chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient stated that immediately after receiving the vaccine he felt a burning sensation throughout his whole body that lasted for a whole day. He also stated he began to have a hard time breathing that same day and has continued to have this issue off and on ever since. He stated he has heart issues and he is refusing to get the 2nd shot as a result. He did not seek medical attention.
CHILLS; FEVER; This spontaneous report received from a patient concerned an 87 year old male. The patient's height, and weight were not reported. The patient's past medical history included copd, and concurrent conditions included streptomycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: 25-MAY-2021) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever. This report was non-serious.
Information has been received from a registered nurse referring to a 7 month old patient of unknown gender. On 27-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K011952, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
24 hrs p/vax area became swollen; 48 hrs p/vax erythematous; 72 hrs p/vax area still swollen but erythema gone;
Fever (102), body chills, body aches, headache, abdominal pain, water retention, nausea, insomnia. Most of the symptoms occurred on the first night. Nausea took 4 days to subside. I'm on day 6 and I had an ultrasound done to my leg as my left leg has started to hurt. Ultrasound showed no blood clots. Pending blood work results. Water retention is still present however it does seem to be subsiding today, day 6.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with GARDASIL lot# K007264 exp. 02-MAR-2017, lot# K008931 exp. 04-MAR-2017, K010574 exp. 08-APR-2017 (dose, route of administration not reported). The GARDASIL was improperly stored. There was no adverse effects reported. Additional information has been requested.
pt brought to office 27MAY96 mom reports fever x 2 days-rash since 26MAY97;stools loose & green faint maculo papular rash;conjunctivitis tx w/Garamycin eye gtts;
I was diagnosed with Covid-19 after 4-5 days after my first dose Moderna vaccine.
The day after had fever, chills, headache, dermal pain, aches, could not smell, and fever blisters in mouth.  The fever has improved, dermal pain went away, still has headache, body is soar, fatigued, and cannot smell. to stay home form work until 10 days from onset of symptoms due to the fact that we are not sure if it is covid or not.
itching in left arm; Pain around the injection site-left arm; Joint pain; Restless leg syndrome has intensified; Restless leg syndrome has intensified; hard for him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless leg syndrome (restless leg syndrome has intensified), Acid reflux (esophageal), Sleep disorder and Anxiety. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM (ALPROZOLAM) for Anxiety, TRAZODONE from March 2021 to an unknown date for Sleep problem.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), VACCINATION SITE PAIN (Pain around the injection site-left arm) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced PRURITUS (itching in left arm). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified) and INSOMNIA (hard for him to sleep) outcome was unknown, PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) had not resolved and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added medical history, concomitant medication, facility details and event. Updated patient demographics, re-challenge field and event outcome.
Malignant small cell cancer. admitted on 12/27/2021 from planned endoscopy / EUS with hypoxia. She developed worsening resp failure and was intubated with subsequent 7 minute cardiac arrest. She subsequently developed MSOF and severe septic shock. She remains unresponsive off sedation and MRI brain revealed multifocal infarcts. Family were counseled on terminal nature of patients condition and elected to transition to comfort cares. She passed away 1/10/2022. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
Hives in palms and between fingers on both hands (severe itching, swelling, redness). BENADRYL and anti-itch lotion. (Lasted 24 hrs.). This was my 10th flu shot but my first high-dose.
C/O throat and tongue feeling tingly and slightly swollen.  This is the same symptoms she gets when she eats shellfish.  Usually Benadryl will resolve shellfish symptoms.  Alert and oriented.  VSS.  No outward signs of swelling.  No difficulty swallowing or breathing.  Prefers not to have 911 called.  Explained our policy and that she can refuse transport after ambulance is here.  Agrees to transport to Hospital ER by ambulance after EMTs arrive.  Sent to ER at 1436 with symptoms unchanged.
Started Sunday 09/02/2001, numerous scattered papular rash, itchy on chest, back, upper and lower extremities.
Child had received a Pfizer dose #1 on 08/12/2022 and therefore should have received a Pfizer product however not Pfizer product was available. / Notified Dr. Medical Director
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 10-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000180:
pt recvd vax; high T 106 on 16mar & 22mar;
I had a bad reaction in the place I went to get the COVID vaccine from. My blood pressure was dangerously high. I usually have low blood pressure, and I haven't had high blood pressure before. I had felt flushed, and then I think I had passed out because when I had opened my eyes I saw health care workers surrounding me with EpiPen's. I was wheeled out the facility in a wheelchair. Since that time I have been having a spike of high blood pressure. Sometimes the bottom number will get over 100. When receiving the 2nd dose (Lot #ER8733 or ER8722) my doctor gave me the vaccine while laying down on my side on a stretcher. I had no adverse reaction, but on June 28, 2021 I had tightness in my chest and pain down my back. I felt very flushed. I called the EMT. My blood pressure was 168/100. They took me to the ER. I didn't have a heart attack. My blood pressure was initially very high then it normalized and went down somewhat. I have had spiking blood pressures ever since receiving the COVID vaccine. I was sent to a cardiologist and he wanted to do a treadmill test on me, but since I am immunocompromised I dint feel comfortable performing that test without a mask since COVID cases was high at the time. I had another incident where I had terrible pains in my head. I usually don't get headaches. It wasn't sinuses it just felt like someone was drilling in my head. I went to an urgent care and they didn't find anything. I was given a prescription for nitroglycerin, but I never took it. I was also prescribed an alternative drug to statin. When I talked to a pharmacist about the medicine they said it had horrible side effects so I didn't take it. On November 10, 2021 I had received my 3rd dose on my side while lying on the couch. I had no adverse reactions.
Headache, Arthralgia, FATIGUE, CHILLS, INJECTION SITE PAIN/SWELLING Narrative:
REDNESS AND SWELLING, ITCHING, FEVER, GENERAEL ACHES/PAIN, JOINT PAIN, HEADACHE, DIZZINESS
pt sx started 6APR97;pt got pain in rt shoulder, fever, h/a;7APR(7 on erythematous area 10cm x 8cm rt deltoid w/mild induration;fever 102;pt was referred to ER;
Body aches in the form of significant chronic pain flare up (6 out of 10 on pain scale) Fever (101 degrees F) Nausea and vomiting Loss of appetite  For 4 days
Pt got DTA, IPV, PCV, VZV on 8/12/08. Mom noticed 3 red raised bumps on (R) thigh and 1 beside (R) eye on evening of 8/12/08. Child refused supper 8/12 and breakfast and lunch on 8/13/08. No fever, itching or any other problems noted. Mom gave Tylenol 8/12 and 8/13. To give Benadryl and see Pediatrician as needed.
Chills - lasted only one day  Purchased Analgesic & Astringent Rinse for these symptoms (recommended by Pharmacist): Symptoms still persist:      * Ulcers in mouth      * Soreness of tongue
Pt developed ITP with a platelet count of 6,000 and petechia and purpura. He was hospitalized for 24 hours and treated with IVIG with good response. Platelet count was 42,000 on 11/30/01. Per 1 year follow up: pt recovered. No additional comments.
Head and neck suddenly became very hot. My head, neck, face, particularly my lips, and upper limbs were tingling and numb
pt exp soreness, swelling, & bruising @ the inject site p/receiving flu vax;
Increased temp 103 on 4/23. Rash began on 4/24 x3days then started resolving. Is doing fine now.
Rt leg started with swelling, redness, "hard", from diaper area to knee.  Started nest day after receiving DTaP.
Initial unsolicited case received from a consumer, who is the patient's wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient's right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.
had an infection in march after my covid vaccine; chronic leg pain; headache here or there; insomnia; nausea; tired; This is a spontaneous report from a contactable other hcp.    A 42-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included oestrogen receptor assay. Concomitant medication(s) included cetirizine (CETIRIZINE); melatonin (MELATONIN); vitamin d3 (VITAMIN D3); paroxetine hcl (PAROXETINE HCL); ondansetron hcl (ONDANSETRON HCL); fluticasone propionate (FLUTICASONE PROPIONATE); azelastine hcl (AZELASTINE HCL); metformin hcl (METFORMIN HCL. It was Reported that, patient missed 1 cycle because she had an infection in March after my covid vaccine. chronic leg pain, headache here or there, insomnia, and nausea. labs are off & pre-diabetic since covid vaccine. Tired on an unspecified date with outcome of unknown, tired (fatigue) (non-serious) on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
The vaccine was administered on 5/11/2021 but was expired on 5/6/2021 by the 30 day rule. We received the vaccine on 4/6/2021.
The morning after the 2nd shot, I woke to severe tinnitus, hearing sensitivity, headache, earache, and fullness in the ears. I went to my PCP and she said that I had an infection of the middle ear. I took a course of Augmentin. Later, when I sent an ENT, the infection had cleared but the symptoms remained.
Dizziness getting out of bed, then large hives on arm and shoulder over the next 5-6 days. I double-dosed on Zyrtec for several days, then continued with 1 pill a day.
Pain at injection site 6 hours after injection. Woke up at approximately 3 am (roughly 12 hours after injection) with feverish symptoms such as dramatic body temperature changes and general malaise. At this same time the entire left side of my body was in pain, which lasted the entire next day. Side effects lasted through the next night and had noticeably subsided by the following morning.
On 8/3/21 I got fever, 103, chill, shaking that lasted about three or four hours. Next day, went  to urgent care. Tested not the flu, not a UTI. On 8/14/21 happens again fever and all the rest as stated first time. Temp 102.4. On 8/31/21. 4pm started temp 102 that went to 103.4. Again lasted three or four hours. Went to sleep okay the next day.
Severe headaches for at least 5 days Fatigue persisting for 1 month at least, first week in bed -loss of work week on sick leave Muscular pain in body which had reduced over the weeks Pain in nerves-initiated in right side of my body and then became strongest in spinal cord which required me to go to hospital twice-Emergency Area March19, 2021 being released with medication March 20, 2021 ; then again March 21, 2021 in hospital being released with medication by March 22, 2021. Nervousness
Long term fatigue experienced as inability to perform daily activity and sleeping 10 to 12 hours a night 3 nights a week  from first dose. I don?t have the information to fill out this form because the ink rubbed off my COVID card. I just had my fourth and last booster in September.  I have Fibromyalgia but haven?t experienced this level of fatigue since initial onset in the 1990s.
Patient developed a raised bump at the administration site immediately following the injection. Applied ice pack to raised bump and swelling went down.
S and S consistent with febrile seizure the next day. Low grade temp at ER. Refer to neurologist.
Patient developed multiple sores at the injection site that had scabbed over by the time I saw them - patient reported that the area of the injection site felt bumpy - doc thought patient had an infection and prescribed amoxicillin (per patient reporting) and diphenhydramine.
mom called clinic 6APRR94 stating daughter recvd vax 11JAN94; mom stated that daughter's arm where recvd vax was red-swollen-wamr to touch; mom related took daughter to MD 14JAN94 & was told it was an allergic react;
Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # M001578, expiration date 21-NOV-2018, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hours and 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reseived Moderna 1st dose on 4/11/21 at Pharmacy. Developed some abdominal pain after 3 days on 4/14/21, and had miscarriage  on 4/22/21,  Estimated delivery date was  11/18/2021
Pt presented to the ER with slurred speech and weakness after receiving influenza vaccine at pharmacy.
Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on approximately 01-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) in the deltoid. Concomitant drug therapy included cetrizine hydrochloride (ZYRTEC), ranitidine HCl (ZANTAC) and epinephrine (EPI-PEN). On approximately 30-SEP-2007 the patient experienced anaphylaxis characterized by chronic hives primarily on the extremities and swelling of the laryngeal area. The physician was consulted and the patient and was subsequently hospitalized for 4-5 days. Epinephrine was administered to treat the reaction. The patient was also treated with steroids for awhile. Lab diagnostic studies performed included full biochemistry labs at the hospital, electrolyte test revealing abnormalities, and a 63-64 value for lymphocyte count. The patient was noted to functional but not recovered. There was no product quality complaint. The physician considered hives and laryngeal swelling to be immediately life-threatening, disabling and an other important medical event. Additional information has been requested.
Vaccine leaked from the injection site. No adverse event occured. The dose was repeated and was successful.
Narrative:  03/25 COVID VACCINE dose #1 04/15 COVID VACCINE dose #2 05/04 Pt called clinic to report ear left ear itching and clear discharge x 2 days. States he has a history of severe ear infection with Pseudomonas requiring hospitalization a few years ago. Treated with Ciprodex with resolution. 06/10 During Amb Care visit, pt "states when he got 2nd dose Pfizer vaccine has had skin rash on back, legs, groin it was everywhere but has gotten somewhat better, first week of May when happened."
memory has been affected; memory loss; This is a spontaneous report from a contactable consumer (patient) reported for himself via a Pfizer-sponsored program COVAX US Support. A 64-year-old male patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 07Apr2021 as single dose and dose 2 via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient memory has been affected and had memory loss. The patient stated he received the first dose of the vaccine on 07Apr2021 and the second dose on 28Apr2021. He has noticed since then his memory has been affected every single day. He had gone to a neurologist who has scheduled an MRI and EEG. He was unsure if his memory loss was related to the vaccine or related to his work with acrylic paint. He was asking for Pfizer's recommendation regarding memory loss. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced pain in arm for 2 days (no restriction using arm) and flu-like symptoms for 2 days. The reporter did not agree to follow up from GlaxoSmithKline.
Pt exp swelling, redness, & pain @ the inject site immediately p/receiving Td;
Moderate pain at injection site lasting through the present, which is almost 47 hours after injection. Slight redness at injection site  starting only after 24 hours. Severe systemic joint pain/inflammation - ankles, knees, hips - to the point of making me hobble when walking. It started about 18 hours after injection and lasted until about 32 hours after injection. Was painful even when lying down, resting. Everything hurt. No fever throughout. But lots of body aches, chills and deep fatigue. I came home early from work midday yesterday, Tuesday (injection was Monday at 3:30pm) and slept all afternoon and evening. Did not take anything over the counter or prescription. Woke up this morning feeling better, no joint pain or inflammation anymore. Felt better and went back to work today. Feel fine now.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Tree nuts, nuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: 2 weeks after initial positive result; (23Oct2022) Positive, notes: positive result occurred on 23Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication within 2 weeks of vaccination. Patient received Paxlovid for Treatment of COVID-19 from 09Oct2022 to 13Oct2022. COVID Rebound symptoms and positive result occurred on 23Oct, 2 weeks after initial positive result, and 10 days after completing 1 course of Paxlovid. Symptoms more severe during rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant and refers to a 2 month old patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The medical assistant informed that on 28-JUN-2018, the patient was vaccinated with two doses of PEDVAXHIB Injection, lot # N034410, expiration date 01-FEB-2020, intramuscularly for prophylaxis (incorrect dose administered). No adverse effects reported.