chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours post vax, pt experienced fever, ill feeling. 7 days later, left upper arm still very sore and tender. Diagnosis possible cellulitis. (Pt is a diabetic type II vs significant prolonged reaction to TD.) Pt started on antibiotics and returned in 24 hours with no cellulitis and less tenderness. Pt was afebrile at time of immunization.
joint pain wrist and shoulder pain; fatigue; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Allergic to sulfa drugs), Hypothyroidism, Asthma, COPD and Allergic reaction to antibiotics (allergic to cefin). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, METHOTREXATE and ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021 at 11:13 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 3 Tab. At the time of the report, ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114888, MOD-2021-114888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-MAY-2021. Patient's race and ethnicity, medical history- COPD, Asthma, Hypothyroidism  and allergies- sulfa, cefin were added. Second dose details were added. Concomitant medications- Enberel, diltiazem, albuterol, levothyroxine were added.
DVT in right leg discovered after swollen foot on 2/25/2021 via ultrasound. Clot extends from mid thigh to mid calf.  Placed on Xarelto 15 mg 2x/day until next imaging appointment on March 30, 2021. First incident of blood clot for mother.
PATIENT HAD NO ADVERSE REACTION FOR 6 DAYS. ON THE 7TH DAY, PATIENT EXPERIENCED DULL, ACHEY PAIN ESPECIALLY AT NIGHT. SHE ALSO REPORTED THE FEELING OF THE URGE TO CRACK HER KNUCKLES.  HER INJECTION SITE IS NOT SWOLLEN AND NOT WARM. SHE HAS BEEN TAKING IBUPROFEN FOR THE DISCOMFORT AND IT DOES HELP.
I went to hospital on 06/04/2021.  They x-rayed it and wrapped it.  I followed up with my rheumatologist.   She put a drain in it but it came back that night.  They diagnosed it as olecranon bursitis.  All I have on now is a compression wrap.
throat swelling; headache; Pain; little bit of chills; GI upset; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EK9231, expiry: 30Apr2021), via an unspecified route of administration on an unspecified date at 0.3 mL, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date for covid-19 immunization and experienced pain at the injection site. On an unspecified date, the patient experienced head ache, throat swelling, gastrointestinal (GI) upset, pain, and little bit of chills (don't believe to have had fever). It was clarified that the event took place after use of product. The outcome of the events was unknown.; Sender's Comments: The information in this report is limited, and does not allow a full medically meaningful assessment of the case.   Considering temporal relationship, a causal relationship between the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events including throat swelling cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from nurse practitioner referring to a 26 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications were not reported. In 1993, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) 1 dose, once for prophylaxis (dose, route of administration, lot # and expiration date were not reported). In 1999, the patient was vaccinated with VARIVAX 1 dose, once for prophylaxis (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included MERCK STERILE DILUENT. In May 2015, Measles, Mumps, Rubella and Varicella titers were measured to the patient and all titers showed that she was not immune (antibody test negative, rubella antibody negative and measles antibody negative). It was stated that the patient went to see her physician on an unreported date. On 02-JUN-2015, the patient received PROQUAD as a booster immunization. At the time of reporting, the patient's status of immunity was unknown as new titers were not drawn. The causality assessment between the events and the suspect therapies was not provided.
Patient started with a sore throat and then it progressed into a fever of 103 with coughing, congestion and other flu like symptoms.  As of today 10/7/11 he still has a fever 102 and still has flu like symptoms.  We will be seeing the doctor at 5pm today. I am concerned that the Flumist nasal spray that he received on 9/23/11 is the cause of this illness.
Narrative:  55yo male died of unknown causes found by family in his home with suspicion for drug use as cause of death. Patient had received covid vaccines on 4/7/21 & 5/7/21. Death does not appear to be related to vaccines. Pt's problem list below: PROBLEM LAST MOD PROVIDER Methamphetamine dependence (SCT 426873000) 02/27/2020 (ICD-10-CM F15.222) Sleep apnea (SCT 73430006) (ICD-10-CM G47.30) 02/25/2019 History of cocaine abuse (SCT 288791000119106) 02/25/2019 (ICD-10-CM F14.10) Chronic hepatitis C (SCT 128302006) (ICD-10-CM 02/25/2019 B18.2) Nicotine dependence (SCT 56294008) (ICD-10-CM F17.200) Hypertensive disorder (SCT 38341003) (ICD-10-CM 01/25/2019 I10.) Paranoid schizophrenia (SCT 64905009) (ICD-10-CM 01/25/2019 F20.0)
Started out had time breathing, heart fluttering that progress like someone seating on my chest, dizzy, and Massive Headache. Was sent to ED.  Had EKG, Chest x-ray, Cat scan, and blood test.
Pt seen x 3 days ago now presents with red, hot, swelling, (cellulitis) left deltoid. Treated with cephalexin 500mg x 7 day.
contracts Covid after being vaccinated; contracts Covid after being vaccinated; This is a spontaneous report from a contactable consumer (patient). A 49-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 (age at vaccination: 49 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On an unspecified date, the patient was inquiring if there are any clinical trials for someone who contracts Covid after being vaccinated. The lab tests included Covid-19 test, result: positive in 2021. The outcome of the event was unknown. Clinical Trial Information: N/A  Information on Lot/Batch number has been requested.
Patient had a first time Tonic Seizure 2 days after the new Moderna Covid vaccine for fall 2023. Patient had previously received all the other recommended Covid vaccines only they were Pfizer. This was his first Moderna Covid shot. One day after the shot he felt tired, achy, lack of appetite. Then 2 days after the shot he had a the seizure. Patient was admitted  to the hospital on the  9/21/2023. They did numerous testing, CT, MRI, heart ultrasound etc and found no other reason for this first time siezure.  They have put him on anti seizure med for 2 years.  We don?t know the outcome yet or whether he will have another seizure.
I feel overweight; I had very mild symptoms; I only had a runny nose and blowing my nose a little more then normal.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had very mild symptoms), RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.) and OVERWEIGHT (I feel overweight) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0M) for COVID-19 vaccination.     The patient's past medical history included COVID-19 PCR test positive.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (I had very mild symptoms) and RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.). On an unknown date, the patient experienced OVERWEIGHT (I feel overweight). At the time of the report, VACCINATION COMPLICATION (I had very mild symptoms), RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.) and OVERWEIGHT (I feel overweight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
muscle aches, joint aches, tingling, lump at injections site. redness from injection site to biceps. some swelling.  Bruise at injection site, redness and mild swelling. mild tenderness. lungs clear. cool compress and Tylenol.  return for swelling, wheezing, SOB.
Acute swelling of arm around injection site and down full arm for 2 days then resolved without Tx.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case contains the information of 17th patient out of 77 reported.  Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 87 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Jan2021 11:00 (Lot number: EL8982) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "when she was young , likely to schrimp that has disappeared" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; HYDROCHLOROTHIAZIDE; WARFARIN; ESTRADIOL. The following information was reported: PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling".  Additional information: After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling and after the booster dose, in about 2 weeks after pain to the right arm slowly increasing, palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks, presently pain along the chest wall like neuralgic pain, and appearance of small spots here and there in the chest and neck regions, none so acute but uncomfortable. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.   Follow-up attempts are completed. No further information is expected.
Initial unsolicited report received from an other healthcare professional on 03-Aug-2018. This case involves a six-month old male patient who was inadvertently vaccinated with an expired dose of 0.5 ml PENTACEL lot number: C5386AB expiry date: 17-Jul-2018 (frequency once) via unknown route in the left thigh on 03 Aug 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. 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.
Reaction occured, about 2 hours after shot was received , had reported back to work site.  Transported via EMT to Medical.
Minor soreness, brief.  One month later itchy rash which worsened,  got better, got worse, got better, ongoing.
Herpes zoster; Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-JUN-2014, at age 50, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
HPI:  Patient is a 45-year-old female who presents for evaluation after COVID-19 vaccine reaction.  Patient just received 1st vaccine this morning.  She was being observed in the vaccine clinic when she started to experience numbness all over her body and hives over the upper chest.  She was brought immediately to the emergency department for treatment.  Upon assessment, she is lying flat in the bed.  States she feels weird.  No difficulty swallowing, no difficulty breathing.  She is not itching.  She has no known allergies.  MEDICAL DECISION MAKING Upon arrival to the emergency department patient was immediately assessed at the bedside.  She was lying in the bed, eyes closed, appeared somnolent with answering questions.  She did have urticaria on the upper chest.  She was also tachycardic.  IV was established, she was treated with intramuscular epinephrine, IV Benadryl, famotidine, and Solu-Medrol.  Patient was observed in our emergency department for 3 hours and had complete resolution in her symptoms.  She was reassessed on multiple occasions during her emergency department stay and continued to show signs of improvement.  I do feel that she is safe for discharge home.  Recommend not getting COVID-19 vaccine in the future given her allergic reaction today.  Patient is in agreement with this plan, she was discharged home in improved condition. Medications EPINEPHrine anaphylaxis kit 0.3 mg (0.3 mg Intramuscular Given 3/26/21 0814) methylPREDNISolone sodium succinate (SOLU-Medrol) injection 125 mg (125 mg Intravenous Given 3/26/21 0818) famotidine (PEPCID) injection 20 mg (20 mg Intravenous Given 3/26/21 0818) diphenhydrAMINE (BENADRYL) injection 50 mg (50 mg Intravenous Given 3/26/21 0816) sodium chloride 0.9% bolus injection 1,000 mL (0 mL Intravenous Stopped 3/26/21 0948)   broke out in hives, heart started racing, went to ED where they treated her.   Patient got home a couple hours ago and back of neck is breaking out again and says throat feels funny.
Nausea, diarrhea, chills, fever, headache, extreme weakness, ringing in ears for 24 hours, lower back pain, mild weakness for a couple days after.
PATIENT RETURNED TO THE PHARMACY WITH REDNESS ADJACENT TO INJECTION SITE; PATIENT ALSO STATED THE RASH WAS WARM TO THE TOUCH
Low back pain to the point of temporary paralysis for 5 hours  Abdominal pain and insomnia one day after second dose After first dose severe menstrual flow
Severe joint pain started out in left hip and right shoulder, over 3-4 days moved to all joints with surrounding muscle pain and weakness. especially in hands. Had difficulty with fine motor skills such as writing, tying shoes and driving. Had to take ibuprofen continuously to function. Symptoms started to ease up by tuesday oct 18th. There is still some residual muscle pain around knee joints and wrists. Also there was a fine red rash across face neck and chest.
Patient received Moderna initial vaccine instead of the expected Moderna Bivalent booster shot. Patient reported feeling tired and weak the next day but nothing out of the ordinary for a typical vaccine reaction.
Started with fussiness and fever, then it developed into seizures, went to Emergency Department on 2/19/14.
Pt. returned to clinic with swollen right side of lip. NO respiratory distress. Sent to urgent care for higher level of care.
bruise on the back of their left and right hands; titanium plate in their skull became inflamed; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included Brain operation (Titanium plate insertion in the skull.).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed). At the time of the report, CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax to the front of rt arm, soreness, redness around area & deep aching pain in muscles;pt states felt like someone was hitting the arm w/their fist;
This spontaneous report was received from a pharmacist and a field representative refers to a female patient of approximately 81 years of age. There was no relevant medical history of the patient reported. The patient had a history of codeine allergy. It was reported that the patient had never experienced chicken pox. On 06-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # K003596, expiration date: 12-MAR-2014) (strength, dose number and site of administration were not reported) subcutaneous. Other suspect therapies included a high dose influenza virus vaccine (unspecified) (reported as an unspecified high dose flu shot) administered on the same date (strength, dose number, route, site of administration, lot number and expiration dates were not reported). Concomitant therapies included unspecified proton pump inhibitors (PPIs). The patient called the pharmacist on 22-SEP-2014, and reported that on an unkonwn date in September 2014 (reported as within the last few days) she patient experienced itchy bumps on her legs, upper thighs, arms, knees and her waistline and it is one sided. The pharmacist advised the patient to treat with BENADRYL and to follow up with her primary care physician. There were no lab diagnostic studies performed. The patient sought medical attention by calling the pharmacist. There was no product quality complaint (PQC) involved. The outcome of itchy bumps on her leg, upper thighs, arms, knees and waistline and it is one sided was reported as not recovered at the time of the report. The causality of the events was not provided. Additional information has been requested.
Developed infection. Cellulitis. (Also Diabetic). Increased blood glucose. Missed 1 week work w/blood glucose probs (395 mg/DL). Given cephalexin 500 3x/day x 1 wk.