chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after receiving my second vaccine I experienced the worst uncontrollable vaginal bleeding and continue 6 months later to have almost non-stopping bleeding. My cycle had been over about a week before this began and I am an extremely regular and light flow person.  I experienced massive clots at alarming numbers. I could not leave the house a lot of days since April due to the extreme heaviness of the flow that even the maximum capacity of tampon PLUS pad worn at the same time could not buy me a hour to leave the house to run an errand. This has thankfully began to ease for me over the months but I basically have MAYBE 5 days off from bleeding each month now.. I have been examined and everything is normal and my OBGYN said the vaccine could not cause this to happen. I have seen we?re countless other women have experienced the same exact issues as I have. I finally decided to write in on this reporting website and hope that others decide to at least try reporting also. I just want awareness and research brought to this issue so maybe together there can be a solution or treatment discovered to relieve these side effects if a woman develops them. We all want everyone to get vaccinated and I am pro-vaccines but thoughts are weighing on me about not taking a booster if needed because of my experience. Please research and fix what causes this or find something to help so other women don?t not get vaccinated because it seems these women?s side effects keep getting brushed off my everyone and we want answers and help please!!!! I guarantee there are a lot of women not getting vaccinated worried about this exact issue!
One week exactly after shot arm was swollen and red with rash all around injection site. (Almost whole upper arm) Was hot and extremely itchy. Finally was better after 3 days but still slightly itchy today.
patient became light-headed after immunization and fainted, falling off of the chair. Emergency services were called and he was determined to be okay.
3 inch redness on the injection site; Rash on injection site; Swelling on the injection site looks like half a baseball size/bumpy injection site; Hard on injection site; Injection area is firm/ Painful to touch; Hot on the injection site; Itching on the injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE PRURITUS (Itching on the injection area), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitation. Concomitant products included METOPROLOL for Palpitation.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection area). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site), VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site), VACCINATION SITE INDURATION (Hard on injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch). On 15-Jan-2021, VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) and VACCINATION SITE INDURATION (Hard on injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch) outcome was unknown and VACCINATION SITE PRURITUS (Itching on the injection area) and VACCINATION SITE RASH (Rash on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
doses given after date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided
Injection site soreness..trouble lifting arm...pain from right under left ear, back of neck to elbow and under arm. Tingling in left hand & fingertips.  One month later, all except injection site soreness is still present.
Papulomacular rash on trunk and upper extremities on Day 11 after MMR II vaccine.
Purple hands and feet extremely painful., Reactivated EBV and after 2 different treatments still unable to rid of it.
RED PLATELETS ON BACK AND LEFT LEG; This spontaneous report received from other manufacture AbbVie, and the patient was enrolled in non-Company sponsored solicited program Facilitated Collection and concerned an 8 decade old elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 1) (suspension for injection, intramuscular, batch number and expiry date was not reported) dose, 01 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced red platelets on back and left leg (dose number in series 1). Laboratory data (dates unspecified) included: Platelet count (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from red platelets on back and left leg. The patient received pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2), (form of admin: unknown, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported 1 total for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2). This report was non-serious.
On 10/3/99, the pt developed a pruritic rash all over his legs. The pt was examined by his physician and dx with probable Henoch-Schonlein purpura. It was reported that the pt was exposed to poison ivy one week earlier.
Injection site is sore, my body feel achy.  101.2 temp. It is down to 99.6 at 2:00 pm My joints feel like a dull pain.
Sudden hearing loss in both ears 5 days after 2nd vaccination.; inflammation; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 46-year-old via an unspecified route of administration in the right arm on 29Apr2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included meniere's disease. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 46-year-old on 09Apr2021 at 10:30 AM in the left arm for Covid-19 immunisation. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), both indications and therapy dates were not reported. The patient did not have other vaccine in four weeks. The patient received the vaccine in a doctor's office/urgent care. On 04May2021 07:30 AM, the patient experienced sudden hearing loss in both ears 5 days after 2nd vaccination. The event resulted in doctor or other healthcare professional office/clinic visit and received the treatment of steroid to relieve inflammation (04May2021 07:30 AM). The patient has not been tested post vaccination. The outcome of the event sudden hearing loss was recovering while the outcome of the other event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash on legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on legs and arms) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (rash on legs and arms). At the time of the report, RASH (rash on legs and arms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient received expired dose of the Moderna vaccine; vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided  A part-time Pharmacist called 30SEP2021 to report that expired doses of the Moderna vaccine was administered to 25 patients.  This was patient's 1st dose. The vials were in refrigerator for over 30 days.     Lot number(s) 037F21A, Expiration date: 01FEB2022~ Number of doses/vials - 27SEP2021 1 vials of 14 doses, 29SEP2021, 1 vial, 11 doses Date the vial was initially stored in the refrigerator:   24AUG2021 Date(s) of administration of vaccine, 27SEP2021 and 29SEP2021 Did the vial undergo any temperature excursions? No If yes, go to "temperature excursion" section and ask list of questions - N/A   This case was linked to MOD-2021-338604 (Patient Link).
Patient experienced chest pain after administration of vaccine- was told from Patient First that he experienced muscle ache in chest - After administration of Ibuprofen, patient is feeling much better.
Patient received 2nd dose of primary series of COVID vaccine 8 days after her 1st primary dose (per pharmacy instruction). Reports s/s started ~15 mins after receiving vaccination; redness, swelling at the site. Reports rash from shoulder to elbow. Describes swelling as moderate to severe and states "it looked like fluid under the skin." Patient with GI s/s x3 weeks (nausea, vomiting). Fever x3-4 days, highest temp was 103*F. Patient treated s/s using Tylenol, Ibuprofen, Zofran, Dayquil/Nyquil. S/s resolved after ~3 weeks of treating.
Patient felt significant tachycardia lasting for approximately 12 hours. She also felt short of breath.
Initial information and follow up has been received from a nurse concerning a 26 year old female who on 22-APR-2008 was vaccinated in the left deltoid with her third dose of GARDASIL (lot# 659964/1978U0. On 22-APR-2008 the patient stated that she developed a white area around the injection site from the last two injections. The nurse did see a vague white area- half circle to the left of what looks like the needle stick. Also looks like white vague outline of a bandaid. The patient sought unspecified medical attention and her outcome was not reported. On 14-SEP-2007 the patient was vaccinated in the left deltoid with her first dose of GARDASIL (lot# 658554/0928U). On 16-NOV-2007 the patient was vaccinated in the left deltoid with her second dose of GARDASIL (lot# 659437/1266U).
Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAR-2023, the patient received the 2nd dose of Havrix 1440. On 08-MAR-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 9-Mar-2023 The reporter  consented to follow-up via postal. The patient received an expired dose of Havrix, which led to expired vaccine used.
Arm felt sore and heavy immediately after administration; soreness improved. Today woke up with burning sensation, warmth to injection site and  large raised rash around injection site.  Rash measured 265cm x 295cm
Information has been received from a licensed practical nurse through the Merck Pregnancy registry concerning a 19 year old female with no previous pregnancies and no significant past medical history, who on an unspecified date during her first trimester of pregnancy was vaccinated (given by her primary care physician) with GARDASIL (lot number not reported). On 17-JUN-2008 the patient was treated with 1 gram of ZITHROMAX for infection. The patient was put on prenatal vitamins (unspecified) QD. On 22-JUN-2008 the patient underwent an ultrasound indicated for dating, which showed that she was 9 weeks and 3 days. On 12-JUL-2008 the patient underwent MSAFP which was negative. The reporter noted the patient's estimated delivery date as 22-JAN-2009. The patient's LMP was approximately 17-APR-2008. Additional information has been requested.
Received SHINGRIX vaccine subcutaneous instead of intermuscular. Felt feverish with chills. Severe injection site swelling, hot to touch, and pin-like pain. Called Dr. and she prescribed antibiotics and ibuprofen. Will see Dr. tomorrow if symptoms don't improve.
Pt received first dose of Moderna COVID19 Vaccine Lot 029L0A.  History of allergies and anaphylaxis to pollens and shellfish.  Cleared to receive vaccine by her provider.  Pt pre-medicated with Zyrtec earlier today.  Patient observed for 30 minutes.  Cough started without difficulty breathing.  Pt went to her office, used her inhaler.  Symptoms continued, pt self administered Epi pen.  Observation RNs notified.  Pt taken to ED, ambulatory for additional treatment. Monitored for 4 hours then d/c'd home
Received the smallpox vaccination on 11 July. Last night my temp was 103.0, I had a HA, nausea and vomited once. I took Tylenol and fever went down to 101.0. The headache now hurts so bad that I cannot sleep. Two hours ago my temp was 101.0, so I took ibuprofen 800 mg. The nausea is gone and I have not vomited again. I can drink fluids well, 3 canteens so far today. No blurry vision, neck stiffness or pain. The SPV site has erythema extending about an inch around it and tender. Axillary nodes tender, not enlarged. I called our family practice clinic and they have no appts. They said to call back if my vision got blurry or my neck got stiff. Seen at ED. Temp came down to 101.2 after taking ibuprofen. Dx cellulitis---given Bactrim.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 21-MAY-2014 the patient was vaccinated with single dose ZOSTAVAX (lot # J000443, expiry date: 11-APR-2014) subcutaneously. The patient was vaccinated with ZOSTAVAX which was expired on 11-APR-2014 and no adverse effects were reported. The outcome of the patient was inadvertently administered ZOSTAVAX on 21-MAY-2014 that had expired on 11-APR-2014 was unknown. Additional information has been requested.
This spontaneous report was received from a nurse regarding an 11 year old male patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route were not specified). The nurse stated that the patient may also had received a dose of an Hepatitis B vaccine (manufacturer unspecified) at the same office visit. The nurse reported that the patient experienced a vasovagal reaction, and fainted after receiving his first dose of GARDASIL. The patient recovered and then fainted a second time while still in the physician's office. It was reported that the patient is now fully recovered. No treatment information was reported. The reporting nurse did not assess the causality between GARDASIL, and Hepatitis B vaccine (manufacturer unknown) and vasovagal reaction and faint. Additional information has been requested.
I developed a gluten allergy; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Apr2021 at 14:00 (Lot number: unknown) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Allergic reaction to analgesics" (unspecified if ongoing), notes: Known allergies: NSAIDS. There were no concomitant medications. Past drug history included: Aspirin, reaction: "Drug allergy", notes: Known allergies: aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: left arm, Administration time: 13:00), administration date: 09Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: GLUTEN SENSITIVITY (non-serious) with onset 04Jun2021, outcome "not recovered", described as "I developed a gluten allergy". The event "I developed a gluten allergy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of gluten sensitivity.  Additional Information: The patient did not receive any other vaccines within four 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. Treatment taken as a result of gluten sensitivity included Daily Benadryl.   The lot number for BNT162b2 was not provided and will be requested during follow up.
I woke up and thought I was going to die. I tested positive for COVID-19 on December 26, 2022. I received Paxlovid. On January 2, 2023, I retested for COVID-19. The result was negative. I also tested positive for Flu and a UTI on March 14, 2023. I was treated for both, and I'm fine.
Patient complained of a swollen arm on morning of 4/27/07 after he awoke. No pain in arm, just swelling from elbow to shoulder and color of upper arm was "splotchy". Arm felt hard to the touch up around the shoulder area according to mother. No fever noted. Mother gave him Benadryl and applied a cool pack. He was seen by his Pediatrician that day and she started him on an antibiotic. By 4/30/07 his arm appeared "normal" to mother.
Sweats, sore throat, fatigue intitially.  Followed by severe stomatitis, gingivitis, glossitis, labialitis.  Appearance of primary HSV but no risk factors.  Was given Valtrex trial just in case.
The patient is an 84-year-old gentleman who presented on July 13, 2012, with unresponsiveness. He had been doing well up until July 9, when he had a minor dog bite in his left calf. The following day he went to get a tetanus shot and was also placed on antibiotics. However, following this seemed to have dizziness and become weak. He fell twice and after the second fall was not able to get up on his own and thus ambulance was summoned. He was taken to the ER where he was admitted. While at the hospital, he underwent CT scan of his brain which showed no acute abnormality. He also had a carotid duplex scan which did not show any significant abnormalities. Lower extremity Doppler showed a nonocclusive thrombus in the right mid lower femoral vein which was thought to be chronic. During his hospital stay where he continued to have difficulty with walking. He could stand briefly but not walk then he developed speech disturbance, became progressively less responsive. At the time of transfer, he was completely unresponsive and unable to give history and subsequently was transferred to another hospital for further evaluation. While here he underwent an MRI of the brain and shortly after admission had an EEG and lumbar puncture. Infectious disease was consulted. He was intubated given his altered mental status and inability to protect his airway. Multiple studies were obtained. LP showed no significant findings. Several serologies were sent including Q fever. He was able to be extubated on July 17, 2012, then from that point did progress in terms of his mental status as significantly improved. He was still severely deconditioned at time of discharged and will need subsequent therapies for strengthening. His Q fever came back positive after he was dismissed back to the swing bed. He was maintained on multiple antibiotics and antivirals and ID did recommended completing a 2-week course and actually would have been on doxycycline for 3 weeks. This would be sufficient for his Q fever. As mentioned at time of discharge, he was deemed hemodynamically stable. His mental status had improved. He was up to the chair with assistance of 2 with PT. He remained on oxygen but a previous history of nocturnal oxygen was used. Vital signs at time of discharge include temp 98.2, pulse 83, respirations 24, blood pressure 145/68, O2 saturation was 92% on room air.