chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have 100.8 fever; Extreme pain; I feel awful; extreme swelling; redness and hot; redness and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma. Concomitant medication(s) included: ADVAIR; THEOPHYLLINE; NEXIUM 24HR; SINGULAIR; XYZAL. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I have 100.8 fever"; PAIN (non-serious), outcome "unknown", described as "Extreme pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel awful"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "extreme swelling"; ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "redness and hot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Prevnar 20 Vaccine yesterday and yesterday morning and patient felt fine yesterday and now patient have 100.8 fever and the vaccine site was about 4 inches actually its probably about 5 inches in diameter and red and hot and swollen then patient feel awful and patient was just thinking my new vaccine have got many side effects and it feels like a COVID vaccine (Event captured as per Verbatim and COVID Vaccine captured as suspect conservatively). Stated, "Extreme pain, extreme swelling, redness and hot. I guess my question is, Is this an extreme reaction". Patient stated "You can't tell me about the fever I am experiencing extreme because I never had a fever because of the vaccine." Treatment: Consumer stated, "I have taken Advil and Ibuprofen and I think my arms (Sentence incomplete)."  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
patient has received the Diluted portion of the Pentacel and they have the patient coming in to received the powder form of the Pentacel with no adverse event reported.; Initial information regarding an unsolicited valid non serious case was received from another health professional via Medical Information (Reference number- 00778419) and transmitted to Sanofi on 21-Sep-2021.   This case involves an unknown demographic (unknown age and unknown gender) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was "patient has received the diluted portion of the pentacel and they have the patient coming in to received the powder form of the pentacle" (wrong technique in product usage process).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ543AA, expiry date 10-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong technique in product usage process (latency unknown).  It was reported "patient has received the Diluted portion of the PENTACEL and they have the patient coming in to received the powder form of the Pentacel and now what can they use instead of the diluent that come with the Pentacel? Can she use sterile water? Healthcare professional (HCP) asks what can be used to mix the HIB part of Pentacel? Also, what amount of 0.4% NaCl is used?"  At time of reporting, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Rotateq #1 given on 6-4-07. No s/s, no adverse reaction, no treatment.
Got an infection after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Got an infection after being vaccinated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INFECTION (Got an infection after being vaccinated). At the time of the report, INFECTION (Got an infection after being vaccinated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt received his second dose of Pfizer vaccine in his L deltoid at approximately 1500 on 10/4. At approximately midnight on 10/5 pt began having itching and diffuse hives. He took OTC benadryl with resolution. He had onset of oral angioedema involving mostly his upper lip at approx 1600 on 10/5. He reported associated chest and throat tightness, subjective wheezing. On arrival to our emergency department at 1700, he had angioedema of his upper lip, no edema of his posterior oropharynx, no audible wheezing, however his SpO2 was 93-95% on RA. He had itching of his head and upper torso without obvious urticaria. He was given 125 mg solumedrol IV, 20 mg pepcid IV, and 25 mg benadryl IV. He was also given 0.3 mg of epinephrine IM. He had improvement of his subjective chest and throat tightness but perioral angioedema persisted. He was normotensive with heart rate in 80s. He has no history of atopy or allergic reaction. He is currently being monitored in the emergency department.
At 1:00 AM, I started to have dizzy, the whole ceiling was spinning .  I waited until 8:00 AM that Urgent Care opened,  My husband drove me to Urgent Care at 8:00, got medicine for stopping dizziness. I slept almost for two days.  On 4/26, my dizziness started again.  I went to my family doctor and ENT.  Since I still have very light dizziness.  It has been for a month.
Nausea, so far three days Sweats and chills. Temp reading normal Severe headache 2 days Sleeplessness four nights Extreme fatigue
Patient is a 85-year-old male with a past medical history of rectal bleed/melena, rectal biopsy revealing malignant mass, macrocytic anemia, CAD, history of seizures, history of CVA who presented to Hospital on 5/17/2022 from nursing home with complaints of shortness of breath.  Reported fever of 101 Fahrenheit, on 2 L nasal cannula and no supplemental O2 at baseline.  Upper extremity edema bilaterally, lower extremity edema bilaterally.  No abdominal pain.  No reports of bloody stools.  No reports of nausea or vomiting.  Denies any tobacco use.  Denies any alcohol use.  Reports history of pacemaker.  Allergies and medications have been reviewed and reconciled.  Family history has been reviewed.   ER course: T-max 101.1.  Tachycardic up to 102.  Tachypneic up to 28.  Blood pressures are on the lower end of normal with most recent pressure of 108/62.  Labs significant for leukocytosis of 27,300.  Hemoglobin 8.5, repeat of 8.0.  D-dimer 963.  Potassium 3.3 and then 2.9, this has been replaced.  Creatinine 1.36 with GFR 47.  LFTs unremarkable.  Troponin 169 and subsequent level was 166.  Lactate 1.6 and then 1.4.  ABG unremarkable.  Urinalysis with some yeast, large leukocyte esterase, 51-100 WBCs, trace hemoglobin.  Blood type is O+ with indirect Coombs negative.  COVID antigen negative.  Chest x-ray with significant left pleural effusion and associated air opacities.  CTA chest negative for pulmonary embolism, bilateral pleural effusions, subcutaneous edema, 2.2 cm gallstone within the gallbladder but no evidence of acute cholecystitis, 2.1 cm right thyroid lobe dominant nodule.   Of note patient was recently admitted to hospital from 5/4/2022 until 5/9/2022.  At that time he was admitted for rectal bleeding with melena.  No family history of colorectal cancer was reported.  Biopsy of rectal mass revealed malignancy.  EGD on 5/5/2022 with flexible sigmoidoscopy revealed hiatal hernia, esophageal stricture, status post dilatation, duodenal diverticulum.  Gastroenterology at that time was recommending endoscopic ultrasound for staging as well as referral to colorectal surgery. Last set of labs on 5/7/2022 showed a hemoglobin of 7.5 with hematocrit of 23.7%.  White blood cell count of 12,000.  MCV of 101.2.  BMP with GFR in the mid 40s.  LFTs were unremarkable.
Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis.     No known allergies were reported.  Concurrent medical conditions included GERD since 20-Aug-2020, Hyperlipidemia since 15-Jul-2020, Migraine since 08-Dec-2018, Hypertension since 08-Dec-2018 and Vitamin D deficiency since 15-Jul-2020. Concomitant products included FAMOTIDINE from 22-Jul-2020 to an unknown date for GERD, PRAVASTATIN from 06-Jul-2022 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 21-Mar-2019 to an unknown date for Hypertension, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL SANDOZ) from 08-Nov-2019 to an unknown date for Migraine and Hypertension, CHOLECALCIFEROL from 15-Jul-2020 to an unknown date for Vitamin D deficiency.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Nov-2021 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Nov-2021 at 9:19 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2022-607851 (Patient Link).
Felt woozy. Nausea. "Violent" vomiting and diarrhea.
Swelling of (L) deltoid, 8/10 pain, low grade fever (100.0).
very tired-2days; pain in left hip joint that radiated all the way down left leg and leg felt like it would give out; Blisters on 3 toes of left foot/Painful to touch and felt like they were burning; Blisters on 3 toes of left foot/Painful to touch and felt like they were burning/sore are 2 days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0158) via an unspecified route of administration, administered in arm left on 08Apr2021 14:30 (age at vaccination 83-year-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 VACCINE was administered was reported as other. Medical history included high blood pressure, type 2 diabetes, arthritis, degenerative disc disease and Spinal Stenosis. The patient had no known allergies. Concomitant medications included metformin, amlodipine besylate and lisinopril. The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: er263) via an unspecified route of administration, administered in arm left on 18Mar2021 15:15 (age at vaccination 83-year-old) as dose 1, single for COVID-19 immunization and experienced pain in left hip joint, sore arm 2 days. The patient did not receive other vaccine in four weeks. Patient had no Covid prior vaccination and was not Covid tested post vaccination. On 08Apr2021 16:00, the patient experienced very tired-2days, pain in left hip joint that radiated all the way down left leg and leg felt like it would give out, blisters on 3 toes of left foot/painful to touch and felt like they were burning/ sore are 2 days. The patient did not receive any treatment for the adverse events. The outcome of the event very tired-2days was recovered on 10Apr2021 and other events was recovering. No follow-up attempts are possible. No further information is expected.
After receiving Japanese Encephalitis vaccine, severe pain level 10. Loss of range of motion. Loss of strength in left arm. Loss of sleep due to pain in arm radiating to elbow during sleep. Pain radiates up to shoulder when carrying or lifting weight of 15 or more pounds. Followed up with Doctor at Clinic on 13 September 2016.
Two weeks post vax, pt experienced weakness, subnormal temperatures, sweating, scratchy throat, and tiredness. The pt was found to have a virus and was treated with antibiotics. Pt still experiences sweating.
Information has been received from a medical assistant concerning an approximately 5-year-old female who was with a dose of Varivax. The medical assistant reported that the patient subsequently experienced an adverse event. The medical assistant also reported that the patient's sibling developed a red, itchy rash after being vaccinated with Varivax (WAES #0607USA00676). Additional information has been requested.
persistent headache. mild headache ~7 days after vaccine. increased severity leading to two emergency room visits to check blood and have cat scan in order to rule out blood clot.
Short of breath during yard work on Sunday (11/14) next day evolved into some sinusitis like symptoms with fever. Refilled amoxicillin from local pharmacy and after a week was clear for a week. On 11/26 had what seemed to be a recurrence and was more severe (Ear ache, Sore throat, 100.6° fever, sinus pressure) Saw my PCP on 12/2 where I had a physical and was prescribed amoxicillin for 10 days and recovered. 12/17 at night I started having a cough and throughout the weekend had same symptoms come back. 12/20 Called my PCP and he directed me to Urgent Care. Got a few test done, Chest X-Ray and a rapid antigen test (negative) and a PCR (positive). Full examination. Failed to get an appointment in time for infusion treatment.
Migraine Dizziness Rapid heart rate (110-122) Disorientation Nausea/vomiting
Developed hives the day after the vaccine. Called a dermatology office, my regular physician wasn't there, so I spoke with  his colleague. Decided to send pictures of my rash instead of physically going in. Prescribed valacyclovir (antiviral), and am still taking medicine. Am still in pain because of Shingles.
Patient was found lying on the floor in front of pharmacy having passed out.  She had received the immunization minutes earlier. She was assessed for head injury or extremities. None were found. She was alert in seconds and reported no unusual discomfort aside from menstrual cramping which began earlier in day. She rested here for about 45 minutes before leaving with her boyfriend stating she was fine.  Only reason she rested so long was actually the cramps.
Rt arm swelling and fever within 24 hours of vaccine, newly diagnosed, type I diabetes mellitus, on insulin for only 1 mo. Fever persisted x 24 hours but swelling decreased. Mother gave benadryl and fever med. Doing much better 48 hours post vaccine.
Bradycardia, Syncope, diaphoresis, dizziness, pale skin
Patient states no arm pain immediately, also thought she was breathing better.  Her RA MD told her not to resume MTX for 1 week.  She took next dose of MTX on 10/7/23.  She said that day she started to get back pain under her shoulders and shoulder pain that became more severe as the day went on.  She went to the Emergency Dept on 10/8/23 and they found a blood clot in her lung.  They told her they thought it was a result of the RSC vaccine and that she should not get any further new vaccines.
DIZZY; TIRED; PRODUCT STORED AT INAPPROPRIATE STORAGE CONDITION; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced dizzy. On 27-APR-2021, the subject experienced tired. On 27-APR-2021, the subject experienced product stored at inappropriate storage condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 27-APR-2021, and tired on 28-APR-2021, and the outcome of product stored at inappropriate storage condition was not reported. This report was non-serious.
Severe muscle, bone and joint aches. Weakness and lightheaded. Severe symptoms continued for 12 hours. Moderate symptoms continued for 72 hours.  Fatigue continued for 3 weeks after injection.
keratosis; left arm swollen; blood blister; itching; redness; scab; Rash/red rash; Headache/headcahe back of head; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching) and ERYTHEMA (redness) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer (Returned 2010- 2019) and Keratosis in 2010. Previously administered products included for an unreported indication: FLU VACCINE VII (first time getting a reaction from this shot. Rash- swollen arm) since 10-Jun-2020. Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Nausea), Drug allergy (Nausea), Drug allergy (Diarrhea), Bronchiectasis and Pseudomonas aeruginosa infection NOS. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CHARCOAL, VITAMIN B12 [VITAMIN B12 NOS], AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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 HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching), ERYTHEMA (redness), SCAB (scab), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head). At the time of the report, HYPERKERATOSIS (keratosis) was resolving, PERIPHERAL SWELLING (left arm swollen), PRURITUS (itching), ERYTHEMA (redness) and SCAB (scab) outcome was unknown and BLOOD BLISTER (blood blister), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included no new information On 02-Jul-2021: Significant Follow-up appended- medical history added, allergies, and outcome
Loose stool, runs; Diarrhea; Cramps; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps). At the time of the report, DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported her bowel condition was due to eating too many nuts and it was not related to the vaccine. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up was received on -1-FEB-2021 and causality is updated by patient
After receiving a Zostavax vaccine, left arm became reddened, swollen from elbow to shoulder.  Developed low grade fever, chills, aching.  Arm was warm to touch.  On 4th day after shot redness and swelling improved.
Pt's mother-in-law called pharmacy to report that pt was 4-5 weeks pregnant at the time of immunization & had a miscarriage on 11/29/10.
Pain, redness, swelling. Tenderness to touch. Reddened area at site. Fatigue and urinary incontinence. Redness/swelling 3inch diameter/indurated/ warm to touch.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-APR-2016, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Breakthrough case admission after 3 vaccines Pfizer 5/3/21 lot# ER8736;  Pfizer 5/24/21 lot# Ew0167;  Pfizer 2/21/22 Lot# FK9894
Did not have the Lot #.  Jan4-Jan11 had no reactions.  1/12, 8am notice the right arm was itching at the inj site all day. 1/13 8am  saw a red circle around the inj site with swelling and hardness, redness and heat.  No pain no fever.
Pt was receiving 1st dose of Moderna vaccine. I noticed he seemed very tense and nervous. I had difficulty getting him to relax his arm. Seconds within giving him the shot he fell forward hitting his head on the ground. He came to within a few seconds with no recollection of what happened. I gave him some water and had him sit down. I asked if he had any previous reactions to a vaccine, he said he hasn't but he does get lgih