floor on her face. Lay on the bathroom floor face down until assisted living facility staff found her in the morning when they were passing out medications.  Taken to ER at hospital on 2/9/2021. Was not admitted to hospital-  all CT scans and x-rays and blood work were normal. Taken back to assisted living facility where she exhibited dramatic change in behavior- uncooperative, refusing to eat or take meds, refusing to get OOB. Mentally a decline in cognition. Transferred to different facility with higher level of care on February 15th and is improving somewhat.
Site of injection was red and hot to the touch. Cheeks were also flush. Reaction happened 10 min. after admin. of vaccine. Gave pt 1 tsp of BENADRYL. Check on pt after 20 min. of medication. Pt was looking better site was still red but better. Cheeks were better as well. Adverse reaction was on left thigh.
pertussis, coughing for 4 wks; recvd last booster in 1986; 10JAN94 prior h x of bad cold 3 wks prev to 13AUG93 when seen in persistant cough & wheezing; tx Erythromycin & ventolin; CBC nl 13AUG93;
Student had gotten a flu vaccine on 9/19/20 by her PCP. She came to the campus flu clinic on 1/26/21 and received another flu vaccine, her first dose being unbeknownst to the flu clinic staff.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure due to COVID-19 .
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from GlaxoSmithKline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter
I woke up the morning after the injection running a fever of 101.2 degrees. I had severe muscle/body aches, nausea, a severe headache, and remarkable fatigue. I spent all day in bed and was unable to eat anything. The fever broke around noon. The body aches and fatigue improved by 75% by 9:00 pm the same evening. The next day I still had a headache with some fatigue until around 2:00 p.m. on Thursday after the shot on Tuesday.