chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph nodes were tender and painful to touch; ears were throbbing; thighs and legs felt they were on fire; air felt like hurting her skin; felt head was exploding; shooting  pain everywhere / painful to touch; felt freezing cold; shooting arthritic pain everywhere; teeth were chattering hard; temperature of 101-102 degrees Fahrenheit; felt less tired/ fatigue; felt slight headache / very bad headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin) and EXPLODING HEAD SYNDROME (felt head was exploding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Apr-2021, the patient experienced HEADACHE (felt slight headache / very bad headache) and FATIGUE (felt less tired/ fatigue). On 09-Apr-2021, the patient experienced LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin), EXPLODING HEAD SYNDROME (felt head was exploding), PAIN (shooting  pain everywhere / painful to touch), FEELING COLD (felt freezing cold), ARTHRALGIA (shooting arthritic pain everywhere), CHILLS (teeth were chattering hard) and PYREXIA (temperature of 101-102 degrees Fahrenheit). At the time of the report, LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin), EXPLODING HEAD SYNDROME (felt head was exploding), PAIN (shooting  pain everywhere / painful to touch), FEELING COLD (felt freezing cold), ARTHRALGIA (shooting arthritic pain everywhere), HEADACHE (felt slight headache / very bad headache), CHILLS (teeth were chattering hard), PYREXIA (temperature of 101-102 degrees Fahrenheit) and FATIGUE (felt less tired/ fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported , No treatment medication was reported .   This case was linked to MOD-2021-163466 (Patient Link).   Reporter did not allow further contact
Following a booster dose ot ttox, pt devel a sc nodule @ inject site;
I tried to lay down and go to sleep that night and my stomach started cramping really bad the pain was excruciating like there was an issue with my gall, bladder. I couldn't ignore the pain and at that point I went to the emergency room at  Hospital. While I was in the ER they ran tests. The doctor pressed my abdomen. and I had some pain. The gave me fluids and medication but I did not take the medicine. I was given morpheme for pain but it did not help with the pain. I was in the ER for 4-5 hours and then was released. The pain lasted for two days.
administration of an expired Daptacel with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 15 months old male patient who had administration of an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (TET TOX) (ACTHIB) for Immunisation; and Hepatitis A vaccine (Hepatitis A Vaccine) for Immunisation.  On 18-Jul-2023, the patient had administration of a standard expired dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml once (lot C5893AA, expiry date- 21-JUN-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks if they should administer another dose after the incident.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID infection following COVID vaccine series 03/05 COVID  vaccine dose #1 03/24 COVID vaccine dose #2 05/14 pt seen in ED c/o right  abdominal pain, discharged to home with treatment for UTI 12/16 pt seen in ED  c/o sore throat, rhinorrhea; COVID positive, no treatment given 12/17 pt declines  daily calls, then calls agency to report feeling "terrible" and states going to pursue  monoclonal antibody treatment 12/20 pt denies calling agency on 12/17, states  completely asymptomatic and feels well, unclear if error or pt forgot
Pt noticed painful lump in L arm a few days after second dose.  Ultrasound -- > CT-- >Biopsy revealed Granulomatous lymphadenitis.
6/19/07 onset of urticaria , Left index finger swelling; 6/20/07 generalized urticaria, joint swelling of wrists/index finger, pain of coccyx, pain bilateral forearms with redness slight tonsil/ 6/21/07 swelling severe of hands, wrists, knees, increased urticara.
Patient presented to the ED with altered mental status and extreme agitation. Patient was given lorazepam 1 mg IV,  haloperidol 5 mg IM, and Olanzapine 5 mg IM. Patient's quetiapine was also increased. Infectious workup was negative besides elevated temperature. Patient's agitation had resolved by the next morning 01/21 but was still experiencing AMS. By 01/23 patient had seen marked improved mental status and fever free for > 24 hours.
Shivering; possible fever (feeling hot); Severe headache; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concomitant products included bupropion hydrochloride (Wellbutrin) and sertraline hydrochloride (Zoloft).   On 23rd September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd September 2020 10:00, the patient received Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Wellbutrin, the patient experienced shivering, fever, headache and pain in arm. On 24th September 2020, the outcome of the shivering, fever, headache and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shivering, fever, headache and pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The patient experienced shivering, a possible fever, severe headache and a sore arm after the 2nd dose of Shingrix, he also had administered the Flu vaccine at the same time. The patient also mentioned that, he had started taking Zoloft and Wellbutrin as new medications. The reporter did not consetnt to follow up.
SNIFFLES, HEADACHE, COUGH, CHILLS- STARTED 8/30/21. NO CONTACT WITH OR EXPOSED TO COVID
right shoulder swollen & extremely sensitive with severe pain for approx. 3 weeks. called office was told to ice area. went to other office was told something similar. after several months of having pain went to orthopedist his diagnosis is adesive capsulitis. erecommend physical therapy and MRI
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright  & lump in throat bigger within  10 mins to the ER for treatment
Fever 103.6 for 12 hours, extreme fatigue for 3 days, brain fog for 2 days
It was reported that a 63 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly on 01/27/2001 at 7am the pt developed a left forearm volar 5cm x 8cm of redmess, 2cm round induration and "buli at center" with itching. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, U2001-00448, U2001-00450 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Flu like symptoms within 2 hours of sore throat, coughing, fever, aches, laryngitis, full clinical influenza, then secondarily pneumonia.  Bed ridden for 2 weeks, numerous incidents of being bedridden afterwards.
September 6th, patient suffered stomach pain, with nausea, vomiting, diarrhea, headache; event lasted from 8 Am until next morning upon awakening. September 12th about 1:30 pm the same episode took place and lasted until awakening the next morning.
Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assisted Client to stand up from vaccination chair. Client began to have unsteady gate. Both RN and RN assisted Client back to the gravity chair. At 1348, RN and PHN responded to the event. At 1348, vital signs are blood pressure 116/72, heart rate 64, oxygen saturation 100%. Client reported no blurry vision no headache, appearance is pale. Client is accompanied by mother. Per client's mother, Client has no medical history, allergies to dogs, and a history of syncope and lightheaded with needles/vaccines. At 1352, vital signs are blood pressure 118/82, heart rate 62, oxygen saturation 100%. Client reports lightheaded, feels tired, no shortness of breath, no headache. Supplemental nutrition and fluids provided to Client . Client accepted. At 1357, vital signs are blood pressure 116/76, heart rate 63, oxygen saturation 100%. Client reports no headache, no blurred vision, lightheaded improving, feels "sleepy", and skin tone returning to appropriate ethnicity. PHN educated client and mother ED precautions, common adverse effects of COVID vaccine, and emphasize a follow up with primary care provider. At 1400, vital signs are blood pressure 118/72, heart rate 63, oxygen saturation 100%. At 1402 Client stood up with no complains. At 1403 Client walked out of vaccination facility with a steady gait accompanied by mother.
Two days after the vaccine, I started feeling great lethargy.  I slept all day 4/17 & 4/18. I got up, had coffee and went right back to bed and slept all day, got up, ate dinner and slept all night for both days.  Starting on 4/19, I started getting sharp headaches at about 10 am.   As time goes on, the headaches are starting later in the day.   Yesterday, 4/26, it didn't start until about 4 pm.  Today (4/27), however, it started about 11:30 am.  I was concerned about being dehydrated, so I have been drinking Pedialyte.  It doesn't really help.  I am also still tired, but don't have to nap - I can work all day and just go to bed early (7:30/8 pm).   The headaches are so severe that I also feel sick to my stomach.  I am also very fuzzy headed - I have trouble remembering things.  This started with the headaches and happens even if the sharp pain is not present.   By 4/22, the fuzzy  head feeling was nearly gone.  While it was happening, I didn't feel safe to be driving, and did not drive.  Even though the fuzzy head feeling is leaving, I am still forgetting words and have a slight, occasional stutter when talking.  I also forget things I am supposed to be doing.  The headaches persist.
I had congestion, sore throat, diarrhea, and high fever. I had a little bit of SOB, cough and headache. These symptoms are still ongoing. I went to urgent care on Jan 2nd. They did strep throat test and a Covid-19 test, positive result.  I also had an ear infection.
Patient became light-headed after receiving Hep A and Tdap 25 minutes prior. Patient had not eaten anything on this day, and had just completed 6 minutes of exercise just before receiving vaccines. She was quite anxious about receiving vaccines. She was light-headed and pale.BP 83/38 HR 63 RR 16. Oxygen administered, and patient was transported to the hospital ED via ambulance.
Experienced lightheadedness within a few hours, woke in the middle of the night with violent shivers, fever of 101° . Experiencing flulike symptoms. Some muscle weakness, headache, sensitivity to light, some disorientation and dizziness. Significant pain at injection site, and a hard lump.
pt states started with symptoms 1 hour after receiving vaccine: fever, chills, body aches, headache, difficulty breathing, nausea, diarrhea, and fatigue
Chills; Muscle Pain; Low grade fever of 101°C to 103°C; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle Pain) and PYREXIA (Low grade fever of 101°C to 103°C) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle Pain) and PYREXIA (Low grade fever of 101°C to 103°C). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), MYALGIA (Muscle Pain) and PYREXIA (Low grade fever of 101°C to 103°C) outcome was unknown. Not Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101°c to 103°c (Low) Low grade fever of 101°C to 103°C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications Ibuprofen.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: 6K8729) and in Oct2021 as dose 3 (booster), single (Lot number: 301550A) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Lot number: 049L21A) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), in Oct2022 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid treatment for COVID-19 from 21Dec2022 to 26Dec2022.   No follow-up attempts are possible. No further information is expected.
2AM on 9/15/2021 I woke up with a severe headache. I experienced a muscle and joint pain all over my body including my arms, legs, and hip area. I had a 1 degree temperature increased fever, and I experienced nausea. The morning of 9/17/2021 the pain had subsided a lot in my body. I had a mild headache though so I just took some Tylenol. Since then my joints still ache a little especially in my right shoulder and hip area. The morning of 9/19/2021 around 6AM I woke up with severe leg cramps in both of my legs. When I stood up out of bed I guess I stood up too fast because I had fainted back onto my bed. My wife called 911 and then the paramedics transported me to a local ER hospital. Numerous test were performed and they were all negative. The doctors didn't see a need to keep me overnight. They just said to keep in contact with my PCP about my health event. I was there for about 3 hours before I was discharged back home. Since then my blood pressure is back to normal. I'm feeling better, but I am still experiencing the leg cramps. I have followed up with my doctor and he said it was possible since I had fell back that I may have injured my neck. I am being treated for a neck injury, and I am awaiting results for the x-ray.
got the vaccine, had shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was ex husband of reporter. The patient got the vaccine and then had singles months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case was linked with US2021AMR205467 and US2021AMR205468, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205467:Same reporter US-GLAXOSMITHKLINE-US2021AMR205468:Same reporter
swelling,rash,itching injection site, lump noted in center of swelling, fever, chills, fatigue, headaches. Symptoms started 6 hrs after receiving shot.
The patient came into the pharmacy the morning following her vaccination 1/8/21 complaining of extreme pain on her right side near her ribs, stomach and lower back. She experienced this pain the same night of receiving her vaccine, and it disrupted her sleep. She also complained of difficulty breathing up on inhalation, saying that it hurts to inhale.
This is a spontaneous report from a contactable pharmacist reported for a patient that: A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration on at  0.5, ml, single an unspecified date for immunization (Pneumonia invasive disease). The patient medical history and concomitant medications were not reported.  On an unspecified date the patient got sick and went to the hospital after receiving the vaccine with outcome of unknown. The reporter did not provide if the patient was hospitalized or just got treated in the ER. Sender's Comments: The current information is very limited and does not allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, and event details including the actual reason for being sick and the time lag between the onset of the event and vaccination date of PREVENAR 13. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient had no pertinent medical history  or drug reactions/allergies. On 26-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J000434, expiration date: 10-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications. The pharmacist reported that on an unspecified date in September 2013, after patient was administered ZOSTAVAX, the patient developed swelling and warmth in an area with a circumference of about 3 to 4 inches around the injection site. The pharmacist stated that the patient spoke to an unspecified nurse that told her to ice the injection site periodically, however, the pharmacist was unsure if the patient had begun to ice the injection site. The outcome of swelling and warmth in an area around the injection site was not reported. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Patient sought medical attention. Called physician. Additional information has been requested.
States started having tingling in right arm as well as abdominal pain/diarrhea a couple days after H1N1 vaccine.  Was seen at facility.  Has been seen there as well as Emergency Room and another Emergency Room.  States diarrhea 2-3x per week, and lasts all day when she has it. Last diarrhea bowel movement was 2 days ago. Has nausea, doesn't vomit every day but may vomit every 2-3 days.  States doctors tested her for stomach problems, but "nothing showed up". States stomach pains worse and more frequent now. States tingling started in right arm (first symptom) in fingertips and toes and they feel numb.  This happens 3-4 times per day.  States has some trouble walking at times.  Denies using cane or mobility aid.  Denies using any meds to help with these symptoms now.  Quit using things doctors prescribed, but she is taking Emycin 500 mg. for strep. Husband states he bought some pills to help her with digestion (unable to recall name), and she took it for 1 month without relief from symptoms.
About a week after receiving the vaccine, I noted that I seemed to have some loss hearing.  It has not improved as of yet.
Pt had an apparent syncopal episode approx. 5 minutes after receiving 3 vaccines, witnessed by myself and a nurse practitioner. He fell forward off exam table hitting his head on chair, after a few seconds of jerking motion of arms and hands he was turned over on his back. He regained consciousness within several seconds had forehead and nose pain. Layed on back for 20-25 min, drank juice, ate crackers (did not have anything to eat all day). Dr. evaluated pt went home.
Positive covid test after vaccine; This is a spontaneous report from a Pfizer Sponsored program . An unspecified age of male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that on 25Jan2021 was first dose of covid vaccine, had positive covid test on 31Jan2021, second dose is scheduled for 15Feb2021. He is wondering if it is okay to receive the second dose of the vaccine. Read ISI, cold transfer to Drug and Safety, long hold time, AE`/PCOM for positive covid test after vaccine faxed to Pfizer CEP 2191  Information on the lot/batch number has been requested.