chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case received from a healthcare professional on Oct 03 2005. A 36 year old male patient, with no significant health problems or drug allergy, had received, for a puncture wound of minor degree, an intra muscular right arm injection of TD ads thiomersal free vaccine (Decavac, lot # U1596AA) on Aug 19 2005 at 1:30pm and 6 hours later, he had sudden episode of diaphoresis, nausea and vomiting and had a generalized seizure with incontinence of bowel and bladder. He was seen in the ER via ambulance and had a normal workup including CT of the head, cardiac evaluation and chemistries, except for a minor decrease in potassium of 3.3. On follow up patient had an EEG of the brain that was also normal. Final patients recovery status was not reported.
Severely sore arm from Gardasil shot. It is still sore 5 days later, and touching it is painful. The arm cannot bear weight very well and many common movements are painful.
come back with rashes; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Few patients came back with rashes after Shingrix.  The pharmacist provided general statement after transfer of call from first line specialist. Due to technical difficulties experienced with during the call, no further details were requested. This case has been linked with case US2020176166, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176166:same reporter
Approx. 10 hours after Pneumovax given, RN noted patient's arm swollen and red and hot to touch
Pain from injection site (left deltoid) to mid back at 8:00 AM, increasing to neck by noon. Decreased Range of motion and pain in left shoulder by 5:00 PM, lasting extreme for 5 days. Flu-like symptoms by Tuesday.
The pt developed redness in right deltoid and warm and tender to touch. Diagnosed with local reaction to DTaP and advised Motrin prn.
Patient fainted in chair shortly after vaccine, patient started to snore, then his body shaked for a couple of seconds. Shortly thereafter patient arose and was feeling tired. Patient did not have any trouble breathing.  Patient remained seated while being supervised and ems was called. Patient declined to go to hospital. No further incidents occured
3 days after receiving my second covid Moderna vaccine I developed significant loud high pitched tinnitus in my left ear this symptom still persists over 3 months later  I did see an audiologist I never had covid illness I am sure it's from the vaccine
Limited information as patient received vaccine at outside facility.  During ED visit for unrelated issue patient report receiving the vaccine on 1/6/21 and started getting quarter sized blisters on his left hand the next day.  Unsure if this was previously reported so submitting in case it was not.  Patient resides at nursing home/rehab
ARM SORENESS; SLIGHT HEADACHE; SLIGHT MUSCLE SORENESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: contrast dye allergy. The patient experienced drug allergy when treated with ampicillin, clindamycin, and gemifloxacin mesilate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced arm soreness, slight headache, and slight muscle soreness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and slight headache, and slight muscle soreness on 19-MAR-2021. This report was non-serious.
100 degree fever for 8-10 hours; started approximately 9 hours after vaccination; treated with Tylenol
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Additional Details: PATIENT FAINTED ROUGHLY 30 SECONDS AFTER RECEIVING COVID VACCINATION
long 24 hour after my first dose I got my period few days earlier than normal like 4 days earlier; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8733) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE MENARCHE (non-serious) with onset 2021, outcome "not recovered", described as "long 24 hour after my first dose I got my period few days earlier than normal like 4 days earlier"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea". Therapeutic measures were taken as a result of premature menarche.  Additional information:  The patient stated that she did Cystofert medicine for event of premature menarche. Patient received the second dose of the Pfizer BioNTech COVID-19 Vaccine last Friday have experienced side effects. She did not specify all the side effects she has experienced but she did mentioned nausea and she mentioned that she wanted to know menstrual cycle could be affected by this vaccine. but she didn't go to explaining what is happen exactly." Patient was calling to that what she was experiencing abnormal side effects. So, she got her second dose this past Friday and long 24 hour after her first dose she got her period few days earlier than normal like 4 days earlier and she just letting us she is not on the pills but she is very, very regular so, she wanted to letting know use to her period being, and she unusually track it and patient usually receive it 1 or 2 days before or after so, and then for the time she received her second dose she need to not for like 6 to 7 days and starting feeling like she know, to feel it, how she done, oh this is, it's coming early. The patient stated that she took OTC when she need it.  No follow-up attempts are possible. No further information is expected.
2 x cyanosis, irritability, fever (prolonged), vomiting and sleepiness, leg pain.
hypertension in lungs; it is hard to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "knee replacement", start date: 11Aug2021 (unspecified if ongoing), notes: Caller clarified surgery as a complete knee replacement on left leg. She had cortisone in left knee then he did the surgery on 11Aug2021.; "Hypertension" (unspecified if ongoing), notes: she had hypertension because of lungs. Concomitant medication(s) included: VITAMIN D3. Vaccination history included: BNT162b2 (First dose, On the card it says Pfizer, 0.3ml, 6 hours, lot number: EL3247), administration date: 23Jan2021, for COVID-19 Immunization; BNT162b2 (Second dose, Lot Number: EL3251), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "swelling in both feet", "swelling in left leg". The following information was reported: PULMONARY HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "hypertension in lungs"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it is hard to walk". The patient underwent the following laboratory tests and procedures: Blood test: Improved, notes: her blood tests improved; Echocardiogram: noticed hypertension, notes: showed something about right side of heart enlarged a little bit then noticed hypertension; Tests: Normal, notes: did all kinds of test on her and everything looked normal; Renal function test: little lower, notes: but had improved from prior month. Therapeutic measures were taken as a result of pulmonary hypertension, gait disturbance.  Follow-Up (02Jun2022): Follow-up attempts are completed. No further information is expected.
Sever flu like symptoms, fever, chills, body aches, fatigue, head ache. I feel positively awful.  This will be the last time I get a covid vaccine. I've never had a reaction to a vaccine remotely this bad.
Patient presented to the ED on 6/7/21 with abdominal pain that had started earlier that day. CT abdomen, CXR, and urinalysis were done and all came back negative. Patient denied any respiratory symptoms. On physical exam, he was found to have severe swelling, erythema,  and ecchymosis on his left leg extending into the upper thigh and knee. A lower extremity doppler was done and found extensive occlusive thrombosis within the left lower extremity beginning in the external iliac vein and extending into the common femoral, femoral, profunda, popliteal and visualized deep calf veins.  No evidence of PE or DVT in the RLE was found. Vascular Surgery was consulted, who did not recommend any procedures, but patient was started on a heparin drip. Hematology later saw the patient and changed the heparin drip to rivaroxaban on 6/9/21. Infectious Diseases was also consulted for possible sepsis.
pt recvd vax;crying & grenting for several hrs;mom states that on ?oce, he would stiffen then relax; no sz activity
patients who have received vaccines that were previously exposed to temperatures below 32 degrees F/No AE; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193111, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 5 months old female patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) and IPV (VERO) [IPOL] (lot PIA461M, expiry date- 03-May-2020) via intramuscular route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse 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 Directive and Module VI of the Practices. 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.  List of documents held by sender: none.
I tested positive January 04, 2022 for Omicron. I had a horrible headache and I started throwing everything up and that was it. It was a very mild case. No other type symptoms.
Breakthrough case of COVID-19. I had a sore throat, headache, cough, and runny nose. I took two home test and both showed I was positive for COVID-19. I called my doctor and was prescribed Paxlovid.
No pain at injection site 10/26/2021  Didn't notice anything in the evening either.   On 10/27 0660-noticed pain - 1-2 on scale of 10 Gradually getting worse over the week.  Up to 5/10 today.   Slightly swollen, warm to touch, feels similar to a burn type of pain.  radiates to diameter about 4 inches from injection site. Clothing sleeve is very irritating over the site.  Also having achy type of pain from mid lower arm to finger tips.  It's a feeling I can't describe.  I can still type and do my job, but it is constantly there and hurts  2-3 / 10 pain Having major cramps in arm several times a day.  Mostly in my hand/forearm area up to elbow.  Pain during the cramps is 7-8 / 10.  ( I do have some cramping from a previous injury, but only occasionally - a few times a week) this is so much more and much more pain involved.  And finally,  I am so tired it's difficult to stay awake.  That is so unusual for me.  I'm actually eating ice while working to try to stay awake and focused. ( I hate chewing on ice, but it works)  This is not even close to what I went through before, but it is highly distressing and frustrating to deal with.  .
Received at 7am and by 6pm was trembling, freezing 102.4 fever with pain shooting through my body. continued to reoccur every 4 hours for 2 days then leveled off and was able to return to work on the third day.  Following week my great toenails fell off I went to podiatrist Dr and it was called covid toes
Afternoon after shot legs starting aching, felt weak and fatigued, ran low fever that night and next day.  Second day aching, headache, arm with injection swelled, red around site, pain went down arm and into hand. Felt this way for 4 days.  Took Tylenol and used ice pack on head and arm.
Redness / warmth around the site. Induration in the area of immunization. No systemic symptoms, afebrile.  Symptoms have persisted until 2 days later (10/14), and the area has not grown. Will continue to assess patient to ensure she does not develop cellulitis. Patient was 24 weeks, 2 days pregnant at the time of vaccination (EDD 1/30/2023).
She feels that the vaccine caused some swelling in the upper and lower lip; Woke up the next morning and the swelling was worse causing disfigurement. I was really scary; Facial Swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip), SWELLING FACE (Facial Swelling) and SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SWELLING FACE (Facial Swelling). On 26-Mar-2021, the patient experienced SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary). On 29-Mar-2021, the patient experienced LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip). On 25-Mar-2021, SWELLING FACE (Facial Swelling) had resolved. At the time of the report, LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip) and SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information included benadryl
I got the shot on Thursday, July 22, 2021. I woke up Friday having numbness in my left hand.  That went away and now I have a tingly sensation throughout my left arm.  The shot was given me in my left arm.
7 days after 1st dose...woke up and noticed I was itchy at the site of injection, noticed raised rash around injection site. Continously itchy, red rash, warm to the touch.
Death following severe breathing difficulties starting shortly after vaccination. Patient had a second vaccination but this was not reported on her vaccine card.
A high fever and was very lethargic. Left arm had hives, redness, swelling and hot to the touch from pectoral muscle to bend in arm. Could not lift arm for a day and a half without pain. Continue to have a picking sensation, soreness and discomfort in arm. Follow up: Arm swollen, turned red. Fever (did not take until next day 101 F). Felt tired. Went to bed. Went to Hosp ER states she was given 2 pills and sent home. Doesn't know what they were. Thinks it was a steroid.
A couple days after vaccination 10/24/2021 I started with a lot of shoulder and neck pain and pain that went down to your hands and now had back pain for one night then it went away.
5/10/04: flu ER visit: redness, swollen left leg. Tx: Orapred 15/5 1tsp of q bidx 5 days. Atarax 10/5 3/4tsp q6x 1 week.
Violent vomiting episodes after each Anthrax shot. Flu like symptoms for at least two weeks after each shot. Body aches for two weeks after each shot.
foggy head; Nasal congestion; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) outcome was unknown. Event outcome reported as unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
This spontaneous report as received from a consumer who refers to a male patient, her husband of unknown age. The patient's concurrent conditions and medical history were unknown. On 07-JUL-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # and Expiration date not provided), (dose and route unknown). There was no concomitant medication reported. The consumer states her husband received the PNEUMOVAX 23 injection on 07-JUL-2016 and has been sleeping a lot and not eating since that same evening. The consumer states that her husband has lost 10 pounds since 07-JUL-2016. The consumer states she contacted her husbands physician but cannot get an appointment until 12-JUL-2016. The consumer stated, she did not know if the PNEUMOVAX 23 injection was given by her husband's primary physician. Lab diagnostics studies were reported as unknown by the consumer. The outcome of hypersomnia, weight decreased and eating disorder was reported as not recovered/not resolved. The reported did not assess the causal relationship between the adverse events. The consumer did not want to give any other information regarding this situation. No further information was provided. Additional information is not expected.
2 y/o female received #2 of H1N1 - later that evening vomited x 1, T=100.2. Next day @ 6am vomited x 1 T=100.2. Went to ER on 1/3/10. Pt was still active, has rhinorrhea and cough
Diifficilty breathing, difficulty spittinh, eye would not blink, diagnosis: Bell's Palsy. Treated with: methyl pred, famciclovir, erythromycin, ofloxacin for eye.
fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (the patient was covid-19 positve) in July 2020.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test positive: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:00 as dose 1, single (Lot number: 025A21A), on 02Apr2021 at 12:00 as dose 2, single (Lot number: 016B21A), in left arm, on 14Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 065F2IA), in left arm and on 31May2022 at 15:45 as dose 4 (booster), single (Lot number: 049L2IA) at the age of 51 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CLOBETASOL, start date: 12Jun2022, stop date: 14Jun2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Erythromycin, reaction(s): "Known allergies: erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti viral details: product: COVID 19 Treatment, brand: Pfizer, treatment start date: 15Jun2022, lot number: GCO470, indication=Treatment of COVID-19. Clinical course details: The patient received other medications in 2 weeks (Topical steroid). No follow-up attempts are possible. No further information is expected.
large red spot 3 to 4 diameter; Extremally itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included No adverse event (No Reported Medical event).    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy). At the time of the report, RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact