chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It (arm) was also warm; Tenderness (at injection site); swelling at injection site; Pain (at injection site); Vertigo started to getting worse; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo started to getting worse), FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 025A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced VERTIGO (Vertigo started to getting worse). On an unknown date, the patient experienced FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Vertigo, at a dose of 12.5 milligram three times a day. At the time of the report, VERTIGO (Vertigo started to getting worse) had not resolved and FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller also notes that about 4 months ago she did get a scooter to help her move around without falling.  No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-360746 (Patient Link).
i became the sickest ive felt since a child i puked bile for over 72 hours n my whole body hurt and on top of it i could take none of my meds that made me sick because im medically dependent on them and not being able to take then caused me to relapse on heroin ....thanks guys your crazy if you think im getting a 2nd shot or any other vaccine for that matter ever again....thats how sick i was n still am and my sobriety was compromised n i lost months of clean time and am just now getting back on my meds.....worst decision i made was to get that vaccine .....give my second dose to the next sucker sheep.....p.s i also had a mental break down that all stemmed from your vaccine....thank you so much for almost killing me
Headache, chills, sore arm, nausea, stomach ache, malaise
Narrative: COVID infection following COVID vaccine series 03/30, Pfizer, dose #1 04/20, Pfizer, dose #2 01/03 COVID swab, result: detected 01/03 pt cc: epigastric, LUQ pain with vomiting, exposure: unknown 01/03 pt admit ED cc: epigastric, LUQ pain with vomiting. dx: UC, covid LOS: 1 day 01/03 us gallbladder: 1. Cholelithiasis, gallbladder wall thickening and pericholecystic fluid concerning for acute cholecystitis. No reported ultrasonographic Murphy's sign, clinical correlation if patient was provided pain medication. 2. No focal liver lesion. 01/03 CT ABD & PELVIS IMPRESSION: 1. New pericholecystic fluid in the setting of cholelithiasis. Findings can be seen with acute cholecystitis. Consider right upper quadrant ultrasound. 2. stable submucosal fat deposition within colon without findings to suggest acute colitis. 01/03 PT/INR: 11.8/1.05 01/03 TROPONIN I: <0.016 01/03 LIPASE: 17
Mom reports child's arm is very tight, swollen from shoulder to elbow, with small blisters. Child is afebrile and complains of arm hurting. Advised to see MD or go to ER.
Patient had left the covid vaccine clinic after being observed for 15 minutes.  She came back in breathing quickly and hyperventilating.  Complaining of "throat feeling funny".  Patient was brought into a private room and sat down. She was responsive and coherent at that time.  VS obtained and stable. She appeared anxious. Patient continued to complain of her throat feeling tight so a dose of Epi was given and 911 called.  After 10 minutes she became more anxious and breathing increased.  Another dose of epi was given due to pt still feeling like throat was tight.  EMS here at that time and they intervened.  Patient transferred to the ER.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8731), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in 2 weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
a little bit of swelling at the injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medication included anticoagulant. On Feb2021 the patient experienced a little bit of swelling at the injection site. The Caller reporting AE information for husband (77 year old, male) who experienced "a little bit of swelling at the injection site" after receiving the first dose of the Covid vaccine yesterday. Caller asked if there is a problem with taking an anticoagulant and receiving the Covid vaccine. Caller stated that her and her husband were reading the papers that were given to them, during the 15-minute hold time, after receiving their injections. Caller stated that the papers say to mention if you are on an anticoagulant. Caller stated that her husband takes an anticoagulant, but did not mention it to the vaccination provider because he was unaware that he needed to and it wasn't on the questionnaire that they filled out prior to receiving the vaccine. Caller asked, will the injection site bruise. Caller stated, thank you very much for your help. The event was reported as non-serious. The outcome of the event was unknown. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Around 05/01/2021 I started having diarrhea, cramps in my stomach. Currently undergoing test to try and figure out a diagnosis.
Started to notice some numbness in my lower lip while talking and waiting for the shot to settle in (maybe about 15-20 min in).  Stayed for 30 minutes initially.  Pharmacist gave me 25mg of liquid Benadryl after I experienced numbness and swelling in both lips.  I waited an additional 30 minutes under the observation of the pharmacist and was given an additional 25mg of liquid Benadryl.  My swelling and numbness got a little better, so I was discharged after being told to go to the ER if I experience any trouble breathing or other allergic reaction symptoms.
Pt started feeling lightheaded and nauseated about 2 minutes after getting shot.  Pt turned pale/green. Pt had lower blood pressure and pulse, lightheadedness went away and patient still nausea and abd cramping.  Pt was given 0.3 mg epi and 1000 ml of fluid.
PATIENT DEVELOPED SHORTNESS OF BREATH AT SCHOOL THE DAY FOLLOWING VACCINE.  PT WAS PICKED UP AND BROUGHT TO THE PCP'S OFFICE FOR TREATMENT.
A report was received from a health care professional on 12/18/03 concerning a mid-40 year old male vaccinee who developed a large hard, swollen and painful knot on the right thigh around the site of injection immediately after self-administration of Fluvirin on an unspecified date in November 2003. On an unspecified date in November 2003, the vaccinee self-administered Fluvirin into the right thigh. Immediately after administration, the vaccinee developed a large hard, swollen and painful knot around the area of administration that increased in size to 10 inches in diameter. The knot then slowly abated and disappeared in about a week. The same events happened with last year's vaccine but the knot was not as large. At the time of reporting, the vaccinee was not experiencing any symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt reported seeing spots less than 1 min after both injections, had her sit with head down.  Vision went black, assisted her to floor.  Accompanied by severe nausea, sweating & "cold and clammy".  pt sat on floor for about 15 min before feeling well enough to return to chair for continued observation.  Extreme nausea continued & chills.  Dizzyness resolved.  Still felt nausea & chills 20 min later. Partner drover her home & will be monitoring her and will bring to ER if sx worsen/dont resolve
States she woke up and her arm at injection site was red and itchy, looked in mirror and had whelps all over body and face was bright red. States she took her epi pen and Benadryl, states that she still has whelps and is itchy, has doctors appt in the morning 11-15-11.
I have a sharp pain in my left ear. I can still hear noises like usual, such as background fridge noise. But this pain is an incident condition that I did not ever experience before. It?s not a constant pain and comes in waves. My right ear feels normal. I have not sought a medical appointment yet, and am waiting to see if the pain goes away.
Headache, Myalgia, Fever, rigors, chills, fatigue, malaise, generalized weakness, aesthenis Narrative: Developed rigors/chills around 9:00PM on 1/20/21, woke ~3:00AM on 1/21/21 with 102-103 fever, myalgia, headache, weakness and took ibuprofen. Missed work on 1/21/21 due to reaction. Had low-grade fever the rest of the day with fatigue, myalgias, generalized weakness, aesthenia. Resolution of symptoms on 1/22/21.
seizure (prob febrile) adm dx 5MAY92 complicated by recent head trauma & vax
This case was reported by a healthcare professional and described the occurrence of heat sensation in arm in an adult female subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On 28 September 2010 at 13:00 the subject received 1st dose of HAVRIX adult (1 ml, unknown route and site). On 9 October 2010, 11 days after vaccination with HAVRIX adult, the subject experienced heat sensation in arm, stinging arm and arm numbness. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with HAVRIX adult. The healthcare professional reported that an adult subject was vaccinated with HAVRIX and reported that her arm felt hot, stinging, and numbness down her arm for 48 hours after the vaccination. The symptoms were improving but not resolved.
About 60 minutes after receiving the vaccine, patient came complained of tingling in lips and itching on scalp.  She stated she had the same feeling when she had a reaction to Mangos in the past.  BP 150/90 pulse 70 and regular, breathing normal, no swelling noted, no hives or rash noted.  Benadryl 25 mg given. Patient remained stable through out the incident.  After 30 min, patient stated she felt a little better, but still has tingling of lips and itching on scalp, but it wasn't any worse BP 148/98, pulse 76 and regular.  PHN asked patient to contact her healthcare provider for further follow up.  Patient contacted her healthcare provider and healthcare provider had patient take another 25 mg of Benadryl.  Approx 60 min after start of symptoms, all of symptoms resolved.
1. Swelling on left side of  neck (knot); 2. Swelling at medical clavicle (knot) left side; 3. Arm tingling and occasional numbness (left side arm); 4. Left axillary swelling.
Pt states she had fibromyalgia and neuromyalgia, malaise local pain and swelling, no rash, no fever no Gi s/sx.  Symptoms lasted for a couple of days.
I developed a rash (in the evening and continued all night).  The instructions I received was to seek medical attention. I went to  Urgent Care at 8 AM on Feb.25.  I was instructed to take one tablet Claritin and then 2 Benedryls in the evening.  By 5:30 PM on Feb 25 I was extremely uncomfertible and took two benedryls.  Still could not sleep and at 11:30 PM took 2 more benedryls.  When I woke up at 7:30 AM on Feb 26, the rash was gone and has been gone since.  I was also instructed not to take the second shot.  (Which I will not)
pt recv  vax 26MAR96 & in 2hr mom reported to grandma pt had rash on shoulder & back area proceeding downward to legs;pt exp pimple-like raised areas;area appeared blistered badly looked as if skin peeled;throat red;
This spontaneous report was received from the patient's mother, referring to her son, who was an 18 year old male patient. The reporter refused to provide information concerning the patient's pertinent medical history, concurrent conditions or concomitant medications. On unspecified dates, the patient received the first and second dose of GARDASIL 9 according to schedule, and the third dose 5 months after the first dose. Additionally, it was mentioned that the patient received a fourth dose of GARDASIL 9 in the left arm on 09-OCT-2017 (lot# and route of administration were unspecified for all doses) all of them for prophylaxis. It was also reported that after fourth dose, the patient began experiencing soreness and redness at injection site on left arm (injection site pain and injection site erythema), and that he was using ice to treat these conditions. The patient was not hospitalized and there were no intervention to prevent serious criteria. The patient's conditions were not significant disability or incapacity or life threatening. At the time of the report, the outcome of injection site pain and injection site erythema was unknown. The relatedness assessment between GARDASIL 9 and the aforementioned adverse events was not provided.
Patient brought into the ED on 7/17 by EMS for weakness, chest pain, and shortness of breath.  COVID-19 PCR swab taken in the ED  was positive.  Patient was admitted from 7/17 - 8/9 with acute hypoxic respiratory failure and NSTEMI. During admission, patient was on BIPAP, eventually weaned to room air. Discharge diagnoses included congestive heart failure and NSTEMI.  Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Tested positive for the Covid virus, after both vaccines; Tested positive for the Covid virus, after both vaccines; This is a spontaneous report from a contactable consumer patient mother), received via the Pfizer-sponsored program.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included exposure to SARS-COV-2 (patient was at a school event and a woman, at the event, was Covid positive). The patient's concomitant medications were not reported.  The patient was tested positive for the COVID virus, after both vaccines. It was reported that patient had two young children (5 and almost 2 years old) and a husband, who were exposed, and they were in quarantine. Children were tested negative for COVID, they had to continue to quarantine. Only the patient got COVID.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date.    The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : 202101041383 Same reporter, different patient
Itchy rash (hives) below the injection site appeared one week after injection.  Rash area is approximately 3" in diameter.
Pt had seizure 5 minutes after administration of 12 month immunization. Seen in  ER had T 103. Fine 2 minutes after event. No further fever or seizure. Information recieved from Medical records states staring, drooling sliva and jerking as additional symptoms. msv
This spontaneous case reported by a consumer, describes the occurrence of back pain (low-back pain), migraine headache and chills in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A and 032B21A) for COVID-19 immunization. Concurrent medical conditions included migraine. On Apr 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 5, 2021, patient experienced back pain (low-back pain), migraine headache and chills. At the time of the report, back pain (low-back pain), migraine headache and chills outcome: unknown. Action taken with mRNA-1273 in response to the events: not applicable. Concomitant medication not provided. Treatment: ice applied to back. Most recent follow-up information incorporated: On May 6, 2021: Follow-up received on May 6, 2021 contained no new information. On Jun 9, 2021: Follow-up information received contained non-significant information.
The pt developed redness, swelling and hot to touch area on and around the injection site (left upper thigh).
Loss of weight, shortness of breath; Loss of weight, shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath). At the time of the report, WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided
March 13 & 14 - fever, fatigue, headache March 15 -18 headache (migraine like) March 19 - current date  1. severe debilitating headache, non-responsive to: immitrex migraine medication, Vicodin, flexaril, excedrin, or butalbital/acetaminophen/caffeine tablets 2. Blurry vision 3. Extreme light sensitivity  April 7 - injection of Toradol (4 hours of relief) April 8 - current (4/13) Toradol every 6 hours with Tylenol supplements as needed between doses
66 year old woman admitted 10/25 with acute on chronic hypoxemic resp failure requiring HFNC - differential: IPF, interstitial pneumomnia with autoimmune features, connective tissue disease associated ILD (mildly elevated RF and ANA, cysts on chest CT may suggest Sjogrens), post-COVID ILD, and GERD-associated lung injury (has GERD/HH). Course notable for extensive ILD w/u as detailed in notes, small pneumomediastinum due to presumed bled rupture, treatment with empiric BSABX, high dose steroids, Cellcept, and lasix with some slow improvement (7-12 LPM at rest, still significantly desaturates with exertion requiring NRB), hyperglycemia due to steroids, and severely debilitated state after prolonged critical illness. She did not want to pursue lung transplant. She was felt to have secondary pulmonary HTN. She wast reated empirically for OSA with nocturnal CPAP. She had progressive and refractory hypoxemic respiratory failure not responsive to steroids and diuresis. There was no evidence of sepsis/new infection. She requested transition to comfort care and died peacefully.
Patient was given an expired Td dose. State consultant consulted and informed us to repeat the dose. We called and informed the parent and she voiced understanding.
Patient had a local vascular reaction. Had redness, knot, fever around injection site upper left deltoid. DX: Allergic purpura.
Chronic ulcers mostly on the tongue, some other places on the mucosa areas; Chronic ulcers mostly on the tongue, some other places on the mucosa areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left), administration date: 28May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Location of injection: Leg Left"; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left), administration date: 07May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: TONGUE ULCERATION (non-serious), MUCOSAL ULCERATION (non-serious) all with onset 03Dec2021, outcome "not recovered" and all described as "Chronic ulcers mostly on the tongue, some other places on the mucosa areas". Therapeutic measures were taken as a result of tongue ulceration, mucosal ulceration.  Additional information: Patient had no known allergies. No other vaccine in four weeks. Patient had no covid prior to vaccination and not tested for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M047661, Expiry date: 02-DEC-2018; lot #N008828 expiry date: 16-MAR-2019). On an unknown date, the vaccine was exposed to temperature of -11 degrees C for 50 minutes. No adverse effects reported. No previous temperature excursion was reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011303: