chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diziness 1st dose; fever 1st dose; tiredness1st dose; headache1st dose; lot of arm pain 1st; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (diziness 1st dose), PYREXIA (fever 1st dose), FATIGUE (tiredness1st dose), HEADACHE (headache1st dose) and VACCINATION SITE PAIN (lot of arm pain 1st) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (diziness 1st dose), PYREXIA (fever 1st dose), FATIGUE (tiredness1st dose), HEADACHE (headache1st dose) and VACCINATION SITE PAIN (lot of arm pain 1st). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, DIZZINESS (diziness 1st dose), PYREXIA (fever 1st dose), FATIGUE (tiredness1st dose), HEADACHE (headache1st dose) and VACCINATION SITE PAIN (lot of arm pain 1st) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2021-163717 (Patient Link).
Severe muscle aches in joints. Like having a headache in my joints; got worse at night. Took pain killers and ADVIL, Thursday - Saturday. Muscles still feel sore today.
Felt fine this AM then a few hours after awakening started having under eye swelling on the left side of my face which spread to left side of the face swelling. I started to feel a little lightheaded and then my throat started to feel restricted.
About 2 weeks, post vax, pt broke out in pox all over her body. Still with pox, 2 weeks later. Initially pt felt faint for 2-3 days prior to outbreak. Tolerated IZ well when given. Conservative treatment.
Fever, body aches, sore joints, and swelling at injection site. Area of concern (R) upper arm.
6 hrs after vaccines given-pt had extreme pallor- circumoral cyanosis-extremely sleepy-poor feeding. Went to the ER. CBC normal EKG (-).  5/29/2008 MR received for DOS 4/30-5/01/2008 with DX: Acute Life Threatening Event s/p 1 month vaccinations.  Infant found by parent in crib pale with circumoral cyanosis and limp.  Lasted ~45". by arrival in ER infant was pink and smiling.  W/U (-).  Observed o/n with no further episodes.
fatigue; vomiting; nausea; fever; abdominal pain; This case was reported by a physician via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 6th May 2020, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOVAX 23. In May 2020, less than a week after receiving Shingrix, the patient experienced fatigue, vomiting, nausea, fever and abdominal pain. On an unknown date, the outcome of the fatigue, vomiting, nausea, fever and abdominal pain were unknown.   It was unknown if the reporter considered the fatigue, vomiting, nausea, fever and abdominal pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on unknown site and pneumonia vaccine on the left arm and experinced fatigue, vomiting, nausea, fever and abdominal pain. The doctor was transferred to medical information for additional assistance.  He did not want to provide date of birth or other information specific to the patient due to confidentiality concerns.
Patient reported pain behind her eyes 1 week after shot.  She then was seen in ER on 09/15 with slurred speech and right facial droop .   CTA head and neck normal.  WBC 11.5, refused admission for further workup and MRI.   Evaluated in clinic 09/17.  Bilateral facial droop, severe thoracic back pain, fine motor tremor. refused ER.  agreed to MRI.   MRI below.  Admitted to hospital for lumbar puncture and eval.  Left AMA.  Seen in clinic 09/27/21 -   facial droop somewhat improved, right leg weakness  09/29 - admitted - lumbar puncture and neurology eval.  diagnosed post vaccine inflammation and cranial neuritis by neurology.  No inpatient treatment administered.  10/7/21  -10/8/21  admitted again for worsening tremors,  waxing/waning facial droop.  Started on primedone for tremors.  Evaluated again by neurology
After the vaccine, I had chills, fever (39.5C), bone pain, cough, and runny nose; They gave me antibiotics, I got bronchopneumonia. I took a home test for COVID-19 and it came back positive and I got cold sores. COVID-19 lasted 2 months, I had to go to the Pulmonologist and they did X-rays and they gave me medicine and I was cured, (Ivermectin). Now I also have Liver Metastases. I had been clean from cancer for 10 years and until 2020 I was fine and now with liver cancer they won't let me get vaccinated again.
Continued pain in the arm near injection site when arm/shoulder is moved. Pain started the day of the injection. Had difficulty moving arm without severe pain for 5 days after injection. Pain has continued for 2 weeks. Pain increases at night.
Low fever; injection site pain; gout pain in feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; FENOFIBRATE; LIPITOR; PANTOPRAZOLE. The following information was reported: PYREXIA (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "Low fever"; GOUT (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "gout pain in feet"; VACCINATION SITE PAIN (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, gout.  Additional information: The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Other medications in two weeks included allopurinol, Fenofibrate Lipitor and "pantorzole." The patient did not have any known allergies. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt recvd vax & was screaming over 3 hrs; tx w/ apap;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hemolytic anemia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medications in 2 weeks. Anti-viral details: product: COVID 19 treatment, brand=Paxlovid, treatment start date was 03Nov2022 and treatment stop date was 08Nov2022, indication was treatment of COVID-19. Device timestamp was reported as 13Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm of injection hot to touch; site of injection has a bump; sore arm of injection; arm of injection has red area size of an orange; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE, FAMOTIDINE, METOPROLOL, BUPROPION, SERTRALINE HCL, TRAZODONE, SPIRONOLACTONE, ATORVASTATIN, LISINOPRIL and FLECAINIDE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
30 minutes after receiving the vaccine I began to have tingling in my throat, tongue, and lips. Also had a slight metallic taste in my mouth that subsided within 10 minutes. My upper lip began to swelling along the edge only. The tingling and swelling subsided after 3 hours. On day 4 after the vaccine, my left arm felt "cool and heavy" for 3 hours, and returned on day 5 (02/01/21).
This spontaneous report was received from a 76 year old male patient who is reporting on herself. The patient's concurrent conditions included pulmonary mass, cancer pain, basal cell carcinoma, metastases to spine, squamous cell carcinoma, hypercholesterolemia, drug hypersensitivity, hypertension and blood cholesterol increased. The patient's medical history included skin cancer, skin neoplasm excision, skin neoplasm excision and skin operation. The patient is an ex-tobacco user. On an unknown date (reported as 3-4 years ago), the patient received an unspecified shingles vaccine (manufacturer unknown) for prophylaxis. Then approximately on 18-MAY-2017 (reported as 2 weeks ago), he was diagnosed with shingles. He was prescribed an unspecified medication which he took for 5 days and then saw his physician for a follow-up appointment. The physician then prescribed the same unspecified medication for another 7 days. The patient stated at that time the shingles was 80-90% resolved and he felt it was a mild case (reported as "cause") of shingles. Causality assessment was unknown. This case is linked to the same patient link (MAARS ID: 1702USA009738).; Sender's Comments: US-009507513-1702USA009738:
PATIENT WAS ADMINISTERED 1ML INSTEAD OF 0.5ML DOSE. NO S/SX OF ADVERSE REACTIONS.
This spontaneous report was received from a register nurse referring to an unspecified number of patients of unknown age and gender, whom concurrent condition and medical history were not provided. On an unknown dates in 2015, reported as since 02-NOV-2015, an unspecified number of patients were vaccinated with ROTATEQ lot # L008057, expiration date 01-DEC-2016, oral (dose, concentration and dose number were not provided) exposed to temperatures outside of the recommended range, concomitant therapies were reported. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
Had initial onset of arm pain (generalized) and injection site soreness within 12 hours. Over 3-5 days, the acute symptoms gradually cleared. However, a localized, subcutaneous swelling (a "knot") remains at the time of this report which is day 12. The "knot" is slightly painful when rubbed; has not seemed to decrease in size.  It is questioned if the injection needle placement might be a factor, since the same size needle is used for my tiny, skinny arm (I am Asian, 100 lbs) as is used for my caucasian husband whose arm is 3 times the size as mine.
RACING HEARTBEAT; EXTREMELY ACHY BACK; BODY ACHES; FELT TO PASS OUT; SHAKING; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: UNKNOWN, expiry: UNKNOWN)) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced racing heartbeat, extremely achy back, body aches, felt to pass out, shaking, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, extremely achy back, body aches, headache, racing heartbeat, felt to pass out and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Severe bruising with pain in left arm, armpit, and left breast/chest. Pain, fever of 102 for 24hrs. Temperature after 24hrs was 99-100. Tylenol used to help control temperature. Now with painful fluid filled pustules, rash on right buttocks.
Mouth pain; Sore gums; I am having oral pain; This spontaneous case was reported by a nurse and describes the occurrence of ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain). At the time of the report, ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain) 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.   No concomitant medications were reported. No treatment medications were reported.
7 hours after vaccination took place, I developed a headache and then became really cold. I got colder and colder and then started to shiver and couldn't stop. My husband reported that I was really hot. I continued to shake for about 2 hours when I finally fell asleep. The next day, I continued to have a headache and lacked energy. I still felt I had a temperature but not as extreme as overnight. I took paracetamol every 4 hours to combat the feeling of being unwell and had frequent lie-down breaks. I woke up today feeling well enough to go about my household chores whilst still feeling unwell. I still feel quite tired and have a slight temperature. After my evening meal, I had an upset stomach which led to diarrhoea.
10PM 15JAN97 pt noted w/bradycardia & apnea, color, tonic clonic movements of upper extremities;pt suctioned via tracheostomy & placed on ventilator;sepsis w/u initiated & placed on ATB;
Feeling of pins and needles that started around week 2. Now is 8/29/2021 and hasn't gone away after about 5 weeks.
TOOK A DOSE OF VIVOTIF ON 23-MAY-2019 AND HAS NOT TAKEN ANY DOSES SINCE THEN; This spontaneous case (PVX2019-1377) was received from a nurse on 29-May-2019. It describes a 33-year-old adult male consumer who "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took a dose of Vivotif on 23-May-2019 and then, did not take any further doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event  "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then" was considered as not applicable.
Flu vaccine 0.25 given at 4 months of age. Mom made aware today.
Pt became dizzy, nauseated and hypertensive. Pt was placed on precautionary O2 and zofran given by EMS. Pt remained hypertensive and was transported by private vehicle to local ER.
Started feeling really tired and off one day. Started tracking heart rate the next day, because heartrate was getting faster. Home heart monitor showed I was in Tachycardia. Took a low dose of husbands beta blocker and went to an urgent care the next day. Urgent care gave an EKG, heartrate was slightly elevated. Sent to ER because they wanted to test for Troponin tested for past heart attack. ER did a blood panel and another ECG. Blood pressure was 136 and pulse was 54. After blood pressure leveled out to normal, went home and rested. Went to primary care physician for a follow up. Am being sent to a Cardiologist in a couple of days and they want me to wear a Holter monitor.
Patient called several days following administration stating she had experienced redness, swelling the size of her palm, and a knot developing where the immunization was given. She stated the pain was radiating down her arm.  This lasted 2 days, the redness lasted 3 or 4 days.  She consulted with her physician who advised her to wait another day.  She applied no ice pack nor took any pain reliever.  When I talked to her later in the week, she stated it was much better, and did not require a doctor's visit.
Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
11OCT95 pt screamed from 1PM to 8PM; rt leg was swollen & tender; no fever; parents gave APAP as directed q 4hrs; pt devel a rash; parents took pt to ER-DPH & APAP given; pt slept all noc; 12OCT95 pt fine-no more screaming or fussiness;
Information has been received from a physician concerning a patient, who is a twin, who on 02-JUL-2008 was vaccinated with an oral first dose of ROTATEQ vaccine live (human-bovine). Within days of receiving the vaccination the twin experienced severe diarrhea, approximately 10 times per day. The physician reported that the twin was being tested for rotavirus (no information was provided). No lot number was provided. No product quality complaint was involved. This is one of two reports from the same source. The patient's twin was administered an oral first dose of ROTATEQ vaccine live (human-bovine) and had a similar experience (WAES# 0807USA02912). Additional information has been requested.
Vaccines given at 2:30 pm on 1-25-22, and after dinner in the evening noticed for first time around 8pm a rash on abdomen/chest area. Described the rash as red oval in color and shape, approx. 2 to 3 times the size of a mosquito bite and bright red. He was happy at that time. He was given the evening dose of Benadyl. Morning of 1-26-2022 child had bright red hives, and "blood blister" coloring to the rash.  His thighs at site of vaccines was "hot to touch", red and "really warm" . He was now at day care, provider said he had appetite, but then did not want activity, and was fussy and wanting to be held. The foster mother of child then picked him up from day care and took him to his pediatrician.  No obvious itching but noted to have scratch marks on buttock area.
Information has been received from a consumer concerning a fried of the physician's daughter, who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient died. The cause of death was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of two reports from the same source. No further information is available.
SWELLING OF THE LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE BURNING AND ITCHING URTICARIA  ON THE INSIDE OF THE THIGH, INSIDE CROOKS OF THE ELBOW HANDS, AND LOWER LIMBS ( KNEE'S ) COUPLED WITH ANGIOEDEMA OF THE LIPS.
He got his vaccine, he felt tiredness but nothing major.  The next day he started feeling nauseous and really out of strength.  His muscles were tired, and he got a strange bump under his right armpit, and had a mild fever.  He also had little bumps around the vaccine site.  The arm is red, but not itchy but does hurt upon touching the arm.   It's beginning to get better.  He did run fever, and had fever blisters in his mouth that are still there, and he has a lot of pain on the right arm, and on the shoulder blade area.  He has taken Ibuprofen for these symptoms.  He did not call his doctor.