chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning herself with no previous pregnancies and no reported past drug history who on 01-MAY-2009 was vaccinated with a dose of GARDASIL. Secondary suspect vaccine given on the same day included MMR II (manufacturer unknown). There was no concomitant medication reported. It was reported that on 01-MAY-2009, in the evening after getting the vaccines the patient got really sharp belly pain. On 02-MAY-2009 a home pregnancy test was done and the result was positive. The last menstrual period of the patient was on 25-APR-2009 and the estimated delivery date was 30-Jan-2010. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/12/2009.  Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning herself with no previous pregnancies and no reported past drug history who on 01-MAY-2009 was vaccinated with a dose of GARDASIL.  Secondary suspect vaccine given on the same day included MMR II (manufacturer unknown).  There was no concomitant medication reported.  It was reported that on 01-MAY-2009, in the evening after getting the vaccines the patient got really sharp belly pain.  On 02-MAY-2009 a home pregnancy test was done and the result was positive.  The last menstrual period of the patient was on 25-APR-2009 and the estimated delivery date was 30-Jan-2010.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0905USA00271 is a duplicate of WAES # 0905USA00270.  Therefore, WAES # 0905USA00271 is being deleted from our files and the reports consolidated into WAES # 0905USA00270.
6/12/2021: Nausea, slight fever, dizziness, black outs, fatigue, muscle aches By night time, rashes started appearing all over his body including arms and legs and all over his face. The rashes looks like big blotches/ map looking red marks all over his whole body. His face was all covered with the blotches of rashes including his scalp. He had no fever though. He was breathing normally but the rashes were very itchy. gave him double dose of Benadryl. Then switched to adult Benadryl but still taking double the dose. This went on for 2 days and no sign of improvement despite taking Benadryl every 6 hours. Patient was sleeping most of the days due to the medication.  6/15/2021: reached to Family doctor and explained the situation. doctor recommended to go to ER after seeing pictures of the rashes. Patient adamantly refuses to go. Doctor suggested take Allegra on top of Benadryl. Patient took Allegra 24D. Patient mostly sleeping. 6/16/2021: saw some slight improvements. Back and chest cleared of the rashes but still heavy on the arms, most especially the thigh area and legs. still taking Benadryl but only the normal dosage. 6/17/2021: All rashes are gone and cleared/
My full list of symptoms were:  Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms.  It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso.  I had full muscle control but I did have problems with my bladder and bowels.  I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully.  No treatment was administered except to wait and see.  Three days later and I am improving but not fully recovered yet.
- Hives reported - symptoms of Brachial neuritis - R arm deep ache, weakness, numbness.
Eczema on hand Flared up; Excruciating pain in arm/sore arm; Pain extending to neck, back and chest; Pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ECZEMA (Eczema on hand Flared up), PAIN IN EXTREMITY (Excruciating pain in arm/sore arm), PAIN (Pain extending to neck, back and chest), INJECTION SITE PAIN (Pain at injection site) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.
When withdrawing needle from patient arm, she sprayed some blood out of the injection site for a second. Following this, the injection site started to bleed, and a bump appeared at the site of the reaction. Patient reported soreness in the muscle, similar to soreness that typically follows immunizations administered in the the deltoid muscle. Patient reported no itchiness or other tenderness or difficulty breathing. Patient was on the way to physician's office when she came to get her flu shot and she is going to report the reaction to the physician to be evaluated.
Breakthrough Covid + 65-year-old female who was brought to the emergency room by her daughter for chief complain of change in mental status. Patient continues to describes symptoms as cough and shortness of breath, and with a well known history of chronic obstructive pulmonary disease and cardiac conditions patient was referred approximately 2 days ago for IV concentrated antibodies treatment.
Very irritable, abdominal pain, screaming started 4-5 hours after immunization, but no blood in stool or vomiting.
Grade 2 Arthritis; I have arthritis in a few finger joints.  After my Covid Booster my hands were very painful.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Oct2021 12:00 (Lot number: EW0178) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "DCIS treated 2012" (unspecified if ongoing), notes: DCIS treated 2012; "history of Graves disease treated years ago" (unspecified if ongoing), notes: history of Graves disease treated years ago; "I have arthritis in a few finger joints" (unspecified if ongoing), notes: I have arthritis in a few finger joints; "Hyperthyroid" (unspecified if ongoing); "osteoarthritis in my knees" (unspecified if ongoing), notes: do have pretty bad osteoarthritis in my knees which I get Viscosupplementation injections for. Concomitant medication(s) included: ADVAIR taken for asthma, start date: 28Sep2021 (ongoing); SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 16Apr2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Oct2021 19:00, outcome "recovering", described as "I have arthritis in a few finger joints.  After my Covid Booster my hands were very painful."; ARTHRITIS (non-serious) with onset 18Oct2021 19:30, outcome "recovering", described as "Grade 2 Arthritis". Therapeutic measures were taken as a result of pain in extremity, arthritis.  Additional information: It was stated that patient had arthritis in a few finger joints. After her Covid Booster her hands were very painful. Needed to apply ice, heat and take Advil. It's now day 4 after the shot and still having problems albeit not as bad as the two days after where she  was taking Advil round the clock. she  do have pretty bad osteoarthritis in her knees which she  get Viscosupplementation injections for. Oddly enough her knees were not an issue  No follow-up attempts are possible. No further information is expected.
Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine shot.  The next morning at the breakfast table she began crying and shouting that she had lost her vision and everything went dark.  Within minutes she stopped breathing and her eyes rolled back in her head.  Her body went rigid and her mother caught her as she was falling backward in her chair. Her skin was white and her lips blue.  I administered CPR and after approximately 4 mouth to mouth breathes she began breathing again.  When she regained conciousness she said she could not hear.  The paramedics arrived and tended to her.
My heart was raining and very strong palpitations, I was referred to a cardiologist on 03/08/2021.
. Woke up  in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth.  I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
Hive like rash left arm with c/o itch noted 1/3/03 a.m. Rash also noted on neck and face 1/4/03 then cleared. Benadryl PO taken PRN for itchiness.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 14-AUG-2013 one patient was vaccinated with an improperly stored dose of VAQTA (lot # H010659 expiration date 01-MAR-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which was an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored (Intramuscular injection) GARDASIL (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Large red rash at injection site. Doctor prescribed antibiotic thinking its an infection could be allergy as well, unclear.
I started to itch on the afternoon of 10/25/2021 at approximately 1pm.  It started in one area then started in another until I was covered with itching including the inside of my ear canal, the bottoms of my feet, my palms, the top of my head, neck, chest, legs backside everywhere.  All the on call locations were booked and had nowhere to go.  I went to pharmacy and a pharmacist pointed me to a box of Benadryl.  I tried it and it did tamp down the itch within 45 minutes then I was able to sleep.  I went to the doctor and they saw what I looked like.  They said it looked like I was whipped with a belt..  I had huge welts on my legs, back, chest, and it itched like crazy. and it still does as of this writing.  They put me on Prednisone and I just took my second dose and I'm not seeing much difference.  I drive a school bus so I cannot take the Benadryl during the day but I do at night when I'm home.  Currently I still itch all over including my forehead, face, neck back the bottoms of my feet, everywhere.
Mom stated the child started crying inconsolably approximately 5 hours post vax. After awhile he threw up then went to sleep. He was fine after that, no fever. She can't remember if he had eaten anything different but "it was such a long time ago."
myoclonus; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONUS (myoclonus), DIZZINESS (dizziness) and HEADACHE (headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001B21A) for COVID-19 vaccination.     Patient did not had Covid-19 diagnosis prior to and after getting the Covid-19 vaccine.  Concurrent medical conditions included Allergy (allergies to Pizigam). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Contraception.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). On 08-May-2021, the patient experienced MYOCLONUS (myoclonus). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; TOPIRAMATE (TOPAMAX) at an unspecified dose and frequency; FREMANEZUMAB (AJOVY [FREMANEZUMAB]) at an unspecified dose and frequency; IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) at an unspecified dose and frequency; RIMEGEPANT SULFATE (NURTEC ODT) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) at an unspecified dose and frequency. At the time of the report, MYOCLONUS (myoclonus) was resolving and DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported lot of blood tests. On an unknown date, Electrocardiogram: results not reported Results not reported. On an unknown date, Electroencephalogram: results not reported Results not reported. On an unknown date, Lumbar puncture: results not reported Results not reported. On an unknown date, Magnetic resonance imaging: results not reported Results not reported.         Vaccines were given in pharmacy in separate states.  Patient has consulted many neurologists.  Patient was treated with Pizigam and Qulipta. Prescribed treatment medications did not give her any relief so they stopped all these medications.  Laboratory information also included MRA and MRV.
Pt grandmother reported to staff on 9.8.09 that pt seen in ER on 9/5/09 for L thigh redness & swelling.
6-7 days after shot develop red  blotchiness, rash-like appearance around the the injection site and a swollen lymph node under the left armpit. No medical attention sought.
Anaphylaxis and swelling of the lips - administered benadryl and patient felt better
Acute hypoxemic respiratory failure due to COVID-19; thrombocytopenia; acute kidney injury on chronic kidney disease stage III; type 2 diabetes mellitus, requiring insulin;
Immunizations given 2-26-09 had not been entered into system & mom did not bring immunization record.
Mother reports that 3 days after patient received the Rotavirus vaccine he had bloody bowel movements. Mother said that first bowel movement that had blood occurred on 12/24 at 2:40 pm. Patient had another bowel movement with blood at 4:30 and then a few minutes later had a stool that was "all blood." Patient was evaluated at Hospital Emergency Department on 12/24 and discharged home after completing stool testing. Stool testing negative for pathogens. Mother reports that patient had about 12 bowel movements total on 12/24.  Mother said on 12/25 patient had one bowel movement with blood in it and then they did not see any further blood in stool. Mother said patient did not have a fever or any other symptoms after receiving vaccine. Mother said patient usually has 4-5 bowel movements a day.
Headache, Sedation, Myalgia, Arthralgia, UrticariaPruritus & NauseaVomiting
Localized, non-raised rash on left anterior thigh, red and patchy in appearance, none on posterior thigh, lower leg, groin, buttocks or abdomen.
*Low temperature (96.5F and normal for patient is 97.1-97.8F) - Gone after 12hrs *Fatigue - still occurring after 12+ hours *Dry, scratchy & slightly sore throat - gone after 12hrs *moderate soreness in left arm (feels like a boxer punched me) - still occurring after 12+ hours *headache - still occurring after 12+ hours  Sought no formal treatment.
PT PRESENTED TO PHARMACY 4 DAYS POST-VACCINATION TO REPORT REDNESS AND SWELLING  THAT HAD SPREAD PAST INJECTION SITE TO UNDER THE ARM. PT HAD SELF-TREATED WITH BENADRYL AND HAD SEEN IMPROVEMENT OVER TIME.
Swelling, pain, slight warmth of left axillae, left chest reported to our clinic~2:00PM 11/19/21; unable to sleep previous night due to pain. Instructed to take acetaminophen  650mg and apply ice to area and recheck at 7:30pm. Provider unable to reach mother 11/19/21 @7:30pm-no answer. Follow-up 11/20/21: mother states she took child to church evening of 11/19/21; later that night child was getting worse with chest pain-took pt to ED-given ECG-normal per mother, ibuprofen- child able to fall asleep in ED and discharged early morning 11/20/21. Child starting to feel better 11/20/21. Unable to reach mother today, 11/22/21-left message
The vaccine was prepared with a multi-dose vial of diluent. The diluent vial was punctured twice to mix two different vials of vaccine. The dose of medication may have been given IM with a 5/8 inch needle.
Mother called 10/21/05 reporting left arm upper red/purple/hard and hot. instructed to bring in child. Child started c/o pain in arm last evening. Noted of LUA, 50X40cm red/swollen/tight hot area mid arm to lateral. Appears like a "bug bite" in middle - Different location than MMR. Mother called PMD while here and advised cold packs, no need for being seen. child normal otherwise, no fever, playing normal, eating normal. 10/18/05 continues to decrease per Mom with cold compresses gone by 10/26/05.
After vaccine at around 9PM, I started feeling nauseous, body ache, feverish, dizziness, I fainted on the floor, vomiting. Monday 10/25/2021 I woke up with swollen left arm. All this week I've been feeling weak and haven't been eating much. I know this vaccine has given me every symptom since 10/22/2021 when I received it.
Bruised and later it turned black and blue; turned black and blue; red in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-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 VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.  Patient reported no adverse event with dose 1.
Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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 details were provided as follows: The age at vaccination was not reported. The patient received a dose of Twinrix, two days after the expiration date, which led to expired vaccine used. Number for GlaxoSmithKline Medical Information given for future reference and warm transfer was provided. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned a 50 year old male. 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 (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid. Laboratory data (dates unspecified) included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150408 and 20220150229.
TIA 11/26/2021, TIA 12/04/2021, TIA 12/11/2021, Cerebral stent placed 12/15/2021
Multiple areas of palpable raised redness, that client describes as tender.   3 on left axilla  2 on right axilla  1 below right eyebrow   Client states that redness appeared a few days after vaccination.
Fever 100.3, weakness, shakey, body aches, headache. After visiting with nurse went home to rest.
No adverse effects but I am in an AB (antibody) study at a local University using the alternate ref lab. My AB levels have always gone up significantly after my vaccines except this time when it was 1:25600 6 weeks before the bivalent booster (my 5th shot) and 1:12800 1 month post booster meaning there was no response. I am concerned that either the batch was defective or the pharmacist did not reconstitute it properly therefore giving me in essence no vaccine. They said it no longer needs reconstitution and told me to report this to you. I am concerned I am less protected or not protected at this point and am considering getting another booster. I also wanted Pfizer to check the batch for efficacy if still available and to notify others if it is defective. I wouldn't know about this had in it been in a study checking my AB levels every 1-3 months and after every booster.
Severe headache, fever, diaphoretic, rash on face, neck and eats, and severe dehydration.
It started with sore throat and I took a COVID-19 test. I had just been at a wedding. I was positive that morning. For the first few days I had sinus and inflamed throat. At night I had joint and muscle pain. I trouble getting PAXLOVID so first few nights were really bad. Then after starting PAXLOVID it was more extreme fatigue. I felt better after a week and tested negative. Then 2 days later I tested positive. Later in the month I found strange bruises in odd places like my abdomen and had some itchy spots and what appeared as hives. I have had response like this to wheat gluten but I haven't consumed that in years, so I thought this flare up could be as a result to COVID.