chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM HURT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 year old female. 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 and batch number: 202A21A expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced arm hurt. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, fever, headache and fatigue on 03-MAY-2021. This report was non-serious.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from registered nirse and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039726, expiration date: 15-DEC-2023, administered for prophylaxis (dose, route of administration and anatomical location were not provided) was administered to the patient.  The vaccine experienced a temperature excursion of minus 11.8 degree Celsius for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA000872: US-009507513-2210USA001538: US-009507513-2210USA001524: US-009507513-2210USA001062: US-009507513-2210USA001278: US-009507513-2210USA000999: US-009507513-2210USA001209: US-009507513-2210USA001904:
This spontaneous report has been received from a license practical nurse concerning a 12 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (lot # J006850 exp date 31-MAR-2016)(dose and route not specified). IT was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
I had mild body aches, and ~30 hours after Injection I got bad chills; I had mild body aches, and ~30 hours after Injection I got bad chills; This is a spontaneous report received from 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 05Oct2021 09:30 (Lot number: FF8841) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pennicillin" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: hornet/wasp venom" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FLUZONE HIGH DOSE, administration date 28Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 20Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 27Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), CHILLS (non-serious) all with onset 06Oct2021, outcome "recovered" (2021) and all described as "I had mild body aches, and ~30 hours after Injection I got bad chills". Therapeutic measures were not taken as a result of pain, chills.  Additional information: Patient received other vaccine in four weeks: Fluzone High Dose, Other medications in two weeks: Amlodipine, multi-vitamin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
1) injection 2/15 2) chills 2:00 am 2/16 fatigue rest of day 3) rapid heart rate, light headed 9 pm 2/16 4) rapid heart rate woke me out of my sleep, call EMS, HR 160, BP 156/106, EKG normal. Resolved after 1 hr 5) rested for 2 day with episodes of tachycardia after walking up/down stairs. 6) 2/21 worked 2 hours became lightheaded, HR 106, BP 138/96, went to ER.  All labs negative, EKG, negative. 7) continue fatigue 8) tachycardia 2/23 8 pm. lasted 20 min. HR 130
This spontaneous report as received from a medical assistant, refers to an unspecified patient of unknown of gender. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # reported as M001814, expiration date 15-OCT-2018), 0.5 ml and dose of ROTATEQ (lot # L033694, expiration date 16-JUN-2017), 2 ml orally. No adverse effects reported. Additional information has been requested.
Covid19 breakthrough.  1st vaccine received on 05/31/2021.  20 y/o PMH sickle cell presents to ED with c/o sickle cell pain, lower abdominal pain and left leg pain that is consistent with sickle cell pain.  Pain is now radiating to back and pt also c/o cough, congestion and HA x4 days.  CXR no acute dz, temp 101.8.  Room air sat 99%.  Treated with IV Abx.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# K014697, expiry date 04-FEB-2016, lot# L016417, expiry date 13-APR-2017, lot# L016959, expiry date 12-MAR-2018, and lot# L006231, expiry date 06-OCT-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu symptoms including high fever, body aches and headache for 5 days after 2nd shot. Headache continued for 1 month straight without reprieve. Headaches relented and then restarted 30 days later with severe fatigue, brain fog, sore throat, post exertional malaise. Symptoms of a severe ME/cfs flair up, something I have not dealt with in over a decade.
11/15/21 presents to  ED for "abdominal pain, nausea, and vomiting". PMHx of "laparoscopic cholecystectomy on 11/11" "GERD, diverticulitis, and recent gallstone pancreatitis".
Was told that the only way to get the shot was with the latex tip, unsure if this was an allergic reaction. When I got home I started feeling really sick and getting contractions and was dizzy so I headed in to L&D. They were monitoring baby and I. I soon after had a seizure, which I don't have a history of. After saying it was a seizure they said they were wrong and I just passed out. We still don't know for sure which actually happened. They ended up sending me home because I would have lost too much blood during my csection. 38 weeks along, scheduled C-section for 07/24/2019. They gave me iron and sent me home without much reassurance that I would be safe at home.
Received vaccination and after being observed for 15 minutes with no symptoms went out to car to leave, while driving felt onset of tingling to left side of face.  Following day, tingling improved and isolated to small area at top of cheek.  Contacted PCP's office.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Thyroid disorder NOS (found out  when pregnant for first time) and Drug allergy (Ibuprofen). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Dec-2020 and the estimated date of delivery was 06-Oct-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Previous pregnancy end date included 12-26-2019 with live birth.  No treatment information provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a healthcare facility concerning a 7 year old white female who on 01/17/1998 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  On 05/16/2004 the patient developed more than 30 lesions.  Follow up information indicated that on 05/18/2004 the patient presented with a rash on the abdomen and groin and scabs on her head which started on 05/15/2004.  Greater than 30 lesions were noted and the patient was diagnosed with atypical varicella.  Additional information has been requested.
Fever 102F, localized warmth at injection site (without) erythema), body aches.
Information has been received from a licensed visiting nurse concerning a 64 year old female with no medical history and a sulfonamide allergy, who on 04-OCT-2007 was vaccinated intramuscularly with a 0.5mL first dose of PNEUMOVAX 23 (Lot# 658555/0964U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction with pain, swelling, and inflammation. The inflammation spread from the deltoid down to the elbow. The patient called the office. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three cases from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
Headache, Fever, NauseaVomiting, Chills, body aches (not specified) Narrative:
Narrative: Patient reports that skin on left land was peeling off and her hand felt like it was burning/tingling. Also reports nausea. All events occurred after second dose of COVID 19 vaccine.
This 49 Y/O male was given the Pediatric Pfizer vaccine (undiluted) After speaking with Pfizer and CDC we determined the patient was given the correct dose of 30mcg. He was given 0.3 ml at 100mcg/ml  No other repeat vaccines were recommended. The patient had no adverse reactions.
FAINTING UPON RECEIPT; EXPIRED VACCINE ADMINISTERED; PERSISTENT CHEST PAIN; LEG PAIN; MUSCLE ACHES; This spontaneous report received from a patient concerned an adult male of unspecified age, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, 1 Total administered on 27-SEP-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient was administered expired vaccine and experienced fainting upon receipt. About 3-4 days later on an unspecified date the patient complained of persistent chest pain and leg pain described as muscle aches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered, fainting upon receipt, persistent chest pain, leg pain and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211009169-Covid-19 vaccine ad26.cov2.s- fainting upon receipt. This event(s) is considered unassessable. The event(s) 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(s). 20211009169-Covid-19 vaccine ad26.cov2.s-expired vaccine administered. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
Arm became sore at 5:25 pm (03/31/2021) developed chills,  could not sleep for shaking, headache and joint pain (03:08 pm on 04/01/2021)  ***this is what she texted to me and my other sister and the 03:08 pm text was the last text she had texted***
Fever, Chills, Nausea, Photosensitivity, Headache and Tinnitus within first day.    After second day all returned to normal, except the Tinnitus.  It is persistent, severe and worse on one side.
her fingernails were turning purple at some point; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size./She also felt hot to touch; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; The knot has gotten bigger/Clarified that the knot is not super raised, but it is swollen. The knot is expanding outward, it is spreading across her arm; She had flu like symptoms; Fever; She had chills, shivers and was shaking; She had chills, shivers and was shaking; She also felt hot to touch; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right (right bicep area) on 26Mar2021 11:00 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included she was allergic to penicillin. The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204) at right bicep area (Right arm as dose 1, single on 05Mar2021 at 11:00 (at the age of 25-year-old) for covid-19 immunisation. The patient experienced she had flu like symptoms on 26Mar2021 21:30 and fever, she had chills, shivers and was shaking on 26Mar2021, she also felt hot to touch on 26Mar2021, she has a knot near her injection site, right next to it. the knot has gotten bigger. the knot is hot, swollen, hard, and very red (Her chills, shivers and shaking was the main problem for her, freezing. She also felt hot to touch). the knot has doubled in size; was reported as worsened, about 13 hours later, the knot has gotten bigger/clarified that the knot is not super raised, but it is swollen. the knot is expanding outward, it is spreading across her arm on 27Mar2021, her fingernails were turning purple at some point on an unspecified date. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event Flu like symptoms, chills, shivers and was shaking, She also felt hot to touch was recovered on 28Mar2021 and Fever recovered on 26Mar2021, outcome for her fingernails were turning purple at some point was unknown and rest all event were not recovered.  No follow-up attempts are needed. No further information is expected.
Pt developed a 7cm area with redness around injection site immediately after administration. Benadryl given. The home was called and the rash was going within hours.
pt was vaccinated with both vaccines in left arm. flu on top and covid below.  pt went to sit in the lobby for the 15 minutes. he reports his daughter calling him so to be polite he got up from the lobby to take his phone call.  he fainted in one of our aisles, hit his head on the shelving. ended up with 3 lacerations on his head (forehead, nose bridge, under right eye).  I ran over to to assist. grabbed a chair to have him sit in. tech called for store supervisor. pt started to phase out and faint, used ammonia salts. called emergency. EMT's arrived to assess. EMT released him at the scene. family came to pick him up.
Vaccine given on 6/23/21 had expired on 11/27/2020.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, these patients were vaccinated with improperly stored doses of ROTATEQ oral injection (lot # L047185 with expiry date: 17-SEP-2017; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 30 degrees Fahrenheit for 30 days. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Patient was in waiting room about 10 to 15 minutes after vaccination and was waiting to leave the building when patient began to complain of 'feeling funny.' Patient was brought back into exam room and patient stated that her head hurt, she felt dizzy and she felt hot. Patient was brought back into an exam room and allowed to lie down. Vitals were taken and were wnl. After lying down in the exam room for five minutes, patient stated that she felt better and wanted to leave.
On Dec 5, 2014 I began experiencing numbness in feet and hands. The numbness quickly spread up legs and arms. I was diagnosed with Guillain-Barre Syndrome in January 2015. I received IVIG treatments every 3 weeks for a year. The numbness in hands improved but I still have numbness in my legs and feet.
3/4" neck node popped out-painful swollen;negative fever, no other sx went to primary MD for tx;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter physician. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07May2022 at 10:00, outcome "unknown", COVID-19 (medically significant) with onset 07May2022 at 10:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information:-Recurrence of symptomatic covid infection after apparent resolution. Symptoms fully resolved with treatment by 02May22 and began with symptoms again 07May22 with positive antigen testing. Anti-viral details includes that product-Covid 19 treatment, treatment start date was 29Apr2022,treatment stop date was 03May2022, via oral route of administration. No other medication in 2weeks. Patient had no Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID - 19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
New onset burning sensation on left foot 48h after administration of vaccine. Has persisted and extended into left leg. No h/o trauma, no diabetes.
Patient was given Moderna Vaccine. Patient was discovered to be age 17 and 10 months after the fact. No adverse reaction. Patient was monitored and notified of Modern Vaccine given off label use. Patient denies any complications s/p injections
Upon billing for a COVID-19 vaccine administered on 4/5/2021, insurance rejected that the series was already completed.  a 1st dose was administered on 12/22, with subsequent doses being administered on 3/18/2021 and 4/5/2021 (Pfizer). No adverse events were reported and the individual's consent completed on 3/16/2021 marked that no other COVID-19 vaccinations were received.
1 minute after injection, noted acute diaphoresis, lightheadedness, and throat/tongue numbness. HR at rest increased to 160. Offered water by pharmacy staff, sx resolved after 25 minutes
Initial report received from a consumer who is the patient's parent on 31 January 2011. A 9 week-old female patient who had no illnesses, no known allergies and no use of other medications, had received a dose of ACTHIB, IPOL, DTAP (manufacturer unknown), and PNEUMOVAX (manufacturer Merck) on 07 December 2005. The lot numbers, routes, and sites of administration were unknown for all vaccines. The following day after receiving the vaccinations, the patient had a seizure and he continued to have a seizure each day for the next few days requiring hospitalization. The patient has been on anti seizure medication since then. At the time of this report, the patient had recovered (date not reported). Documents held by sender: None.
After receiving my first dose, I started to have a humming in my ears. It would be like plugging in a electric guitar to a speaker. It was constant. I went to my doctor before my second dose and he performed my annual and I had a hearing test. My ears were completely clean and he did an audio toner test. He told me that my hearing is perfectly fine. I went and got my second dose and the sound went away. It feels like I'm waiting for my ears to pop. I take a Claritin and Ultimately, I want to say that it has moments where it lessens and creeps up at times. This all started in my left in, moved to my right ear and sometimes it's in both. I've never had any issues with my ears before. I feel like there is a constant pressure build up inside my ear.