chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning in vaginal / perineal area, followed within a few days by numbness, burning, pins and needles in legs.  Diagnosed as transverse myelitis.
Symptoms began 4 days after second Pfizer shot.   +accelerated heart rate, chest pain, heart inflammation   I have been experiencing this intermittently with a few bad episodes since June 11, 2021. So over four months now. Symptoms have improved but still happening sometimes.
Esporádic  severe headache pressure pain, treatment: Tylenol Traquea swollen and dry, unable to breath only while sleeping  head up. Treatment: drink some water and sleep on the side
Initial report received from health care professional on 11 Jan 2010: This three year old boy received a 0.5 ml of Novartis H1N1 vaccine (batch no. 1013266P) at deltoid on 09 Jan 2010. No other information was reported. After internal review on 12 Jan 2010 of the data received on 11 Jan 2010, it was identified that the suspect drug has been wrongly coded. The suspect drug has been recoded to S-OIV FLUVIRIN.
Myocarditis: began day after shot. Heart palpitations/racing heart feeling. Due to previous anaphylaxis with vaccines, thought it might be anxiety. Took Xanax to calm down, but heart palpitations persisted. They continued through August.
fever for 12 hours, chills, body ache. arm is swollen and red, itchy. feels hot. this is the same lot # that was in the news, that is why I am reporting it.
horrible, debilitating Tinnitus in both ears. Constant. it effects my hearing and ability to work/communicate/sleep.
Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 11:30 (Lot number: EL1283) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lethargic".  No follow-up attempts are possible. No further information is expected.
lump where shot was given; lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.; now is reddish-brown like a bruise; stayed in bed all day; became sick for 3 days; back of her neck was hurting; got hot and cold; had chills; top of her head was hurting/headache; injection site pain under left arm; Accidental overdose; Off label use; got nervous; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (got nervous), ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold) and BEDRIDDEN (stayed in bed all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (medication sensitivities including latex).    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced NERVOUSNESS (got nervous), ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use). On 15-Oct-2021, the patient experienced ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm). On 16-Oct-2021, the patient experienced BEDRIDDEN (stayed in bed all day). On 18-Oct-2021, the patient experienced VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.) and CONTUSION (now is reddish-brown like a bruise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qid. On 14-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use) had resolved. In October 2021, ILLNESS (became sick for 3 days) had resolved. On 18-Oct-2021, BEDRIDDEN (stayed in bed all day) was resolving. At the time of the report, NERVOUSNESS (got nervous), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.), CONTUSION (now is reddish-brown like a bruise), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm) outcome was unknown.            Concomitant medications were not reported.  Patient lump was about the size of a dime. The patient has gained 25 lbs.   This case was linked to MOD-2021-355953 (Patient Link).
Redness at site that expanded, warmth at site, fever of 100.8 and 101.6, lump noted at site and swelling at site. Cefdinir 300 mg 1 capsule PO BID X 10 days for cellulitis.
I have been tracking my ovulation over the past several months by way of LH ovulation test strips as I am actively trying to get pregnant. I have always had a LH peak each month. I have never missed a LH peak.  The day after receiving my first dose of the covid-19 moderna vaccine, my LH peak which was on the rise had a sharp decline on 7/31/21.  I am not sure if this is due to chance, but I am very upset this means I am likely not going to be able to get pregnant this month. Feel free to reach out and follow along. I am eager to see if getting the second dose at the end of the month will prevent next expected ovulation. My employer is mandating the vaccine in order to remain employed. I was also encouraged to get the vaccine by my healthcare provider. I am pro vaccines, but if this did not occur by chance, I wanted to make sure it was documented.
COVID 19 Treatment; COVID 19 Treatment; positive 9 days after paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high bmi" (unspecified if ongoing). There were no concomitant medications. No known allergies. There were no concomitant medications (No other medication in 2weeks). The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "positive 9 days after paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) High; SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 2 days after paxlovid; (Aug2022) Positive, notes: positive 9 days after paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 28Jul2022 to 01Aug2022, tested negative 2 days after paxlovid and positive 9 days after paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received FLUARIX Quadrivalent 2014/2015.  On 20th OCTOBER 2014, the patient received the 1st dose of FLUARIX Quadrivalent 2014-2015 season. In October 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: FLUARIX QIV and BOOSTRIX. This report is for FLUARIX QIV. Both vaccines got down to 30.6 deg F from 20 OCTOBER to 23 OCTOBER 2014. Vaccine was not stable because it was too cold. Then patients were vaccinated during this time period with these vaccines, both adult and pediatric. No demographics or lot numbers were available at the time of this report as they are researching who was vaccinated with each vaccine.
Menstrual cycle was early by 3 weeks; This is a spontaneous report from a non- contactable consumer, the patient. A 16-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 27April2021 at 15:00 (16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06May2021, nine days after vaccination, the patient experienced a menstrual cycle, which was early by 3 weeks. No therapeutic measures were taken for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX (batch number 47JA3, expiry date 12th May 2020) and (batch number 72AA3, expiry date 10th October 2021) for prophylaxis. On 29th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 30th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain (serious criteria clinically significant/intervention required) and injected limb mobility decreased (serious criteria clinically significant/intervention required). The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. The batch number (72AA3) and expiry date (10th October 2021) for adjuvant. The patient was complaining of injection site arm soreness. It was lasted for 3 to 4 days but had continued intermittently off and on since then. The patient treated with TYLENOL, but had no relief. The reporter consented to follow up.
Dizziness; Diarrhea; Vomiting; Prevented to move head, get out of bed; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 6 days after receiving Shingrix, the patient experienced dizziness, diarrhea, vomiting and mobility decreased. On an unknown date, the outcome of the dizziness, diarrhea, vomiting and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the dizziness, diarrhea, vomiting and mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR183381   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: On an unknown date in 2020, the patient received his first and second Shingrix doses six months apart.  About 6 days after each dose of Shingrix the patient experienced dizziness, diarrhea and vomiting (adverse events recovered). The dizziness prevented him from moving his head or getting out of bed for 3 or 4 days. The dizziness gradually improved then resolved after 7 to 14 days. The vomiting and diarrhea lasted for 3 or 4 days. The patient had nothing else to report. The patient did not want to be contacted. Declined to provide his mailing address. The reporter did not consent to follow-up. For tolerance to the 2nd dose refer case US2022AMR183381.; Sender's Comments:  US-GSK-US2022AMR183381:Same reporter
9MAR97 AM felt aching all over;10MAR97 stiff joints;no fever;
THE PATIENT RECIEVED A JANSSEN VACCINE THAT WAS PAST THE 6 HOURS BEYOND USE TIME ONCE PUNCTURED; THE VACCINE WAS ADMINISTERD 6 HOURS AND 50 MIN AFTER PUNCTURED BUT THE PATIENT HASNT HAD ANY ADVERSE REACTIONS AT THIS TIME RELATED TO THE ACCIDENTAL VACCINATION
stiffness in the arm; fever of 102; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PYREXIA (fever of 102) and MYALGIA (muscle aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 046B21A and 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PYREXIA (fever of 102) and MYALGIA (muscle aches). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PYREXIA (fever of 102) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102.         No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-375520, MOD-2021-375542 (Patient Link).
Presented to ED w c/o Intermittent Confusion, Fever, Chills, Generalized Weakness; acute COVID infection prior to arrival; admitted for acute toxic metabolic encaphalopathy d/t COVID infection but asymptomatic w/COVID.
This spontaneous report was received from an office manager referring to a 4-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010637: US-009507513-1901USA010788: US-009507513-1901USA010790.
Headache, Fever, fatigue, fever 100.1 Narrative:  Other Relevant History:
Chills, Fever, 104, Body Aches, Sweating, Headache, Nausea, Tired, no appetite, Large rash under the injection site
patient received the Varicella vaccine on 4/21/23, on 4/30/23 the family noticed a rash on his right upper leg close to where the injection was give. Patient called into the office on 5/1 and appointment made with Dr. on 5/2. Patient was seen in office on 5/2 for the rash and diagnosed with Adverse reaction caused by the varicella virus live vaccine. At time of appointment the rash was still only present on the child's upper right leg.
initial arm soreness resolved w/in 48 hours. but starting today 4/27/21 8 days after vaccination, the site is quite swollen, red, hot, itchy, and the lymph node in my associated arm pit is swollen.
weakness from neck down to knees upon movement; no appetite; numbness in right hand; swelling in hand; no energy; unable to grip anything with right hand; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand) and ASTHENIA (no energy) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand), ASTHENIA (no energy) and MONOPARESIS (unable to grip anything with right hand). At the time of the report, ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand), ASTHENIA (no energy) and MONOPARESIS (unable to grip anything with right hand) outcome was unknown.             No relevant concomitant medications provided. No relevant treatment information provided.
Pt reports after receiving 2nd covid-19 vaccine in May her menstrual cycles have been irregular and heavier and she sought care in our office (OBGYN) to control her bleeding.
On the morning following my injection, I experienced mild diarrhea and nausea.  I was unable to hold down my normal morning medication without vomiting until after I took some bismuth subsalicylate pills (generic for Pepto-Bismol).  I also took some lopermaide pills to calm my digestion.  I was able to perform most of my daily functions after that, but felt like I had been punched in the stomach for about 24 hours.  I was completely recovered by Sunday morning, 12/12.
1. after vax arm began to get sore, then red on outside of arm. warm to the touch 2. Soreness was worse, hotter and swollen. 3. Began icing arm, 2 days later took more Tylenol, still sore,  red and swollen.  4. 3 days redness had spread to elbow area. 5. 4 days began to get better.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA000697: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
The day after receiving the bivalent Pfizer vaccine, I noticed a rash on my right inside forearm. It looked like contact dermatitis. It didn't look like poison ivy. A few days later, it turned into poison ivy. I went to my NP and she prescribed prednisone. I took that for three weeks. After completing the prednisone I was diagnosed with a sinus infection. I was taking OTC medications, but it turned into bronchitis. I was given doxycycline, yesterday, for the bronchitis.
One week after vaccine a red, swollen, painful, itchy patch appeared at injection site.  It has lasted over a week so far.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended.  Patient presented pain at injection site during 24 hours.
Localized skin reaction to varicella vaccine in the back of left arm. Small area of redness noted. No fever, chills, malaise, difficulty breathing noted or reported.
Information has been received from a physician concerning a 73 year old female patient with a history of shingles "on her left side in the S2 region of her body in September, 2007" who in approximately March 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported), 0.65 ml. Physician stated that in February 2011, the patient presented with acute zoster in the same region, on her left side in the S2 region of her body. The patient was treated with an unspecified anti-viral and an unspecified pain medication. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Follow-up information was received from the physician concerning a female with allergy to sulfa, atenolol and statins, diabetes, hypertension, chronic obstructive pulmonary disease (COPD), hypothyroidism, atherosclerotic cardiovascular disease and a history of an initial event on 12-SEP-2007 on the S2 left HSV outbreak treated with VALTREX who in February 2009 (previously reported as approximately March 2009, by the physician), was vaccinated with the first dose of ZOSTAVAX (Merck), intramuscularly in the left deltoid at a pharmacy. The physician stated that on 23-FEB-2011 (previously reported as in February 2011) at 10 a.m., the patient was diagnosed with a second S2 left HSV outbreak and since 16-FEB-2011, the patient required a high dose of acyclovir 800 mg five times a day for 10 days. The second S2 HSV outbreak was considered by the physician to be an other important medical event. Additional information has been requested.
Persistent numbness and tingling from to of left shoulder to tip of fingers lasting hours at time.
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned two patients of unspecified age, race and ethnicity. The patients height, and weight were not reported. None of the patients had prior issues. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. One patient died within less than 48 hours and another died 5 days after. It was unspecified if an autopsy was performed. As per the reporter, "3 people within 2 miles of me died after the jab. One less than 48 hours. One 28 years old and the other 5 days after. None had prior issues" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211154559.; Sender's Comments: V0: 20211154617-COVID-19 VACCINE AD26.COV2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH