chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lip and tongue numbness/tingling lasting 5-6 hours, resolving spontaneously
Unable to lift arm w/in 30 min. of injection. (Left arm) intense pain shoulder to fingers w/in 6 hrs; intolerant to even light touch of clothing. Full body pain (most intense on left side) w/in 12 hrs; difficulty walking w/in 24 hrs. Symptoms gradually subsided btn day 5-13. Not yet completely resolved on left side.
Fever for three days, 6cm induration, heat and erythema over right thigh.
Nerve pain on left side of head/Nerve Pain Left Scalp; tongue and throat swelling; tongue and throat swelling; face numbing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left (also reported as Left Upper Arm) on 17May2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Nerve pain on left side of scalp from 09Sep2020 to 05Jan2021 (also reported stop date nerve pain left in January and came back immediately when the shot was administered I still have it). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medication in two weeks. The patient previously took cypro and experienced allergies (also reported as Known allergies: Cypro). It was reported that the patient experienced Tongue and Throat swelling, Face numbing & Nerve pain on left side of head on 17May2021 at 14:00 (also reported as 02:30 PM). It was added reported that the patient experienced Nerve Pain Left Scalp on 17May2021 at 14:00. The reporter considered the event Nerve Pain Left Scalp as serious (criteria: Important medical event) and resulted in physician office visit. It was further reported that: "Immediately upon receiving my 1st dose of Pfizer vaccine , my tongue swelled, my throat swelled, my face went numb and the nerve pain I had experienced 6 months prior came back. The nerve pain is constant to this day. My pcp and the infectious disease dept recommended, Do not get a 2nd dose of either pfizer or moderna. I am unsure of johnson & johnson too." The patient had no COVID prior vaccination:, however covid tested post vaccination (Nasal swab/ Rapid COVID test) on 09Sep2021 and was negative. The patient also went laboratory tests which includes: Covid-19 test on 19Mar2021 and 26Sep2021 all were negative. No treatment was initiated. The outcome of the events was recovered with sequel (also reported as Recovered with lasting effects); for the event Nerve Pain Left Scalp was not recovered.   Follow-up attempts are completed. No further information is expected.
Hoarse voice, itchy throat, tight chest, trouble breathing, difficulty swallowing, throat closing (happened sequentially in that order)
sore arm; extreme fatigue; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 12-years-old patient of unspecified gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiration date were not reported) via an unspecified route of administration on un unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, extreme fatigue, headache and nausea. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt pain from shot travel from arm to neck; severe pain in spine (mostly neck area) and painful headache (above the eyebrows) within a few hours of shot. Within 3 hours from shot, felt very nauseous. Injection site checked by NP - okay. Four hours from shot feeling very, very cold - shivering. After 6 hours from shot headache better and nauseous feeling gone, but pain in spine (from neck to lower back) remained for 2 days.
Arm being itchy at the injection site; Swollen lymph nodes in her arm and shoulder; Whole upper arm looked like there was red dye under the skin in an oval shape; Whole upper arm is sensitive; Eye started to swell up; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye started to swell up), LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced EYE SWELLING (Eye started to swell up). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eye started to swell up), LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt c/o sweats, chills, ha, vomiting, ears hurting, on 2/7/23 the night of vaccine
Information has been received from a registered nurse concerning a 12-month-old male with a history of respiratory syncytial virus infection (RSV) in which he was hospitalized for on 18-NOV-2006 and discharged on 19-NOV-2006, who on 23-AUG-2007 was vaccinated subcutaneous in the left arm with 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 658177/1012U).  On 05-SEP-2007 the patient developed a few vesicles filled with yellow fluid.  At the time of the report the patient's status was unknown.  The patient's vaccination records indicated the patient received 2 doses of IPOL (07-FEB-2007 and 11-APR-2007), 2 doses of DTP (17-JAN-2007 and 09-MAY-2007) and 2 doses of ACTHIB (2006 and 11-APR-2007).  It was also reported the patient's sibling had an adverse experience WAES # 0708USA04004.  Additional information has been requested.
weak; arm was swollen; big blotches; Arm swelled up; got really hard; got like a bruise; itchy; headache; feverish; couldn't move arm; felt like someone smashed it off/it hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen) and RASH MACULAR (big blotches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol. Concomitant products included SIMVASTATIN for Hyperlipidemia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm) and PAIN (felt like someone smashed it off/it hurts). On 17-Apr-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes in a female patient who received SHINGRIX for prophylaxis. On 22nd April 2018, the patient received the 1st dose of SHINGRIX. On 22nd April 2018, immediately after receiving SHINGRIX the patient experienced genital herpes. The patient was treated with Antiviral. On an unknown date, the outcome of the genital herpes was unknown. It was unknown if the reporter considered the genital herpes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient immediately had an outbreak of genital herpes which was treated with antivirals. The health care professional called to ask if we had any reports of patients having an outbreak of HSV-2 (genital herpes) after the administration of SHINGRIX. The health care professional did state that the patient received her 2nd dose of SHINGRIX on the day before reporting (on 1st July 2018) but so far, the patient had not contacted the health care professional that she had another outbreak of genital herpes yet after the 2nd dose of SHINGRIX. No further information was provided. The health care professional was calling us from home, and not from her work location, so she did not have any additional details to provide at the time of the call.
25 yo male who developed symptoms of hyperglycemia in Jan-March 2009. Admitted to Hospital (17-20 March) with DKA and diagnosed with T1DM. No family history of T1DM except for maternal cousin. No history of infections preceding diagnosis. Symptoms: Polydipsia/increased thirst, Polyuria/Increased urination, Fatigue.
she reports leg pain, went to ER for this, and Headache 8/10 10 days after vaccine
Patient's housemate,  called pharmacy 3/26/21 to report pt patient's sx.  3/25/21 approx. 11:00pm fever up to 100.9 F 3/26/21 approx. 9:00am severe abdominal pain, approx. 12:00pm vomiting x2, approx. 3:45pm pt clammy Pharmacist reviewed literature on FDA website regarding Janssen Vaccine ADE's. There was a very small percentage of pts that had appendicitis following vaccine. Although pt is 19.5 yrs old,  here  sx were also consistent with those experiencing MIS-C due to the virus. Pharmacist recommended pt to contact doctor immediately and follow his/her advice as to the need of further medical care. At 4:30pm 3/26/21 Pharmacist contacted pt to see how she was doing. Pt admitted feeling a little better and able to keep down soup. Pt stated that her provider told her sx were normal s/e of vaccine and that she received the vaccine too early, following 3/8/21 dx of COVID. Pt stated provider ordered meds for abdominal pain. Names unknown and not sent to our pharmacy.
No adverse event; Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 026C21A and FR2587) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021).    No concomitant medications were provided. The Patient reports no adverse events after the administration.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724228:(Bivalent Case)
pt recv vax 7MAR96 & 3-4hr later devel an inj site rxn affecting the entire thigh;the rxn resolved on its own;
Minor fever on Day 5-8 after the vaccine, then generally very lethargic/no energy from Day 8-10. On Day 11-13, noticed red spots popping up, first around his groin area, then most prominent on face where it looks like a minor form of measles.
Felt nervous; Felt "restless",; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep). At the time of the report, NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep) outcome was unknown.            No treatment information was provided.    This case was linked to MOD-2021-076761 (Patient Link).
Had shots 3/4/09 (MMR, VARIVAX, PCV, Hep A) had fever 3/7 (100-101) and 3/8, 3/9) developed rash on back and neck is cranky. Sat night 3/7 screaming. No appetite.
PT REPORTED NAUSEA AND VOMITING, AND FATIGUE. ACHING SORENESS ALL DOWN VACCINATED ARM (LEFT) X 3 DAYS. SHE FELT THIS WAS VERY SIGNIFICANT AS SHE HAD BOTH VACCINES IN SAME ARM.
Tested (+) for Covid-19 6/24/2022 PM via home test (iHealth COVID-19 Antigen Rapid Test) after rapid onset of Flu-like symptoms. Tested negative via same test kit 6/23/2022 AM. Exposed to Covid positive individual 6/17/2022.  Rx of Paxlovid pack beginning 6/25/2022.  Tested negative 6/29/2022 via same test kit.
Patient treated in our office 5/5/2021 for persistant tremors in bilateral hands since vaccinations recieved 2/13/21 and 3/13/21.  Patient referred to neurology for evaluation
Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fainted approximately 1 minute after administration of vaccine. Started as syncopal episode then patient started seizing - tonic/clonic. Patient was still seated in chair and seizing lasted about 1 minutes.  911 called.  BP 138/78. P 115.  Patient moved to cot after she was alert and oriented.  By the time paramedics arrived patient was awake and oriented.  She refused transport by EMS. She left with fiancé who was driving patient.
Information has been received from a physician concerning a 36-month-old male with no pertinent medical history and no known allergies who on 17-May-2007 was vaccinated subcutaneously in the left arm with a first dose of ProQuad (lot# 656941/0227U). There was no concomitant medication. On 17-MAY-2007 "the patient experienced cellulitis in left arm from shoulder to elbow receiving ProQuad". The patient was seen in the doctors office on 18-May-2007 for unspecified medical attention. No laboratory/diagnostic tests were performed. At the time of this report the patient was recovering. No product quality complaint was involved. The reporter considered cellulitis to be an other important medical event. Additional information has been requested.
Tinnitus  Tremors Diaphoresis Sob Epipen given, paramedics called, sx resolved 20 minutes after sx onset
Metallic taste in mouth 15 minutes after receiving vaccine also headaches & chills diarrhea
3/25/21: woke up in the middle of the night to ringing in the right ear which was persistent.  went to see ENT MD 3 weeks after event and diagnosed with partial hearing loss.  2 weeks after with follow up appointment with ENT and was diagnosed with complete hearing loss.  will follow up again with ENT MD 7/1/21 for follow up diagnostic testing.
Raised hive with two small blisters the size of a grapefruit on right upper arm at site of the injection. Itching at site with heat on site lasting about a week.
Approx 13 - 14 hours after 0900 injection , low grade fever under 100 deg F and great fatigue. Next morning  continued fever, gradual increase in substantial  joint pain, muscle ache and slowly intensifying headache. By evening could not tolerate intense headache and took Ibuprofen 400mg. Symptoms worsened the following day but tried not to take medication since advisories were not encouraging it so vaccine would work at that time.  By Tuesday began feeling better  and each day felt better, but L arm still sore and edematous. By Friday, felt fine. Vaccine symptoms switched off like a light switch.  Returned to work following Monday 1/11/21 without a problem.  I will describe Dose 2 in another report.
STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210438125-covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Within a minute of giving patient her first dose patient leaned backwards in chair seemed like she fainted for brief moment, grabbed her to make sure she didnt fall out of chair and was responsive within a few seconds.  It happened a 2 more times where she leaned back again for a brief moment and doesnt rememeber.  The 3rd time she leaned foward and spit up a little of the water she just had.  Called 911 after the second time EMS came and checked her blood pressure  and make sure she was ok.
Childs mother reports that client had fever of 100.3 beginning the evening after vaccine.  She also reported extreme nausea, headache and vomited x 3 the next 24 hours with severe pain and moderate swelling. around injection area for 24 hours.
Patient complained of Nausea and dizziness on following evening and and vomited few times after that and symptoms were relieved after that.  on January 19th , about 80 hours after the vaccination patient complained of being very weak and lost strength to move which lasted for about 30 minutes and family called ambulance.  They checked  vitals. They were okay.  After that patient felt better and went to rest.
Received HPV vaccine, went to the lab to get blood drawn, after blood drawn, he got on the elevator and started getting dizzy with c/o near fainting episode.
neighbor who is "lady down the hall, we are both very sick she has been for 7 months"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months"). At the time of the report, VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided. No Treatment medications was provided.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My husband has been healthy all of his life. A military career man with 23 years in. He was fine up until he was deployed right before the war broke out. In order to go, he had to have his Anthrax shots so they gave him three shots in less than one month in the same arm and then gave him a smallpox vaccine in the same arm right away also. Since coming back from deployment, he has had numerous blackouts. Short term memory is totally gone, bone pain, muscle pain, headaches, impotency and the list goes on. It has totally destroyed the relationship that we had. I do not know this man anymore. I do not like this man anymore--he is a total stranger. The spot where he had the Anthrax shot gives him problems and that is where he had the most bone pain and muscle pain. (OMIC)
no adverse events.   Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Patient received a previous pneumovax 23 vaccine in 2013.  On Wednesday, 9/30/20 patient received a pneumovax 23 vaccine in a syringe at 5:24pm on his right arm.  On Thursday, October 1st, at 8:00am, he noticed redness, swelling and tenderness in his right bicep. He took one over the counter aleve 200mg tablet on 10/1/20 in the morning and at night.  He will contact Dr.'s office.
fever of 100.2 degrees, slight dizziness, dry mouth and mild dehydration soreness at injection site
Patient age 17 was administered Moderna vaccine at healthcare. Age limit for Moderna is 18.
Pfizer vaccine was administered outside of hospital - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 11/27/2021 ANEMIA DUE TO CKD