chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started menstrual cycle less than 24 hours after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), zonisamide (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (SEASONIQUE); all from an unknown date for unknown indication and unknown if ongoing. The patient previously took salicylic acid (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) for an unknown indication on an unknown date and experienced drug allergy. On 27Feb2021 at 06:00, the patient started menstrual cycle less than 24 hours after receiving vaccine, have not had menstrual cycle in 6 years due to birth control medication. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started menstrual cycle less than 24 hours after receiving vaccine was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Hives in face/neck area. Not life threatening, but more than annoying. First noticed about 8 hours after immuniztion on 02/06/08. Lasted until midday 02-10-08. Used home remedies to relieve discomfort. Would have contacted physician if hives had continued past weekend.
Pt developed left side back pain two weeks after receiving her second dose. Pain persisted until June 10 when she went to the ER and was diagnosed with bilateral pulmonary blood clots. Pt hospitalized for two days and discharged on apixaban.
fever 102 x ax; eyes rolled back, shivering & shaking-had sz; was seen by paramedics; no rx was given; seen by PMD next day
Redness, large, hard, two inch diameter that looks more bruised than inflamed.  It still itches as well but does not hurt.
itching/pruritus; redder and itchier; pretty large erythematous area; allergic reaction to a component; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  An 85-year-old female patient received pf-06928316 (ABRYSVO), on 08Sep2023 at 17:57 as dose 1, single (Lot number: HF5014, Expiration Date: 28Feb2025) at the age of 85 years intramuscular, in right deltoid for immunisation, respiratory syncytial virus immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (medically significant), outcome "not recovered", described as "itching/pruritus"; ERYTHEMA (medically significant), outcome "not recovered", described as "redder and itchier"; RASH ERYTHEMATOUS (medically significant), outcome "unknown", described as "pretty large erythematous area"; ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "unknown", described as "allergic reaction to a component". Therapeutic measures were taken as a result of pruritus.  Clinical course: The caller stated the patient mentioned she had redness, she has some erythema but said it is about palm size so it is large. Then she has itching, but the caller thinks she is scratching it which is making it redder and itchier. She has an itch cream on it. The itching is what is concerning her most because she does not see it listed as an adverse reaction. The caller is more worried about the patient's itching and stated maybe it is an allergic reaction to a component. The caller stated she saw on the website under adverse reactions that redness the size of over 100 mm happens in about in 0.1% of people, so that part is addressed, so she feels like that part is probably normal. She stated she will have the patient report to her doctor and decide whether they need to follow up. The patient may be scratching it because she is nervous about it. It is a pretty large erythematous area so she can recommend she is seen by somebody. Calling about Abrysvo, caller is a pharmacist and had a patient call, caller knows swelling and redness is common, but patient reported having redness the size of palm of hand as well as itching from it, almost like an allergic reaction. Caller doesn't see pruritus listed. Caller stated this is not an emergency, patient is fine, just worried about how big the spot was.   The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association. Events are possibly not related to the devise.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
A pharmacist reported a pt received vaccine 11/8/00. A nasopharyngeal culture was performed; the result was positive for pertussis. Additional info received from the reporter on 01/25/2001 indicated that the pt concomitantly received IPV on 11/08/2000, on 11/09/2000 Prevnar and Comvax. The reporter noted that the pt has a concurrent history of Hirschsprung's disease.
This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot, dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Muscle aches, inability to lift arm injected above head for two days, followed by itchy, warm, red rash localized to injection site. Minor, did not impact functioning. No treatment as it has not impacted functioning.
Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 17 out of 26 patients.
Patient developed Herpes Zoster 9-10-2018; diagnosed in clinic visit 9-11-2018.
Immunizations 3/14/03 MMR, DTaP, Polio. Slightly red site of injection, some pain.
vaccine was administered around 1115am patient was fine before and during vaccine. known history of fainting. after vaccine was administered patient was seated on chair for post vaccine observation and fainted. so signs or symptoms patient was going to faint. patient was alert and oriented within seconds. no signs or symptoms of any injury or severe reaction.
Inflamed arm, hot, red, swollen, low grade temp - 100.8, chills, headache, spreading rash. Went to MD (personal physician) on 10/03/2013 who prescribed BACTROBAN. Applied 3x day for diagnosed cellulitis for 1 week.
My initial side effect on Monday 1/11/2021, was slight dizziness after about 5 minutes. I was not impaired, and it faded after about 10 more minutes. The next day, the arm that received the injection was very sore and achy.  It was difficult to get dressed, and the ache was located from my collar bone to my elbow of the injected arm. This ache lasted 3 days.  My range of motion has returned. On Wednesday (48 hours post injection) I began to develop an itchy rash on the insides of my arms in the soft tissue area.  I took two benadryl last night and applied benadry cream to the rash.  This morning, 1/15, the rash has spread down my arms onto the back of my hand, and onto my torso.  It is itchy.  Taking more benadryl, and I called my doctor.
I am prone to varicose veins but discomfort is always linked to cyclical or pregnancy  hormones. Within a day my leg was in such discomfort that I had to use a compression stocking. Along with the leg discomfort, weird pains were felt in various parts of my body. The deep pain usually lasted 1-3 hours and then subsided. Sometimes it was in my lower back, but most often on either leg. I took a baby aspirin each morning for a week until the feelings of blood clotting subsided. The veins feel almost back to normal, only slightly discomfortable. The deep pains have subsided - none for the last 2 days. (Day 8, 9).  I did not want to go to any facility because I was hoping it would go away without having to go to a hospital emergency room with many sick and waiting.
Severely fatigued,  lapse of memory (so much that he missed 6 1/2 days work so far), depression, loss of appetite, feeling of gloom.
Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date; The patient administered the vaccine after the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient was not ever diagnosed with/ tested positive for Covid-19.  there were no known drug allergies of the patient to medications, food and other products.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.     On 20-May-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-May-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had any prescriptions, over the counter medication, dietary supplements or herbal remedies taken at the time of vaccination  Vials with batch no 027L21A were initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patients had not reported symptoms.  No additional doses, medications or treatments had been administered.
Shortly after vaccination patient reported heart racing, panic, tingling on tongue, and cold throat.  Transported to ER by EMS.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021, 2/21/2021, and 8/25/2021. Presented to ED on 8/31/2021 with malaise, low-grade fever, and feeling lightheaded. His daughter was recently diagnosed with COVID and had been quarantining. Patient admitted for acute hypoxic respiratory failure secondary to COVID PNA. Initially required BiPAP, but able to be weaned off. Patient transferred to ICU 9/4 due to increased work of breathing and increased oxygen requirements. Hospital course complicated by worsening hypoxic respiratory failure requiring emergent intubation 9/8 overnight. Pt with a total of 2 cardiac arrests overnight. PEA Arrest on 9/9/2021 @ 0658. Patient converted to DNAR/COT per family wishes and patient expired at 0750 on 9/9/2021. Patient treated with dexamethasone, remdesivir,
Fever going on day 3, nausea, body aches, lymph node swelling left side extremely painful, injection site pain and redness (all persisting day 3)
Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-year-old female patient (reporter's grandmother) that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history was reported as 'no'.  Concomitant medications were not reported. The patient had a vaccine appointment on the 30th but she tested positive on the 11Jan2021 and she was wondering if she went to get her vaccine or did she wait until other guys call her. Treatment received for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be fully excluded.
Muscle aches, joint aches, prickly skin. Minor lightheadedness and slight headache. No fever. Events began around 9 am and have begun to subside now (about 7 pm). I did not feel the need for medical intervention, as I was made aware of the possibility of these events prior to receiving the vaccine.
First day serious enervation, second day worse, tailing off next 3-4 days
COVID PNA with Hypoxia: COVID+10/16/21, admitted to UH on 10/18 for further management of COVID-19 pneumonia. He was treated with dexamethasone and remdesivir from 10/18-10/21 and was able to be weaned from 4L to room air. He passed a home O2 eval on room air, maintaining O2 sats ~94%. Patient was discharged home with dexamethasone to complete a 7d course.
very sensitive on rt side of lower to upper neck & head; burning centralized pain on large bumps (beg 19AGU92);
Pt rec'd DTP #3 8MAR91; On 11MAR91 developed temp 103.8(R) in clinic w/hypotonic unresponsive; episode x 2. Sent to ER;
patient called the pharmacy about an hour after receiving the vaccine stating he could not taste his food. that his soda tasted flat and that he had a headache.
I developed vertigo, with the first serious episode 5/6/2021. I do not know if it is vaccination related or not, but figured I should report to be on the safe side. I had several other serious episodes: 6/7/0221 6/10/2021 7/14/2021 Doing the maneuver under the treatment of a physical therapist has alleviated the dizziness, but I still experience it some three months after the first vertigo episode.
migraines; Daily Headaches; Nausea; Dizziness; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL9266) as dose 1, single and administered in arm left, administration date 12Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Daily Headaches"; NAUSEA (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Nausea"; DIZZINESS (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Dizziness"; MIGRAINE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "migraines". The events "daily headaches", "nausea", "dizziness" and "migraines" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, migraine. Therapeutic measures were not taken as a result of nausea, dizziness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any vaccine within 2 weeks of vaccination. Treatment was received and still ongoing. Prior to vaccination, Patient was not diagnosed with covid-19. Since the vaccination, patient has been tested for covid. No known allergies reported.  Follow-up attempts are completed. No further information is expected.
Menstrual cycle completely changed. First cycle after shot in April there were intense cramping, like early contraction type of pains. The volume and length of my cycle was incredibly higher and longer than normal. It was life altering to the point I could not leave the house because I was bleeding so much and had to be close to a bathroom. This continued in May. The cramps were not as bad as April but the volume and length was still unusual. May?s cycle was like my heaviest day for 6 straight days. In June I miscarried at about 6 weeks. July?s cycle seemed closer to normal and now in August I have not gotten a period at all and have tested negative for pregnancy. This shot has most definitely changed my menstrual cycle. For the last 20+ years I am very regular and my cycle typically follows a pattern but since the shot, everything?s changed. I feel this is common enough of a problem it should be looked into more. As a woman, it sure doesn?t feel like any one cares about this aspect of the shot. As a mother of young girls, I want peace of mind when they are eligible for the shot I am not somehow screwing up their little systems long term.
My Sons leg was swollen on the side where vaccine was administered.  Fever, vomiting, chills, SOB, wheezing. (My son could not walk after adminstration).
PT VACCINATED WITH DTP DEVELOPED TREMULOUSNESS IN HANDS FOREARMS ON DAY 3 AND 4 FOLLOWING DTP #2, SLIGHT ACTIVITY SEEN IN FEET & LEGS BUT NOT AS PRONOUNCED.
PT RIGHT ARM STARTED SWELLING AT SITE, BASEBALL SIZED RAISED HARD ERYTHEMIC KNOT. PROGRESSED TO HIVE REACTION RASH ON CHEST AND C/O OF NAUSEA. CG-EMT ADMINISTERED O2 VIA NASAL CANULA @4LPM AND DRIVER ESCORTED PT & EMT TO LOCAL URGENT CARE FACILITY
Patient Covid + on 10/13/2021. Received Pfizer vaccine with 1st dose on 04/28/2021 and 2nd dose on 05/19/2021. History of Present Illness  Patient is 67-year-old male with past medical history significant for hypertension, hyperlipidemia, coronary disease and atrial fibrillation presented to the ER with complaints of abdominal pain which has been going on since last couple of days.  As per the patient pain is more in the upper abdominal area more on the right side.  Patient tells me that pain is more when he lies down at night and he could not sleep because of that and he decided to come to the ER for further evaluation he does not have much nausea and vomiting.  Patient said that he cannot eat much and initially was thinking that he had some heartburn.  He denies any diarrhea or constipation.  Patient denies any chest pain.  He denies any cough or phlegm production.  He denies any fever or chills.  He denies any complaints of urination.  He denies any headache dizziness or lightheadedness.  On further evaluation in the ER he was found to have anemia with hemoglobin of 10.7 WBC was 2.46 INR was 1.33 UA was positive his creatinine was 1.32 CT abdomen and pelvis was performed which showed cirrhosis with mild splenomegaly with cholelithiasis with mild gallbladder wall thickening and adjacent soft tissue edema and hyperemia consistent with acute cholecystitis with small non-obstructing left renal stone.  Patient has been kept n.p.o. and surgery services has been consulted.
Where injection was given more pain than normal injection, red swelling with fever in arm Fever 100.9  Chills Nausea Dry Heaves body aches
This spontaneous report as received from a registered nurse refers to an approximately 20 year old female patient with no medical history. The patient's concurrent conditions included allergy to iodine, shellfish and CEFZIL. On 31-MAR-2015, the patient was inadvertently vaccinated with a single dose of GARDASIL, lot # K009482, expiration date 06-MAR-2017, dose 0.5 ml, intramuscular (administration site was not reported) instead of Tdap, while pregnant. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) and Tdap. No lab diagnostic studies were performed. No adverse events were reported. The patient became pregnant with Last Menstrual Period (LMP) of approximately 16-SEP-2014 and Estimated Delivery Date (EDD) of 23-JUN-2015. The date of LMP was calculated on basis of gestational age on 31-MAR-2015. Initial exposure to GARDASIL was at third trimester (also reported as 28 weeks). The outcome of the event was not reported. The relatedness between the inadvertent vaccination and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
4/3/12 took oral Typhoid capsule #1 at 2300 - onset of severe abdominal pain 0900 4/4/12 - "like very bad gas pains" - no vomiting or diarrhea - seen by work site RN - refused treatment.