chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a neurologist, who is also the patient, on 25 March 2015. A female patient (age not reported), with no reported medical history, received an intramuscular, left deltoid injection of ADACEL (lot number U5081AA) on 02 March 2015. Immediately after vaccination, she experienced a numbing, aching sensation down her left arm. Within one hour, she began experiencing body aches, fever, chills, dizziness, and an ability to move her arm. She stated that she felt as if "bones had been crushed". She treated the symptoms with ADVIL and TYLENOL, however symptoms continued to worsen. While attempting to fall asleep, she noted severe arm pain, chills, and sweating. She got out of bed at 3:00 am and went to the kitchen, at which point she became dizzy and lost consciousness, falling to the floor and landing on her face. She stated that she was unconscious for an unknown amount of time, and upon arousing was only able to get to her living room couch. She continued to have severe arm pain, nausea, and sweating, and was unable to move or lift arm. She later noted swelling and a black and blue area around the right eye. She cancelled work for the next few days, and treated with TYLENOL and Aspirin; she noted improvement in her right eye, but pain and difficulty moving the left arm and shoulder continued. She had been seen by an orthopedic surgeon, who prescribed a course of steroids. She was planning to follow-up with the surgeon, as she still had pain and difficulty moving her arm. Outcome was not recovered. Documents held by sender: None.
10:30 a.m. - 1:00 p.m. (05/04/2021): No symptoms.  1:00 p.m. - 8:30 p.m. (05/04/2021): Shoulder and leg myalgia 8:30 p.m. - 9:30 p.m. (05/04/2021): Chills and fever of 100.2 Midnight (05/05/2021): Fever of 101.1 (took Tylenol Flu Nighttime after taking temperature) 6:30 a.m. (05/05/2021): Headache, fatigue, and fever of 100.9 7:00 a.m. (05/05/2021): Took Tylenol Flu Daytime 1:37 p.m. (05/05/2021): Took ibuprofen for continuing myalgia and headache 4:02 p.m. (05/05/2021): Fatigue, mild myalgia, body temperature 97.9 05/06/2021: Mild fatigue and arm pain; 05/07/2021: Very mild arm pain
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Moderna COVID-19 Vaccine EUA Fatigue; chills; headache; hallucination (1)--over 48 hours (very small price to pay).
Fever, nausea, headache, fatigue, myalgias, forgetfulness for 2 days after. Fatigue lasted 1 week. Then 2 weeks later back pain and tingling in hands and feet. Also now have large platelets on CBC which wasn?t present before.
Patient was nervous among arriving into immunization room. He said shots and other medical procedures made him nervous. He was shaky and nervous.  He recived the vaccine and was waiting in the waiting area in front of the pharmacy, when his wife yelled for help. Among arriving patient had briefly passed out, for a couple of seconds and then regained conciousness. Patient was fine and could tell me where he was, and was coherent. Watched patient for another 30 minutes he was fine and left.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 08Sep2023 to 12Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
lt hip pain w/inability to bear weight followed by a sparse erythematous macular rash on extremities;
Patient received Pfizer vaccine and reports she started feeling body paresthesia, nausea, and general malaise. Was transported to hospital, fluids and EKG performed, patient stated she was feeling better and all symptoms resolved and patient discharged.
Information has been received from a physician concerning his son who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed a fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
sore arm; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, see case US2019AMR097029).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown.   It was unknown if the reporter considered the pain in arm and swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she has experienced adverse events sore arm, swelling with Bexsero that seemed to be higher incidence after 1st dose than 2nd dose.
nausea; chills; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also include thyroid and bloodpressure medications.
Patient experienced joint pain,  back pain, mild fever and chills for the first few days. Seven days post vaccination he experienced pain on right elbow. Fourteen days post vaccination the elbow pain subsided but he began to lose sensation on his right arm from his pinky up to his elbow/upper arm area. He described it as if his arm fell asleep and was numb and tingly.
Swollen lymph nods on right side of the neck, 2 sores inside of my nose, continued fever of 102, for 6 days, swollen right side of the face.
Pt c/o tingling & burning going down Left arm.  Shot was given in appropriate location: 3 finger breadths below acromion process.  No redness but slightly tender to touch.  Instructed to put ice on area & take ibuprofen as needed.
This case was reported by a healthcare professional and described the occurrence of stiff neck in a 31-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and Yellow fever (non-gsk). Concurrent medications included Azithromycin. On 14 March 2014, the subject received 1st dose of TWINRIX (unknown route, left arm), 1st dose of Typhoid vaccine (Non-GSK) (oral), 1st dose of Yellow fever (unknown route and injection site). On 15 March 2014, 1 day after vaccination with TWINRIX, Typhoid vaccine (Non-GSK) and Yellow fever, the subject experienced stiff neck and weakness in neck. At the time of reporting the events were unresolved.
Within 24 hours post vax, the pt became blue at the mouth and toes. The pt also developed a rash, vomiting, diarrhea and hives. The pt was seen in an urgent care center. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Within half hour, nausea and severe headache vomiting and headache persist 18 hours after with temperature of 102. Marked headache and crying with pain; injection site ok.
Developed shingles 6 days post vaccination.  Painful rash on the right side of the back, above waist line.   Treatment:  Valacyclovir (Valrex) Omeprasol ( Prilosec) Prednisone (Deltasone) Betamethasone augmented (Diprolene AF)
Pt came in this weekend complaining her arm still hurts & states I gave the shot too high in the arm.
Redness, swelling and warmth approx 24hrs after vaccine administration with continued worsening. Started on KEFLEX BID x 10 days for concerns with cellulitis.
Head ache Fatigue Joint ache:  neck, lower back, knees Muscle ache: calves Loss of appetite Night sweats/fever Deep chills Redness and swelling at shot site
Initial report received from a health care professional on 19/Jul/2005. A cluster of "several" four year olds (no specific patient identification provided), had received injections of Daptacel, lot number not reported, on an unspecified date. An unspecified amount of time later, the patients developed large area of redness and swelling at the injection site. They were subsequently diagnosed with cellulitis. It was not reported whether the patients recovered from these events.
Felt very ill. Vomited 8 times. Felt very shaky. Flu shot given 10-9-13 in am. Symptoms appeared am 10-9-13. Went to cousins home, didn't want to be alone. Did not call MD or go to emergency room. Reported to provider 11-5-13. Self treating by eating aloe vera gel.
Headache, nausea, vomiting, myalgias, arthralgias, dizziness, tachycardia, fatigue, slowed cognition, and memory loss. The first 6 symptoms resolved in about 24 hours. The remaining 3 (fatigue and cognitive symptoms) persist.
Left lateral upper arm inflamed red and swollen. No whelps or lesions or tender upper arm to shoulder. Advises treatment with Benadryl 25 mg GM gave Benadryl before he left MD. Heat inupper arm area. 4/1/04: mother called arm much better
Developed cellulitis at left thigh. Seen at ER and started on Keflex. Area measured 11cm X 7cm.
Received the 1st shot in April and as of today not gotten the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose) had resolved.        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 medications was reported.  No treatment details were provided.
I contracted COVID-19 on 5/4/2022 with symptoms of fatigue, cough, sore throat, headache, runny nose, congestion and diarrhea. I was prescribed Paxlovid and Azithromycin on 5/5/2022 and my symptoms are beginning to improve.
Sore Knee; tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore Knee) and FATIGUE (tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ARTHRALGIA (Sore Knee) and FATIGUE (tired). At the time of the report, ARTHRALGIA (Sore Knee) and FATIGUE (tired) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment details were provided.
I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night; I felt a little weak; flu; I was very sluggish; having hot and cold chills; Vaccination site swelling; This spontaneous case was reported by a nurse and describes the occurrence of SLUGGISHNESS (I was very sluggish), FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 05-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills). On an unknown date, the patient experienced SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu). On 10-Apr-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. On 07-May-2021, FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills) had resolved. At the time of the report, SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided. Concomitant medication information was not provided.   This case was linked to MOD-2021-068790 (Patient Link).
After receiving my 2nd Shot 4/29/2021, in my right Deltoid, I began to experience stiffness and pain at the injection site about 2-3 weeks post-vaccine. As the time has progressed the pain has not subsided and is localized to my right Deltoid and has shooting pain if the arm is raised over the head or reach behind the back causing a limiting range of motion without pain. My PCP suggested in August 2021  an anti-inflammatory pain medication( Naproxen) and topical analgesics as a suggestion for pain relief.  In August 2021 I went to the chiropractor to see if an adjustment would relieve the pain in my arm and pain still persists. After receiving 3rd shot on 11/9/2021 in my right Deltoid  I have continued to have pain. I have intermittent pain in the right deltoid and downside of the arm when moved in certain positions (raise the arm up overhead and if I reach behind my back, put on a coat or book bag.). On 11/30/2021. I went back to the chiropractor to see if there was something I could do and was referred to the place  I received injection as any adjustment would not help with the pain. When I completed my daily symptom tracker VSAFE I noted the issue.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Ongoing. I have taken an antihistamine to reduce the reaction. I felt tired with a headache for the first 2 days after the vaccine. Today I feel well aside from my arm is red and swollen, and warm to the touch. I did receive the first and second dose both in my left arm.
Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report from a non-contactable consumer. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284) intramuscularly in left arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included traumatic brain injury from 2019 and ongoing, syncope from 2019 and ongoing (both reported as current Illness: traumatic brain injury? 2019 syncope? 2019). Concomitant medication included midodrine. The patient experienced fever, chills, pain/aches, on 22Jan2021 pm, condition aggravated on 22Jan2021, syncopal episodes X 4 on 23Jan2021 - transferred to ed - admitted. Events categories per reporter was permanent disability, hospitalized (3 days in hospital), emergency room visited. No office visited. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant regarding a 17-year-old female patient. The patient's medical history, drug allergies/reaction, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2003, the patient was vaccinated with M-M-R II (dose, frequency, lot# and expiry date were unknown) via subcutaneous route for prophylaxis. Other suspect therapies included sterile diluent (dose, frequency, lot# and expiry date were unknown). On an unknown date, it was reported that the patient was waiting for a lung transplant" for an unspecified reason" (lung transplant). It was reported that patient was seen in doctor's office and sought medical attention. Action taken with sterile diluent was unknown. The outcome of lung transplant was reported was not recovered at the time of report. The causality assessment was not given by the reporter. Upon internal review, lung transplant was determined to be medically significant.
Patient a itchy, burning rash (ankles to knees, wrists to upper arms, and forehead) {Patient referred to rash looking like "tractor tracks"} [No rash on trunk] Patient's condition has improved but is still resolving: Patient still has some rash, minor burning, and minor itching (also, still some evidence of "tractor tracks").
Received vaccine 12-9-13, woke with rash covering body 12-10-13.
Phantosmia: strong sense of smelling smoke when none present, started ten days after vaccine, continues today
Information has been received from an NP concerning a 39 year old female who on 7/7/00, was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 8/4/00, during a routine check-up, the pt's urine was HCG positive. LMP: 7/4/00. The pt used the rhythm birth control method. The pt had not yet seen her gynecologist. Follow-up information from the nurse practitioner noted that the pt had a miscarriage and was currently well and was trying to conceive again. No further information is available. F/U states: The date of 2000 was added to field 11 to reflect the adverse event onset date of the miscarriage.
12/13 generalized malaise and fatigue. She was recently diagnosed covid+. She complains of a productive cough of yellow sputum. She's had chest pain and shortness of breath. She endorses Abdominal pain. She denies vomiting or diarrhea. She reports normal urination with no dysuria. EMS reported patient 100% on 2 L nasal cannula home. That is her normal oxygen flow rate. 12/16 COVID 19 Pneumonia & Acute hypoxic Resp Failure, start Remdesivir 12/17 The patient is currently maintained on 2 L nasal cannula.  Started her today on Decadron, remdesivir, and the rest of the treatment.  When seen, the patient complained cough and shortness of breath. 12/19 The patient is currently maintained on remdesivir and Rocephin, this is day #4 of the Rocephin.  The patient's white count is slightly elevated, however, this is likely related to her Decadron.  The patient is also maintained on Epzicom and Isentress as for her HIV treatment.  She is also on Decadron 12/20 Chest Xray: Bibasilar subsegmental atelectasis and patchy left basilar infiltrate with slightly improved aeration.  12/21 Discharged: COMPLETED  REDESIVIRE IV TODAY, ON STEROID/BT/O2
1/8/21, 1600: Received second dose of COVID-19 vaccine 1/9/21, 1800: Began to feel feverish and achy, and later identified some pruritic lesions beginning to emerge 1/10/21: Developed a crop of raised red pruritic lesions on distal extremities; later noticed visible swelling of the face. Patient did not experience swelling of tongue or respiratory compromise. Patient self-administered Benadryl and a Medrol Dosepak. The lesions expanded to involve torso.  1/11/21: Symptoms subsided, though there was a sensation of recrudescent pruritis at unspecified time. 1/11/21, 1631: Labs ordered; patient CBC and CMP were WNL. Noted that platelets were normal, no eosinophilia, and LFTs were WNL. Positive COVID-19 antibody test. The patient stated he had COVID-19 in November, but no positive test is noted in the patient chart.