chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of menstruation after only 14 days (instead of 28 days)  - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly).  Not a normal cycle; severe debilitating cramps like giving birth; headache; pain; Gained 5 lbs the day of the vaccination each time; swollen legs; This is a spontaneous report from a Non-contactable Consumer. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 26Mar2021 14:30 (age at the time of vaccination 46-years-old), as a single dose; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 16Apr2021 14:30 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to CYP2D6 (ultra-fast metabolizer), codeine cannot take codeine, and doxycycline. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 26Mar2021 17:00, the patient experienced Onset of menstruation after only 14 days (instead of 28 days) - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly), Not a normal cycle, severe debilitating cramps like giving birth, headache, pain, Gained 5 lbs the day of the vaccination each time, and swollen legs. On an unspecified date, the patient underwent lab tests and procedures which included Weight increased: 5lbs. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as a result of adverse events which included pain medication and rest. The outcome for all the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
At approximately 5pm on 3-10-08 while sitting in high chair, patient started shaking all over, eyes rolled back in his head and he began foaming from his mouth.  Patient had 5 similar events within a 30 minute time period, with limpness in between episodes; prior to EMS arrival.
Cellulitis R thigh and rash which seemed consistent varicella rash  14 days after varicella vaccine. Treated with CEPHALEXIN 250/5ml 1 tsp BID x 5 days.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/2/2022 SECONDARY PULMONARY HTN
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 42 years old female patient who experienced Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain while she received vaccine FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 11-Oct-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA (expiry date: 30-Jun-2019) in right arm. On unknown date, the patient started to feel sick, was achy, wasn't feeling good, skin felt like I was on fire, face was peeling, skin hurts if anything touched, it was reported that there was soreness at the injection site and that the burning was in her face and neck post vaccination with FLUZONE QUADRIVALENT. No lab test was reported. Final diagnosis was Pain of skin, Burning sensation, vaccination site pain, Skin exfoliation, Feeling hot, Malaise and pain. As corrective treatment, patient received Prednisone which she took for three days. Outcome of the events was recovering (reported that there was relief in her symptoms). Documents held by sender: none.
Pfizer BIO-NTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer BIO-NTech vaccine on 2/13/21, 3/06/21 and 12/03/21. Presented to ED 7/30 c/o fatigue x3days. In ED, fever of 100.4, spO2 91% on R and RR 26 and hypotensive. Admitted for Covid PNA w/acute resp failure and AKI. Cr was 1.41, lactic 0.7. Required High Flow oxygen as well as bipap to maintain oxygenation. He had an acute decline overnight on 8/3 and was transitioned to DNR/DNI. Expired on 8/3/22. Treated w/azithromycin, ceftriaxone, vancyomycin, aztreonam, levofloxacin, remdesivir, tocilizumab, and decadron.
Case number PHEH2015US021631 is an initial spontaneous report received from a nurse on 15 Oct 2015. This report refers to a 26 year old female patient who was a nurse. Past medical history and concomitant medications were not reported. It was reported that on 11 Oct 2015 she accidentally stuck herself with the smaller of the two needles that comes with RABAVERT (batch number: not reported) after injecting the patient. The nurse was trying to recap the needle when she got stuck. She did not report the incident until 13 Oct 2015. The reporter stated that the needles provided with RABAVERT were not safety needles which allowed the incident to occur. The outcome, seriousness and causality of the events were not reported. Follow-up information received on 22 December 2015: In 2015, HIV test, RPR test, Hepatitis B and C antigen test were negative. On an unknown date, the outcome of the accidental needle stick was recovered/resolved.
Tingling and numbness in the hand and arm of the same side of injection (left); Tingling and numbness in the hand and arm of the same side of injection (left); This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an intramuscular route of administration in the left arm on 05Aug2021 at 15:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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 vaccination. The patient did not receive any concomitant medications. On 05Aug2021 at 20:00, the patient experienced tingling and numbness in the hand and arm of the same side of the injection (left). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events tingling and numbness in the hand and arm of the same side of injection (left) were not recovered at the time of this report.
First days just very little pain. Starting about a week after the shot was given a dime size red swollen, hard area formed around the injection site. The next day it was slightly bigger and also developed a rash like tiny goosebumps. The following days including today the area got bigger but less hard, although still red and swollen. It is now about 2 inch in diameter but irregular. Slowly the lymph node just below the armpit has also started swelling and is hard and painful to the touch.
Patient was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement they are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Pfizer vaccine that was provided to the patient was improperly stored in the freezer for greater than 14 days.
Extreme weakness, body aches, fever/chills, Pain rating #8 back pain & headache. Unable to hold cell phone. Awoke, approx 0800, with symptoms. With great difficulty, walked from bedroom to couch, getting phone along the way to call husband.
With previous two COVID-19 Vaccines, injection site was sore 2-3 days/first two doses her arm was sore for about a week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101426931 (Pfizer).  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6208) at the age of 71 years as dose 1, single and administered in arm left, administration date 02Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (Flu shot, 3-4 weeks ago. , /LOT/EXP: Unknown, Injected into left arm), for immunization, reaction(s): "no adverse effect". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "With previous two COVID-19 Vaccines, injection site was sore 2-3 days/first two doses her arm was sore for about a week".  Additional information: With previous two COVID-19 Vaccines, injection site was sore 2-3 days. She didn't look at her arm to see if it was red, just figured it was sore. With the first two doses her arm was sore for about a week but that she never really noticed any swelling or redness but that it could have just been due to not looking at it. AE(s) did not require a visit to Emergency Room or Physician Office.  Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a physician concerning an 8 week old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 06-AUG-2014 the patient was vaccinated with her first dose of ROTATEQ (Lot # not provided) 2 ml, oral. Concomitant therapies administered on 06-AUG-2014 included RECOMBIVAX HB (dose, route and lot # not provided) and PENTACEL. Patient's mom reported that patient started having urticaria within 12-16 hours of receiving vaccines, on approximately 06-AUG-2014. Patient was not seen by physician for that first urticaria reaction and urticaria subsided quickly (on an unknown date in 2014). Then, patient received her second dose of ROTATEQ (Lot # not provided) 2 ml, oral, on 08-OCT-2014 and again within 24 hours of receiving ROTATEQ, the patient developed urticaria. Following day, patient was brought into the office and physician examined her and diagnosed urticaria. By the time physician saw the patient, urticaria has already started to subside and patient was not given any treatment. There were not laboratory tests or diagnostic studies performed. At the time of the report, the patient was recovering from urticaria. Additional information has been requested.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Information has been received from a physician concerning a 56 year old female patient with a past history of shingles and no allergies who on 03-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# reported as "1824Y"). Concomitant therapy included LAMICTAL. It was reported that the patient had been experiencing shingles on her left elbow every 3 weeks after getting ZOSTAVAX (Merck). Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Follow up information has been received which reported that they obtained a sample from the patient and they would be sending the sample on 13-SEP-2010. Follow up information has been received from the physician concerning the 56 year old female patient with a history of chickenpox as a child who on 03-JUN-2008, in the morning, was vaccinated subcutaneously with a 0.5ml dose of ZOSTAVAX (Merck) (lot#659326/1824U) into her deltoid. There was no illness at time of vaccination. Concomitant therapy also included VALTREX. On 09-SEP-2010, in the morning, the patient developed vesicle rash at the right trunk and abdomen. There were less than 10 lesions. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 3 on a scale of 1 to 10. She had no other systemic symptoms. No rash occurred at the injection site or elsewhere within 42 days of the vaccination. No photos had been taken. At the time of this report, the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild type (WT) VZV strain or the Merck vaccine strain. On 10-SEP-2010, vesicle lesion sample was collected and on 13-SEP-2010, the sample was sent to laboratory. The PCR result for the vesicular specimen was negative for varicella zoster virus, B-globin DNA was amplified. Additional information is not expected.
he developed a fever that lead to acute confusion which led to acute worsening of chronic weakness which required hospitalization
The injection site became very itchy, puffy/raised, and red in the evening on 3/30/21.  As of this morning (3/31/21), it is no longer itchy, just puffy/raised and red.
Possible Rubella infection after receiving 2nd dose of MMR. 2nd vaccine received 2/22/16. Began to have skin rash and fever on 3/24/16. Diagnosed by PCP with Rubella infection. Blood work done by PCP. MEDROL Dose Pack stated 3/26/16. Continues to have rash.
worsened psoriatic arthritis joint pain which did improve over time but flared again after 2nd vaccine and 3rd booster injection. Has not completely resolved
Pt said she got itching and rash on back of head, chest and other areas. But not at the site of injection,  little bit on arms.
she has slept all Sunday and Monday/I could not wake myself up on Sunday; experienced extreme fatigue; she has zero energy; hard and swollen lymph nodes; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 (Lot number: ER8732) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing), notes: I have chronic pain. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ZOLOFT; LAMICTAL; LIPITOR [ATORVASTATIN]; OXYCODONE taken for pain. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 16May2021, outcome "not recovered", described as "she has slept all Sunday and Monday/I could not wake myself up on Sunday"; ASTHENIA (non-serious) with onset 15May2021, outcome "not recovered", described as "she has zero energy"; FATIGUE (non-serious) with onset 16May2021, outcome "unknown", described as "experienced extreme fatigue"; LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "hard and swollen lymph nodes"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of hypersomnia, asthenia, fatigue, lymphadenopathy, vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Since  day 2 post vaccine I have had a constant metallic taste in mouth, weird feeling inside nostrils and fatigue.
Pain in my left arm/shoulder area-unable to move arm without terrible pain and no mobility of arm. Visited internist, 2 orthopedic doctors. Prescribed inflammatory meds/prescription, then x-ray and cortisone shot-tendonitis. Nerve damage in arm.
I may have started bleeding on July 5th because I called and then went to the Gyn on July 6th. I was having bleeding a lot. It stopped and then I went back again for the other transvaginal ultrasound and they said it wasn't developing and then they said come back again and there was no heartbeat and then they said come back again 8/13 it was a miscarriage and on the 21st of Aug they gave me pills to clear everything out and 8/25 said it was all clear. Pregnancy history: 1st pregnancy; estimated due date 3/10/2022. I am still having cramping but it is probably the uterus resetting, the doctor says it can take awhile. Urgent care visits, 2 visits, had to go because of cramping.
Patient recieved Zostavax (LOT# 1125AA) exp date: 10/12/12) on 1/24/12 in Left Deltoid.  Approx. 3-4 days later patient complained of ache in back and right arm. Then 2/2/12 patient developed papulovesicular lesion over right back following the dermatone.   Patient presented to office 2/3/12 with above signs/symptoms. She was given Valtrex 500mg q8h.
pt exp temp 102.5 w/in few hr p/ inj; temp increased to 105 and pt developed gen sz; FH sx in mtr and epilepsy mtr uncle;
Brought me out of menopause. I had not had a menstrual cycle for 14 months. 4 days after I had my first Covid-19 vaccine shot, my menstrual cycle resumed. Never did I have cramps with my cycles prior. Now that my menstrual cycle resumed after the vaccine shot, I have tremendous cramping. Large volumes of blood. Previously, my periods were very light. My hormone levels are still not balanced.
pt recvd vax & observed a rash; also devel inner ear infect rt;
Persistent constant ringing in both ears at same consistent pitch. Onset within 2 hours of vaccine injection and continuing now as of 2 weeks later
I woke up at 3 am with terrible head, body and eye pain. My right arm is very sore and cold feeling, and I am extremely tired. (more than normal even in pregnancy).   I am currently 10 weeks pregnant, due date is 04/26/2022.  My doctor advised a Tylenol regimen, which I began at 8am this morning. Symptoms are lessening, with the Tylenol, but I thought it important to report them.
the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before; immediate swelling in the area; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area). At the time of the report, PAROSMIA (the injection arm has a different smell than the other/musty smell/something that I never felt before/never had before) and VACCINATION SITE SWELLING (immediate swelling in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other concomitant medication  provided by the reporter The Treatment information was not provided.   This case was linked to MOD-2021-147695 (Patient Link).
The female patient is 16 years of age and received a booster vaccination without double-checking at our clinic. It is also 5 months rather than 6 months window.  The booster has yet to be approved for this age.
Dose was given after expiration date; Expired vaccine was stored in refrigerator and then administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered). On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Vaccine was placed in refrigerator on 18-Oct-2021. Vaccine did not undergo any temperature excursion. No adverse events were reported.
Diagnosed with painful case of gout. First time in life. Prescribed prednisone for 1 week and pain gone, swelling mostly gone as of 2/26. But on 2/28 gout returned and very painful/
neutropenia of unclear origin or significance noted on labs 2/11/21 WBC 2.2, NT count 35%, other cell lines within normal limits last labs done was > 1 year prior and had normal WBC count 6-7 repeat labs 2/22/21 WBC 1.9, NT 25%, ANC 570 Asymptomatic, no infections, no fevers
My throat was very sore and scratchy, my eyes were very itchy and my right arm was very sore; it felt like the muscle was drawn up tightly. My arms, neck and body except for lower half, itches very badly; like it's skin deep.
this is one of 5 pt who recv vax & devel a nodule @ the inj site 24 to 48hr later;the inj site nodule was 4 to 6 mm in diameter, red, warm, & tender;
Initial and follow-up information has been received from a licensed practical head nurse, concerning a mentally challenged female who in March 2007, was vaccinated with Gardasil. Almost immediately after the vaccination, the patient experienced pain, tingling, and slight paralysis going down the arm. The licensed practical head nurse thought the complaint of "paralysis" was a result of having to hold the patient down. Subsequently, the patient recovered from the pain, tingling and slight paralysis going down the arm before she left the office. Upon internal review, slight paralysis going down the arm was considered to be an important medical event. This is one of two reports from the same source. No further information is available.