chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 19 year old female who on 04-AUG-2008 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL vaccine (yeast) (LOT# 0250X). After the vaccination, the patient stated that she felt faint. The nurse laid the patient down and the patient's eyes rolled back into her head and she began shaking and became rigid. The nurse used ammonia to bring the patient around. Oxygen was provided in the office since the patient looked grey. The nurse also mentioned that the patient tried biting her. There was no loss of consciousness or loss of bowel or bladder control. The patient was observed in the office and then discharged home with her sister. On the same day, the patient recovered from the symptoms. Additional information has been requested.
Arm  is itchy; Red all around the shot; Hot to the touch; Sore arm; Hardness and lump in her arm; A spontaneous report was received from a Consumer concerning a 66Years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, hardness, lump in her arm, a delayed reaction in her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 02-FEB-2021, The patient experienced  sore arm, hardness, lump in her arm,  on 14-FEB-2021, a delayed reaction in her arm.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were unknown.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information on the patients' pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with PROQUAD, lot # M043310 with expiry date on 22-APR-2018, lot # M044575 with expiry date on 04-MAY-2018, lot # M043306 with expiry date on 24-APR-2018, lot # N004631 with expiry date on 07-AUG-2018 (albumin status: recombinant human albumin), lot # M042499 with expiry date on 17-APR-2018 and lot # M049122 with expiry date on 13-JUN-2018 (albumin status: recombinant human albumin) (dose and route of administration were not reported) for prophylaxis. The doses of vaccine were reconstituted with properly stored MERCK STERILE DILUENT. Administered doses of vaccine experienced a temperature excursion between 15 and 46 degrees Fahrenheit for 1 hours 28 minutes. There was no previous temperature excursion reported. Data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000413.
Headache X 24 hours. Rigors, low grade fever, nausea X 1 hour 12 hours after injection. Improved with tylenol.  Fever of 101 at hour 36.
She tested positive for COVID-19 on Thursday 6/30/22 but started showing symptoms on Tuesday 6/28/22
Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness under arm/side of breast.
Next morning injection site soreness and swelling, turning red later in the day and continues into day 2.   Next day an increased level of fatigue and headache.  Fever in the afternoon measured 99.5, 2 degrees over typical.  At dinner a cold meal caused chills.  Wet lungs late in the day and continues into day 2.
Client fainted approximately 10 minutes after vaccine administration. Client regained consciousness approximately 2 to 3 seconds after fainting. Vital signs were taken immediately following event. Vitals were WNL and appropriate for client's age. After assessment client stated " I feel normal". No deficits were observed.
Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Vancomycin/flagyl, antibiotics for UTI
Pink maculopapular rash all over body, fever x 2 days, loose stools. No treatment except Tylenol for fever.
Red spots on legs, where shots were given.  Pt's mom called to report symptoms on 4-23-10 at 1:46 PM.  Pt told to give MOTRIN and BENADRYL and draw line around area that is red.  Per Dr.
Information has been received from a physician concerning a 20 year old female patient who on 06-MAY-2008 "two days ago" was vaccinated a dose of Gardasil (lot # not available).  Concomitant therapy included MENACTRA.  The physician in the hospital reported that one half hour after the patient received a dose of Gardasil, she started to have trouble breathing and was admitted to the hospital.  At the time of this report the patient was in the hospital and had been there for "two day so far."  No further information was available.  The patient had not recovered.  Additional information has been requested.
Severe pain in inner right thigh, tender to touch and with movement, increasing in pain over the course of 72 hours.  No apparent swelling, bruising or redness.
MYOCARDITIS 5/5/2022 SUPERVISION NORMAL FIRST PREGNANCY, THIRD TRIMESTER
AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.
On day 8 (after vaccine), I noticed 3 red bumps near the injection site.  They are itchy.   I noticed these this morning.
Patient stated that she had fever for 12 hours, sore arm, redness at injection site
Laid up for about 36 hours; Itchy at the site of the injection; Red rash at the site of the injection; Red rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (Laid up for about 36 hours), VACCINATION SITE PRURITUS (Itchy at the site of the injection), VACCINATION SITE ERYTHEMA (Red rash at the site of the injection) and VACCINATION SITE RASH (Red rash at the site of the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BED REST (Laid up for about 36 hours), VACCINATION SITE PRURITUS (Itchy at the site of the injection), VACCINATION SITE ERYTHEMA (Red rash at the site of the injection) and VACCINATION SITE RASH (Red rash at the site of the injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, BED REST (Laid up for about 36 hours), VACCINATION SITE PRURITUS (Itchy at the site of the injection), VACCINATION SITE ERYTHEMA (Red rash at the site of the injection) and VACCINATION SITE RASH (Red rash at the site of the injection) was resolving.            Concomitant product use was not provided by the reporter. Treatment for events included antihistamines.   This case was linked to MOD21-054285, MOD-2021-045004 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non-significant follow up received and contains information about husband's case
Red spots on R hand, wrist, L knee, and both elbows were present around 2/12/21. The red spots were not itchy, they were painful when pressure was applied.   The spots seemed to be swollen at the end of the day on 2/16/21.  I reached out to my doctor and saw her on 2/18/21 and the spots had cleared up.  My second dose was given on 2/20/21. I have felt similar pains in my earlier affected joints. The pain is not as bad, yet and there are no red spots.
Pt complained of pressure in her head.  Also complained of head pain, pressure behind the eyes, swollen glands and trouble swallowing.  Pt suffers from anxiety neurosis.
Headache, took Tylenol which helped. Then about 3pm on 4/14/2021 I started to feel dizzy and nauseous
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-OCT-2022 Reporter's comment: The Health care provider (HCP) had asked via chat if there was an expired Hep A (Havrix) vaccine given to the patient, was it invalid. It had expired on 30th September 2022 and it was given to the patient on 07th October 2022. The chat had got disconnected. No patient or HCPs identifiers were reported. The report was completed with the only information that was gathered during the chat. Follow-up would not possible as no contact details were available. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used.
Pt was lying down after getting imms. Dad reported some jerking movements of arms & legs, then he picked her up and carried her to the door to alert us. Pt quiet but awake.
Patient called stating she had an adverse reaction to her SHINGRIX vaccination. She was given the vaccination on 4/8/19. She described the reaction at the injection site as being a swollen, big red circle that was hot to the touch. She went to urgent care on 4/10/19 and was diagnosed with cellulitis. Patient also stated that she did not believe that she had her arm cleaned with an alcohol swab and let dry before receiving her immunization.
Soreness at injection site after first dose for a few days at first (which I understand is normal).  9 days later (April 6), red, oval patch appeared at injection site, at first about the size of a quarter.  Now (April 8), more circular and approximately 2 inches in diameter. Mild itching and slightly raised, hard feeling, but no pain.  My understanding is this is the "Covid Arm" that has been reported and should be harmless, but I am reporting for purposes of providing another data point.
Narrative: COVID infection following COVID vaccine series 12/31 , Pfizer, dose #1 01/21, Pfizer, dose #2 04/06 COVD swab, result: not detected 07/19 Patient reports prior COVID-19 Diagnosis (Private sector) 07/21 visit to ED for right sided jaw pain around the mandibular molar tooth and radiate to right neck/shoulder area, xq1 day. 08/03 COVID, result: defected 08/03 pt cc: no symptoms exposure: unknown 08/04 clinically resolved
While the patient was being observed after his vaccine, he informed me after close to 10 minutes that he was starting to feel dizzy and couldn't see clearly because of the dizziness.  He was moved to the floor, lying on his back, and his legs were elevated on the chair.  I informed the patient to take slow, deep breaths.  The patient said he immediately started to feel better once moving to the floor.  He remained in this position for about 10 minutes, feeling better the entire time.  He slowly sat up to a seated position for about a minute, and upon feeling fine, he stood up and felt normal.  The patient informed me that he has a history of dizziness and fainting with different vaccines in the past and this is not an unusual reaction for him.
Developed acute urticaria 10 days after receiving booster shot. Hives appear randomly and disappear within 30 minutes. Appearance of hives is continual throughout the day and currently ongoing as of reporting date. Treating with once daily doses of over-the-counter Zyrtec, which has reduced urticaria to tolerable levels.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethinicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-APR-2021, the patient underwent Antibody test and result was 3 with the highest possible being greater than 2500. On 11-MAY-2021, the patient again underwent Antibody test which was found to be 30 and identified as confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210532357-COVID-19 VACCINE AD26.COV2.S-Confirmed immunlogical vaccine failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
severe myalgia, bedridden for 24 hours- then resolved severe arm pain better after 48 hours
Vomiting causing severe dehydration  Unable to keep water down Diarrhea  Muscle soreness Headache with severe sensitivity to light and noise Light headed Sinus drainage High temperature Swollen and painful arm at injection site Swollen and painful lymph nodes armpit on arm where injection was given
headache; chills; fatigue; This is a spontaneous report from a non-contactable nurse. This nurse reported for a 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EK5730) Intramuscularly at Left arm at single dose for COVID-19 immunisation on 19Dec2020 (02:30 PM). Relevant history and concomitant drugs were unknown. The patient experienced had chills, fatigue, headache in the morning of  20Dec2020 at 7:00 am.  The patient received Tylenol as treatment and the outcome of events was resolved in unknown date of Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
HEART ATTACK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, on an unspecified date, reporter's friend's husband had a heart attack after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211251030 and 20211251833.; Sender's Comments: V0:20211251043- COVID-19 VACCINE AD26.COV2.S- Heart attack. This event is considered Un assessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pt was vaxed w/2nd dose of HIB on 8JUL92 & approx 6 to 7 hrs following vax pt devel generalized hives;
Numbness & tingling of toes, spread to total foot esp R side. Cramping of calf, thigh, & temp. Changes alt hot & cold.  Some numbness of R thigh. Numbness of R fingers. Generalized weakness. Suspected GBS.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Congenital hypothyroidism" (unspecified if ongoing), notes: Synthroid CH. Concomitant medication(s) included: Lexapro; Buspar; Metoprolol; Cardura; Losartan Potassium; Synthroid taken for congenital hypothyroidism. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound of Covid after Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She got her vaccine, none the first day.  She drove home by herself, didn't have any reaction at all, shaking the arm to get the drug disributed throughout her body.  The next day when she woke up she was very very disoriented, she could not move well, woozy, shaky, not steady on her feet.  she was nauseous for a couple of days, but did not drive for 3 weeks.  Even her head just did not feel herself.  She felt like she was somebody else, like a zombie.  She was very tired and her body was very weak.  She was so weak she did not call her doctor, but after feeling disoriented after a few days and feeling shaky and nauseous for a week.  Everything was just an effort, everything she does she has to rest a lot.  She noticed that things have changed.  She was driving back and forth twice a week to see her doctor 1 hour away but now hardly goes as it is too long a distance for her to go.  It has affected her whole life in an adverse way.  She told her doctor a few days after the vaccine, and she told her she was not getting a 2nd vaccine.  She did not give her any recommendations.  Her doctor does not act like there is anything wrong and is surprised that she has not given her anything or seems concerned about her reaction.    She had trouble walking, which she still has, had better balance before the vaccine.  She is able to drive now, and she is still tired (but could come with age).   She does take naps, and has before, and she feels now her body is very, very tired moreso than she was before.  She does a not of gardening, and camping, but had problems with urinary issues.
PATIENT HAS RASH ON HER ARM THAT SHE STATES BEGAN NEAR THE INJECTION SITE AND THEN MOVED DOWN THE ARM AND TO THE OTHER ARM.  SHE STATES THAT SHE DID VISIT HER PRIMARY CARE PHYSICIAN ON 9/30/2019 FOR A STEROID CREAM AND ORAL STEROID BECAUSE SHE FELT THAT SHE MAY BE ALLERGIC.  SHE DID RECEIVE THE SAME BRAND OF SHOT LAST YEAR.
Had to go to Emergency Room I was having severe pain from my shoulder down to my little finger on my left arm I got the shot; Had swelling in my right; The outer side of my shoulder was swollen; Lymph node under my armpit was swollen; Pain is like constant ache, like tooth ache; My arm still killing me, kind of swollen around in elbow area; Blood in urine; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 24Feb2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. Medical history included emphysema, irritable bowel syndrome (IBS), migraine and arthritis. Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL). The patient reported that she had to go to the emergency room yesterday, a week ago on Wednesday, 24Feb2021 she had my second Covid shot she went home and she laid down for a while and when she woke up she was having severe pain from her shoulder down to her little finger on her left arm and that the arm she got the shot in and today she have been putting heat and ice and taking stuff for pain and it was just not going away so yesterday she finally went to the doctor who was sure it was from Covid shot and told her to take tylenol and keep using heat and ice. She had swelling in her right, the outer side of her shoulder was swollen and she had a lymph node under her armpit that was swollen, now today swelling was gone but the pain was still there it was like constant ache, like tooth ache. She wanted to know if she should report this. She stated that her arm was still killing her, it was still swollen in her, kind of swollen around her elbow area. She stated that she took Tylenol but it didnot do much. She was going to take Ibuprofen but she did not know how much to take. She also had hydrocodone with acetaminophen and she took one of those, that was an old and it really did not do anything either so she did not take anymore. She had blood in the urine. The patient underwent lab tests and procedures which included blood in my urine. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
came in w/ c/o h/a, sore throat, cannot stay awake;pt given shot 27JAN99 430PM;the c/o not feeling good Friday but still went to school that morning;feeling dizzy & not wanting to to open eyes, walk w/support w/eye closed when examined;
Myalgia, Fever, Chills, Fatigue, injection site pain Narrative: